{ "schema": "uplifting.world/list/v1", "licence": { "name": "CC BY 4.0", "url": "https://creativecommons.org/licenses/by/4.0/", "attribution": "Uplifting World — Weight-loss medicines", "terms": "Reuse freely, including commercially, with attribution and a link to the source page." }, "theme": { "slug": "weight-loss-drugs", "status": "live", "name": "Weight-loss medicines", "standfirst": "What is approved, where, and what the trials actually showed — plus an honest account of what is sold online with no evidence behind it at all.", "url": "https://uplifting.world/en/weight-loss-drugs", "locale": "en", "cadence_days": 14, "last_verified_at": "2026-08-20T00:00:00+00:00", "next_review_at": "2026-09-03T00:00:00+00:00", "generated_at": "2026-08-21T11:24:43+00:00" }, "counts": { "entities": 33, "retired": 6, "core_cells": { "total": 198, "absent": 79, "published": 119, "percent": 40 }, "changes": 412 }, "fields": [ { "key": "brand", "label": "Brand", "type": "text", "unit": null, "decimals": 0, "is_core": false, "help": null }, { "key": "drug_class", "label": "Class", "type": "text", "unit": null, "decimals": 0, "is_core": false, "help": null }, { "key": "route", "label": "Route", "type": "text", "unit": null, "decimals": 0, "is_core": false, "help": null }, { "key": "dose", "label": "Dose", "type": "text", "unit": null, "decimals": 0, "is_core": false, "help": null }, { "key": "weight_change", "label": "Weight change", "type": "number", "unit": "%", "decimals": 1, "is_core": true, "help": "Mean body-weight change on the medicine in its own pivotal trial. Not comparable across trials without the placebo arm beside it." }, { "key": "placebo_change", "label": "Placebo arm", "type": "number", "unit": "%", "decimals": 1, "is_core": true, "help": null }, { "key": "placebo_adjusted", "label": "Placebo-adjusted", "type": "number", "unit": "pp", "decimals": 1, "is_core": true, "help": "The drug arm minus its own placebo arm, in percentage points. It is the only figure on this page that can be put on one axis, and even then the trials differ." }, { "key": "trial", "label": "Pivotal trial", "type": "text", "unit": null, "decimals": 0, "is_core": true, "help": null }, { "key": "trial_n", "label": "Participants", "type": "number", "unit": null, "decimals": 0, "is_core": true, "help": null }, { "key": "trial_weeks", "label": "Duration", "type": "number", "unit": "weeks", "decimals": 0, "is_core": true, "help": null }, { "key": "discontinuation", "label": "Stopped for side effects", "type": "text", "unit": null, "decimals": 0, "is_core": false, "help": null }, { "key": "human_rct", "label": "Randomised human evidence", "type": "text", "unit": null, "decimals": 0, "is_core": false, "help": "The result of a ClinicalTrials.gov and PubMed search, not an assumption. \"None\" is a search result with a date on it." } ], "agencies": { "fda": { "name": "FDA", "jurisdiction": "United States", "full": "Food and Drug Administration", "lang": "en" }, "ema": { "name": "EMA", "jurisdiction": "European Union", "full": "European Medicines Agency", "lang": "en" }, "mhra": { "name": "MHRA", "jurisdiction": "United Kingdom", "full": "Medicines and Healthcare products Regulatory Agency", "lang": "en" }, "anvisa": { "name": "ANVISA", "jurisdiction": "Brazil", "full": "Agência Nacional de Vigilância Sanitária", "lang": "pt" }, "pmda": { "name": "PMDA", "jurisdiction": "Japan", "full": "Pharmaceuticals and Medical Devices Agency", "lang": "en" }, "nmpa": { "name": "NMPA", "jurisdiction": "China", "full": "National Medical Products Administration", "lang": "en" }, "hc": { "name": "Canada", "jurisdiction": "Canada", "full": "Health Canada", "lang": "en" }, "tga": { "name": "TGA", "jurisdiction": "Australia", "full": "Therapeutic Goods Administration", "lang": "en" } }, "entities": [ { "slug": "semaglutide-24", "name": "Semaglutide 2.4 mg", "maker": "Novo Nordisk", "country": null, "region": null, "form": "Injection", "status": "approved", "evidence": "confirmed", "subtitle": "The only weight-loss medicine with proven cardiovascular outcome benefit · First generic anywhere arrived in Canada through an administrative accident", "note": "Outcomes — SELECT (N=17,604, mean 40 months) showed a real cardiovascular benefit in people with established heart disease and no diabetes: major adverse cardiac events 6.5% vs 8.0%, HR 0.80. This is the strongest outcome evidence for any medicine on this page.\n\nBoxed warning — Thyroid C-cell tumours (rodent finding). Contraindicated with a personal or family history of medullary thyroid carcinoma or MEN 2.\n\nHarms — Nausea 44%, diarrhoea 30%, vomiting 24%, constipation 24%. Serious: pancreatitis, gallbladder disease, acute kidney injury, pulmonary aspiration under anaesthesia.\n\nGenerics — First generics for weight management have arrived, but not in the US. Health Canada authorised Apotex's Sevmia on 29 Jun 2026 — the first generic semaglutide indicated for chronic weight management, though other generic semaglutide products were already listed in Canada. Trade reporting attributes the early entry to a lapsed patent maintenance fee; Health Canada does not say so. Brazil approved locally-made generics (EMS, Germed) on 17 Aug 2026.\n\nPrice — US list $1,349.02 per 28-day package; manufacturer cash-pay $299/month. Covered under the Medicare GLP-1 Bridge from 1 Jul 2026 at roughly $50 to the beneficiary. No verifiable EU or Brazilian list price exists in a primary source.\n\nSupply — Shortage resolved 21 Feb 2025.", "unveiled_on": "2021-06-04", "last_verified_at": "2026-08-21T08:38:32+00:00", "values": { "brand": { "absent": false, "value": "Wegovy", "unit": null, "confidence": "confirmed", "qualifier": null, "observed_on": null, "verified_at": "2026-08-21T08:38:32+00:00", "citation": { "title": "FDA — Wegovy label, rev. 03/2026", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/215256s029lbl.pdf", "publisher": "FDA", "kind": "regulator", "primary": true, "published_on": "2026-03-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "drug_class": { "absent": false, "value": "GLP-1 receptor agonist", "unit": null, "confidence": "confirmed", "qualifier": null, "observed_on": null, "verified_at": "2026-08-21T08:38:32+00:00", "citation": { "title": "FDA — Wegovy label, rev. 03/2026", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/215256s029lbl.pdf", "publisher": "FDA", "kind": "regulator", "primary": true, "published_on": "2026-03-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "route": { "absent": false, "value": "Injection, weekly", "unit": null, "confidence": "confirmed", "qualifier": null, "observed_on": null, "verified_at": "2026-08-21T08:38:32+00:00", "citation": { "title": "FDA — Wegovy label, rev. 03/2026", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/215256s029lbl.pdf", "publisher": "FDA", "kind": "regulator", "primary": true, "published_on": "2026-03-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "dose": { "absent": false, "value": "2.4 mg weekly after a 16-week escalation", "unit": null, "confidence": "confirmed", "qualifier": null, "observed_on": null, "verified_at": "2026-08-21T08:38:32+00:00", "citation": { "title": "FDA — Wegovy label, rev. 03/2026", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/215256s029lbl.pdf", "publisher": "FDA", "kind": "regulator", "primary": true, "published_on": "2026-03-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "weight_change": { "absent": false, "value": -14.9, "unit": "%", "confidence": "confirmed", "qualifier": "treatment policy · NEJM 2021;384:989", "observed_on": null, "verified_at": "2026-08-21T08:38:32+00:00", "citation": { "title": "SELECT trial summary, NEJM 2023;389:2221", "url": "https://www.acc.org/latest-in-cardiology/clinical-trials/2023/11/09/15/04/select", "publisher": "acc.org", "kind": "journal", "primary": true, "published_on": "2023-11-11", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "placebo_change": { "absent": false, "value": -2.4, "unit": "%", "confidence": "confirmed", "qualifier": "treatment policy · NEJM 2021;384:989", "observed_on": null, "verified_at": "2026-08-21T08:38:32+00:00", "citation": { "title": "SELECT trial summary, NEJM 2023;389:2221", "url": "https://www.acc.org/latest-in-cardiology/clinical-trials/2023/11/09/15/04/select", "publisher": "acc.org", "kind": "journal", "primary": true, "published_on": "2023-11-11", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "placebo_adjusted": { "absent": false, "value": -12.5, "unit": "pp", "confidence": "confirmed", "qualifier": "treatment policy · NEJM 2021;384:989", "observed_on": null, "verified_at": "2026-08-21T08:38:32+00:00", "citation": { "title": "SELECT trial summary, NEJM 2023;389:2221", "url": "https://www.acc.org/latest-in-cardiology/clinical-trials/2023/11/09/15/04/select", "publisher": "acc.org", "kind": "journal", "primary": true, "published_on": "2023-11-11", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "trial": { "absent": false, "value": "STEP 1", "unit": null, "confidence": "confirmed", "qualifier": "treatment policy · NEJM 2021;384:989", "observed_on": null, "verified_at": "2026-08-21T08:38:32+00:00", "citation": { "title": "SELECT trial summary, NEJM 2023;389:2221", "url": "https://www.acc.org/latest-in-cardiology/clinical-trials/2023/11/09/15/04/select", "publisher": "acc.org", "kind": "journal", "primary": true, "published_on": "2023-11-11", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "trial_n": { "absent": false, "value": 1961, "unit": null, "confidence": "confirmed", "qualifier": null, "observed_on": null, "verified_at": "2026-08-21T08:38:32+00:00", "citation": { "title": "SELECT trial summary, NEJM 2023;389:2221", "url": "https://www.acc.org/latest-in-cardiology/clinical-trials/2023/11/09/15/04/select", "publisher": "acc.org", "kind": "journal", "primary": true, "published_on": "2023-11-11", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "trial_weeks": { "absent": false, "value": 68, "unit": "weeks", "confidence": "confirmed", "qualifier": null, "observed_on": null, "verified_at": "2026-08-21T08:38:32+00:00", "citation": { "title": "SELECT trial summary, NEJM 2023;389:2221", "url": "https://www.acc.org/latest-in-cardiology/clinical-trials/2023/11/09/15/04/select", "publisher": "acc.org", "kind": "journal", "primary": true, "published_on": "2023-11-11", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "discontinuation": { "absent": false, "value": "6.8% vs 3.2% placebo", "unit": null, "confidence": "confirmed", "qualifier": null, "observed_on": null, "verified_at": "2026-08-21T08:38:32+00:00", "citation": { "title": "FDA — Wegovy label, rev. 03/2026", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/215256s029lbl.pdf", "publisher": "FDA", "kind": "regulator", "primary": true, "published_on": "2026-03-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } } }, "approvals": [ { "agency": "fda", "state": "approved", "decided_on": "2021-06-04", "date_precision": "day", "indication_official": "NDA 215256. Four indications on the 03/2026 label, including cardiovascular risk reduction (Mar 2024) and non-cirrhotic MASH with F2–F3 fibrosis under accelerated approval (Aug 2025).", "note": null, "confidence": "confirmed", "verified_at": "2026-08-21T08:38:32+00:00", "citation": { "title": "FDA — Wegovy label, rev. 03/2026", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/215256s029lbl.pdf", "publisher": "FDA", "kind": "regulator", "primary": true, "published_on": "2026-03-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "agency": "ema", "state": "approved", "decided_on": "2022-01-06", "date_precision": "day", "indication_official": "BMI ≥30, or ≥27 with a weight-related comorbidity. Adolescents from 12 years.", "note": null, "confidence": "confirmed", "verified_at": "2026-08-21T08:38:32+00:00", "citation": { "title": "EMA — Wegovy EPAR", "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/wegovy", "publisher": "EMA", "kind": "regulator", "primary": true, "published_on": "2026-08-20", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "agency": "mhra", "state": "approved", "decided_on": "2023-11-01", "date_precision": "month", "indication_official": "NICE restricts NHS use to tier 3/4 specialist services, maximum two years.", "note": null, "confidence": "claim", "verified_at": "2026-08-21T08:38:32+00:00", "citation": null }, { "agency": "anvisa", "state": "approved", "decided_on": "2023-01-01", "date_precision": "month", "indication_official": "Month-level date only; ANVISA does not publish an accessible day-level record.", "note": null, "confidence": "claim", "verified_at": "2026-08-21T08:38:32+00:00", "citation": null }, { "agency": "pmda", "state": "approved", "decided_on": "2023-03-10", "date_precision": "day", "indication_official": "Narrower than the West: requires BMI ≥27 with two or more obesity-related disorders, or BMI ≥35. Sources give the decision date variously as 27 Mar and 10 Apr 2023.", "note": null, "confidence": "claim", "verified_at": "2026-08-21T08:38:32+00:00", "citation": null }, { "agency": "nmpa", "state": "approved", "decided_on": "2024-06-01", "date_precision": "month", "indication_official": "Month-level date only.", "note": null, "confidence": "claim", "verified_at": "2026-08-21T08:38:32+00:00", "citation": null }, { "agency": "hc", "state": "approved", "decided_on": "2021-11-25", "date_precision": "day", "indication_official": "BMI ≥30, or ≥27 with one comorbidity.", "note": null, "confidence": "confirmed", "verified_at": "2026-08-21T08:38:32+00:00", "citation": { "title": "Health Canada — first generic semaglutide approved", "url": "https://www.canada.ca/en/health-canada/news/2026/06/canada-approves-first-generic-semaglutide-for-weight-loss.html", "publisher": "Health Canada", "kind": "regulator", "primary": true, "published_on": "2026-06-29", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "agency": "tga", "state": "approved", "decided_on": "2024-01-01", "date_precision": "month", "indication_official": "Registered; specific decision date not retrievable. Not PBS-subsidised.", "note": null, "confidence": "claim", "verified_at": "2026-08-21T08:38:32+00:00", "citation": null } ] }, { "slug": "semaglutide-72", "name": "Semaglutide 7.2 mg", "maker": "Novo Nordisk", "country": null, "region": null, "form": "Injection", "status": "approved", "evidence": "confirmed", "subtitle": "Almost every press account quotes −20.7% without the comparison arm; the registry has had it all along", "note": "Outcomes — None specific to this dose.\n\nBoxed warning — Thyroid C-cell tumours, as for 2.4 mg.\n\nHarms — Same profile as 2.4 mg; dose-specific incidence not published.\n\nGenerics — None.\n\nPrice — US manufacturer cash-pay $399/month for new patients.\n\nSupply — No shortage reported.", "unveiled_on": "2026-03-19", "last_verified_at": "2026-08-21T08:38:32+00:00", "values": { "brand": { "absent": false, "value": "Wegovy HD", "unit": null, "confidence": "confirmed", "qualifier": null, "observed_on": null, "verified_at": "2026-08-21T08:38:32+00:00", "citation": { "title": "ClinicalTrials.gov NCT05646706 — posted results including the placebo arm", "url": "https://clinicaltrials.gov/study/NCT05646706", "publisher": "ClinicalTrials.gov NCT05646706", "kind": "journal", "primary": true, "published_on": "2026-08-20", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "drug_class": { "absent": false, "value": "GLP-1 receptor agonist", "unit": null, "confidence": "confirmed", "qualifier": null, "observed_on": null, "verified_at": "2026-08-21T08:38:32+00:00", "citation": { "title": "ClinicalTrials.gov NCT05646706 — posted results including the placebo arm", "url": "https://clinicaltrials.gov/study/NCT05646706", "publisher": "ClinicalTrials.gov NCT05646706", "kind": "journal", "primary": true, "published_on": "2026-08-20", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "route": { "absent": false, "value": "Injection, weekly", "unit": null, "confidence": "confirmed", "qualifier": null, "observed_on": null, "verified_at": "2026-08-21T08:38:32+00:00", "citation": { "title": "ClinicalTrials.gov NCT05646706 — posted results including the placebo arm", "url": "https://clinicaltrials.gov/study/NCT05646706", "publisher": "ClinicalTrials.gov NCT05646706", "kind": "journal", "primary": true, "published_on": "2026-08-20", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "dose": { "absent": false, "value": "7.2 mg weekly, escalated from 2.4 mg", "unit": null, "confidence": "confirmed", "qualifier": null, "observed_on": null, "verified_at": "2026-08-21T08:38:32+00:00", "citation": { "title": "ClinicalTrials.gov NCT05646706 — posted results including the placebo arm", "url": "https://clinicaltrials.gov/study/NCT05646706", "publisher": "ClinicalTrials.gov NCT05646706", "kind": "journal", "primary": true, "published_on": "2026-08-20", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "weight_change": { "absent": false, "value": -19.5, "unit": "%", "confidence": "confirmed", "qualifier": "registry-posted results, 7.2 mg · NCT05646706; Lancet Diab Endocrinol 2025 (PMID 40961952)", "observed_on": null, "verified_at": "2026-08-21T08:38:32+00:00", "citation": { "title": "ClinicalTrials.gov NCT05646706 — posted results including the placebo arm", "url": "https://clinicaltrials.gov/study/NCT05646706", "publisher": "ClinicalTrials.gov NCT05646706", "kind": "journal", "primary": true, "published_on": "2026-08-20", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "placebo_change": { "absent": false, "value": -3.8, "unit": "%", "confidence": "confirmed", "qualifier": "registry-posted results, 7.2 mg · NCT05646706; Lancet Diab Endocrinol 2025 (PMID 40961952)", "observed_on": null, "verified_at": "2026-08-21T08:38:32+00:00", "citation": { "title": "ClinicalTrials.gov NCT05646706 — posted results including the placebo arm", "url": "https://clinicaltrials.gov/study/NCT05646706", "publisher": "ClinicalTrials.gov NCT05646706", "kind": "journal", "primary": true, "published_on": "2026-08-20", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "placebo_adjusted": { "absent": false, "value": -15.7, "unit": "pp", "confidence": "confirmed", "qualifier": "registry-posted results, 7.2 mg · NCT05646706; Lancet Diab Endocrinol 2025 (PMID 40961952)", "observed_on": null, "verified_at": "2026-08-21T08:38:32+00:00", "citation": { "title": "ClinicalTrials.gov NCT05646706 — posted results including the placebo arm", "url": "https://clinicaltrials.gov/study/NCT05646706", "publisher": "ClinicalTrials.gov NCT05646706", "kind": "journal", "primary": true, "published_on": "2026-08-20", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "trial": { "absent": false, "value": "STEP UP", "unit": null, "confidence": "confirmed", "qualifier": "registry-posted results, 7.2 mg · NCT05646706; Lancet Diab Endocrinol 2025 (PMID 40961952)", "observed_on": null, "verified_at": "2026-08-21T08:38:32+00:00", "citation": { "title": "ClinicalTrials.gov NCT05646706 — posted results including the placebo arm", "url": "https://clinicaltrials.gov/study/NCT05646706", "publisher": "ClinicalTrials.gov NCT05646706", "kind": "journal", "primary": true, "published_on": "2026-08-20", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "trial_n": { "absent": true, "reason": "The trial's sample size has not been disclosed.", "confidence": "absent", "verified_at": "2026-08-21T08:38:32+00:00" }, "trial_weeks": { "absent": false, "value": 72, "unit": "weeks", "confidence": "confirmed", "qualifier": null, "observed_on": null, "verified_at": "2026-08-21T08:38:32+00:00", "citation": { "title": "ClinicalTrials.gov NCT05646706 — posted results including the placebo arm", "url": "https://clinicaltrials.gov/study/NCT05646706", "publisher": "ClinicalTrials.gov NCT05646706", "kind": "journal", "primary": true, "published_on": "2026-08-20", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "discontinuation": { "absent": true, "reason": "Not published for this dose", "confidence": "absent", "verified_at": "2026-08-21T08:38:32+00:00" } }, "approvals": [ { "agency": "fda", "state": "approved", "decided_on": "2026-03-19", "date_precision": "day", "indication_official": "Weight reduction only — this dose does not carry the cardiovascular indication.", "note": null, "confidence": "claim", "verified_at": "2026-08-21T08:38:32+00:00", "citation": null }, { "agency": "ema", "state": "approved", "decided_on": "2026-07-15", "date_precision": "day", "indication_official": "European Commission approval of the single-dose pen; CHMP positive opinion 12 Dec 2025.", "note": null, "confidence": "claim", "verified_at": "2026-08-21T08:38:32+00:00", "citation": null }, { "agency": "mhra", "state": "approved", "decided_on": "2026-01-01", "date_precision": "month", "indication_official": "BMI ≥30. Explicitly not licensed for cardiovascular risk reduction. NICE appraisal pending.", "note": null, "confidence": "claim", "verified_at": "2026-08-21T08:38:32+00:00", "citation": null }, { "agency": "anvisa", "state": "none", "decided_on": null, "date_precision": "day", "indication_official": null, "note": "No approval found.", "confidence": "claim", "verified_at": "2026-08-21T08:38:32+00:00", "citation": null }, { "agency": "pmda", "state": "none", "decided_on": null, "date_precision": "day", "indication_official": null, "note": "No approval found.", "confidence": "claim", "verified_at": "2026-08-21T08:38:32+00:00", "citation": null }, { "agency": "nmpa", "state": "none", "decided_on": null, "date_precision": "day", "indication_official": null, "note": "No approval found.", "confidence": "claim", "verified_at": "2026-08-21T08:38:32+00:00", "citation": null }, { "agency": "hc", "state": "none", "decided_on": null, "date_precision": "day", "indication_official": null, "note": "No approval found.", "confidence": "claim", "verified_at": "2026-08-21T08:38:32+00:00", "citation": null }, { "agency": "tga", "state": "none", "decided_on": null, "date_precision": "day", "indication_official": null, "note": "No approval found.", "confidence": "claim", "verified_at": "2026-08-21T08:38:32+00:00", "citation": null } ] }, { "slug": "oral-semaglutide", "name": "Semaglutide 25 mg, oral", "maker": "Novo Nordisk", "country": null, "region": null, "form": "Tablet", "status": "approved", "evidence": "confirmed", "subtitle": "Removes the “there is no pill” argument that drove much grey-market buying", "note": "Outcomes — The cardiovascular labelling rests on SOUL, which studied oral semaglutide 14 mg — the diabetes product, not this 25 mg obesity product. No dedicated outcome trial of the 25 mg dose exists.\n\nBoxed warning — Thyroid C-cell tumours.\n\nHarms — Gastrointestinal adverse events in 74% vs 42% placebo.\n\nGenerics — None.\n\nPrice — US manufacturer cash-pay $149/month — the cheapest branded GLP-1 in the United States.\n\nSupply — No shortage reported.", "unveiled_on": "2025-12-22", "last_verified_at": "2026-08-21T08:38:32+00:00", "values": { "brand": { "absent": false, "value": "Wegovy tablets", "unit": null, "confidence": "confirmed", "qualifier": null, "observed_on": null, "verified_at": "2026-08-21T08:38:32+00:00", "citation": { "title": "FDA — Wegovy tablets label, rev. 12/2025", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/218316Orig1s000lbl.pdf", "publisher": "FDA", "kind": "regulator", "primary": true, "published_on": "2025-12-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "drug_class": { "absent": false, "value": "GLP-1 receptor agonist", "unit": null, "confidence": "confirmed", "qualifier": null, "observed_on": null, "verified_at": "2026-08-21T08:38:32+00:00", "citation": { "title": "FDA — Wegovy tablets label, rev. 12/2025", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/218316Orig1s000lbl.pdf", "publisher": "FDA", "kind": "regulator", "primary": true, "published_on": "2025-12-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "route": { "absent": false, "value": "Tablet, daily", "unit": null, "confidence": "confirmed", "qualifier": null, "observed_on": null, "verified_at": "2026-08-21T08:38:32+00:00", "citation": { "title": "FDA — Wegovy tablets label, rev. 12/2025", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/218316Orig1s000lbl.pdf", "publisher": "FDA", "kind": "regulator", "primary": true, "published_on": "2025-12-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "dose": { "absent": false, "value": "25 mg daily, on an empty stomach with ≤120 ml water, then nothing for 30 minutes", "unit": null, "confidence": "confirmed", "qualifier": null, "observed_on": null, "verified_at": "2026-08-21T08:38:32+00:00", "citation": { "title": "FDA — Wegovy tablets label, rev. 12/2025", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/218316Orig1s000lbl.pdf", "publisher": "FDA", "kind": "regulator", "primary": true, "published_on": "2025-12-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "weight_change": { "absent": false, "value": -14, "unit": "%", "confidence": "confirmed", "qualifier": "treatment policy · NEJM 2025;393:1077", "observed_on": null, "verified_at": "2026-08-21T08:38:32+00:00", "citation": { "title": "OASIS 4 — PubMed 40934115", "url": "https://pubmed.ncbi.nlm.nih.gov/40934115/", "publisher": "OASIS 4", "kind": "journal", "primary": true, "published_on": "2025-09-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "placebo_change": { "absent": false, "value": -2, "unit": "%", "confidence": "confirmed", "qualifier": "treatment policy · NEJM 2025;393:1077", "observed_on": null, "verified_at": "2026-08-21T08:38:32+00:00", "citation": { "title": "OASIS 4 — PubMed 40934115", "url": "https://pubmed.ncbi.nlm.nih.gov/40934115/", "publisher": "OASIS 4", "kind": "journal", "primary": true, "published_on": "2025-09-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "placebo_adjusted": { "absent": false, "value": -12, "unit": "pp", "confidence": "confirmed", "qualifier": "treatment policy · NEJM 2025;393:1077", "observed_on": null, "verified_at": "2026-08-21T08:38:32+00:00", "citation": { "title": "OASIS 4 — PubMed 40934115", "url": "https://pubmed.ncbi.nlm.nih.gov/40934115/", "publisher": "OASIS 4", "kind": "journal", "primary": true, "published_on": "2025-09-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "trial": { "absent": false, "value": "OASIS 4", "unit": null, "confidence": "confirmed", "qualifier": "treatment policy · NEJM 2025;393:1077", "observed_on": null, "verified_at": "2026-08-21T08:38:32+00:00", "citation": { "title": "OASIS 4 — PubMed 40934115", "url": "https://pubmed.ncbi.nlm.nih.gov/40934115/", "publisher": "OASIS 4", "kind": "journal", "primary": true, "published_on": "2025-09-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "trial_n": { "absent": false, "value": 307, "unit": null, "confidence": "confirmed", "qualifier": null, "observed_on": null, "verified_at": "2026-08-21T08:38:32+00:00", "citation": { "title": "OASIS 4 — PubMed 40934115", "url": "https://pubmed.ncbi.nlm.nih.gov/40934115/", "publisher": "OASIS 4", "kind": "journal", "primary": true, "published_on": "2025-09-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "trial_weeks": { "absent": false, "value": 64, "unit": "weeks", "confidence": "confirmed", "qualifier": null, "observed_on": null, "verified_at": "2026-08-21T08:38:32+00:00", "citation": { "title": "OASIS 4 — PubMed 40934115", "url": "https://pubmed.ncbi.nlm.nih.gov/40934115/", "publisher": "OASIS 4", "kind": "journal", "primary": true, "published_on": "2025-09-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "discontinuation": { "absent": false, "value": "7% vs 6% placebo", "unit": null, "confidence": "confirmed", "qualifier": null, "observed_on": null, "verified_at": "2026-08-21T08:38:32+00:00", "citation": { "title": "FDA — Wegovy tablets label, rev. 12/2025", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/218316Orig1s000lbl.pdf", "publisher": "FDA", "kind": "regulator", "primary": true, "published_on": "2025-12-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } } }, "approvals": [ { "agency": "fda", "state": "approved", "decided_on": "2025-12-22", "date_precision": "day", "indication_official": "NDA 218316. Carries both weight reduction and cardiovascular risk reduction indications.", "note": null, "confidence": "confirmed", "verified_at": "2026-08-21T08:38:32+00:00", "citation": { "title": "FDA — Wegovy tablets label, rev. 12/2025", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/218316Orig1s000lbl.pdf", "publisher": "FDA", "kind": "regulator", "primary": true, "published_on": "2025-12-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "agency": "ema", "state": "approved", "decided_on": "2026-07-15", "date_precision": "day", "indication_official": "First oral GLP-1 for weight management in the EU.", "note": null, "confidence": "claim", "verified_at": "2026-08-21T08:38:32+00:00", "citation": null }, { "agency": "mhra", "state": "approved", "decided_on": "2026-06-11", "date_precision": "day", "indication_official": "First weight-loss tablet licensed in the UK.", "note": null, "confidence": "claim", "verified_at": "2026-08-21T08:38:32+00:00", "citation": { "title": "Pharmaceutical Journal — MHRA approves oral semaglutide", "url": "https://pharmaceutical-journal.com/article/news/mhra-approves-semaglutide-oral-tablets-for-weight-loss", "publisher": "Pharmaceutical Journal", "kind": "trade", "primary": false, "published_on": "2026-06-11", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "agency": "anvisa", "state": "review", "decided_on": null, "date_precision": "day", "indication_official": null, "note": "Submitted and under review.", "confidence": "claim", "verified_at": "2026-08-21T08:38:32+00:00", "citation": null }, { "agency": "pmda", "state": "none", "decided_on": null, "date_precision": "day", "indication_official": null, "note": "No approval found.", "confidence": "claim", "verified_at": "2026-08-21T08:38:32+00:00", "citation": null }, { "agency": "nmpa", "state": "none", "decided_on": null, "date_precision": "day", "indication_official": null, "note": "No approval found.", "confidence": "claim", "verified_at": "2026-08-21T08:38:32+00:00", "citation": null }, { "agency": "hc", "state": "none", "decided_on": null, "date_precision": "day", "indication_official": null, "note": "No approval found.", "confidence": "claim", "verified_at": "2026-08-21T08:38:32+00:00", "citation": null }, { "agency": "tga", "state": "none", "decided_on": null, "date_precision": "day", "indication_official": null, "note": "No approval found.", "confidence": "claim", "verified_at": "2026-08-21T08:38:32+00:00", "citation": null } ] }, { "slug": "tirzepatide", "name": "Tirzepatide", "maker": "Eli Lilly", "country": null, "region": null, "form": "Injection", "status": "approved", "evidence": "confirmed", "subtitle": "Largest weight effect of any approved medicine · Its cardiovascular evidence is weaker than semaglutide's, which is the reverse of the popular impression", "note": "Outcomes — SURPASS-CVOT compared tirzepatide against active dulaglutide, not placebo: non-inferior, superiority not met. SURMOUNT-MMO, the obesity outcomes trial, is still running with no results. Anyone citing SURMOUNT-MMO results today is citing nothing.\n\nBoxed warning — Thyroid C-cell tumours (rat finding).\n\nHarms — Nausea 28%, diarrhoea 23%, constipation 17%, vomiting 13%, hair loss 5%.\n\nGenerics — None anywhere. Composition-of-matter patents run into the mid-2030s.\n\nPrice — US self-pay $299–$449/month depending on dose. Only the Zepbound KwikPen is on the Medicare covered list.\n\nSupply — Shortage resolved 19 Dec 2024.", "unveiled_on": "2023-11-08", "last_verified_at": "2026-08-21T08:38:32+00:00", "values": { "brand": { "absent": false, "value": "Zepbound (US) / Mounjaro", "unit": null, "confidence": "confirmed", "qualifier": null, "observed_on": null, "verified_at": "2026-08-21T08:38:32+00:00", "citation": { "title": "FDA — Zepbound label, rev. 01/2026", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/217806s037lbl.pdf", "publisher": "FDA", "kind": "regulator", "primary": true, "published_on": "2026-01-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "drug_class": { "absent": false, "value": "Dual GIP + GLP-1 receptor agonist", "unit": null, "confidence": "confirmed", "qualifier": null, "observed_on": null, "verified_at": "2026-08-21T08:38:32+00:00", "citation": { "title": "FDA — Zepbound label, rev. 01/2026", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/217806s037lbl.pdf", "publisher": "FDA", "kind": "regulator", "primary": true, "published_on": "2026-01-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "route": { "absent": false, "value": "Injection, weekly", "unit": null, "confidence": "confirmed", "qualifier": null, "observed_on": null, "verified_at": "2026-08-21T08:38:32+00:00", "citation": { "title": "FDA — Zepbound label, rev. 01/2026", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/217806s037lbl.pdf", "publisher": "FDA", "kind": "regulator", "primary": true, "published_on": "2026-01-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "dose": { "absent": false, "value": "5, 10 or 15 mg weekly", "unit": null, "confidence": "confirmed", "qualifier": null, "observed_on": null, "verified_at": "2026-08-21T08:38:32+00:00", "citation": { "title": "FDA — Zepbound label, rev. 01/2026", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/217806s037lbl.pdf", "publisher": "FDA", "kind": "regulator", "primary": true, "published_on": "2026-01-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "weight_change": { "absent": false, "value": -20.9, "unit": "%", "confidence": "confirmed", "qualifier": "treatment regimen, 15 mg · NEJM 2022;387:205", "observed_on": null, "verified_at": "2026-08-21T08:38:32+00:00", "citation": { "title": "SURMOUNT-1 — PubMed 35658024", "url": "https://pubmed.ncbi.nlm.nih.gov/35658024/", "publisher": "SURMOUNT-1", "kind": "journal", "primary": true, "published_on": "2022-06-04", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "placebo_change": { "absent": false, "value": -3.1, "unit": "%", "confidence": "confirmed", "qualifier": "treatment regimen, 15 mg · NEJM 2022;387:205", "observed_on": null, "verified_at": "2026-08-21T08:38:32+00:00", "citation": { "title": "SURMOUNT-1 — PubMed 35658024", "url": "https://pubmed.ncbi.nlm.nih.gov/35658024/", "publisher": "SURMOUNT-1", "kind": "journal", "primary": true, "published_on": "2022-06-04", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "placebo_adjusted": { "absent": false, "value": -17.8, "unit": "pp", "confidence": "confirmed", "qualifier": "treatment regimen, 15 mg · NEJM 2022;387:205", "observed_on": null, "verified_at": "2026-08-21T08:38:32+00:00", "citation": { "title": "SURMOUNT-1 — PubMed 35658024", "url": "https://pubmed.ncbi.nlm.nih.gov/35658024/", "publisher": "SURMOUNT-1", "kind": "journal", "primary": true, "published_on": "2022-06-04", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "trial": { "absent": false, "value": "SURMOUNT-1", "unit": null, "confidence": "confirmed", "qualifier": "treatment regimen, 15 mg · NEJM 2022;387:205", "observed_on": null, "verified_at": "2026-08-21T08:38:32+00:00", "citation": { "title": "SURMOUNT-1 — PubMed 35658024", "url": "https://pubmed.ncbi.nlm.nih.gov/35658024/", "publisher": "SURMOUNT-1", "kind": "journal", "primary": true, "published_on": "2022-06-04", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "trial_n": { "absent": false, "value": 2539, "unit": null, "confidence": "confirmed", "qualifier": null, "observed_on": null, "verified_at": "2026-08-21T08:38:32+00:00", "citation": { "title": "SURMOUNT-1 — PubMed 35658024", "url": "https://pubmed.ncbi.nlm.nih.gov/35658024/", "publisher": "SURMOUNT-1", "kind": "journal", "primary": true, "published_on": "2022-06-04", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "trial_weeks": { "absent": false, "value": 72, "unit": "weeks", "confidence": "confirmed", "qualifier": null, "observed_on": null, "verified_at": "2026-08-21T08:38:32+00:00", "citation": { "title": "SURMOUNT-1 — PubMed 35658024", "url": "https://pubmed.ncbi.nlm.nih.gov/35658024/", "publisher": "SURMOUNT-1", "kind": "journal", "primary": true, "published_on": "2022-06-04", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "discontinuation": { "absent": false, "value": "4.8–6.7% vs 3.4% placebo", "unit": null, "confidence": "confirmed", "qualifier": null, "observed_on": null, "verified_at": "2026-08-21T08:38:32+00:00", "citation": { "title": "FDA — Zepbound label, rev. 01/2026", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/217806s037lbl.pdf", "publisher": "FDA", "kind": "regulator", "primary": true, "published_on": "2026-01-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } } }, "approvals": [ { "agency": "fda", "state": "approved", "decided_on": "2023-11-08", "date_precision": "day", "indication_official": "NDA 217806. Obstructive sleep apnoea indication added 20 Dec 2024. No US cardiovascular indication.", "note": null, "confidence": "confirmed", "verified_at": "2026-08-21T08:38:32+00:00", "citation": { "title": "FDA — Zepbound label, rev. 01/2026", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/217806s037lbl.pdf", "publisher": "FDA", "kind": "regulator", "primary": true, "published_on": "2026-01-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "agency": "ema", "state": "approved", "decided_on": "2022-09-15", "date_precision": "day", "indication_official": "Weight management sits on the Mounjaro label; “Zepbound” is not an EU brand. No EU sleep apnoea indication.", "note": null, "confidence": "claim", "verified_at": "2026-08-21T08:38:32+00:00", "citation": null }, { "agency": "mhra", "state": "approved", "decided_on": "2023-11-01", "date_precision": "month", "indication_official": "NICE phased NHS rollout from Dec 2024, starting at BMI ≥35 with comorbidity, over as long as twelve years.", "note": null, "confidence": "claim", "verified_at": "2026-08-21T08:38:32+00:00", "citation": null }, { "agency": "anvisa", "state": "approved", "decided_on": "2025-06-09", "date_precision": "day", "indication_official": "Weight-management indication; BMI >30, or >27 with comorbidities.", "note": null, "confidence": "claim", "verified_at": "2026-08-21T08:38:32+00:00", "citation": { "title": "Agência Brasil — ANVISA approves Mounjaro for weight loss", "url": "https://agenciabrasil.ebc.com.br/saude/noticia/2025-06/anvisa-aprova-uso-do-medicamento-mounjaro-para-perda-de-peso", "publisher": "Agência Brasil", "kind": "trade", "primary": false, "published_on": "2025-06-09", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "agency": "pmda", "state": "approved", "decided_on": "2024-12-01", "date_precision": "month", "indication_official": "Approved for obesity; exact MHLW date not retrievable.", "note": null, "confidence": "claim", "verified_at": "2026-08-21T08:38:32+00:00", "citation": null }, { "agency": "nmpa", "state": "approved", "decided_on": "2024-07-19", "date_precision": "day", "indication_official": "Brand 穆峰达. Company announcement; NMPA document not retrieved.", "note": null, "confidence": "claim", "verified_at": "2026-08-21T08:38:32+00:00", "citation": null }, { "agency": "hc", "state": "approved", "decided_on": "2025-05-13", "date_precision": "day", "indication_official": "Zepbound KwikPen; launched 9 Jul 2025.", "note": null, "confidence": "claim", "verified_at": "2026-08-21T08:38:32+00:00", "citation": null }, { "agency": "tga", "state": "approved", "decided_on": "2023-01-01", "date_precision": "month", "indication_official": "Mounjaro registered with the weight-management indication. Zepbound is not registered in Australia. Not PBS-listed for obesity.", "note": null, "confidence": "claim", "verified_at": "2026-08-21T08:38:32+00:00", "citation": null } ] }, { "slug": "orforglipron", "name": "Orforglipron", "maker": "Eli Lilly", "country": null, "region": null, "form": "Tablet", "status": "approved", "evidence": "confirmed", "subtitle": "First small-molecule oral GLP-1 — no peptide manufacturing constraint, which is what makes global scale plausible · Approved in exactly one country", "note": "Outcomes — None. No cardiovascular outcomes trial has reported.\n\nBoxed warning — Thyroid C-cell tumours — applied as a class warning even though the label states orforglipron itself produced no tumours in rodents, because human relevance is undetermined.\n\nHarms — At the top dose: nausea 35%, diarrhoea 25%, vomiting 24%, constipation 24%.\n\nGenerics — None. New chemical entity.\n\nPrice — US self-pay from $149/month; Medicare Part D $50/month from 1 Jul 2026.\n\nSupply — No shortage reported.", "unveiled_on": "2026-04-01", "last_verified_at": "2026-08-21T08:38:32+00:00", "values": { "brand": { "absent": false, "value": "Foundayo", "unit": null, "confidence": "confirmed", "qualifier": null, "observed_on": null, "verified_at": "2026-08-21T08:38:32+00:00", "citation": { "title": "FDA — Foundayo label, rev. 04/2026", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/220934Orig1s000lbl.pdf", "publisher": "FDA", "kind": "regulator", "primary": true, "published_on": "2026-04-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "drug_class": { "absent": false, "value": "Small-molecule (non-peptide) GLP-1 receptor agonist", "unit": null, "confidence": "confirmed", "qualifier": null, "observed_on": null, "verified_at": "2026-08-21T08:38:32+00:00", "citation": { "title": "FDA — Foundayo label, rev. 04/2026", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/220934Orig1s000lbl.pdf", "publisher": "FDA", "kind": "regulator", "primary": true, "published_on": "2026-04-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "route": { "absent": false, "value": "Tablet, daily", "unit": null, "confidence": "confirmed", "qualifier": null, "observed_on": null, "verified_at": "2026-08-21T08:38:32+00:00", "citation": { "title": "FDA — Foundayo label, rev. 04/2026", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/220934Orig1s000lbl.pdf", "publisher": "FDA", "kind": "regulator", "primary": true, "published_on": "2026-04-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "dose": { "absent": false, "value": "Up to 17.2 mg daily, no food or water restrictions", "unit": null, "confidence": "confirmed", "qualifier": null, "observed_on": null, "verified_at": "2026-08-21T08:38:32+00:00", "citation": { "title": "FDA — Foundayo label, rev. 04/2026", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/220934Orig1s000lbl.pdf", "publisher": "FDA", "kind": "regulator", "primary": true, "published_on": "2026-04-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "weight_change": { "absent": false, "value": -11.1, "unit": "%", "confidence": "confirmed", "qualifier": "treatment policy, 17.2 mg · FDA label, Trial 1", "observed_on": null, "verified_at": "2026-08-21T08:38:32+00:00", "citation": { "title": "FDA — Foundayo label, rev. 04/2026", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/220934Orig1s000lbl.pdf", "publisher": "FDA", "kind": "regulator", "primary": true, "published_on": "2026-04-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "placebo_change": { "absent": false, "value": -2.1, "unit": "%", "confidence": "confirmed", "qualifier": "treatment policy, 17.2 mg · FDA label, Trial 1", "observed_on": null, "verified_at": "2026-08-21T08:38:32+00:00", "citation": { "title": "FDA — Foundayo label, rev. 04/2026", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/220934Orig1s000lbl.pdf", "publisher": "FDA", "kind": "regulator", "primary": true, "published_on": "2026-04-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "placebo_adjusted": { "absent": false, "value": -9, "unit": "pp", "confidence": "confirmed", "qualifier": "treatment policy, 17.2 mg · FDA label, Trial 1", "observed_on": null, "verified_at": "2026-08-21T08:38:32+00:00", "citation": { "title": "FDA — Foundayo label, rev. 04/2026", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/220934Orig1s000lbl.pdf", "publisher": "FDA", "kind": "regulator", "primary": true, "published_on": "2026-04-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "trial": { "absent": false, "value": "ATTAIN-1", "unit": null, "confidence": "confirmed", "qualifier": "treatment policy, 17.2 mg · FDA label, Trial 1", "observed_on": null, "verified_at": "2026-08-21T08:38:32+00:00", "citation": { "title": "FDA — Foundayo label, rev. 04/2026", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/220934Orig1s000lbl.pdf", "publisher": "FDA", "kind": "regulator", "primary": true, "published_on": "2026-04-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "trial_n": { "absent": false, "value": 3127, "unit": null, "confidence": "confirmed", "qualifier": null, "observed_on": null, "verified_at": "2026-08-21T08:38:32+00:00", "citation": { "title": "FDA — Foundayo label, rev. 04/2026", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/220934Orig1s000lbl.pdf", "publisher": "FDA", "kind": "regulator", "primary": true, "published_on": "2026-04-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "trial_weeks": { "absent": false, "value": 72, "unit": "weeks", "confidence": "confirmed", "qualifier": null, "observed_on": null, "verified_at": "2026-08-21T08:38:32+00:00", "citation": { "title": "FDA — Foundayo label, rev. 04/2026", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/220934Orig1s000lbl.pdf", "publisher": "FDA", "kind": "regulator", "primary": true, "published_on": "2026-04-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "discontinuation": { "absent": false, "value": "8% vs 3% placebo — the highest of the GLP-1 agents", "unit": null, "confidence": "confirmed", "qualifier": null, "observed_on": null, "verified_at": "2026-08-21T08:38:32+00:00", "citation": { "title": "FDA — Foundayo label, rev. 04/2026", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/220934Orig1s000lbl.pdf", "publisher": "FDA", "kind": "regulator", "primary": true, "published_on": "2026-04-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } } }, "approvals": [ { "agency": "fda", "state": "approved", "decided_on": "2026-04-01", "date_precision": "month", "indication_official": "NDA 220934. Reviewed under the Commissioner's National Priority Voucher programme — approved 50 days after filing, 294 days ahead of its target date.", "note": null, "confidence": "confirmed", "verified_at": "2026-08-21T08:38:32+00:00", "citation": { "title": "FDA — Foundayo label, rev. 04/2026", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/220934Orig1s000lbl.pdf", "publisher": "FDA", "kind": "regulator", "primary": true, "published_on": "2026-04-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "agency": "ema", "state": "none", "decided_on": null, "date_precision": "day", "indication_official": null, "note": "No approval found.", "confidence": "claim", "verified_at": "2026-08-21T08:38:32+00:00", "citation": null }, { "agency": "mhra", "state": "none", "decided_on": null, "date_precision": "day", "indication_official": null, "note": "No approval found.", "confidence": "claim", "verified_at": "2026-08-21T08:38:32+00:00", "citation": null }, { "agency": "anvisa", "state": "none", "decided_on": null, "date_precision": "day", "indication_official": null, "note": "No approval found.", "confidence": "claim", "verified_at": "2026-08-21T08:38:32+00:00", "citation": null }, { "agency": "pmda", "state": "none", "decided_on": null, "date_precision": "day", "indication_official": null, "note": "No approval found.", "confidence": "claim", "verified_at": "2026-08-21T08:38:32+00:00", "citation": null }, { "agency": "nmpa", "state": "none", "decided_on": null, "date_precision": "day", "indication_official": null, "note": "No approval found.", "confidence": "claim", "verified_at": "2026-08-21T08:38:32+00:00", "citation": null }, { "agency": "hc", "state": "none", "decided_on": null, "date_precision": "day", "indication_official": null, "note": "No approval found.", "confidence": "claim", "verified_at": "2026-08-21T08:38:32+00:00", "citation": null }, { "agency": "tga", "state": "none", "decided_on": null, "date_precision": "day", "indication_official": null, "note": "No approval found.", "confidence": "claim", "verified_at": "2026-08-21T08:38:32+00:00", "citation": null } ] }, { "slug": "liraglutide", "name": "Liraglutide 3.0 mg", "maker": "Novo Nordisk; Teva (generic)", "country": null, "region": null, "form": "Injection", "status": "approved", "evidence": "confirmed", "subtitle": "The first GLP-1 to face real generic competition — a preview of where the class goes", "note": "Outcomes — LEADER showed cardiovascular benefit at the 1.8 mg diabetes dose. There is no outcome trial at the 3.0 mg obesity dose.\n\nBoxed warning — Thyroid C-cell tumours.\n\nHarms — Nausea 40%, diarrhoea 21%, vomiting 16%.\n\nGenerics — The only genericised GLP-1. Teva launched generic liraglutide in the US on 28 Aug 2025.\n\nPrice — Brand reference around $1,324/month in the US; generic launch price not disclosed. Not on the Medicare covered list.\n\nSupply — None current.", "unveiled_on": "2014-12-23", "last_verified_at": "2026-08-21T08:38:32+00:00", "values": { "brand": { "absent": false, "value": "Saxenda + generics", "unit": null, "confidence": "confirmed", "qualifier": null, "observed_on": null, "verified_at": "2026-08-21T08:38:32+00:00", "citation": { "title": "EMA — Saxenda EPAR", "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/saxenda", "publisher": "EMA", "kind": "regulator", "primary": true, "published_on": "2026-08-20", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "drug_class": { "absent": false, "value": "GLP-1 receptor agonist", "unit": null, "confidence": "confirmed", "qualifier": null, "observed_on": null, "verified_at": "2026-08-21T08:38:32+00:00", "citation": { "title": "EMA — Saxenda EPAR", "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/saxenda", "publisher": "EMA", "kind": "regulator", "primary": true, "published_on": "2026-08-20", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "route": { "absent": false, "value": "Injection, daily", "unit": null, "confidence": "confirmed", "qualifier": null, "observed_on": null, "verified_at": "2026-08-21T08:38:32+00:00", "citation": { "title": "EMA — Saxenda EPAR", "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/saxenda", "publisher": "EMA", "kind": "regulator", "primary": true, "published_on": "2026-08-20", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "dose": { "absent": false, "value": "3.0 mg daily", "unit": null, "confidence": "confirmed", "qualifier": null, "observed_on": null, "verified_at": "2026-08-21T08:38:32+00:00", "citation": { "title": "EMA — Saxenda EPAR", "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/saxenda", "publisher": "EMA", "kind": "regulator", "primary": true, "published_on": "2026-08-20", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "weight_change": { "absent": false, "value": -8, "unit": "%", "confidence": "confirmed", "qualifier": "as published · NEJM 2015;373:11", "observed_on": null, "verified_at": "2026-08-21T08:38:32+00:00", "citation": { "title": "SCALE, NEJM 2015;373:11", "url": "https://www.nejm.org/doi/full/10.1056/NEJMoa1411892", "publisher": "nejm.org", "kind": "journal", "primary": true, "published_on": "2015-07-02", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "placebo_change": { "absent": false, "value": -2.6, "unit": "%", "confidence": "confirmed", "qualifier": "as published · NEJM 2015;373:11", "observed_on": null, "verified_at": "2026-08-21T08:38:32+00:00", "citation": { "title": "SCALE, NEJM 2015;373:11", "url": "https://www.nejm.org/doi/full/10.1056/NEJMoa1411892", "publisher": "nejm.org", "kind": "journal", "primary": true, "published_on": "2015-07-02", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "placebo_adjusted": { "absent": false, "value": -5.4, "unit": "pp", "confidence": "confirmed", "qualifier": "as published · NEJM 2015;373:11", "observed_on": null, "verified_at": "2026-08-21T08:38:32+00:00", "citation": { "title": "SCALE, NEJM 2015;373:11", "url": "https://www.nejm.org/doi/full/10.1056/NEJMoa1411892", "publisher": "nejm.org", "kind": "journal", "primary": true, "published_on": "2015-07-02", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "trial": { "absent": false, "value": "SCALE Obesity and Prediabetes", "unit": null, "confidence": "confirmed", "qualifier": "as published · NEJM 2015;373:11", "observed_on": null, "verified_at": "2026-08-21T08:38:32+00:00", "citation": { "title": "SCALE, NEJM 2015;373:11", "url": "https://www.nejm.org/doi/full/10.1056/NEJMoa1411892", "publisher": "nejm.org", "kind": "journal", "primary": true, "published_on": "2015-07-02", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "trial_n": { "absent": false, "value": 3731, "unit": null, "confidence": "confirmed", "qualifier": null, "observed_on": null, "verified_at": "2026-08-21T08:38:32+00:00", "citation": { "title": "SCALE, NEJM 2015;373:11", "url": "https://www.nejm.org/doi/full/10.1056/NEJMoa1411892", "publisher": "nejm.org", "kind": "journal", "primary": true, "published_on": "2015-07-02", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "trial_weeks": { "absent": false, "value": 56, "unit": "weeks", "confidence": "confirmed", "qualifier": null, "observed_on": null, "verified_at": "2026-08-21T08:38:32+00:00", "citation": { "title": "SCALE, NEJM 2015;373:11", "url": "https://www.nejm.org/doi/full/10.1056/NEJMoa1411892", "publisher": "nejm.org", "kind": "journal", "primary": true, "published_on": "2015-07-02", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "discontinuation": { "absent": true, "reason": "Not published", "confidence": "absent", "verified_at": "2026-08-21T08:38:32+00:00" } }, "approvals": [ { "agency": "fda", "state": "approved", "decided_on": "2014-12-23", "date_precision": "day", "indication_official": "Paediatric indication (12–17 years) added Dec 2020.", "note": null, "confidence": "claim", "verified_at": "2026-08-21T08:38:32+00:00", "citation": null }, { "agency": "ema", "state": "approved", "decided_on": "2015-03-23", "date_precision": "day", "indication_official": "Adults and adolescents from 12 years.", "note": null, "confidence": "confirmed", "verified_at": "2026-08-21T08:38:32+00:00", "citation": { "title": "EMA — Saxenda EPAR", "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/saxenda", "publisher": "EMA", "kind": "regulator", "primary": true, "published_on": "2026-08-20", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "agency": "mhra", "state": "approved", "decided_on": "2015-03-23", "date_precision": "day", "indication_official": "Licensed; NHS access limited.", "note": null, "confidence": "claim", "verified_at": "2026-08-21T08:38:32+00:00", "citation": null }, { "agency": "anvisa", "state": "approved", "decided_on": null, "date_precision": "day", "indication_official": "Approved; date not retrievable.", "note": null, "confidence": "claim", "verified_at": "2026-08-21T08:38:32+00:00", "citation": null }, { "agency": "pmda", "state": "none", "decided_on": null, "date_precision": "day", "indication_official": null, "note": "Not approved for obesity in Japan — only the diabetes product.", "confidence": "claim", "verified_at": "2026-08-21T08:38:32+00:00", "citation": null }, { "agency": "nmpa", "state": "none", "decided_on": null, "date_precision": "day", "indication_official": null, "note": "Not approved for weight management.", "confidence": "claim", "verified_at": "2026-08-21T08:38:32+00:00", "citation": null }, { "agency": "hc", "state": "approved", "decided_on": null, "date_precision": "day", "indication_official": "Approved; date not retrievable.", "note": null, "confidence": "claim", "verified_at": "2026-08-21T08:38:32+00:00", "citation": null }, { "agency": "tga", "state": "withdrawn", "decided_on": "2025-12-01", "date_precision": "month", "indication_official": null, "note": "Saxenda discontinued in Australia in December 2025 — a commercial withdrawal, not a regulatory action.", "confidence": "claim", "verified_at": "2026-08-21T08:38:32+00:00", "citation": null } ] }, { "slug": "qsymia", "name": "Phentermine / topiramate ER", "maker": "Vivus", "country": null, "region": null, "form": "Tablet", "status": "approved", "evidence": "confirmed", "subtitle": "The clearest case of two competent regulators reading the same dossier and reaching opposite conclusions", "note": "Outcomes — None. The required post-marketing cardiovascular trial was never completed.\n\nBoxed warning — None — but the warnings are extensive.\n\nHarms — Embryo-fetal toxicity including cleft lip and palate, suicidal ideation, acute angle-closure glaucoma, cognitive impairment, metabolic acidosis, kidney stones, slowed growth in adolescents. Paraesthesia 20%, dry mouth 19%.\n\nGenerics — Generic available in the US since 2023–24.\n\nPrice — As low as about $63/month with coupons. Not Medicare-covered for obesity.\n\nSupply — None.", "unveiled_on": "2012-07-17", "last_verified_at": "2026-08-21T08:38:32+00:00", "values": { "brand": { "absent": false, "value": "Qsymia", "unit": null, "confidence": "confirmed", "qualifier": null, "observed_on": null, "verified_at": "2026-08-21T08:38:32+00:00", "citation": { "title": "FDA — Qsymia label, rev. 09/2024", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022580s026lbl.pdf", "publisher": "FDA", "kind": "regulator", "primary": true, "published_on": "2024-09-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "drug_class": { "absent": false, "value": "Sympathomimetic + anticonvulsant combination", "unit": null, "confidence": "confirmed", "qualifier": null, "observed_on": null, "verified_at": "2026-08-21T08:38:32+00:00", "citation": { "title": "FDA — Qsymia label, rev. 09/2024", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022580s026lbl.pdf", "publisher": "FDA", "kind": "regulator", "primary": true, "published_on": "2024-09-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "route": { "absent": false, "value": "Tablet, daily", "unit": null, "confidence": "confirmed", "qualifier": null, "observed_on": null, "verified_at": "2026-08-21T08:38:32+00:00", "citation": { "title": "FDA — Qsymia label, rev. 09/2024", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022580s026lbl.pdf", "publisher": "FDA", "kind": "regulator", "primary": true, "published_on": "2024-09-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "dose": { "absent": false, "value": "7.5/46 mg or 15/92 mg daily", "unit": null, "confidence": "confirmed", "qualifier": null, "observed_on": null, "verified_at": "2026-08-21T08:38:32+00:00", "citation": { "title": "FDA — Qsymia label, rev. 09/2024", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022580s026lbl.pdf", "publisher": "FDA", "kind": "regulator", "primary": true, "published_on": "2024-09-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "weight_change": { "absent": false, "value": -9.8, "unit": "%", "confidence": "confirmed", "qualifier": "FDA label analysis, 15/92 mg · FDA label §14", "observed_on": null, "verified_at": "2026-08-21T08:38:32+00:00", "citation": { "title": "FDA — Qsymia label, rev. 09/2024", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022580s026lbl.pdf", "publisher": "FDA", "kind": "regulator", "primary": true, "published_on": "2024-09-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "placebo_change": { "absent": false, "value": -1.2, "unit": "%", "confidence": "confirmed", "qualifier": "FDA label analysis, 15/92 mg · FDA label §14", "observed_on": null, "verified_at": "2026-08-21T08:38:32+00:00", "citation": { "title": "FDA — Qsymia label, rev. 09/2024", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022580s026lbl.pdf", "publisher": "FDA", "kind": "regulator", "primary": true, "published_on": "2024-09-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "placebo_adjusted": { "absent": false, "value": -8.6, "unit": "pp", "confidence": "confirmed", "qualifier": "FDA label analysis, 15/92 mg · FDA label §14", "observed_on": null, "verified_at": "2026-08-21T08:38:32+00:00", "citation": { "title": "FDA — Qsymia label, rev. 09/2024", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022580s026lbl.pdf", "publisher": "FDA", "kind": "regulator", "primary": true, "published_on": "2024-09-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "trial": { "absent": false, "value": "CONQUER", "unit": null, "confidence": "confirmed", "qualifier": "FDA label analysis, 15/92 mg · FDA label §14", "observed_on": null, "verified_at": "2026-08-21T08:38:32+00:00", "citation": { "title": "FDA — Qsymia label, rev. 09/2024", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022580s026lbl.pdf", "publisher": "FDA", "kind": "regulator", "primary": true, "published_on": "2024-09-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "trial_n": { "absent": false, "value": 2487, "unit": null, "confidence": "confirmed", "qualifier": null, "observed_on": null, "verified_at": "2026-08-21T08:38:32+00:00", "citation": { "title": "FDA — Qsymia label, rev. 09/2024", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022580s026lbl.pdf", "publisher": "FDA", "kind": "regulator", "primary": true, "published_on": "2024-09-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "trial_weeks": { "absent": false, "value": 56, "unit": "weeks", "confidence": "confirmed", "qualifier": null, "observed_on": null, "verified_at": "2026-08-21T08:38:32+00:00", "citation": { "title": "FDA — Qsymia label, rev. 09/2024", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022580s026lbl.pdf", "publisher": "FDA", "kind": "regulator", "primary": true, "published_on": "2024-09-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "discontinuation": { "absent": false, "value": "Label reports only all-cause withdrawal of 31–40%, which is not comparable to other drugs' figures", "unit": null, "confidence": "confirmed", "qualifier": null, "observed_on": null, "verified_at": "2026-08-21T08:38:32+00:00", "citation": { "title": "FDA — Qsymia label, rev. 09/2024", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022580s026lbl.pdf", "publisher": "FDA", "kind": "regulator", "primary": true, "published_on": "2024-09-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } } }, "approvals": [ { "agency": "fda", "state": "approved", "decided_on": "2012-07-17", "date_precision": "day", "indication_official": "Paediatric indication added June 2022. Distributed under a REMS for embryo-fetal toxicity — certified pharmacies only.", "note": null, "confidence": "confirmed", "verified_at": "2026-08-21T08:38:32+00:00", "citation": { "title": "FDA — Qsymia label, rev. 09/2024", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022580s026lbl.pdf", "publisher": "FDA", "kind": "regulator", "primary": true, "published_on": "2024-09-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "agency": "ema", "state": "refused", "decided_on": "2013-02-21", "date_precision": "day", "indication_official": null, "note": "CHMP negative opinion 18 Oct 2012, refusal confirmed on re-examination. Grounds: unknown long-term cardiovascular effects, topiramate psychiatric and cognitive effects, teratogenicity, and a high probability of off-label use that could not be managed.", "confidence": "confirmed", "verified_at": "2026-08-21T08:38:32+00:00", "citation": { "title": "EMA — Qsiva refusal question-and-answer document", "url": "https://www.ema.europa.eu/en/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-qsiva-phentermine-topiramate_en.pdf", "publisher": "EMA", "kind": "regulator", "primary": true, "published_on": "2013-02-21", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "agency": "mhra", "state": "none", "decided_on": null, "date_precision": "day", "indication_official": null, "note": "Not licensed; followed the EU refusal.", "confidence": "claim", "verified_at": "2026-08-21T08:38:32+00:00", "citation": null }, { "agency": "anvisa", "state": "none", "decided_on": null, "date_precision": "day", "indication_official": null, "note": "Not registered.", "confidence": "claim", "verified_at": "2026-08-21T08:38:32+00:00", "citation": null }, { "agency": "pmda", "state": "none", "decided_on": null, "date_precision": "day", "indication_official": null, "note": "Not approved.", "confidence": "claim", "verified_at": "2026-08-21T08:38:32+00:00", "citation": null }, { "agency": "nmpa", "state": "none", "decided_on": null, "date_precision": "day", "indication_official": null, "note": "Not approved.", "confidence": "claim", "verified_at": "2026-08-21T08:38:32+00:00", "citation": null }, { "agency": "hc", "state": "none", "decided_on": null, "date_precision": "day", "indication_official": null, "note": "Not approved.", "confidence": "claim", "verified_at": "2026-08-21T08:38:32+00:00", "citation": null }, { "agency": "tga", "state": "none", "decided_on": null, "date_precision": "day", "indication_official": null, "note": "Not registered. Phentermine alone is available as Duromine.", "confidence": "claim", "verified_at": "2026-08-21T08:38:32+00:00", "citation": null } ] }, { "slug": "contrave", "name": "Naltrexone / bupropion ER", "maker": "Currax; Orexigen Ireland", "country": null, "region": null, "form": "Tablet", "status": "approved", "evidence": "confirmed", "subtitle": "One in four people stopped it because of side effects · Its outcomes trial was destroyed by the sponsor's own conduct", "note": "Outcomes — The LIGHT cardiovascular outcomes trial was terminated early in 2015 after the sponsor's unauthorised disclosure of interim data, and never produced a valid result. The label states plainly that the cardiovascular effect has not been established.\n\nBoxed warning — Suicidal thoughts and behaviours — the antidepressant class warning.\n\nHarms — Seizure risk, blood pressure and heart rate increases, hepatotoxicity, angle-closure glaucoma, opioid blockade. Nausea 33%, constipation 19%, headache 18%.\n\nGenerics — Generic available in the US.\n\nPrice — About $199/month with coupons. Not Medicare-covered for obesity.\n\nSupply — None.", "unveiled_on": "2014-09-10", "last_verified_at": "2026-08-21T08:38:32+00:00", "values": { "brand": { "absent": false, "value": "Contrave (US) / Mysimba (EU)", "unit": null, "confidence": "confirmed", "qualifier": null, "observed_on": null, "verified_at": "2026-08-21T08:38:32+00:00", "citation": { "title": "FDA — Contrave label, rev. 03/2021", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/200063s020lbl.pdf", "publisher": "FDA", "kind": "regulator", "primary": true, "published_on": "2021-03-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "drug_class": { "absent": false, "value": "Opioid antagonist + aminoketone antidepressant", "unit": null, "confidence": "confirmed", "qualifier": null, "observed_on": null, "verified_at": "2026-08-21T08:38:32+00:00", "citation": { "title": "FDA — Contrave label, rev. 03/2021", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/200063s020lbl.pdf", "publisher": "FDA", "kind": "regulator", "primary": true, "published_on": "2021-03-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "route": { "absent": false, "value": "Tablet, twice daily", "unit": null, "confidence": "confirmed", "qualifier": null, "observed_on": null, "verified_at": "2026-08-21T08:38:32+00:00", "citation": { "title": "FDA — Contrave label, rev. 03/2021", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/200063s020lbl.pdf", "publisher": "FDA", "kind": "regulator", "primary": true, "published_on": "2021-03-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "dose": { "absent": false, "value": "32 mg / 360 mg daily", "unit": null, "confidence": "confirmed", "qualifier": null, "observed_on": null, "verified_at": "2026-08-21T08:38:32+00:00", "citation": { "title": "FDA — Contrave label, rev. 03/2021", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/200063s020lbl.pdf", "publisher": "FDA", "kind": "regulator", "primary": true, "published_on": "2021-03-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "weight_change": { "absent": false, "value": -5.4, "unit": "%", "confidence": "confirmed", "qualifier": "FDA label analysis · FDA label §14", "observed_on": null, "verified_at": "2026-08-21T08:38:32+00:00", "citation": { "title": "FDA — Contrave label, rev. 03/2021", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/200063s020lbl.pdf", "publisher": "FDA", "kind": "regulator", "primary": true, "published_on": "2021-03-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "placebo_change": { "absent": false, "value": -1.3, "unit": "%", "confidence": "confirmed", "qualifier": "FDA label analysis · FDA label §14", "observed_on": null, "verified_at": "2026-08-21T08:38:32+00:00", "citation": { "title": "FDA — Contrave label, rev. 03/2021", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/200063s020lbl.pdf", "publisher": "FDA", "kind": "regulator", "primary": true, "published_on": "2021-03-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "placebo_adjusted": { "absent": false, "value": -4.1, "unit": "pp", "confidence": "confirmed", "qualifier": "FDA label analysis · FDA label §14", "observed_on": null, "verified_at": "2026-08-21T08:38:32+00:00", "citation": { "title": "FDA — Contrave label, rev. 03/2021", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/200063s020lbl.pdf", "publisher": "FDA", "kind": "regulator", "primary": true, "published_on": "2021-03-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "trial": { "absent": false, "value": "COR-I", "unit": null, "confidence": "confirmed", "qualifier": "FDA label analysis · FDA label §14", "observed_on": null, "verified_at": "2026-08-21T08:38:32+00:00", "citation": { "title": "FDA — Contrave label, rev. 03/2021", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/200063s020lbl.pdf", "publisher": "FDA", "kind": "regulator", "primary": true, "published_on": "2021-03-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "trial_n": { "absent": false, "value": 1074, "unit": null, "confidence": "confirmed", "qualifier": null, "observed_on": null, "verified_at": "2026-08-21T08:38:32+00:00", "citation": { "title": "FDA — Contrave label, rev. 03/2021", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/200063s020lbl.pdf", "publisher": "FDA", "kind": "regulator", "primary": true, "published_on": "2021-03-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "trial_weeks": { "absent": false, "value": 56, "unit": "weeks", "confidence": "confirmed", "qualifier": null, "observed_on": null, "verified_at": "2026-08-21T08:38:32+00:00", "citation": { "title": "FDA — Contrave label, rev. 03/2021", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/200063s020lbl.pdf", "publisher": "FDA", "kind": "regulator", "primary": true, "published_on": "2021-03-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "discontinuation": { "absent": false, "value": "24% vs 12% placebo — by far the highest of any approved agent", "unit": null, "confidence": "confirmed", "qualifier": null, "observed_on": null, "verified_at": "2026-08-21T08:38:32+00:00", "citation": { "title": "FDA — Contrave label, rev. 03/2021", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/200063s020lbl.pdf", "publisher": "FDA", "kind": "regulator", "primary": true, "published_on": "2021-03-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } } }, "approvals": [ { "agency": "fda", "state": "approved", "decided_on": "2014-09-10", "date_precision": "day", "indication_official": "BMI ≥30, or ≥27 with a comorbidity.", "note": null, "confidence": "confirmed", "verified_at": "2026-08-21T08:38:32+00:00", "citation": { "title": "FDA — Contrave label, rev. 03/2021", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/200063s020lbl.pdf", "publisher": "FDA", "kind": "regulator", "primary": true, "published_on": "2021-03-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "agency": "ema", "state": "approved", "decided_on": "2015-03-26", "date_precision": "day", "indication_official": "Mandatory stopping rule: discontinue at 16 weeks if less than 5% weight has been lost. Under additional monitoring for cardiovascular safety; 2024 EMA advisory on serious opioid interactions.", "note": null, "confidence": "confirmed", "verified_at": "2026-08-21T08:38:32+00:00", "citation": { "title": "EMA — Mysimba EPAR", "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/mysimba", "publisher": "EMA", "kind": "regulator", "primary": true, "published_on": "2026-08-20", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "agency": "mhra", "state": "approved", "decided_on": "2015-03-26", "date_precision": "day", "indication_official": "Licensed as Mysimba.", "note": null, "confidence": "claim", "verified_at": "2026-08-21T08:38:32+00:00", "citation": null }, { "agency": "anvisa", "state": "none", "decided_on": null, "date_precision": "day", "indication_official": null, "note": "No approval found.", "confidence": "claim", "verified_at": "2026-08-21T08:38:32+00:00", "citation": null }, { "agency": "pmda", "state": "none", "decided_on": null, "date_precision": "day", "indication_official": null, "note": "No approval found.", "confidence": "claim", "verified_at": "2026-08-21T08:38:32+00:00", "citation": null }, { "agency": "nmpa", "state": "none", "decided_on": null, "date_precision": "day", "indication_official": null, "note": "No approval found.", "confidence": "claim", "verified_at": "2026-08-21T08:38:32+00:00", "citation": null }, { "agency": "hc", "state": "approved", "decided_on": null, "date_precision": "day", "indication_official": "Approved; decision date not published in an accessible summary.", "note": null, "confidence": "claim", "verified_at": "2026-08-21T08:38:32+00:00", "citation": null }, { "agency": "tga", "state": "approved", "decided_on": "2019-01-01", "date_precision": "month", "indication_official": "Registered as Contrave. Not PBS-listed.", "note": null, "confidence": "claim", "verified_at": "2026-08-21T08:38:32+00:00", "citation": null } ] }, { "slug": "orlistat", "name": "Orlistat", "maker": "Roche; Haleon; many generics", "country": null, "region": null, "form": "Capsule", "status": "approved", "evidence": "confirmed", "subtitle": "The only approved obesity drug available without a prescription · Smallest effect of any approved agent, and the longest safety record", "note": "Outcomes — No cardiovascular outcome trial. XENDOS showed a 42% reduction in progression to type 2 diabetes over four years, and that endpoint is in the label.\n\nBoxed warning — None.\n\nHarms — Oily spotting 27%, flatus with discharge 24%, faecal urgency 22%, faecal incontinence 8%. Post-marketing: severe liver injury; kidney stones and oxalate nephropathy warning added to alli.\n\nGenerics — Extensively genericised worldwide, off patent.\n\nPrice — Brand about $430 per fill; alli about $87; generics cheaper.\n\nSupply — None.", "unveiled_on": "1999-04-26", "last_verified_at": "2026-08-21T08:38:33+00:00", "values": { "brand": { "absent": false, "value": "Xenical (Rx) / alli (OTC)", "unit": null, "confidence": "confirmed", "qualifier": null, "observed_on": null, "verified_at": "2026-08-21T08:38:32+00:00", "citation": { "title": "FDA — Xenical label, rev. 11/2022", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020766s038lbl.pdf", "publisher": "FDA", "kind": "regulator", "primary": true, "published_on": "2022-11-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "drug_class": { "absent": false, "value": "Gastrointestinal lipase inhibitor", "unit": null, "confidence": "confirmed", "qualifier": null, "observed_on": null, "verified_at": "2026-08-21T08:38:32+00:00", "citation": { "title": "FDA — Xenical label, rev. 11/2022", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020766s038lbl.pdf", "publisher": "FDA", "kind": "regulator", "primary": true, "published_on": "2022-11-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "route": { "absent": false, "value": "Capsule, three times daily", "unit": null, "confidence": "confirmed", "qualifier": null, "observed_on": null, "verified_at": "2026-08-21T08:38:32+00:00", "citation": { "title": "FDA — Xenical label, rev. 11/2022", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020766s038lbl.pdf", "publisher": "FDA", "kind": "regulator", "primary": true, "published_on": "2022-11-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "dose": { "absent": false, "value": "120 mg with each fat-containing meal; 60 mg over the counter", "unit": null, "confidence": "confirmed", "qualifier": null, "observed_on": null, "verified_at": "2026-08-21T08:38:32+00:00", "citation": { "title": "FDA — Xenical label, rev. 11/2022", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020766s038lbl.pdf", "publisher": "FDA", "kind": "regulator", "primary": true, "published_on": "2022-11-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "weight_change": { "absent": false, "value": -5.17, "unit": "%", "confidence": "confirmed", "qualifier": "4-year mean · FDA label §14", "observed_on": null, "verified_at": "2026-08-21T08:38:33+00:00", "citation": { "title": "FDA — Xenical label, rev. 11/2022", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020766s038lbl.pdf", "publisher": "FDA", "kind": "regulator", "primary": true, "published_on": "2022-11-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "placebo_change": { "absent": false, "value": -2.75, "unit": "%", "confidence": "confirmed", "qualifier": "4-year mean · FDA label §14", "observed_on": null, "verified_at": "2026-08-21T08:38:33+00:00", "citation": { "title": "FDA — Xenical label, rev. 11/2022", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020766s038lbl.pdf", "publisher": "FDA", "kind": "regulator", "primary": true, "published_on": "2022-11-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "placebo_adjusted": { "absent": false, "value": -2.42, "unit": "pp", "confidence": "confirmed", "qualifier": "4-year mean · FDA label §14", "observed_on": null, "verified_at": "2026-08-21T08:38:33+00:00", "citation": { "title": "FDA — Xenical label, rev. 11/2022", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020766s038lbl.pdf", "publisher": "FDA", "kind": "regulator", "primary": true, "published_on": "2022-11-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "trial": { "absent": false, "value": "XENDOS", "unit": null, "confidence": "confirmed", "qualifier": "4-year mean · FDA label §14", "observed_on": null, "verified_at": "2026-08-21T08:38:33+00:00", "citation": { "title": "FDA — Xenical label, rev. 11/2022", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020766s038lbl.pdf", "publisher": "FDA", "kind": "regulator", "primary": true, "published_on": "2022-11-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "trial_n": { "absent": false, "value": 3305, "unit": null, "confidence": "confirmed", "qualifier": null, "observed_on": null, "verified_at": "2026-08-21T08:38:33+00:00", "citation": { "title": "FDA — Xenical label, rev. 11/2022", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020766s038lbl.pdf", "publisher": "FDA", "kind": "regulator", "primary": true, "published_on": "2022-11-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "trial_weeks": { "absent": false, "value": 208, "unit": "weeks", "confidence": "confirmed", "qualifier": null, "observed_on": null, "verified_at": "2026-08-21T08:38:33+00:00", "citation": { "title": "FDA — Xenical label, rev. 11/2022", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020766s038lbl.pdf", "publisher": "FDA", "kind": "regulator", "primary": true, "published_on": "2022-11-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "discontinuation": { "absent": true, "reason": "Not stated as an AE-specific figure", "confidence": "absent", "verified_at": "2026-08-21T08:38:32+00:00" } }, "approvals": [ { "agency": "fda", "state": "approved", "decided_on": "1999-04-26", "date_precision": "day", "indication_official": "alli 60 mg approved over the counter 7 Feb 2007.", "note": null, "confidence": "confirmed", "verified_at": "2026-08-21T08:38:33+00:00", "citation": { "title": "FDA — Xenical label, rev. 11/2022", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020766s038lbl.pdf", "publisher": "FDA", "kind": "regulator", "primary": true, "published_on": "2022-11-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "agency": "ema", "state": "approved", "decided_on": "1998-07-29", "date_precision": "day", "indication_official": "Xenical centrally authorised 1998; alli 2007.", "note": null, "confidence": "claim", "verified_at": "2026-08-21T08:38:33+00:00", "citation": null }, { "agency": "mhra", "state": "approved", "decided_on": "1998-07-29", "date_precision": "day", "indication_official": "Prescription 120 mg and pharmacy 60 mg.", "note": null, "confidence": "claim", "verified_at": "2026-08-21T08:38:33+00:00", "citation": null }, { "agency": "anvisa", "state": "approved", "decided_on": null, "date_precision": "day", "indication_official": "Approved; date not retrievable.", "note": null, "confidence": "claim", "verified_at": "2026-08-21T08:38:33+00:00", "citation": null }, { "agency": "pmda", "state": "approved", "decided_on": "2023-01-01", "date_precision": "month", "indication_official": "Approved as an over-the-counter product for visceral fat reduction — a distinct Japanese indication, not the Western obesity one.", "note": null, "confidence": "claim", "verified_at": "2026-08-21T08:38:33+00:00", "citation": null }, { "agency": "nmpa", "state": "approved", "decided_on": null, "date_precision": "day", "indication_official": "Approved.", "note": null, "confidence": "claim", "verified_at": "2026-08-21T08:38:33+00:00", "citation": null }, { "agency": "hc", "state": "approved", "decided_on": null, "date_precision": "day", "indication_official": "Approved.", "note": null, "confidence": "claim", "verified_at": "2026-08-21T08:38:33+00:00", "citation": null }, { "agency": "tga", "state": "approved", "decided_on": "2000-01-01", "date_precision": "month", "indication_official": "Registered.", "note": null, "confidence": "claim", "verified_at": "2026-08-21T08:38:33+00:00", "citation": null } ] }, { "slug": "phentermine", "name": "Phentermine", "maker": "Multiple", "country": null, "region": null, "form": "Tablet", "status": "approved", "evidence": "confirmed", "subtitle": "Approved 67 years ago and still the cheapest option · The only one not licensed for long-term use, yet often used that way", "note": "Outcomes — None.\n\nBoxed warning — None, but the label warns of primary pulmonary hypertension — described in the label as a rare, frequently fatal lung disease — and serious regurgitant cardiac valvular disease.\n\nHarms — Abuse and dependence potential; tolerance develops.\n\nGenerics — Long off patent, extremely cheap.\n\nPrice — As low as about $16/month in the US.\n\nSupply — None.", "unveiled_on": "1959-01-01", "last_verified_at": "2026-08-21T08:38:33+00:00", "values": { "brand": { "absent": false, "value": "Adipex-P, Lomaira, Duromine", "unit": null, "confidence": "confirmed", "qualifier": null, "observed_on": null, "verified_at": "2026-08-21T08:38:33+00:00", "citation": { "title": "FDA — Adipex-P label, rev. 01/2012", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/085128s065lbl.pdf", "publisher": "FDA", "kind": "regulator", "primary": true, "published_on": "2012-01-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "drug_class": { "absent": false, "value": "Sympathomimetic amine anorectic", "unit": null, "confidence": "confirmed", "qualifier": null, "observed_on": null, "verified_at": "2026-08-21T08:38:33+00:00", "citation": { "title": "FDA — Adipex-P label, rev. 01/2012", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/085128s065lbl.pdf", "publisher": "FDA", "kind": "regulator", "primary": true, "published_on": "2012-01-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "route": { "absent": false, "value": "Tablet, daily", "unit": null, "confidence": "confirmed", "qualifier": null, "observed_on": null, "verified_at": "2026-08-21T08:38:33+00:00", "citation": { "title": "FDA — Adipex-P label, rev. 01/2012", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/085128s065lbl.pdf", "publisher": "FDA", "kind": "regulator", "primary": true, "published_on": "2012-01-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "dose": { "absent": false, "value": "37.5 mg daily", "unit": null, "confidence": "confirmed", "qualifier": null, "observed_on": null, "verified_at": "2026-08-21T08:38:33+00:00", "citation": { "title": "FDA — Adipex-P label, rev. 01/2012", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/085128s065lbl.pdf", "publisher": "FDA", "kind": "regulator", "primary": true, "published_on": "2012-01-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "weight_change": { "absent": true, "reason": "Approved in 1959, before modern trial standards. There is no contemporary placebo-controlled pivotal trial with a percentage body-weight endpoint in the label. Literature suggests roughly 3–5 kg placebo-subtracted loss over 12–36 weeks, which is not a label-confirmed figure.", "confidence": "absent", "verified_at": "2026-08-21T08:38:33+00:00" }, "placebo_change": { "absent": true, "reason": "Approved in 1959, before modern trial standards. There is no contemporary placebo-controlled pivotal trial with a percentage body-weight endpoint in the label. Literature suggests roughly 3–5 kg placebo-subtracted loss over 12–36 weeks, which is not a label-confirmed figure.", "confidence": "absent", "verified_at": "2026-08-21T08:38:33+00:00" }, "placebo_adjusted": { "absent": true, "reason": "Approved in 1959, before modern trial standards. There is no contemporary placebo-controlled pivotal trial with a percentage body-weight endpoint in the label. Literature suggests roughly 3–5 kg placebo-subtracted loss over 12–36 weeks, which is not a label-confirmed figure.", "confidence": "absent", "verified_at": "2026-08-21T08:38:33+00:00" }, "trial": { "absent": true, "reason": "The sponsor has not named the pivotal trial.", "confidence": "absent", "verified_at": "2026-08-21T08:38:33+00:00" }, "trial_n": { "absent": true, "reason": "The trial's sample size has not been disclosed.", "confidence": "absent", "verified_at": "2026-08-21T08:38:33+00:00" }, "trial_weeks": { "absent": true, "reason": "The trial's duration has not been published.", "confidence": "absent", "verified_at": "2026-08-21T08:38:33+00:00" }, "discontinuation": { "absent": true, "reason": "Not published", "confidence": "absent", "verified_at": "2026-08-21T08:38:33+00:00" } }, "approvals": [ { "agency": "fda", "state": "approved", "decided_on": "1959-01-01", "date_precision": "month", "indication_official": "Schedule IV controlled substance. Indicated for SHORT-TERM use only — “a few weeks”. It is the only US obesity drug not indicated for chronic use, so long-term prescribing is off-label.", "note": null, "confidence": "confirmed", "verified_at": "2026-08-21T08:38:33+00:00", "citation": { "title": "FDA — Adipex-P label, rev. 01/2012", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/085128s065lbl.pdf", "publisher": "FDA", "kind": "regulator", "primary": true, "published_on": "2012-01-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "agency": "ema", "state": "none", "decided_on": null, "date_precision": "day", "indication_official": null, "note": "No centralised authorisation. A 2000 EMA referral restricted or withdrew many anorectics across the EU.", "confidence": "claim", "verified_at": "2026-08-21T08:38:33+00:00", "citation": null }, { "agency": "mhra", "state": "none", "decided_on": null, "date_precision": "day", "indication_official": null, "note": "Not licensed.", "confidence": "claim", "verified_at": "2026-08-21T08:38:33+00:00", "citation": null }, { "agency": "anvisa", "state": "none", "decided_on": null, "date_precision": "day", "indication_official": null, "note": "Not registered in Brazil.", "confidence": "claim", "verified_at": "2026-08-21T08:38:33+00:00", "citation": null }, { "agency": "pmda", "state": "none", "decided_on": null, "date_precision": "day", "indication_official": null, "note": "Not approved.", "confidence": "claim", "verified_at": "2026-08-21T08:38:33+00:00", "citation": null }, { "agency": "nmpa", "state": "none", "decided_on": null, "date_precision": "day", "indication_official": null, "note": "Not approved.", "confidence": "claim", "verified_at": "2026-08-21T08:38:33+00:00", "citation": null }, { "agency": "hc", "state": "approved", "decided_on": null, "date_precision": "day", "indication_official": "Approved for short-term use.", "note": null, "confidence": "claim", "verified_at": "2026-08-21T08:38:33+00:00", "citation": null }, { "agency": "tga", "state": "approved", "decided_on": null, "date_precision": "day", "indication_official": "Registered as Duromine / Metermine.", "note": null, "confidence": "claim", "verified_at": "2026-08-21T08:38:33+00:00", "citation": null } ] }, { "slug": "setmelanotide", "name": "Setmelanotide", "maker": "Rhythm Pharmaceuticals", "country": null, "region": null, "form": "Injection", "status": "approved", "evidence": "confirmed", "subtitle": "Not a general obesity drug — it treats specific genetic and acquired defects in the melanocortin pathway · Shows what obesity medicine looks like when the mechanism is known precisely", "note": "Outcomes — None; the populations are too small.\n\nBoxed warning — None.\n\nHarms — Skin hyperpigmentation, nausea, vomiting, headache in over 20%. Depression and suicidal ideation monitoring; spontaneous penile erections.\n\nGenerics — None; orphan exclusivity.\n\nPrice — About $3,706 per vial in the US. Annual cost widely reported in the high six figures but not corroborated by a primary source.\n\nSupply — None.", "unveiled_on": "2020-11-25", "last_verified_at": "2026-08-21T08:38:33+00:00", "values": { "brand": { "absent": false, "value": "Imcivree", "unit": null, "confidence": "confirmed", "qualifier": null, "observed_on": null, "verified_at": "2026-08-21T08:38:33+00:00", "citation": { "title": "EMA — Imcivree EPAR", "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/imcivree", "publisher": "EMA", "kind": "regulator", "primary": true, "published_on": "2026-08-20", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "drug_class": { "absent": false, "value": "MC4R agonist", "unit": null, "confidence": "confirmed", "qualifier": null, "observed_on": null, "verified_at": "2026-08-21T08:38:33+00:00", "citation": { "title": "EMA — Imcivree EPAR", "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/imcivree", "publisher": "EMA", "kind": "regulator", "primary": true, "published_on": "2026-08-20", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "route": { "absent": false, "value": "Injection, daily", "unit": null, "confidence": "confirmed", "qualifier": null, "observed_on": null, "verified_at": "2026-08-21T08:38:33+00:00", "citation": { "title": "EMA — Imcivree EPAR", "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/imcivree", "publisher": "EMA", "kind": "regulator", "primary": true, "published_on": "2026-08-20", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "dose": { "absent": false, "value": "Titrated by age and weight, up to 3 mg daily", "unit": null, "confidence": "confirmed", "qualifier": null, "observed_on": null, "verified_at": "2026-08-21T08:38:33+00:00", "citation": { "title": "EMA — Imcivree EPAR", "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/imcivree", "publisher": "EMA", "kind": "regulator", "primary": true, "published_on": "2026-08-20", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "weight_change": { "absent": false, "value": -15.8, "unit": "%", "confidence": "confirmed", "qualifier": "mean BMI change · Rhythm / FDA approval", "observed_on": null, "verified_at": "2026-08-21T08:38:33+00:00", "citation": { "title": "EMA — Imcivree EPAR", "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/imcivree", "publisher": "EMA", "kind": "regulator", "primary": true, "published_on": "2026-08-20", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "placebo_change": { "absent": false, "value": 2.6, "unit": "%", "confidence": "confirmed", "qualifier": "mean BMI change · Rhythm / FDA approval", "observed_on": null, "verified_at": "2026-08-21T08:38:33+00:00", "citation": { "title": "EMA — Imcivree EPAR", "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/imcivree", "publisher": "EMA", "kind": "regulator", "primary": true, "published_on": "2026-08-20", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "placebo_adjusted": { "absent": false, "value": -18.4, "unit": "pp", "confidence": "confirmed", "qualifier": "mean BMI change · Rhythm / FDA approval", "observed_on": null, "verified_at": "2026-08-21T08:38:33+00:00", "citation": { "title": "EMA — Imcivree EPAR", "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/imcivree", "publisher": "EMA", "kind": "regulator", "primary": true, "published_on": "2026-08-20", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "trial": { "absent": false, "value": "TRANSCEND", "unit": null, "confidence": "confirmed", "qualifier": "mean BMI change · Rhythm / FDA approval", "observed_on": null, "verified_at": "2026-08-21T08:38:33+00:00", "citation": { "title": "EMA — Imcivree EPAR", "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/imcivree", "publisher": "EMA", "kind": "regulator", "primary": true, "published_on": "2026-08-20", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "trial_n": { "absent": false, "value": 142, "unit": null, "confidence": "confirmed", "qualifier": null, "observed_on": null, "verified_at": "2026-08-21T08:38:33+00:00", "citation": { "title": "EMA — Imcivree EPAR", "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/imcivree", "publisher": "EMA", "kind": "regulator", "primary": true, "published_on": "2026-08-20", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "trial_weeks": { "absent": false, "value": 52, "unit": "weeks", "confidence": "confirmed", "qualifier": null, "observed_on": null, "verified_at": "2026-08-21T08:38:33+00:00", "citation": { "title": "EMA — Imcivree EPAR", "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/imcivree", "publisher": "EMA", "kind": "regulator", "primary": true, "published_on": "2026-08-20", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "discontinuation": { "absent": true, "reason": "Not published", "confidence": "absent", "verified_at": "2026-08-21T08:38:33+00:00" } }, "approvals": [ { "agency": "fda", "state": "approved", "decided_on": "2020-11-25", "date_precision": "day", "indication_official": "For genetically confirmed POMC, PCSK1 or LEPR deficiency; Bardet–Biedl syndrome added 2022; acquired hypothalamic obesity added 19 Mar 2026.", "note": null, "confidence": "claim", "verified_at": "2026-08-21T08:38:33+00:00", "citation": null }, { "agency": "ema", "state": "approved", "decided_on": "2026-03-27", "date_precision": "day", "indication_official": "Covers the genetic indications. For acquired hypothalamic obesity: CHMP positive opinion 27 Mar 2026, European Commission authorisation announced 1 May 2026. EMA does not publish the Commission decision date, so we carry the opinion date.", "note": null, "confidence": "confirmed", "verified_at": "2026-08-21T08:38:33+00:00", "citation": { "title": "EMA — Imcivree EPAR", "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/imcivree", "publisher": "EMA", "kind": "regulator", "primary": true, "published_on": "2026-08-20", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "agency": "mhra", "state": "approved", "decided_on": null, "date_precision": "day", "indication_official": "Licensed for the genetic obesity indications; status of the hypothalamic obesity extension not established.", "note": null, "confidence": "claim", "verified_at": "2026-08-21T08:38:33+00:00", "citation": null }, { "agency": "anvisa", "state": "none", "decided_on": null, "date_precision": "day", "indication_official": null, "note": "No approval found.", "confidence": "claim", "verified_at": "2026-08-21T08:38:33+00:00", "citation": null }, { "agency": "pmda", "state": "none", "decided_on": null, "date_precision": "day", "indication_official": null, "note": "No approval found.", "confidence": "claim", "verified_at": "2026-08-21T08:38:33+00:00", "citation": null }, { "agency": "nmpa", "state": "none", "decided_on": null, "date_precision": "day", "indication_official": null, "note": "No approval found.", "confidence": "claim", "verified_at": "2026-08-21T08:38:33+00:00", "citation": null }, { "agency": "hc", "state": "none", "decided_on": null, "date_precision": "day", "indication_official": null, "note": "No approval found; a pharmacoeconomic review exists, suggesting a submission.", "confidence": "claim", "verified_at": "2026-08-21T08:38:33+00:00", "citation": null }, { "agency": "tga", "state": "none", "decided_on": null, "date_precision": "day", "indication_official": null, "note": "No approval found.", "confidence": "claim", "verified_at": "2026-08-21T08:38:33+00:00", "citation": null } ] }, { "slug": "metreleptin", "name": "Metreleptin", "maker": "Amryt / Chiesi", "country": null, "region": null, "form": "Injection", "status": "approved", "evidence": "confirmed", "subtitle": "Routinely miscategorised as an obesity drug — it is a replacement therapy for a hormone people are missing", "note": "Outcomes — None.\n\nBoxed warning — Two components: neutralising anti-metreleptin antibodies that can cause loss of efficacy and severe infection; and risk of T-cell lymphoma. Available only through a restricted programme.\n\nHarms — Headache, hypoglycaemia, abdominal pain.\n\nGenerics — None.\n\nPrice — Not disclosed in any primary source. Widely reported above $700,000 a year.\n\nSupply — None.", "unveiled_on": "2014-02-24", "last_verified_at": "2026-08-21T08:38:33+00:00", "values": { "brand": { "absent": false, "value": "Myalept (US) / Myalepta (EU)", "unit": null, "confidence": "confirmed", "qualifier": null, "observed_on": null, "verified_at": "2026-08-21T08:38:33+00:00", "citation": { "title": "FDA — Myalept label", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125390s004lbl.pdf", "publisher": "FDA", "kind": "regulator", "primary": true, "published_on": "2014-02-24", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "drug_class": { "absent": false, "value": "Recombinant leptin analogue", "unit": null, "confidence": "confirmed", "qualifier": null, "observed_on": null, "verified_at": "2026-08-21T08:38:33+00:00", "citation": { "title": "FDA — Myalept label", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125390s004lbl.pdf", "publisher": "FDA", "kind": "regulator", "primary": true, "published_on": "2014-02-24", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "route": { "absent": false, "value": "Injection, daily", "unit": null, "confidence": "confirmed", "qualifier": null, "observed_on": null, "verified_at": "2026-08-21T08:38:33+00:00", "citation": { "title": "FDA — Myalept label", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125390s004lbl.pdf", "publisher": "FDA", "kind": "regulator", "primary": true, "published_on": "2014-02-24", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "dose": { "absent": false, "value": "Up to 10 mg daily", "unit": null, "confidence": "confirmed", "qualifier": null, "observed_on": null, "verified_at": "2026-08-21T08:38:33+00:00", "citation": { "title": "FDA — Myalept label", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125390s004lbl.pdf", "publisher": "FDA", "kind": "regulator", "primary": true, "published_on": "2014-02-24", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "weight_change": { "absent": true, "reason": "No randomised placebo-controlled trial exists, by design — the condition is too rare. A placebo-adjusted figure cannot exist for this product.", "confidence": "absent", "verified_at": "2026-08-21T08:38:33+00:00" }, "placebo_change": { "absent": true, "reason": "No randomised placebo-controlled trial exists, by design — the condition is too rare. A placebo-adjusted figure cannot exist for this product.", "confidence": "absent", "verified_at": "2026-08-21T08:38:33+00:00" }, "placebo_adjusted": { "absent": true, "reason": "No randomised placebo-controlled trial exists, by design — the condition is too rare. A placebo-adjusted figure cannot exist for this product.", "confidence": "absent", "verified_at": "2026-08-21T08:38:33+00:00" }, "trial": { "absent": false, "value": "NIH open-label cohort", "unit": null, "confidence": "confirmed", "qualifier": null, "observed_on": null, "verified_at": "2026-08-21T08:38:33+00:00", "citation": { "title": "FDA — Myalept label", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125390s004lbl.pdf", "publisher": "FDA", "kind": "regulator", "primary": true, "published_on": "2014-02-24", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "trial_n": { "absent": false, "value": 107, "unit": null, "confidence": "confirmed", "qualifier": null, "observed_on": null, "verified_at": "2026-08-21T08:38:33+00:00", "citation": { "title": "FDA — Myalept label", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125390s004lbl.pdf", "publisher": "FDA", "kind": "regulator", "primary": true, "published_on": "2014-02-24", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "trial_weeks": { "absent": true, "reason": "The trial's duration has not been published.", "confidence": "absent", "verified_at": "2026-08-21T08:38:33+00:00" }, "discontinuation": { "absent": true, "reason": "Not published", "confidence": "absent", "verified_at": "2026-08-21T08:38:33+00:00" } }, "approvals": [ { "agency": "fda", "state": "approved", "decided_on": "2014-02-24", "date_precision": "day", "indication_official": "Only for complications of leptin deficiency in generalised lipodystrophy. The label explicitly excludes partial lipodystrophy, liver disease, HIV-related lipodystrophy and metabolic disease without generalised lipodystrophy.", "note": null, "confidence": "confirmed", "verified_at": "2026-08-21T08:38:33+00:00", "citation": { "title": "FDA — Myalept label", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125390s004lbl.pdf", "publisher": "FDA", "kind": "regulator", "primary": true, "published_on": "2014-02-24", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "agency": "ema", "state": "approved", "decided_on": "2018-07-30", "date_precision": "day", "indication_official": "Broader than the US: also covers familial and acquired partial lipodystrophy from age 12 where standard treatment has failed.", "note": null, "confidence": "confirmed", "verified_at": "2026-08-21T08:38:33+00:00", "citation": { "title": "EMA — Myalepta EPAR", "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/myalepta", "publisher": "EMA", "kind": "regulator", "primary": true, "published_on": "2026-08-20", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "agency": "mhra", "state": "approved", "decided_on": null, "date_precision": "day", "indication_official": "Licensed.", "note": null, "confidence": "claim", "verified_at": "2026-08-21T08:38:33+00:00", "citation": null }, { "agency": "anvisa", "state": "none", "decided_on": null, "date_precision": "day", "indication_official": null, "note": "No approval found.", "confidence": "claim", "verified_at": "2026-08-21T08:38:33+00:00", "citation": null }, { "agency": "pmda", "state": "approved", "decided_on": null, "date_precision": "day", "indication_official": "Approved for lipodystrophy.", "note": null, "confidence": "claim", "verified_at": "2026-08-21T08:38:33+00:00", "citation": null }, { "agency": "nmpa", "state": "none", "decided_on": null, "date_precision": "day", "indication_official": null, "note": "No approval found.", "confidence": "claim", "verified_at": "2026-08-21T08:38:33+00:00", "citation": null }, { "agency": "hc", "state": "none", "decided_on": null, "date_precision": "day", "indication_official": null, "note": "No approval found.", "confidence": "claim", "verified_at": "2026-08-21T08:38:33+00:00", "citation": null }, { "agency": "tga", "state": "none", "decided_on": null, "date_precision": "day", "indication_official": null, "note": "No approval found.", "confidence": "claim", "verified_at": "2026-08-21T08:38:33+00:00", "citation": null } ] }, { "slug": "mazdutide", "name": "Mazdutide", "maker": "Innovent Biologics", "country": null, "region": null, "form": "Injection", "status": "approved", "evidence": "stated", "subtitle": "“Approved in China” is not “approved” — this is a common grey-market talking point", "note": "Outcomes — None.\n\nBoxed warning — Not established in an accessible label.\n\nHarms — Gastrointestinal effects predominate. Glucagon agonism raises theoretical questions about heart rate and hepatic effects. Incidence figures not in an accessible primary source.\n\nGenerics — None.\n\nPrice — Not corroborated.\n\nSupply — Not known.", "unveiled_on": "2025-06-27", "last_verified_at": "2026-08-21T08:38:33+00:00", "values": { "brand": { "absent": false, "value": "Xin Er Mei (信尔美)", "unit": null, "confidence": "stated", "qualifier": null, "observed_on": null, "verified_at": "2026-08-21T08:38:33+00:00", "citation": { "title": "Innovent — NMPA approval for chronic weight management", "url": "https://www.prnewswire.com/news-releases/innovent-announces-mazdutide-first-dual-gcgglp-1-receptor-agonist-received-approval-from-chinas-nmpa-for-chronic-weight-management-302493152.html", "publisher": "Innovent", "kind": "press", "primary": false, "published_on": "2025-06-27", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "drug_class": { "absent": false, "value": "Dual glucagon + GLP-1 receptor agonist", "unit": null, "confidence": "stated", "qualifier": null, "observed_on": null, "verified_at": "2026-08-21T08:38:33+00:00", "citation": { "title": "Innovent — NMPA approval for chronic weight management", "url": "https://www.prnewswire.com/news-releases/innovent-announces-mazdutide-first-dual-gcgglp-1-receptor-agonist-received-approval-from-chinas-nmpa-for-chronic-weight-management-302493152.html", "publisher": "Innovent", "kind": "press", "primary": false, "published_on": "2025-06-27", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "route": { "absent": false, "value": "Injection, weekly", "unit": null, "confidence": "stated", "qualifier": null, "observed_on": null, "verified_at": "2026-08-21T08:38:33+00:00", "citation": { "title": "Innovent — NMPA approval for chronic weight management", "url": "https://www.prnewswire.com/news-releases/innovent-announces-mazdutide-first-dual-gcgglp-1-receptor-agonist-received-approval-from-chinas-nmpa-for-chronic-weight-management-302493152.html", "publisher": "Innovent", "kind": "press", "primary": false, "published_on": "2025-06-27", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "dose": { "absent": false, "value": "4 mg or 6 mg weekly", "unit": null, "confidence": "stated", "qualifier": null, "observed_on": null, "verified_at": "2026-08-21T08:38:33+00:00", "citation": { "title": "Innovent — NMPA approval for chronic weight management", "url": "https://www.prnewswire.com/news-releases/innovent-announces-mazdutide-first-dual-gcgglp-1-receptor-agonist-received-approval-from-chinas-nmpa-for-chronic-weight-management-302493152.html", "publisher": "Innovent", "kind": "press", "primary": false, "published_on": "2025-06-27", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "weight_change": { "absent": false, "value": -14.8, "unit": "%", "confidence": "confirmed", "qualifier": "efficacy estimand, 6 mg · Innovent / Drugs 2025", "observed_on": null, "verified_at": "2026-08-21T08:38:33+00:00", "citation": { "title": "Mazdutide: First Approval, Drugs 2025 — PubMed 41028652", "url": "https://pubmed.ncbi.nlm.nih.gov/41028652/", "publisher": "Mazdutide: First Approval, Drugs 2025", "kind": "journal", "primary": true, "published_on": "2025-09-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "placebo_change": { "absent": false, "value": -0.5, "unit": "%", "confidence": "confirmed", "qualifier": "efficacy estimand, 6 mg · Innovent / Drugs 2025", "observed_on": null, "verified_at": "2026-08-21T08:38:33+00:00", "citation": { "title": "Mazdutide: First Approval, Drugs 2025 — PubMed 41028652", "url": "https://pubmed.ncbi.nlm.nih.gov/41028652/", "publisher": "Mazdutide: First Approval, Drugs 2025", "kind": "journal", "primary": true, "published_on": "2025-09-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "placebo_adjusted": { "absent": false, "value": -14.3, "unit": "pp", "confidence": "confirmed", "qualifier": "efficacy estimand, 6 mg · Innovent / Drugs 2025", "observed_on": null, "verified_at": "2026-08-21T08:38:33+00:00", "citation": { "title": "Mazdutide: First Approval, Drugs 2025 — PubMed 41028652", "url": "https://pubmed.ncbi.nlm.nih.gov/41028652/", "publisher": "Mazdutide: First Approval, Drugs 2025", "kind": "journal", "primary": true, "published_on": "2025-09-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "trial": { "absent": false, "value": "GLORY-1", "unit": null, "confidence": "confirmed", "qualifier": "efficacy estimand, 6 mg · Innovent / Drugs 2025", "observed_on": null, "verified_at": "2026-08-21T08:38:33+00:00", "citation": { "title": "Mazdutide: First Approval, Drugs 2025 — PubMed 41028652", "url": "https://pubmed.ncbi.nlm.nih.gov/41028652/", "publisher": "Mazdutide: First Approval, Drugs 2025", "kind": "journal", "primary": true, "published_on": "2025-09-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "trial_n": { "absent": true, "reason": "The trial's sample size has not been disclosed.", "confidence": "absent", "verified_at": "2026-08-21T08:38:33+00:00" }, "trial_weeks": { "absent": false, "value": 48, "unit": "weeks", "confidence": "confirmed", "qualifier": null, "observed_on": null, "verified_at": "2026-08-21T08:38:33+00:00", "citation": { "title": "Mazdutide: First Approval, Drugs 2025 — PubMed 41028652", "url": "https://pubmed.ncbi.nlm.nih.gov/41028652/", "publisher": "Mazdutide: First Approval, Drugs 2025", "kind": "journal", "primary": true, "published_on": "2025-09-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "discontinuation": { "absent": true, "reason": "Not published", "confidence": "absent", "verified_at": "2026-08-21T08:38:33+00:00" } }, "approvals": [ { "agency": "fda", "state": "none", "decided_on": null, "date_precision": "day", "indication_official": null, "note": "Not approved.", "confidence": "claim", "verified_at": "2026-08-21T08:38:33+00:00", "citation": null }, { "agency": "ema", "state": "none", "decided_on": null, "date_precision": "day", "indication_official": null, "note": "Not approved.", "confidence": "claim", "verified_at": "2026-08-21T08:38:33+00:00", "citation": null }, { "agency": "mhra", "state": "none", "decided_on": null, "date_precision": "day", "indication_official": null, "note": "Not approved.", "confidence": "claim", "verified_at": "2026-08-21T08:38:33+00:00", "citation": null }, { "agency": "anvisa", "state": "none", "decided_on": null, "date_precision": "day", "indication_official": null, "note": "Not approved.", "confidence": "claim", "verified_at": "2026-08-21T08:38:33+00:00", "citation": null }, { "agency": "pmda", "state": "none", "decided_on": null, "date_precision": "day", "indication_official": null, "note": "Not approved.", "confidence": "claim", "verified_at": "2026-08-21T08:38:33+00:00", "citation": null }, { "agency": "nmpa", "state": "approved", "decided_on": "2025-06-27", "date_precision": "day", "indication_official": "First dual glucagon/GLP-1 agonist approved anywhere. Date is the sponsor's announcement date — NMPA's own database is not machine-accessible, so the regulator's decision date could not be independently confirmed. Note the China-specific thresholds: BMI ≥28 for obesity, ≥24 with a comorbidity — lower than the Western 30 and 27.", "note": null, "confidence": "stated", "verified_at": "2026-08-21T08:38:33+00:00", "citation": { "title": "Innovent — NMPA approval for chronic weight management", "url": "https://www.prnewswire.com/news-releases/innovent-announces-mazdutide-first-dual-gcgglp-1-receptor-agonist-received-approval-from-chinas-nmpa-for-chronic-weight-management-302493152.html", "publisher": "Innovent", "kind": "press", "primary": false, "published_on": "2025-06-27", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "agency": "hc", "state": "none", "decided_on": null, "date_precision": "day", "indication_official": null, "note": "Not approved.", "confidence": "claim", "verified_at": "2026-08-21T08:38:33+00:00", "citation": null }, { "agency": "tga", "state": "none", "decided_on": null, "date_precision": "day", "indication_official": null, "note": "Not approved.", "confidence": "claim", "verified_at": "2026-08-21T08:38:33+00:00", "citation": null } ] }, { "slug": "ecnoglutide", "name": "Ecnoglutide", "maker": "Sciwind Biosciences", "country": null, "region": null, "form": "Injection", "status": "approved", "evidence": "stated", "subtitle": "Approved on data that has never been peer-reviewed and whose sample size is undisclosed", "note": "Outcomes — None.\n\nBoxed warning — Not established in an accessible label.\n\nHarms — Not published in an accessible primary source.\n\nGenerics — None.\n\nPrice — Not disclosed.\n\nSupply — Not known.", "unveiled_on": "2026-03-06", "last_verified_at": "2026-08-21T08:38:33+00:00", "values": { "brand": { "absent": false, "value": "Ecnoglutide (brand not disclosed)", "unit": null, "confidence": "stated", "qualifier": null, "observed_on": null, "verified_at": "2026-08-21T08:38:33+00:00", "citation": { "title": "Sciwind — NMPA approval of ecnoglutide", "url": "https://www.prnewswire.com/news-releases/sciwind-biosciences-announces-ecnoglutide-injection-approved-by-chinas-national-medical-products-administration-nmpa-for-chronic-weight-management-302706442.html", "publisher": "Sciwind", "kind": "press", "primary": false, "published_on": "2026-03-06", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "drug_class": { "absent": false, "value": "cAMP-biased GLP-1 receptor agonist", "unit": null, "confidence": "stated", "qualifier": null, "observed_on": null, "verified_at": "2026-08-21T08:38:33+00:00", "citation": { "title": "Sciwind — NMPA approval of ecnoglutide", "url": "https://www.prnewswire.com/news-releases/sciwind-biosciences-announces-ecnoglutide-injection-approved-by-chinas-national-medical-products-administration-nmpa-for-chronic-weight-management-302706442.html", "publisher": "Sciwind", "kind": "press", "primary": false, "published_on": "2026-03-06", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "route": { "absent": false, "value": "Injection, weekly", "unit": null, "confidence": "stated", "qualifier": null, "observed_on": null, "verified_at": "2026-08-21T08:38:33+00:00", "citation": { "title": "Sciwind — NMPA approval of ecnoglutide", "url": "https://www.prnewswire.com/news-releases/sciwind-biosciences-announces-ecnoglutide-injection-approved-by-chinas-national-medical-products-administration-nmpa-for-chronic-weight-management-302706442.html", "publisher": "Sciwind", "kind": "press", "primary": false, "published_on": "2026-03-06", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "dose": { "absent": false, "value": "2.4 mg weekly", "unit": null, "confidence": "stated", "qualifier": null, "observed_on": null, "verified_at": "2026-08-21T08:38:33+00:00", "citation": { "title": "Sciwind — NMPA approval of ecnoglutide", "url": "https://www.prnewswire.com/news-releases/sciwind-biosciences-announces-ecnoglutide-injection-approved-by-chinas-national-medical-products-administration-nmpa-for-chronic-weight-management-302706442.html", "publisher": "Sciwind", "kind": "press", "primary": false, "published_on": "2026-03-06", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "weight_change": { "absent": false, "value": -15.4, "unit": "%", "confidence": "stated", "qualifier": "company-reported · Sciwind release", "observed_on": null, "verified_at": "2026-08-21T08:38:33+00:00", "citation": { "title": "Sciwind — NMPA approval of ecnoglutide", "url": "https://www.prnewswire.com/news-releases/sciwind-biosciences-announces-ecnoglutide-injection-approved-by-chinas-national-medical-products-administration-nmpa-for-chronic-weight-management-302706442.html", "publisher": "Sciwind", "kind": "press", "primary": false, "published_on": "2026-03-06", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "placebo_change": { "absent": false, "value": -0.3, "unit": "%", "confidence": "stated", "qualifier": "company-reported · Sciwind release", "observed_on": null, "verified_at": "2026-08-21T08:38:33+00:00", "citation": { "title": "Sciwind — NMPA approval of ecnoglutide", "url": "https://www.prnewswire.com/news-releases/sciwind-biosciences-announces-ecnoglutide-injection-approved-by-chinas-national-medical-products-administration-nmpa-for-chronic-weight-management-302706442.html", "publisher": "Sciwind", "kind": "press", "primary": false, "published_on": "2026-03-06", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "placebo_adjusted": { "absent": false, "value": -15.1, "unit": "pp", "confidence": "stated", "qualifier": "company-reported · Sciwind release", "observed_on": null, "verified_at": "2026-08-21T08:38:33+00:00", "citation": { "title": "Sciwind — NMPA approval of ecnoglutide", "url": "https://www.prnewswire.com/news-releases/sciwind-biosciences-announces-ecnoglutide-injection-approved-by-chinas-national-medical-products-administration-nmpa-for-chronic-weight-management-302706442.html", "publisher": "Sciwind", "kind": "press", "primary": false, "published_on": "2026-03-06", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "trial": { "absent": false, "value": "SLIMMER", "unit": null, "confidence": "stated", "qualifier": "company-reported · Sciwind release", "observed_on": null, "verified_at": "2026-08-21T08:38:33+00:00", "citation": { "title": "Sciwind — NMPA approval of ecnoglutide", "url": "https://www.prnewswire.com/news-releases/sciwind-biosciences-announces-ecnoglutide-injection-approved-by-chinas-national-medical-products-administration-nmpa-for-chronic-weight-management-302706442.html", "publisher": "Sciwind", "kind": "press", "primary": false, "published_on": "2026-03-06", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "trial_n": { "absent": true, "reason": "The trial's sample size has not been disclosed.", "confidence": "absent", "verified_at": "2026-08-21T08:38:33+00:00" }, "trial_weeks": { "absent": false, "value": 48, "unit": "weeks", "confidence": "stated", "qualifier": null, "observed_on": null, "verified_at": "2026-08-21T08:38:33+00:00", "citation": { "title": "Sciwind — NMPA approval of ecnoglutide", "url": "https://www.prnewswire.com/news-releases/sciwind-biosciences-announces-ecnoglutide-injection-approved-by-chinas-national-medical-products-administration-nmpa-for-chronic-weight-management-302706442.html", "publisher": "Sciwind", "kind": "press", "primary": false, "published_on": "2026-03-06", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "discontinuation": { "absent": true, "reason": "Not published", "confidence": "absent", "verified_at": "2026-08-21T08:38:33+00:00" } }, "approvals": [ { "agency": "fda", "state": "none", "decided_on": null, "date_precision": "day", "indication_official": null, "note": "Not approved.", "confidence": "claim", "verified_at": "2026-08-21T08:38:33+00:00", "citation": null }, { "agency": "ema", "state": "none", "decided_on": null, "date_precision": "day", "indication_official": null, "note": "Not approved.", "confidence": "claim", "verified_at": "2026-08-21T08:38:33+00:00", "citation": null }, { "agency": "mhra", "state": "none", "decided_on": null, "date_precision": "day", "indication_official": null, "note": "Not approved.", "confidence": "claim", "verified_at": "2026-08-21T08:38:33+00:00", "citation": null }, { "agency": "anvisa", "state": "none", "decided_on": null, "date_precision": "day", "indication_official": null, "note": "Not approved.", "confidence": "claim", "verified_at": "2026-08-21T08:38:33+00:00", "citation": null }, { "agency": "pmda", "state": "none", "decided_on": null, "date_precision": "day", "indication_official": null, "note": "Not approved.", "confidence": "claim", "verified_at": "2026-08-21T08:38:33+00:00", "citation": null }, { "agency": "nmpa", "state": "approved", "decided_on": "2026-03-06", "date_precision": "day", "indication_official": "Chronic weight management in Chinese adults with overweight or obesity. Date comes from the sponsor's announcement; NMPA's database is not machine-accessible, so it is not regulator-confirmed.", "note": null, "confidence": "stated", "verified_at": "2026-08-21T08:38:33+00:00", "citation": { "title": "Sciwind — NMPA approval of ecnoglutide", "url": "https://www.prnewswire.com/news-releases/sciwind-biosciences-announces-ecnoglutide-injection-approved-by-chinas-national-medical-products-administration-nmpa-for-chronic-weight-management-302706442.html", "publisher": "Sciwind", "kind": "press", "primary": false, "published_on": "2026-03-06", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "agency": "hc", "state": "none", "decided_on": null, "date_precision": "day", "indication_official": null, "note": "Not approved.", "confidence": "claim", "verified_at": "2026-08-21T08:38:33+00:00", "citation": null }, { "agency": "tga", "state": "none", "decided_on": null, "date_precision": "day", "indication_official": null, "note": "Not approved.", "confidence": "claim", "verified_at": "2026-08-21T08:38:33+00:00", "citation": null } ] }, { "slug": "retatrutide", "name": "Retatrutide", "maker": "Eli Lilly", "country": null, "region": null, "form": null, "status": "phase-3", "evidence": "stated", "subtitle": "Triple GLP-1 / GIP / glucagon agonist", "note": "Filing slipped to Q1 2027 for manufacturing and quality data. The cardiovascular outcomes trial does not complete until Feb 2029.\n\nTRIUMPH-2 and -3, in people with diabetes and with cardiovascular disease, came in materially lower at roughly 21% and 23%. A dysesthesia signal appeared in 8.8–20.9% of participants in TRIUMPH-4 versus 0.7% on placebo.", "unveiled_on": null, "last_verified_at": "2026-08-21T08:38:33+00:00", "values": { "drug_class": { "absent": false, "value": "Triple GLP-1 / GIP / glucagon agonist", "unit": null, "confidence": "stated", "qualifier": null, "observed_on": null, "verified_at": "2026-08-21T08:38:33+00:00", "citation": { "title": "Retatrutide — Eli Lilly", "url": "https://www.prnewswire.com/news-releases/lillys-triple-agonist-retatrutide-delivered-powerful-weight-loss-in-pivotal-phase-3-obesity-trial-302778859.html", "publisher": "Retatrutide", "kind": "press", "primary": false, "published_on": null, "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "weight_change": { "absent": false, "value": -28.3, "unit": "%", "confidence": "stated", "qualifier": "TRIUMPH-1, N=2,339, 80 weeks", "observed_on": null, "verified_at": "2026-08-21T08:38:33+00:00", "citation": { "title": "Retatrutide — Eli Lilly", "url": "https://www.prnewswire.com/news-releases/lillys-triple-agonist-retatrutide-delivered-powerful-weight-loss-in-pivotal-phase-3-obesity-trial-302778859.html", "publisher": "Retatrutide", "kind": "press", "primary": false, "published_on": null, "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "placebo_change": { "absent": false, "value": -2.2, "unit": "%", "confidence": "stated", "qualifier": "TRIUMPH-1, N=2,339, 80 weeks", "observed_on": null, "verified_at": "2026-08-21T08:38:33+00:00", "citation": { "title": "Retatrutide — Eli Lilly", "url": "https://www.prnewswire.com/news-releases/lillys-triple-agonist-retatrutide-delivered-powerful-weight-loss-in-pivotal-phase-3-obesity-trial-302778859.html", "publisher": "Retatrutide", "kind": "press", "primary": false, "published_on": null, "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "placebo_adjusted": { "absent": false, "value": -26.1, "unit": "pp", "confidence": "stated", "qualifier": "TRIUMPH-1, N=2,339, 80 weeks", "observed_on": null, "verified_at": "2026-08-21T08:38:33+00:00", "citation": { "title": "Retatrutide — Eli Lilly", "url": "https://www.prnewswire.com/news-releases/lillys-triple-agonist-retatrutide-delivered-powerful-weight-loss-in-pivotal-phase-3-obesity-trial-302778859.html", "publisher": "Retatrutide", "kind": "press", "primary": false, "published_on": null, "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "trial": { "absent": false, "value": "TRIUMPH-1", "unit": null, "confidence": "stated", "qualifier": "TRIUMPH-1, N=2,339, 80 weeks", "observed_on": null, "verified_at": "2026-08-21T08:38:33+00:00", "citation": { "title": "Retatrutide — Eli Lilly", "url": "https://www.prnewswire.com/news-releases/lillys-triple-agonist-retatrutide-delivered-powerful-weight-loss-in-pivotal-phase-3-obesity-trial-302778859.html", "publisher": "Retatrutide", "kind": "press", "primary": false, "published_on": null, "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "trial_n": { "absent": false, "value": 2339, "unit": null, "confidence": "stated", "qualifier": "TRIUMPH-1, N=2,339, 80 weeks", "observed_on": null, "verified_at": "2026-08-21T08:38:33+00:00", "citation": { "title": "Retatrutide — Eli Lilly", "url": "https://www.prnewswire.com/news-releases/lillys-triple-agonist-retatrutide-delivered-powerful-weight-loss-in-pivotal-phase-3-obesity-trial-302778859.html", "publisher": "Retatrutide", "kind": "press", "primary": false, "published_on": null, "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "trial_weeks": { "absent": false, "value": 80, "unit": "weeks", "confidence": "stated", "qualifier": "TRIUMPH-1, N=2,339, 80 weeks", "observed_on": null, "verified_at": "2026-08-21T08:38:33+00:00", "citation": { "title": "Retatrutide — Eli Lilly", "url": "https://www.prnewswire.com/news-releases/lillys-triple-agonist-retatrutide-delivered-powerful-weight-loss-in-pivotal-phase-3-obesity-trial-302778859.html", "publisher": "Retatrutide", "kind": "press", "primary": false, "published_on": null, "retrieved_at": "2026-08-20T00:00:00+00:00" } } } }, { "slug": "cagrisema", "name": "CagriSema", "maker": "Novo Nordisk", "country": null, "region": null, "form": null, "status": "filed", "evidence": "claim", "subtitle": "Amylin analogue + GLP-1 agonist", "note": "US application submitted 18 Dec 2025; no confirmed decision date. No EU submission verifiable from EMA sources.\n\nREDEFINE 4, the head-to-head against tirzepatide, MISSED its primary endpoint on 23 Feb 2026 — non-inferiority was not demonstrated. This is the single most under-reported fact in consumer coverage of this drug.", "unveiled_on": null, "last_verified_at": "2026-08-21T08:38:33+00:00", "values": { "drug_class": { "absent": false, "value": "Amylin analogue + GLP-1 agonist", "unit": null, "confidence": "claim", "qualifier": null, "observed_on": null, "verified_at": "2026-08-21T08:38:33+00:00", "citation": { "title": "CagriSema — Novo Nordisk", "url": "https://www.patientcareonline.com/view/cagrisema-achieves-23-weight-loss-but-misses-noninferiority-vs-tirzepatide-in-redefine-4", "publisher": "CagriSema", "kind": "trade", "primary": false, "published_on": null, "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "weight_change": { "absent": false, "value": -20.4, "unit": "%", "confidence": "claim", "qualifier": "REDEFINE 1, N=3,417, 68 weeks", "observed_on": null, "verified_at": "2026-08-21T08:38:33+00:00", "citation": { "title": "CagriSema — Novo Nordisk", "url": "https://www.patientcareonline.com/view/cagrisema-achieves-23-weight-loss-but-misses-noninferiority-vs-tirzepatide-in-redefine-4", "publisher": "CagriSema", "kind": "trade", "primary": false, "published_on": null, "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "placebo_change": { "absent": false, "value": -3, "unit": "%", "confidence": "claim", "qualifier": "REDEFINE 1, N=3,417, 68 weeks", "observed_on": null, "verified_at": "2026-08-21T08:38:33+00:00", "citation": { "title": "CagriSema — Novo Nordisk", "url": "https://www.patientcareonline.com/view/cagrisema-achieves-23-weight-loss-but-misses-noninferiority-vs-tirzepatide-in-redefine-4", "publisher": "CagriSema", "kind": "trade", "primary": false, "published_on": null, "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "placebo_adjusted": { "absent": false, "value": -17.4, "unit": "pp", "confidence": "claim", "qualifier": "REDEFINE 1, N=3,417, 68 weeks", "observed_on": null, "verified_at": "2026-08-21T08:38:33+00:00", "citation": { "title": "CagriSema — Novo Nordisk", "url": "https://www.patientcareonline.com/view/cagrisema-achieves-23-weight-loss-but-misses-noninferiority-vs-tirzepatide-in-redefine-4", "publisher": "CagriSema", "kind": "trade", "primary": false, "published_on": null, "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "trial": { "absent": false, "value": "REDEFINE 1", "unit": null, "confidence": "claim", "qualifier": "REDEFINE 1, N=3,417, 68 weeks", "observed_on": null, "verified_at": "2026-08-21T08:38:33+00:00", "citation": { "title": "CagriSema — Novo Nordisk", "url": "https://www.patientcareonline.com/view/cagrisema-achieves-23-weight-loss-but-misses-noninferiority-vs-tirzepatide-in-redefine-4", "publisher": "CagriSema", "kind": "trade", "primary": false, "published_on": null, "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "trial_n": { "absent": false, "value": 3417, "unit": null, "confidence": "claim", "qualifier": "REDEFINE 1, N=3,417, 68 weeks", "observed_on": null, "verified_at": "2026-08-21T08:38:33+00:00", "citation": { "title": "CagriSema — Novo Nordisk", "url": "https://www.patientcareonline.com/view/cagrisema-achieves-23-weight-loss-but-misses-noninferiority-vs-tirzepatide-in-redefine-4", "publisher": "CagriSema", "kind": "trade", "primary": false, "published_on": null, "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "trial_weeks": { "absent": false, "value": 68, "unit": "weeks", "confidence": "claim", "qualifier": "REDEFINE 1, N=3,417, 68 weeks", "observed_on": null, "verified_at": "2026-08-21T08:38:33+00:00", "citation": { "title": "CagriSema — Novo Nordisk", "url": "https://www.patientcareonline.com/view/cagrisema-achieves-23-weight-loss-but-misses-noninferiority-vs-tirzepatide-in-redefine-4", "publisher": "CagriSema", "kind": "trade", "primary": false, "published_on": null, "retrieved_at": "2026-08-20T00:00:00+00:00" } } } }, { "slug": "amycretin", "name": "Amycretin", "maker": "Novo Nordisk", "country": null, "region": null, "form": null, "status": "phase-2", "evidence": "claim", "subtitle": "Single molecule acting on GLP-1 and amylin receptors", "note": "Phase 3 announced for Q1 2026, but no Phase 3 obesity trial is findable on ClinicalTrials.gov.\n\nTreat any claim of amycretin Phase 3 data as non-existent. The figure here comes from a small early trial and will very likely shrink at scale.", "unveiled_on": null, "last_verified_at": "2026-08-21T08:38:33+00:00", "values": { "drug_class": { "absent": false, "value": "Single molecule acting on GLP-1 and amylin receptors", "unit": null, "confidence": "claim", "qualifier": null, "observed_on": null, "verified_at": "2026-08-21T08:38:33+00:00", "citation": { "title": "Amycretin — Novo Nordisk", "url": "https://www.biospace.com/press-releases/novo-nordisk-to-advance-subcutaneous-and-oral-amycretin-for-weight-management-into-phase-3-clinical-development", "publisher": "Amycretin", "kind": "trade", "primary": false, "published_on": null, "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "weight_change": { "absent": false, "value": -22, "unit": "%", "confidence": "claim", "qualifier": "N=125, up to 36 weeks", "observed_on": null, "verified_at": "2026-08-21T08:38:33+00:00", "citation": { "title": "Amycretin — Novo Nordisk", "url": "https://www.biospace.com/press-releases/novo-nordisk-to-advance-subcutaneous-and-oral-amycretin-for-weight-management-into-phase-3-clinical-development", "publisher": "Amycretin", "kind": "trade", "primary": false, "published_on": null, "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "placebo_change": { "absent": false, "value": 2, "unit": "%", "confidence": "claim", "qualifier": "N=125, up to 36 weeks", "observed_on": null, "verified_at": "2026-08-21T08:38:33+00:00", "citation": { "title": "Amycretin — Novo Nordisk", "url": "https://www.biospace.com/press-releases/novo-nordisk-to-advance-subcutaneous-and-oral-amycretin-for-weight-management-into-phase-3-clinical-development", "publisher": "Amycretin", "kind": "trade", "primary": false, "published_on": null, "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "placebo_adjusted": { "absent": false, "value": -24, "unit": "pp", "confidence": "claim", "qualifier": "N=125, up to 36 weeks", "observed_on": null, "verified_at": "2026-08-21T08:38:33+00:00", "citation": { "title": "Amycretin — Novo Nordisk", "url": "https://www.biospace.com/press-releases/novo-nordisk-to-advance-subcutaneous-and-oral-amycretin-for-weight-management-into-phase-3-clinical-development", "publisher": "Amycretin", "kind": "trade", "primary": false, "published_on": null, "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "trial": { "absent": true, "reason": "The sponsor has not named the trial.", "confidence": "absent", "verified_at": "2026-08-21T08:38:33+00:00" }, "trial_n": { "absent": false, "value": 125, "unit": null, "confidence": "claim", "qualifier": "N=125, up to 36 weeks", "observed_on": null, "verified_at": "2026-08-21T08:38:33+00:00", "citation": { "title": "Amycretin — Novo Nordisk", "url": "https://www.biospace.com/press-releases/novo-nordisk-to-advance-subcutaneous-and-oral-amycretin-for-weight-management-into-phase-3-clinical-development", "publisher": "Amycretin", "kind": "trade", "primary": false, "published_on": null, "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "trial_weeks": { "absent": false, "value": 36, "unit": "weeks", "confidence": "claim", "qualifier": "N=125, up to 36 weeks", "observed_on": null, "verified_at": "2026-08-21T08:38:33+00:00", "citation": { "title": "Amycretin — Novo Nordisk", "url": "https://www.biospace.com/press-releases/novo-nordisk-to-advance-subcutaneous-and-oral-amycretin-for-weight-management-into-phase-3-clinical-development", "publisher": "Amycretin", "kind": "trade", "primary": false, "published_on": null, "retrieved_at": "2026-08-20T00:00:00+00:00" } } } }, { "slug": "bimagrumab-semaglutide", "name": "Bimagrumab + semaglutide", "maker": "Eli Lilly", "country": null, "region": null, "form": null, "status": "phase-2", "evidence": "claim", "subtitle": "Anti-activin receptor antibody, muscle-sparing, combined with a GLP-1", "note": "One Phase 2 in obesity with diabetes was withdrawn before enrolling anyone, for stated strategic reasons.\n\nThe interesting endpoint here is not the weight number but its composition: 92.8% of the loss was fat, with lean mass preserved. Bimagrumab alone added 2.5 kg of lean mass. Comparator arms in the same trial: semaglutide alone −15.7%.", "unveiled_on": null, "last_verified_at": "2026-08-21T08:38:33+00:00", "values": { "drug_class": { "absent": false, "value": "Anti-activin receptor antibody, muscle-sparing, combined with a GLP-1", "unit": null, "confidence": "claim", "qualifier": null, "observed_on": null, "verified_at": "2026-08-21T08:38:33+00:00", "citation": { "title": "Bimagrumab + semaglutide — Eli Lilly", "url": "https://www.hcplive.com/view/believe-bimagrumab-semaglutide-combo-yields-substantial-fat-mass-weight-loss-preserves-lean-mass", "publisher": "Bimagrumab + semaglutide", "kind": "trade", "primary": false, "published_on": null, "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "weight_change": { "absent": false, "value": -22.1, "unit": "%", "confidence": "claim", "qualifier": "BELIEVE, N=507, 72 weeks", "observed_on": null, "verified_at": "2026-08-21T08:38:33+00:00", "citation": { "title": "Bimagrumab + semaglutide — Eli Lilly", "url": "https://www.hcplive.com/view/believe-bimagrumab-semaglutide-combo-yields-substantial-fat-mass-weight-loss-preserves-lean-mass", "publisher": "Bimagrumab + semaglutide", "kind": "trade", "primary": false, "published_on": null, "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "placebo_change": { "absent": true, "reason": "The placebo arm has not been published for this readout.", "confidence": "absent", "verified_at": "2026-08-21T08:38:33+00:00" }, "placebo_adjusted": { "absent": true, "reason": "No placebo-adjusted figure can be calculated: the placebo arm has not been published.", "confidence": "absent", "verified_at": "2026-08-21T08:38:33+00:00" }, "trial": { "absent": false, "value": "BELIEVE", "unit": null, "confidence": "claim", "qualifier": "BELIEVE, N=507, 72 weeks", "observed_on": null, "verified_at": "2026-08-21T08:38:33+00:00", "citation": { "title": "Bimagrumab + semaglutide — Eli Lilly", "url": "https://www.hcplive.com/view/believe-bimagrumab-semaglutide-combo-yields-substantial-fat-mass-weight-loss-preserves-lean-mass", "publisher": "Bimagrumab + semaglutide", "kind": "trade", "primary": false, "published_on": null, "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "trial_n": { "absent": false, "value": 507, "unit": null, "confidence": "claim", "qualifier": "BELIEVE, N=507, 72 weeks", "observed_on": null, "verified_at": "2026-08-21T08:38:33+00:00", "citation": { "title": "Bimagrumab + semaglutide — Eli Lilly", "url": "https://www.hcplive.com/view/believe-bimagrumab-semaglutide-combo-yields-substantial-fat-mass-weight-loss-preserves-lean-mass", "publisher": "Bimagrumab + semaglutide", "kind": "trade", "primary": false, "published_on": null, "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "trial_weeks": { "absent": false, "value": 72, "unit": "weeks", "confidence": "claim", "qualifier": "BELIEVE, N=507, 72 weeks", "observed_on": null, "verified_at": "2026-08-21T08:38:33+00:00", "citation": { "title": "Bimagrumab + semaglutide — Eli Lilly", "url": "https://www.hcplive.com/view/believe-bimagrumab-semaglutide-combo-yields-substantial-fat-mass-weight-loss-preserves-lean-mass", "publisher": "Bimagrumab + semaglutide", "kind": "trade", "primary": false, "published_on": null, "retrieved_at": "2026-08-20T00:00:00+00:00" } } } }, { "slug": "aleniglipron", "name": "Aleniglipron", "maker": "Structure Therapeutics", "country": null, "region": null, "form": null, "status": "phase-2", "evidence": "stated", "subtitle": "Oral small-molecule GLP-1 agonist", "note": "Phase 3 from H2 2026.\n\nFigure quoted is already placebo-adjusted. Small trial; 3.7% discontinued for adverse events among those escalated.", "unveiled_on": null, "last_verified_at": "2026-08-21T08:38:33+00:00", "values": { "drug_class": { "absent": false, "value": "Oral small-molecule GLP-1 agonist", "unit": null, "confidence": "stated", "qualifier": null, "observed_on": null, "verified_at": "2026-08-21T08:38:33+00:00", "citation": { "title": "Aleniglipron — Structure Therapeutics", "url": "https://ir.structuretx.com/news-releases/news-release-details/structure-therapeutics-reports-positive-topline-data-phase-2", "publisher": "Aleniglipron", "kind": "press", "primary": false, "published_on": null, "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "weight_change": { "absent": false, "value": -16.3, "unit": "%", "confidence": "stated", "qualifier": "ACCESS II, N=85, 44 weeks", "observed_on": null, "verified_at": "2026-08-21T08:38:33+00:00", "citation": { "title": "Aleniglipron — Structure Therapeutics", "url": "https://ir.structuretx.com/news-releases/news-release-details/structure-therapeutics-reports-positive-topline-data-phase-2", "publisher": "Aleniglipron", "kind": "press", "primary": false, "published_on": null, "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "placebo_change": { "absent": true, "reason": "The placebo arm has not been published for this readout.", "confidence": "absent", "verified_at": "2026-08-21T08:38:33+00:00" }, "placebo_adjusted": { "absent": true, "reason": "No placebo-adjusted figure can be calculated: the placebo arm has not been published.", "confidence": "absent", "verified_at": "2026-08-21T08:38:33+00:00" }, "trial": { "absent": false, "value": "ACCESS II", "unit": null, "confidence": "stated", "qualifier": "ACCESS II, N=85, 44 weeks", "observed_on": null, "verified_at": "2026-08-21T08:38:33+00:00", "citation": { "title": "Aleniglipron — Structure Therapeutics", "url": "https://ir.structuretx.com/news-releases/news-release-details/structure-therapeutics-reports-positive-topline-data-phase-2", "publisher": "Aleniglipron", "kind": "press", "primary": false, "published_on": null, "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "trial_n": { "absent": false, "value": 85, "unit": null, "confidence": "stated", "qualifier": "ACCESS II, N=85, 44 weeks", "observed_on": null, "verified_at": "2026-08-21T08:38:33+00:00", "citation": { "title": "Aleniglipron — Structure Therapeutics", "url": "https://ir.structuretx.com/news-releases/news-release-details/structure-therapeutics-reports-positive-topline-data-phase-2", "publisher": "Aleniglipron", "kind": "press", "primary": false, "published_on": null, "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "trial_weeks": { "absent": false, "value": 44, "unit": "weeks", "confidence": "stated", "qualifier": "ACCESS II, N=85, 44 weeks", "observed_on": null, "verified_at": "2026-08-21T08:38:33+00:00", "citation": { "title": "Aleniglipron — Structure Therapeutics", "url": "https://ir.structuretx.com/news-releases/news-release-details/structure-therapeutics-reports-positive-topline-data-phase-2", "publisher": "Aleniglipron", "kind": "press", "primary": false, "published_on": null, "retrieved_at": "2026-08-20T00:00:00+00:00" } } } }, { "slug": "maritide", "name": "MariTide", "maker": "Amgen", "country": null, "region": null, "form": null, "status": "phase-2", "evidence": "confirmed", "subtitle": "GIP receptor antagonist conjugated to a GLP-1 agonist", "note": "Phase 3 running; primary completions Jan 2027. Cardiovascular outcomes trial to Jun 2028.\n\nDosed monthly rather than weekly, which is the point of the molecule. No Phase 3 efficacy readout exists — any claim of one circulating now is unsupported.", "unveiled_on": null, "last_verified_at": "2026-08-21T08:38:33+00:00", "values": { "drug_class": { "absent": false, "value": "GIP receptor antagonist conjugated to a GLP-1 agonist", "unit": null, "confidence": "confirmed", "qualifier": null, "observed_on": null, "verified_at": "2026-08-21T08:38:33+00:00", "citation": { "title": "MariTide — Amgen", "url": "https://pubmed.ncbi.nlm.nih.gov/40549887/", "publisher": "MariTide", "kind": "journal", "primary": true, "published_on": null, "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "weight_change": { "absent": false, "value": -16.2, "unit": "%", "confidence": "confirmed", "qualifier": "N=592, 52 weeks, NEJM Sep 2025", "observed_on": null, "verified_at": "2026-08-21T08:38:33+00:00", "citation": { "title": "MariTide — Amgen", "url": "https://pubmed.ncbi.nlm.nih.gov/40549887/", "publisher": "MariTide", "kind": "journal", "primary": true, "published_on": null, "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "placebo_change": { "absent": false, "value": -2.5, "unit": "%", "confidence": "confirmed", "qualifier": "N=592, 52 weeks, NEJM Sep 2025", "observed_on": null, "verified_at": "2026-08-21T08:38:33+00:00", "citation": { "title": "MariTide — Amgen", "url": "https://pubmed.ncbi.nlm.nih.gov/40549887/", "publisher": "MariTide", "kind": "journal", "primary": true, "published_on": null, "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "placebo_adjusted": { "absent": false, "value": -13.7, "unit": "pp", "confidence": "confirmed", "qualifier": "N=592, 52 weeks, NEJM Sep 2025", "observed_on": null, "verified_at": "2026-08-21T08:38:33+00:00", "citation": { "title": "MariTide — Amgen", "url": "https://pubmed.ncbi.nlm.nih.gov/40549887/", "publisher": "MariTide", "kind": "journal", "primary": true, "published_on": null, "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "trial": { "absent": true, "reason": "The sponsor has not named the trial.", "confidence": "absent", "verified_at": "2026-08-21T08:38:33+00:00" }, "trial_n": { "absent": false, "value": 592, "unit": null, "confidence": "confirmed", "qualifier": "N=592, 52 weeks, NEJM Sep 2025", "observed_on": null, "verified_at": "2026-08-21T08:38:33+00:00", "citation": { "title": "MariTide — Amgen", "url": "https://pubmed.ncbi.nlm.nih.gov/40549887/", "publisher": "MariTide", "kind": "journal", "primary": true, "published_on": null, "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "trial_weeks": { "absent": false, "value": 52, "unit": "weeks", "confidence": "confirmed", "qualifier": "N=592, 52 weeks, NEJM Sep 2025", "observed_on": null, "verified_at": "2026-08-21T08:38:33+00:00", "citation": { "title": "MariTide — Amgen", "url": "https://pubmed.ncbi.nlm.nih.gov/40549887/", "publisher": "MariTide", "kind": "journal", "primary": true, "published_on": null, "retrieved_at": "2026-08-20T00:00:00+00:00" } } } }, { "slug": "survodutide", "name": "Survodutide", "maker": "Boehringer Ingelheim / Zealand", "country": null, "region": null, "form": null, "status": "phase-3", "evidence": "confirmed", "subtitle": "Dual glucagon + GLP-1 agonist", "note": "No regulatory filing announced.\n\nA textbook estimand problem. The widely-quoted “16.6%” is the trial-product estimand — people who kept taking it. The NEJM primary analysis, counting everyone randomised, is −13.0% against a −5.4% placebo arm. Both numbers are honest; only one describes real-world use.", "unveiled_on": null, "last_verified_at": "2026-08-21T08:38:33+00:00", "values": { "drug_class": { "absent": false, "value": "Dual glucagon + GLP-1 agonist", "unit": null, "confidence": "confirmed", "qualifier": null, "observed_on": null, "verified_at": "2026-08-21T08:38:33+00:00", "citation": { "title": "Survodutide — Boehringer Ingelheim / Zealand", "url": "https://pubmed.ncbi.nlm.nih.gov/42253238/", "publisher": "Survodutide", "kind": "journal", "primary": true, "published_on": null, "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "weight_change": { "absent": false, "value": -13, "unit": "%", "confidence": "confirmed", "qualifier": "SYNCHRONIZE-1, N=725, 76 weeks", "observed_on": null, "verified_at": "2026-08-21T08:38:33+00:00", "citation": { "title": "Survodutide — Boehringer Ingelheim / Zealand", "url": "https://pubmed.ncbi.nlm.nih.gov/42253238/", "publisher": "Survodutide", "kind": "journal", "primary": true, "published_on": null, "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "placebo_change": { "absent": false, "value": -5.4, "unit": "%", "confidence": "confirmed", "qualifier": "SYNCHRONIZE-1, N=725, 76 weeks", "observed_on": null, "verified_at": "2026-08-21T08:38:33+00:00", "citation": { "title": "Survodutide — Boehringer Ingelheim / Zealand", "url": "https://pubmed.ncbi.nlm.nih.gov/42253238/", "publisher": "Survodutide", "kind": "journal", "primary": true, "published_on": null, "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "placebo_adjusted": { "absent": false, "value": -7.6, "unit": "pp", "confidence": "confirmed", "qualifier": "SYNCHRONIZE-1, N=725, 76 weeks", "observed_on": null, "verified_at": "2026-08-21T08:38:33+00:00", "citation": { "title": "Survodutide — Boehringer Ingelheim / Zealand", "url": "https://pubmed.ncbi.nlm.nih.gov/42253238/", "publisher": "Survodutide", "kind": "journal", "primary": true, "published_on": null, "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "trial": { "absent": false, "value": "SYNCHRONIZE-1", "unit": null, "confidence": "confirmed", "qualifier": "SYNCHRONIZE-1, N=725, 76 weeks", "observed_on": null, "verified_at": "2026-08-21T08:38:33+00:00", "citation": { "title": "Survodutide — Boehringer Ingelheim / Zealand", "url": "https://pubmed.ncbi.nlm.nih.gov/42253238/", "publisher": "Survodutide", "kind": "journal", "primary": true, "published_on": null, "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "trial_n": { "absent": false, "value": 725, "unit": null, "confidence": "confirmed", "qualifier": "SYNCHRONIZE-1, N=725, 76 weeks", "observed_on": null, "verified_at": "2026-08-21T08:38:33+00:00", "citation": { "title": "Survodutide — Boehringer Ingelheim / Zealand", "url": "https://pubmed.ncbi.nlm.nih.gov/42253238/", "publisher": "Survodutide", "kind": "journal", "primary": true, "published_on": null, "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "trial_weeks": { "absent": false, "value": 76, "unit": "weeks", "confidence": "confirmed", "qualifier": "SYNCHRONIZE-1, N=725, 76 weeks", "observed_on": null, "verified_at": "2026-08-21T08:38:33+00:00", "citation": { "title": "Survodutide — Boehringer Ingelheim / Zealand", "url": "https://pubmed.ncbi.nlm.nih.gov/42253238/", "publisher": "Survodutide", "kind": "journal", "primary": true, "published_on": null, "retrieved_at": "2026-08-20T00:00:00+00:00" } } } }, { "slug": "vk2735-oral", "name": "VK2735 (oral)", "maker": "Viking Therapeutics", "country": null, "region": null, "form": null, "status": "phase-2", "evidence": "stated", "subtitle": "Dual GLP-1 / GIP agonist", "note": "Phase 3 is running on the injectable formulation, not this one.\n\nOnly 13 weeks. Short trials flatter weight-loss drugs, because the curve has not yet flattened.", "unveiled_on": null, "last_verified_at": "2026-08-21T08:38:33+00:00", "values": { "drug_class": { "absent": false, "value": "Dual GLP-1 / GIP agonist", "unit": null, "confidence": "stated", "qualifier": null, "observed_on": null, "verified_at": "2026-08-21T08:38:33+00:00", "citation": { "title": "VK2735 (oral) — Viking Therapeutics", "url": "https://www.prnewswire.com/news-releases/viking-therapeutics-presents-data-from-its-13-week-phase-2-venture-oral-dosing-trial-of-vk2735-at-european-congress-on-obesity-eco-2026-302768959.html", "publisher": "VK2735 (oral)", "kind": "press", "primary": false, "published_on": null, "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "weight_change": { "absent": false, "value": -12.2, "unit": "%", "confidence": "stated", "qualifier": "VENTURE-Oral, N=280, 13 weeks", "observed_on": null, "verified_at": "2026-08-21T08:38:33+00:00", "citation": { "title": "VK2735 (oral) — Viking Therapeutics", "url": "https://www.prnewswire.com/news-releases/viking-therapeutics-presents-data-from-its-13-week-phase-2-venture-oral-dosing-trial-of-vk2735-at-european-congress-on-obesity-eco-2026-302768959.html", "publisher": "VK2735 (oral)", "kind": "press", "primary": false, "published_on": null, "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "placebo_change": { "absent": false, "value": -1.3, "unit": "%", "confidence": "stated", "qualifier": "VENTURE-Oral, N=280, 13 weeks", "observed_on": null, "verified_at": "2026-08-21T08:38:33+00:00", "citation": { "title": "VK2735 (oral) — Viking Therapeutics", "url": "https://www.prnewswire.com/news-releases/viking-therapeutics-presents-data-from-its-13-week-phase-2-venture-oral-dosing-trial-of-vk2735-at-european-congress-on-obesity-eco-2026-302768959.html", "publisher": "VK2735 (oral)", "kind": "press", "primary": false, "published_on": null, "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "placebo_adjusted": { "absent": false, "value": -10.9, "unit": "pp", "confidence": "stated", "qualifier": "VENTURE-Oral, N=280, 13 weeks", "observed_on": null, "verified_at": "2026-08-21T08:38:33+00:00", "citation": { "title": "VK2735 (oral) — Viking Therapeutics", "url": "https://www.prnewswire.com/news-releases/viking-therapeutics-presents-data-from-its-13-week-phase-2-venture-oral-dosing-trial-of-vk2735-at-european-congress-on-obesity-eco-2026-302768959.html", "publisher": "VK2735 (oral)", "kind": "press", "primary": false, "published_on": null, "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "trial": { "absent": false, "value": "VENTURE-Oral", "unit": null, "confidence": "stated", "qualifier": "VENTURE-Oral, N=280, 13 weeks", "observed_on": null, "verified_at": "2026-08-21T08:38:33+00:00", "citation": { "title": "VK2735 (oral) — Viking Therapeutics", "url": "https://www.prnewswire.com/news-releases/viking-therapeutics-presents-data-from-its-13-week-phase-2-venture-oral-dosing-trial-of-vk2735-at-european-congress-on-obesity-eco-2026-302768959.html", "publisher": "VK2735 (oral)", "kind": "press", "primary": false, "published_on": null, "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "trial_n": { "absent": false, "value": 280, "unit": null, "confidence": "stated", "qualifier": "VENTURE-Oral, N=280, 13 weeks", "observed_on": null, "verified_at": "2026-08-21T08:38:33+00:00", "citation": { "title": "VK2735 (oral) — Viking Therapeutics", "url": "https://www.prnewswire.com/news-releases/viking-therapeutics-presents-data-from-its-13-week-phase-2-venture-oral-dosing-trial-of-vk2735-at-european-congress-on-obesity-eco-2026-302768959.html", "publisher": "VK2735 (oral)", "kind": "press", "primary": false, "published_on": null, "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "trial_weeks": { "absent": false, "value": 13, "unit": "weeks", "confidence": "stated", "qualifier": "VENTURE-Oral, N=280, 13 weeks", "observed_on": null, "verified_at": "2026-08-21T08:38:33+00:00", "citation": { "title": "VK2735 (oral) — Viking Therapeutics", "url": "https://www.prnewswire.com/news-releases/viking-therapeutics-presents-data-from-its-13-week-phase-2-venture-oral-dosing-trial-of-vk2735-at-european-congress-on-obesity-eco-2026-302768959.html", "publisher": "VK2735 (oral)", "kind": "press", "primary": false, "published_on": null, "retrieved_at": "2026-08-20T00:00:00+00:00" } } } }, { "slug": "petrelintide", "name": "Petrelintide", "maker": "Zealand Pharma / Roche", "country": null, "region": null, "form": null, "status": "phase-2", "evidence": "stated", "subtitle": "Long-acting amylin analogue", "note": "Phase 3 to start H2 2026.\n\nThe headline here is tolerability, not size: discontinuation for adverse events was 4.8% against 4.9% on placebo, with no vomiting at the maximally effective dose. If that holds, it changes who can stay on treatment.", "unveiled_on": null, "last_verified_at": "2026-08-21T08:38:33+00:00", "values": { "drug_class": { "absent": false, "value": "Long-acting amylin analogue", "unit": null, "confidence": "stated", "qualifier": null, "observed_on": null, "verified_at": "2026-08-21T08:38:33+00:00", "citation": { "title": "Petrelintide — Zealand Pharma / Roche", "url": "https://www.zealandpharma.com/pipeline/petrelintide/", "publisher": "Petrelintide", "kind": "press", "primary": false, "published_on": null, "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "weight_change": { "absent": false, "value": -10.7, "unit": "%", "confidence": "stated", "qualifier": "ZUPREME-1, N=493, 42 weeks", "observed_on": null, "verified_at": "2026-08-21T08:38:33+00:00", "citation": { "title": "Petrelintide — Zealand Pharma / Roche", "url": "https://www.zealandpharma.com/pipeline/petrelintide/", "publisher": "Petrelintide", "kind": "press", "primary": false, "published_on": null, "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "placebo_change": { "absent": false, "value": -1.7, "unit": "%", "confidence": "stated", "qualifier": "ZUPREME-1, N=493, 42 weeks", "observed_on": null, "verified_at": "2026-08-21T08:38:33+00:00", "citation": { "title": "Petrelintide — Zealand Pharma / Roche", "url": "https://www.zealandpharma.com/pipeline/petrelintide/", "publisher": "Petrelintide", "kind": "press", "primary": false, "published_on": null, "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "placebo_adjusted": { "absent": false, "value": -9, "unit": "pp", "confidence": "stated", "qualifier": "ZUPREME-1, N=493, 42 weeks", "observed_on": null, "verified_at": "2026-08-21T08:38:33+00:00", "citation": { "title": "Petrelintide — Zealand Pharma / Roche", "url": "https://www.zealandpharma.com/pipeline/petrelintide/", "publisher": "Petrelintide", "kind": "press", "primary": false, "published_on": null, "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "trial": { "absent": false, "value": "ZUPREME-1", "unit": null, "confidence": "stated", "qualifier": "ZUPREME-1, N=493, 42 weeks", "observed_on": null, "verified_at": "2026-08-21T08:38:33+00:00", "citation": { "title": "Petrelintide — Zealand Pharma / Roche", "url": "https://www.zealandpharma.com/pipeline/petrelintide/", "publisher": "Petrelintide", "kind": "press", "primary": false, "published_on": null, "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "trial_n": { "absent": false, "value": 493, "unit": null, "confidence": "stated", "qualifier": "ZUPREME-1, N=493, 42 weeks", "observed_on": null, "verified_at": "2026-08-21T08:38:33+00:00", "citation": { "title": "Petrelintide — Zealand Pharma / Roche", "url": "https://www.zealandpharma.com/pipeline/petrelintide/", "publisher": "Petrelintide", "kind": "press", "primary": false, "published_on": null, "retrieved_at": "2026-08-20T00:00:00+00:00" } }, "trial_weeks": { "absent": false, "value": 42, "unit": "weeks", "confidence": "stated", "qualifier": "ZUPREME-1, N=493, 42 weeks", "observed_on": null, "verified_at": "2026-08-21T08:38:33+00:00", "citation": { "title": "Petrelintide — Zealand Pharma / Roche", "url": "https://www.zealandpharma.com/pipeline/petrelintide/", "publisher": "Petrelintide", "kind": "press", "primary": false, "published_on": null, "retrieved_at": "2026-08-20T00:00:00+00:00" } } } }, { "slug": "bpc-157", "name": "BPC-157", "maker": null, "country": null, "region": null, "form": null, "status": "preclinical", "evidence": "claim", "subtitle": "Healing, gut health, tendon repair", "note": "Evidence — No completed, published human randomised trial. The registry holds three records: a 2015 Phase 1 whose data were withdrawn before peer review, a Phase 2 hamstring trial still recruiting, and an unrelated study. The roughly 200 PubMed entries are almost all animal work from one research group.\n\nRegulatory status — Unapproved drug. Removed from the FDA's significant-safety-risk list around 22 Apr 2026 — which does not make it legal to compound. An advisory panel voted 8–6 to recommend adding it to the compounding list on 23 Jul 2026; that vote is non-binding and rulemaking has not begun.\n\nWADA — Prohibited at all times (S0)\n\nKnown harms — FDA cited immunogenicity risk and impurities. No human safety database exists to characterise the risk.", "unveiled_on": null, "last_verified_at": "2026-08-21T08:38:33+00:00", "values": { "weight_change": { "absent": true, "reason": "No completed, published human randomised trial. The registry holds three records: a 2015 Phase 1 whose data were withdrawn before peer review, a Phase 2 hamstring trial still recruiting, and an unrelated study. The roughly 200 PubMed entries are almost all animal work from one research group.", "confidence": "absent", "verified_at": "2026-08-21T08:38:33+00:00" }, "placebo_change": { "absent": true, "reason": "No completed, published human randomised trial. The registry holds three records: a 2015 Phase 1 whose data were withdrawn before peer review, a Phase 2 hamstring trial still recruiting, and an unrelated study. The roughly 200 PubMed entries are almost all animal work from one research group.", "confidence": "absent", "verified_at": "2026-08-21T08:38:33+00:00" }, "placebo_adjusted": { "absent": true, "reason": "No completed, published human randomised trial. The registry holds three records: a 2015 Phase 1 whose data were withdrawn before peer review, a Phase 2 hamstring trial still recruiting, and an unrelated study. The roughly 200 PubMed entries are almost all animal work from one research group.", "confidence": "absent", "verified_at": "2026-08-21T08:38:33+00:00" }, "trial": { "absent": true, "reason": "No completed, published human randomised trial. The registry holds three records: a 2015 Phase 1 whose data were withdrawn before peer review, a Phase 2 hamstring trial still recruiting, and an unrelated study. The roughly 200 PubMed entries are almost all animal work from one research group.", "confidence": "absent", "verified_at": "2026-08-21T08:38:33+00:00" }, "trial_n": { "absent": true, "reason": "No completed, published human randomised trial. The registry holds three records: a 2015 Phase 1 whose data were withdrawn before peer review, a Phase 2 hamstring trial still recruiting, and an unrelated study. The roughly 200 PubMed entries are almost all animal work from one research group.", "confidence": "absent", "verified_at": "2026-08-21T08:38:33+00:00" }, "trial_weeks": { "absent": true, "reason": "No completed, published human randomised trial. The registry holds three records: a 2015 Phase 1 whose data were withdrawn before peer review, a Phase 2 hamstring trial still recruiting, and an unrelated study. The roughly 200 PubMed entries are almost all animal work from one research group.", "confidence": "absent", "verified_at": "2026-08-21T08:38:33+00:00" }, "human_rct": { "absent": false, "value": "none", "unit": null, "confidence": "claim", "qualifier": "No completed, published human randomised trial. The registry holds three records: a 2015 Phase 1 whose data were withdrawn before peer review, a Phase 2 hamstring trial still recruiting, and an unrelated study. The roughly 200 PubMed entries are almost all animal work from one research group.", "observed_on": null, "verified_at": "2026-08-21T08:38:33+00:00", "citation": null } } }, { "slug": "tb-500", "name": "TB-500", "maker": null, "country": null, "region": null, "form": null, "status": "preclinical", "evidence": "claim", "subtitle": "Recovery, tissue repair", "note": "Evidence — The fragment sold as TB-500 has exactly one registered human trial, still recruiting with no results. Full-length thymosin β4 — a different molecule — does have real Phase 2 and Phase 3 trials, none of which led to approval for anything. Conflating the two is the standard marketing move.\n\nRegulatory status — Unapproved. Same April 2026 list removal and same July 2026 advisory vote as BPC-157, with the same legal effect: none.\n\nWADA — Prohibited (S2.3, growth factors)\n\nKnown harms — No human safety dataset for the fragment.", "unveiled_on": null, "last_verified_at": "2026-08-21T08:38:33+00:00", "values": { "weight_change": { "absent": true, "reason": "The fragment sold as TB-500 has exactly one registered human trial, still recruiting with no results. Full-length thymosin β4 — a different molecule — does have real Phase 2 and Phase 3 trials, none of which led to approval for anything. Conflating the two is the standard marketing move.", "confidence": "absent", "verified_at": "2026-08-21T08:38:33+00:00" }, "placebo_change": { "absent": true, "reason": "The fragment sold as TB-500 has exactly one registered human trial, still recruiting with no results. Full-length thymosin β4 — a different molecule — does have real Phase 2 and Phase 3 trials, none of which led to approval for anything. Conflating the two is the standard marketing move.", "confidence": "absent", "verified_at": "2026-08-21T08:38:33+00:00" }, "placebo_adjusted": { "absent": true, "reason": "The fragment sold as TB-500 has exactly one registered human trial, still recruiting with no results. Full-length thymosin β4 — a different molecule — does have real Phase 2 and Phase 3 trials, none of which led to approval for anything. Conflating the two is the standard marketing move.", "confidence": "absent", "verified_at": "2026-08-21T08:38:33+00:00" }, "trial": { "absent": true, "reason": "The fragment sold as TB-500 has exactly one registered human trial, still recruiting with no results. Full-length thymosin β4 — a different molecule — does have real Phase 2 and Phase 3 trials, none of which led to approval for anything. Conflating the two is the standard marketing move.", "confidence": "absent", "verified_at": "2026-08-21T08:38:33+00:00" }, "trial_n": { "absent": true, "reason": "The fragment sold as TB-500 has exactly one registered human trial, still recruiting with no results. Full-length thymosin β4 — a different molecule — does have real Phase 2 and Phase 3 trials, none of which led to approval for anything. Conflating the two is the standard marketing move.", "confidence": "absent", "verified_at": "2026-08-21T08:38:33+00:00" }, "trial_weeks": { "absent": true, "reason": "The fragment sold as TB-500 has exactly one registered human trial, still recruiting with no results. Full-length thymosin β4 — a different molecule — does have real Phase 2 and Phase 3 trials, none of which led to approval for anything. Conflating the two is the standard marketing move.", "confidence": "absent", "verified_at": "2026-08-21T08:38:33+00:00" }, "human_rct": { "absent": false, "value": "none", "unit": null, "confidence": "claim", "qualifier": "The fragment sold as TB-500 has exactly one registered human trial, still recruiting with no results. Full-length thymosin β4 — a different molecule — does have real Phase 2 and Phase 3 trials, none of which led to approval for anything. Conflating the two is the standard marketing move.", "observed_on": null, "verified_at": "2026-08-21T08:38:33+00:00", "citation": null } } }, { "slug": "ipamorelin", "name": "Ipamorelin", "maker": null, "country": null, "region": null, "form": null, "status": "preclinical", "evidence": "claim", "subtitle": "Growth hormone release, body composition", "note": "Evidence — Two randomised trials, both in postoperative ileus, both unsuccessful; the programme was abandoned. Plus one 1999 pharmacology study in volunteers. No randomised trial for body composition, healing or longevity exists.\n\nRegulatory status — Still on the FDA's significant-safety-risk list. FDA cites immunogenicity risk and serious adverse events including death with intravenous administration. It is the only compound here the agency kept on that list in 2026.\n\nWADA — Prohibited (S2.2.4, growth hormone secretagogues)\n\nKnown harms — The only one on this list FDA has affirmatively kept flagged for safety.", "unveiled_on": null, "last_verified_at": "2026-08-21T08:38:34+00:00", "values": { "weight_change": { "absent": true, "reason": "Two randomised trials, both in postoperative ileus, both unsuccessful; the programme was abandoned. Plus one 1999 pharmacology study in volunteers. No randomised trial for body composition, healing or longevity exists.", "confidence": "absent", "verified_at": "2026-08-21T08:38:33+00:00" }, "placebo_change": { "absent": true, "reason": "Two randomised trials, both in postoperative ileus, both unsuccessful; the programme was abandoned. Plus one 1999 pharmacology study in volunteers. No randomised trial for body composition, healing or longevity exists.", "confidence": "absent", "verified_at": "2026-08-21T08:38:33+00:00" }, "placebo_adjusted": { "absent": true, "reason": "Two randomised trials, both in postoperative ileus, both unsuccessful; the programme was abandoned. Plus one 1999 pharmacology study in volunteers. No randomised trial for body composition, healing or longevity exists.", "confidence": "absent", "verified_at": "2026-08-21T08:38:33+00:00" }, "trial": { "absent": true, "reason": "Two randomised trials, both in postoperative ileus, both unsuccessful; the programme was abandoned. Plus one 1999 pharmacology study in volunteers. No randomised trial for body composition, healing or longevity exists.", "confidence": "absent", "verified_at": "2026-08-21T08:38:33+00:00" }, "trial_n": { "absent": true, "reason": "Two randomised trials, both in postoperative ileus, both unsuccessful; the programme was abandoned. Plus one 1999 pharmacology study in volunteers. No randomised trial for body composition, healing or longevity exists.", "confidence": "absent", "verified_at": "2026-08-21T08:38:33+00:00" }, "trial_weeks": { "absent": true, "reason": "Two randomised trials, both in postoperative ileus, both unsuccessful; the programme was abandoned. Plus one 1999 pharmacology study in volunteers. No randomised trial for body composition, healing or longevity exists.", "confidence": "absent", "verified_at": "2026-08-21T08:38:34+00:00" }, "human_rct": { "absent": false, "value": "negative", "unit": null, "confidence": "claim", "qualifier": "Two randomised trials, both in postoperative ileus, both unsuccessful; the programme was abandoned. Plus one 1999 pharmacology study in volunteers. No randomised trial for body composition, healing or longevity exists.", "observed_on": null, "verified_at": "2026-08-21T08:38:33+00:00", "citation": null } } }, { "slug": "cjc-1295", "name": "CJC-1295", "maker": null, "country": null, "region": null, "form": null, "status": "preclinical", "evidence": "claim", "subtitle": "Growth hormone release", "note": "Evidence — One registered trial, in HIV-associated visceral obesity, terminated. Nothing else. There is no positive human efficacy evidence for any marketed use.\n\nRegulatory status — Unapproved; no approved medical use anywhere.\n\nWADA — Prohibited (S2.2.4, GHRH analogues)\n\nKnown harms — Sustained growth hormone and IGF-1 elevation is the mechanism of concern.", "unveiled_on": null, "last_verified_at": "2026-08-21T08:38:34+00:00", "values": { "weight_change": { "absent": true, "reason": "One registered trial, in HIV-associated visceral obesity, terminated. Nothing else. There is no positive human efficacy evidence for any marketed use.", "confidence": "absent", "verified_at": "2026-08-21T08:38:34+00:00" }, "placebo_change": { "absent": true, "reason": "One registered trial, in HIV-associated visceral obesity, terminated. Nothing else. There is no positive human efficacy evidence for any marketed use.", "confidence": "absent", "verified_at": "2026-08-21T08:38:34+00:00" }, "placebo_adjusted": { "absent": true, "reason": "One registered trial, in HIV-associated visceral obesity, terminated. Nothing else. There is no positive human efficacy evidence for any marketed use.", "confidence": "absent", "verified_at": "2026-08-21T08:38:34+00:00" }, "trial": { "absent": true, "reason": "One registered trial, in HIV-associated visceral obesity, terminated. Nothing else. There is no positive human efficacy evidence for any marketed use.", "confidence": "absent", "verified_at": "2026-08-21T08:38:34+00:00" }, "trial_n": { "absent": true, "reason": "One registered trial, in HIV-associated visceral obesity, terminated. Nothing else. There is no positive human efficacy evidence for any marketed use.", "confidence": "absent", "verified_at": "2026-08-21T08:38:34+00:00" }, "trial_weeks": { "absent": true, "reason": "One registered trial, in HIV-associated visceral obesity, terminated. Nothing else. There is no positive human efficacy evidence for any marketed use.", "confidence": "absent", "verified_at": "2026-08-21T08:38:34+00:00" }, "human_rct": { "absent": false, "value": "none", "unit": null, "confidence": "claim", "qualifier": "One registered trial, in HIV-associated visceral obesity, terminated. Nothing else. There is no positive human efficacy evidence for any marketed use.", "observed_on": null, "verified_at": "2026-08-21T08:38:34+00:00", "citation": null } } }, { "slug": "mots-c", "name": "MOTS-c", "maker": null, "country": null, "region": null, "form": null, "status": "preclinical", "evidence": "claim", "subtitle": "Metabolic health, longevity", "note": "Evidence — No randomised trial of administered MOTS-c in humans. One Phase 2 in prediabetes is recruiting with no results. Every other hit measures naturally occurring MOTS-c or studies exercise.\n\nRegulatory status — Unapproved. Removed from the safety-risk list Apr 2026; advisory vote 7–5 in Jul 2026; not compoundable.\n\nWADA — Prohibited (S0; classed as a metabolic modulator in some national renderings)\n\nKnown harms — Nothing characterised — there is no human exposure dataset.", "unveiled_on": null, "last_verified_at": "2026-08-21T08:38:34+00:00", "values": { "weight_change": { "absent": true, "reason": "No randomised trial of administered MOTS-c in humans. One Phase 2 in prediabetes is recruiting with no results. Every other hit measures naturally occurring MOTS-c or studies exercise.", "confidence": "absent", "verified_at": "2026-08-21T08:38:34+00:00" }, "placebo_change": { "absent": true, "reason": "No randomised trial of administered MOTS-c in humans. One Phase 2 in prediabetes is recruiting with no results. Every other hit measures naturally occurring MOTS-c or studies exercise.", "confidence": "absent", "verified_at": "2026-08-21T08:38:34+00:00" }, "placebo_adjusted": { "absent": true, "reason": "No randomised trial of administered MOTS-c in humans. One Phase 2 in prediabetes is recruiting with no results. Every other hit measures naturally occurring MOTS-c or studies exercise.", "confidence": "absent", "verified_at": "2026-08-21T08:38:34+00:00" }, "trial": { "absent": true, "reason": "No randomised trial of administered MOTS-c in humans. One Phase 2 in prediabetes is recruiting with no results. Every other hit measures naturally occurring MOTS-c or studies exercise.", "confidence": "absent", "verified_at": "2026-08-21T08:38:34+00:00" }, "trial_n": { "absent": true, "reason": "No randomised trial of administered MOTS-c in humans. One Phase 2 in prediabetes is recruiting with no results. Every other hit measures naturally occurring MOTS-c or studies exercise.", "confidence": "absent", "verified_at": "2026-08-21T08:38:34+00:00" }, "trial_weeks": { "absent": true, "reason": "No randomised trial of administered MOTS-c in humans. One Phase 2 in prediabetes is recruiting with no results. Every other hit measures naturally occurring MOTS-c or studies exercise.", "confidence": "absent", "verified_at": "2026-08-21T08:38:34+00:00" }, "human_rct": { "absent": false, "value": "none", "unit": null, "confidence": "claim", "qualifier": "No randomised trial of administered MOTS-c in humans. One Phase 2 in prediabetes is recruiting with no results. Every other hit measures naturally occurring MOTS-c or studies exercise.", "observed_on": null, "verified_at": "2026-08-21T08:38:34+00:00", "citation": null } } }, { "slug": "epitalon", "name": "Epitalon", "maker": null, "country": null, "region": null, "form": null, "status": "preclinical", "evidence": "claim", "subtitle": "Longevity, telomeres", "note": "Evidence — Zero registered human trials on ClinicalTrials.gov. The supporting literature is largely older Russian-language work outside mainstream registries.\n\nRegulatory status — Unapproved; not compoundable.\n\nWADA — Prohibited (S0)\n\nKnown harms — Nothing characterised.", "unveiled_on": null, "last_verified_at": "2026-08-21T08:38:34+00:00", "values": { "weight_change": { "absent": true, "reason": "Zero registered human trials on ClinicalTrials.gov. The supporting literature is largely older Russian-language work outside mainstream registries.", "confidence": "absent", "verified_at": "2026-08-21T08:38:34+00:00" }, "placebo_change": { "absent": true, "reason": "Zero registered human trials on ClinicalTrials.gov. The supporting literature is largely older Russian-language work outside mainstream registries.", "confidence": "absent", "verified_at": "2026-08-21T08:38:34+00:00" }, "placebo_adjusted": { "absent": true, "reason": "Zero registered human trials on ClinicalTrials.gov. The supporting literature is largely older Russian-language work outside mainstream registries.", "confidence": "absent", "verified_at": "2026-08-21T08:38:34+00:00" }, "trial": { "absent": true, "reason": "Zero registered human trials on ClinicalTrials.gov. The supporting literature is largely older Russian-language work outside mainstream registries.", "confidence": "absent", "verified_at": "2026-08-21T08:38:34+00:00" }, "trial_n": { "absent": true, "reason": "Zero registered human trials on ClinicalTrials.gov. The supporting literature is largely older Russian-language work outside mainstream registries.", "confidence": "absent", "verified_at": "2026-08-21T08:38:34+00:00" }, "trial_weeks": { "absent": true, "reason": "Zero registered human trials on ClinicalTrials.gov. The supporting literature is largely older Russian-language work outside mainstream registries.", "confidence": "absent", "verified_at": "2026-08-21T08:38:34+00:00" }, "human_rct": { "absent": false, "value": "none", "unit": null, "confidence": "claim", "qualifier": "Zero registered human trials on ClinicalTrials.gov. The supporting literature is largely older Russian-language work outside mainstream registries.", "observed_on": null, "verified_at": "2026-08-21T08:38:34+00:00", "citation": null } } }, { "slug": "ghk-cu-injected", "name": "GHK-Cu (injected)", "maker": null, "country": null, "region": null, "form": null, "status": "preclinical", "evidence": "claim", "subtitle": "Skin, healing, anti-ageing", "note": "Evidence — The human evidence that exists is topical and thin: one small facial-skin study and one wound-gel trial still recruiting. There is no randomised trial of injected GHK-Cu in humans.\n\nRegulatory status — Injectable routes removed from the safety-risk list Apr 2026; not compoundable. Topical cosmetic use is a separate regulatory category.\n\nWADA — Injectable use captured by S0\n\nKnown harms — Copper load with repeated injection is an unstudied hazard.", "unveiled_on": null, "last_verified_at": "2026-08-21T08:38:34+00:00", "values": { "weight_change": { "absent": true, "reason": "The human evidence that exists is topical and thin: one small facial-skin study and one wound-gel trial still recruiting. There is no randomised trial of injected GHK-Cu in humans.", "confidence": "absent", "verified_at": "2026-08-21T08:38:34+00:00" }, "placebo_change": { "absent": true, "reason": "The human evidence that exists is topical and thin: one small facial-skin study and one wound-gel trial still recruiting. There is no randomised trial of injected GHK-Cu in humans.", "confidence": "absent", "verified_at": "2026-08-21T08:38:34+00:00" }, "placebo_adjusted": { "absent": true, "reason": "The human evidence that exists is topical and thin: one small facial-skin study and one wound-gel trial still recruiting. There is no randomised trial of injected GHK-Cu in humans.", "confidence": "absent", "verified_at": "2026-08-21T08:38:34+00:00" }, "trial": { "absent": true, "reason": "The human evidence that exists is topical and thin: one small facial-skin study and one wound-gel trial still recruiting. There is no randomised trial of injected GHK-Cu in humans.", "confidence": "absent", "verified_at": "2026-08-21T08:38:34+00:00" }, "trial_n": { "absent": true, "reason": "The human evidence that exists is topical and thin: one small facial-skin study and one wound-gel trial still recruiting. There is no randomised trial of injected GHK-Cu in humans.", "confidence": "absent", "verified_at": "2026-08-21T08:38:34+00:00" }, "trial_weeks": { "absent": true, "reason": "The human evidence that exists is topical and thin: one small facial-skin study and one wound-gel trial still recruiting. There is no randomised trial of injected GHK-Cu in humans.", "confidence": "absent", "verified_at": "2026-08-21T08:38:34+00:00" }, "human_rct": { "absent": false, "value": "topical only", "unit": null, "confidence": "claim", "qualifier": "The human evidence that exists is topical and thin: one small facial-skin study and one wound-gel trial still recruiting. There is no randomised trial of injected GHK-Cu in humans.", "observed_on": null, "verified_at": "2026-08-21T08:38:34+00:00", "citation": null } } }, { "slug": "aod-9604", "name": "AOD-9604", "maker": null, "country": null, "region": null, "form": null, "status": "preclinical", "evidence": "claim", "subtitle": "Fat loss", "note": "Evidence — Zero registered trials and zero randomised trials in PubMed. Obesity development was abandoned. The literature that exists consists of doping-detection methods papers.\n\nRegulatory status — Unapproved.\n\nWADA — Prohibited (S2.2.3, growth hormone fragments)\n\nKnown harms — Nothing characterised.", "unveiled_on": null, "last_verified_at": "2026-08-21T08:38:34+00:00", "values": { "weight_change": { "absent": true, "reason": "Zero registered trials and zero randomised trials in PubMed. Obesity development was abandoned. The literature that exists consists of doping-detection methods papers.", "confidence": "absent", "verified_at": "2026-08-21T08:38:34+00:00" }, "placebo_change": { "absent": true, "reason": "Zero registered trials and zero randomised trials in PubMed. Obesity development was abandoned. The literature that exists consists of doping-detection methods papers.", "confidence": "absent", "verified_at": "2026-08-21T08:38:34+00:00" }, "placebo_adjusted": { "absent": true, "reason": "Zero registered trials and zero randomised trials in PubMed. Obesity development was abandoned. The literature that exists consists of doping-detection methods papers.", "confidence": "absent", "verified_at": "2026-08-21T08:38:34+00:00" }, "trial": { "absent": true, "reason": "Zero registered trials and zero randomised trials in PubMed. Obesity development was abandoned. The literature that exists consists of doping-detection methods papers.", "confidence": "absent", "verified_at": "2026-08-21T08:38:34+00:00" }, "trial_n": { "absent": true, "reason": "Zero registered trials and zero randomised trials in PubMed. Obesity development was abandoned. The literature that exists consists of doping-detection methods papers.", "confidence": "absent", "verified_at": "2026-08-21T08:38:34+00:00" }, "trial_weeks": { "absent": true, "reason": "Zero registered trials and zero randomised trials in PubMed. Obesity development was abandoned. The literature that exists consists of doping-detection methods papers.", "confidence": "absent", "verified_at": "2026-08-21T08:38:34+00:00" }, "human_rct": { "absent": false, "value": "none", "unit": null, "confidence": "claim", "qualifier": "Zero registered trials and zero randomised trials in PubMed. Obesity development was abandoned. The literature that exists consists of doping-detection methods papers.", "observed_on": null, "verified_at": "2026-08-21T08:38:34+00:00", "citation": null } } }, { "slug": "semax-selank", "name": "Semax / Selank", "maker": null, "country": null, "region": null, "form": null, "status": "preclinical", "evidence": "claim", "subtitle": "Cognition, anxiety", "note": "Evidence — Semax: zero registered trials; one Russian motor-neurone-disease paper from 2007. Selank: zero registered trials, and no English-language randomised trial exists at all.\n\nRegulatory status — Unapproved; not compoundable.\n\nWADA — Captured by S0\n\nKnown harms — Nothing characterised.", "unveiled_on": null, "last_verified_at": "2026-08-21T08:38:34+00:00", "values": { "weight_change": { "absent": true, "reason": "Semax: zero registered trials; one Russian motor-neurone-disease paper from 2007. Selank: zero registered trials, and no English-language randomised trial exists at all.", "confidence": "absent", "verified_at": "2026-08-21T08:38:34+00:00" }, "placebo_change": { "absent": true, "reason": "Semax: zero registered trials; one Russian motor-neurone-disease paper from 2007. Selank: zero registered trials, and no English-language randomised trial exists at all.", "confidence": "absent", "verified_at": "2026-08-21T08:38:34+00:00" }, "placebo_adjusted": { "absent": true, "reason": "Semax: zero registered trials; one Russian motor-neurone-disease paper from 2007. Selank: zero registered trials, and no English-language randomised trial exists at all.", "confidence": "absent", "verified_at": "2026-08-21T08:38:34+00:00" }, "trial": { "absent": true, "reason": "Semax: zero registered trials; one Russian motor-neurone-disease paper from 2007. Selank: zero registered trials, and no English-language randomised trial exists at all.", "confidence": "absent", "verified_at": "2026-08-21T08:38:34+00:00" }, "trial_n": { "absent": true, "reason": "Semax: zero registered trials; one Russian motor-neurone-disease paper from 2007. Selank: zero registered trials, and no English-language randomised trial exists at all.", "confidence": "absent", "verified_at": "2026-08-21T08:38:34+00:00" }, "trial_weeks": { "absent": true, "reason": "Semax: zero registered trials; one Russian motor-neurone-disease paper from 2007. Selank: zero registered trials, and no English-language randomised trial exists at all.", "confidence": "absent", "verified_at": "2026-08-21T08:38:34+00:00" }, "human_rct": { "absent": false, "value": "none", "unit": null, "confidence": "claim", "qualifier": "Semax: zero registered trials; one Russian motor-neurone-disease paper from 2007. Selank: zero registered trials, and no English-language randomised trial exists at all.", "observed_on": null, "verified_at": "2026-08-21T08:38:34+00:00", "citation": null } } }, { "slug": "tesamorelin", "name": "Tesamorelin", "maker": null, "country": null, "region": null, "form": null, "status": "preclinical", "evidence": "claim", "subtitle": "Abdominal fat reduction", "note": "Evidence — The exception on this list. Real Phase 3 evidence, N=412 plus an extension, and an FDA approval — for one narrow indication only: reduction of excess abdominal fat in people with HIV-associated lipodystrophy.\n\nRegulatory status — APPROVED in the US as Egrifta, NDA 022505, for HIV-associated lipodystrophy only.\n\nWADA — Prohibited (S2.2.4)\n\nKnown harms — Its own label states it is not indicated for weight loss and is weight-neutral. Contraindicated in active malignancy. In trials, 5% developed an HbA1c of 6.5% or above versus 1% on placebo — a hazard ratio of 3.3 for developing diabetes.", "unveiled_on": null, "last_verified_at": "2026-08-21T08:38:34+00:00", "values": { "weight_change": { "absent": true, "reason": "The exception on this list. Real Phase 3 evidence, N=412 plus an extension, and an FDA approval — for one narrow indication only: reduction of excess abdominal fat in people with HIV-associated lipodystrophy.", "confidence": "absent", "verified_at": "2026-08-21T08:38:34+00:00" }, "placebo_change": { "absent": true, "reason": "The exception on this list. Real Phase 3 evidence, N=412 plus an extension, and an FDA approval — for one narrow indication only: reduction of excess abdominal fat in people with HIV-associated lipodystrophy.", "confidence": "absent", "verified_at": "2026-08-21T08:38:34+00:00" }, "placebo_adjusted": { "absent": true, "reason": "The exception on this list. Real Phase 3 evidence, N=412 plus an extension, and an FDA approval — for one narrow indication only: reduction of excess abdominal fat in people with HIV-associated lipodystrophy.", "confidence": "absent", "verified_at": "2026-08-21T08:38:34+00:00" }, "trial": { "absent": true, "reason": "The exception on this list. Real Phase 3 evidence, N=412 plus an extension, and an FDA approval — for one narrow indication only: reduction of excess abdominal fat in people with HIV-associated lipodystrophy.", "confidence": "absent", "verified_at": "2026-08-21T08:38:34+00:00" }, "trial_n": { "absent": true, "reason": "The exception on this list. Real Phase 3 evidence, N=412 plus an extension, and an FDA approval — for one narrow indication only: reduction of excess abdominal fat in people with HIV-associated lipodystrophy.", "confidence": "absent", "verified_at": "2026-08-21T08:38:34+00:00" }, "trial_weeks": { "absent": true, "reason": "The exception on this list. Real Phase 3 evidence, N=412 plus an extension, and an FDA approval — for one narrow indication only: reduction of excess abdominal fat in people with HIV-associated lipodystrophy.", "confidence": "absent", "verified_at": "2026-08-21T08:38:34+00:00" }, "human_rct": { "absent": false, "value": "yes", "unit": null, "confidence": "claim", "qualifier": "The exception on this list. Real Phase 3 evidence, N=412 plus an extension, and an FDA approval — for one narrow indication only: reduction of excess abdominal fat in people with HIV-associated lipodystrophy.", "observed_on": null, "verified_at": "2026-08-21T08:38:34+00:00", "citation": null } } }, { "slug": "redefine-4", "name": "REDEFINE 4", "maker": "Novo Nordisk", "country": null, "region": null, "form": null, "status": "discontinued", "evidence": null, "subtitle": "Failed primary endpoint", "note": null, "unveiled_on": null, "last_verified_at": null, "values": [], "retired": { "on": "2026-02-23", "reason": "CagriSema was not shown non-inferior to tirzepatide 15 mg head to head: −23.0% against −25.5%." } }, { "slug": "bimagrumab-tirzepatide", "name": "Bimagrumab + tirzepatide", "maker": "Eli Lilly", "country": null, "region": null, "form": null, "status": "discontinued", "evidence": null, "subtitle": "Withdrawn with zero participants enrolled", "note": null, "unveiled_on": null, "last_verified_at": null, "values": [], "retired": { "on": "2025-09-25", "reason": "Stated strategic reasons. Context: regulators now expect muscle-sparing agents to show weight loss on top of a GLP-1, not merely alongside it." } }, { "slug": "nnc0519-0130", "name": "NNC0519-0130", "maker": "Novo Nordisk", "country": null, "region": null, "form": null, "status": "discontinued", "evidence": null, "subtitle": "Discontinued despite meeting its endpoint", "note": null, "unveiled_on": null, "last_verified_at": null, "values": [], "retired": { "on": "2025-08-06", "reason": "“Portfolio considerations.” It hit its Phase 2 weight-loss endpoint and was killed anyway — a reminder that working and reaching patients are different questions." } }, { "slug": "zalfermin", "name": "Zalfermin", "maker": "Novo Nordisk", "country": null, "region": null, "form": null, "status": "discontinued", "evidence": null, "subtitle": "Discontinued", "note": null, "unveiled_on": null, "last_verified_at": null, "values": [], "retired": { "on": "2025-08-06", "reason": "Phase 2 failure in MASH." } }, { "slug": "ct-173", "name": "CT-173", "maker": "Roche", "country": null, "region": null, "form": null, "status": "discontinued", "evidence": null, "subtitle": "Dropped", "note": null, "unveiled_on": null, "last_verified_at": null, "values": [], "retired": { "on": "2025-07-24", "reason": "A PYY mimetic dropped because “developability and competitiveness just weren't there”." } }, { "slug": "danuglipron", "name": "Danuglipron", "maker": "Pfizer", "country": null, "region": null, "form": null, "status": "discontinued", "evidence": null, "subtitle": "Discontinued", "note": null, "unveiled_on": null, "last_verified_at": null, "values": [], "retired": { "on": "2025-04-14", "reason": "Potential drug-induced liver injury in a trial participant. Pfizer's second oral GLP-1 to die of a liver signal, after lotiglipron in 2023." } } ], "changelog": [ { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Tesamorelin · Duration", "entity": "tesamorelin", "summary": "Tesamorelin: Duration recorded as —.", "old": null, "new": "—", "citation": null }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Tesamorelin · Participants", "entity": "tesamorelin", "summary": "Tesamorelin: Participants recorded as —.", "old": null, "new": "—", "citation": null }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Tesamorelin · Pivotal trial", "entity": "tesamorelin", "summary": "Tesamorelin: Pivotal trial recorded as —.", "old": null, "new": "—", "citation": null }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Tesamorelin · Placebo-adjusted", "entity": "tesamorelin", "summary": "Tesamorelin: Placebo-adjusted recorded as —.", "old": null, "new": "—", "citation": null }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Tesamorelin · Placebo arm", "entity": "tesamorelin", "summary": "Tesamorelin: Placebo arm recorded as —.", "old": null, "new": "—", "citation": null }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Tesamorelin · Weight change", "entity": "tesamorelin", "summary": "Tesamorelin: Weight change recorded as —.", "old": null, "new": "—", "citation": null }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Tesamorelin · Randomised human evidence", "entity": "tesamorelin", "summary": "Tesamorelin: Randomised human evidence recorded as yes.", "old": null, "new": "yes", "citation": null }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Semax / Selank · Duration", "entity": "semax-selank", "summary": "Semax / Selank: Duration recorded as —.", "old": null, "new": "—", "citation": null }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Semax / Selank · Participants", "entity": "semax-selank", "summary": "Semax / Selank: Participants recorded as —.", "old": null, "new": "—", "citation": null }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Semax / Selank · Pivotal trial", "entity": "semax-selank", "summary": "Semax / Selank: Pivotal trial recorded as —.", "old": null, "new": "—", "citation": null }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Semax / Selank · Placebo-adjusted", "entity": "semax-selank", "summary": "Semax / Selank: Placebo-adjusted recorded as —.", "old": null, "new": "—", "citation": null }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Semax / Selank · Placebo arm", "entity": "semax-selank", "summary": "Semax / Selank: Placebo arm recorded as —.", "old": null, "new": "—", "citation": null }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Semax / Selank · Weight change", "entity": "semax-selank", "summary": "Semax / Selank: Weight change recorded as —.", "old": null, "new": "—", "citation": null }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Semax / Selank · Randomised human evidence", "entity": "semax-selank", "summary": "Semax / Selank: Randomised human evidence recorded as none.", "old": null, "new": "none", "citation": null }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "AOD-9604 · Duration", "entity": "aod-9604", "summary": "AOD-9604: Duration recorded as —.", "old": null, "new": "—", "citation": null }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "AOD-9604 · Participants", "entity": "aod-9604", "summary": "AOD-9604: Participants recorded as —.", "old": null, "new": "—", "citation": null }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "AOD-9604 · Pivotal trial", "entity": "aod-9604", "summary": "AOD-9604: Pivotal trial recorded as —.", "old": null, "new": "—", "citation": null }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "AOD-9604 · Placebo-adjusted", "entity": "aod-9604", "summary": "AOD-9604: Placebo-adjusted recorded as —.", "old": null, "new": "—", "citation": null }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "AOD-9604 · Placebo arm", "entity": "aod-9604", "summary": "AOD-9604: Placebo arm recorded as —.", "old": null, "new": "—", "citation": null }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "AOD-9604 · Weight change", "entity": "aod-9604", "summary": "AOD-9604: Weight change recorded as —.", "old": null, "new": "—", "citation": null }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "AOD-9604 · Randomised human evidence", "entity": "aod-9604", "summary": "AOD-9604: Randomised human evidence recorded as none.", "old": null, "new": "none", "citation": null }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "GHK-Cu (injected) · Duration", "entity": "ghk-cu-injected", "summary": "GHK-Cu (injected): Duration recorded as —.", "old": null, "new": "—", "citation": null }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "GHK-Cu (injected) · Participants", "entity": "ghk-cu-injected", "summary": "GHK-Cu (injected): Participants recorded as —.", "old": null, "new": "—", "citation": null }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "GHK-Cu (injected) · Pivotal trial", "entity": "ghk-cu-injected", "summary": "GHK-Cu (injected): Pivotal trial recorded as —.", "old": null, "new": "—", "citation": null }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "GHK-Cu (injected) · Placebo-adjusted", "entity": "ghk-cu-injected", "summary": "GHK-Cu (injected): Placebo-adjusted recorded as —.", "old": null, "new": "—", "citation": null }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "GHK-Cu (injected) · Placebo arm", "entity": "ghk-cu-injected", "summary": "GHK-Cu (injected): Placebo arm recorded as —.", "old": null, "new": "—", "citation": null }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "GHK-Cu (injected) · Weight change", "entity": "ghk-cu-injected", "summary": "GHK-Cu (injected): Weight change recorded as —.", "old": null, "new": "—", "citation": null }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "GHK-Cu (injected) · Randomised human evidence", "entity": "ghk-cu-injected", "summary": "GHK-Cu (injected): Randomised human evidence recorded as topical only.", "old": null, "new": "topical only", "citation": null }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Epitalon · Duration", "entity": "epitalon", "summary": "Epitalon: Duration recorded as —.", "old": null, "new": "—", "citation": null }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Epitalon · Participants", "entity": "epitalon", "summary": "Epitalon: Participants recorded as —.", "old": null, "new": "—", "citation": null }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Epitalon · Pivotal trial", "entity": "epitalon", "summary": "Epitalon: Pivotal trial recorded as —.", "old": null, "new": "—", "citation": null }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Epitalon · Placebo-adjusted", "entity": "epitalon", "summary": "Epitalon: Placebo-adjusted recorded as —.", "old": null, "new": "—", "citation": null }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Epitalon · Placebo arm", "entity": "epitalon", "summary": "Epitalon: Placebo arm recorded as —.", "old": null, "new": "—", "citation": null }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Epitalon · Weight change", "entity": "epitalon", "summary": "Epitalon: Weight change recorded as —.", "old": null, "new": "—", "citation": null }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Epitalon · Randomised human evidence", "entity": "epitalon", "summary": "Epitalon: Randomised human evidence recorded as none.", "old": null, "new": "none", "citation": null }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "MOTS-c · Duration", "entity": "mots-c", "summary": "MOTS-c: Duration recorded as —.", "old": null, "new": "—", "citation": null }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "MOTS-c · Participants", "entity": "mots-c", "summary": "MOTS-c: Participants recorded as —.", "old": null, "new": "—", "citation": null }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "MOTS-c · Pivotal trial", "entity": "mots-c", "summary": "MOTS-c: Pivotal trial recorded as —.", "old": null, "new": "—", "citation": null }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "MOTS-c · Placebo-adjusted", "entity": "mots-c", "summary": "MOTS-c: Placebo-adjusted recorded as —.", "old": null, "new": "—", "citation": null }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "MOTS-c · Placebo arm", "entity": "mots-c", "summary": "MOTS-c: Placebo arm recorded as —.", "old": null, "new": "—", "citation": null }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "MOTS-c · Weight change", "entity": "mots-c", "summary": "MOTS-c: Weight change recorded as —.", "old": null, "new": "—", "citation": null }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "MOTS-c · Randomised human evidence", "entity": "mots-c", "summary": "MOTS-c: Randomised human evidence recorded as none.", "old": null, "new": "none", "citation": null }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "CJC-1295 · Duration", "entity": "cjc-1295", "summary": "CJC-1295: Duration recorded as —.", "old": null, "new": "—", "citation": null }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "CJC-1295 · Participants", "entity": "cjc-1295", "summary": "CJC-1295: Participants recorded as —.", "old": null, "new": "—", "citation": null }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "CJC-1295 · Pivotal trial", "entity": "cjc-1295", "summary": "CJC-1295: Pivotal trial recorded as —.", "old": null, "new": "—", "citation": null }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "CJC-1295 · Placebo-adjusted", "entity": "cjc-1295", "summary": "CJC-1295: Placebo-adjusted recorded as —.", "old": null, "new": "—", "citation": null }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "CJC-1295 · Placebo arm", "entity": "cjc-1295", "summary": "CJC-1295: Placebo arm recorded as —.", "old": null, "new": "—", "citation": null }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "CJC-1295 · Weight change", "entity": "cjc-1295", "summary": "CJC-1295: Weight change recorded as —.", "old": null, "new": "—", "citation": null }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "CJC-1295 · Randomised human evidence", "entity": "cjc-1295", "summary": "CJC-1295: Randomised human evidence recorded as none.", "old": null, "new": "none", "citation": null }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Ipamorelin · Duration", "entity": "ipamorelin", "summary": "Ipamorelin: Duration recorded as —.", "old": null, "new": "—", "citation": null }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Ipamorelin · Participants", "entity": "ipamorelin", "summary": "Ipamorelin: Participants recorded as —.", "old": null, "new": "—", "citation": null }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Ipamorelin · Pivotal trial", "entity": "ipamorelin", "summary": "Ipamorelin: Pivotal trial recorded as —.", "old": null, "new": "—", "citation": null }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Ipamorelin · Placebo-adjusted", "entity": "ipamorelin", "summary": "Ipamorelin: Placebo-adjusted recorded as —.", "old": null, "new": "—", "citation": null }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Ipamorelin · Placebo arm", "entity": "ipamorelin", "summary": "Ipamorelin: Placebo arm recorded as —.", "old": null, "new": "—", "citation": null }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Ipamorelin · Weight change", "entity": "ipamorelin", "summary": "Ipamorelin: Weight change recorded as —.", "old": null, "new": "—", "citation": null }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Ipamorelin · Randomised human evidence", "entity": "ipamorelin", "summary": "Ipamorelin: Randomised human evidence recorded as negative.", "old": null, "new": "negative", "citation": null }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "TB-500 · Duration", "entity": "tb-500", "summary": "TB-500: Duration recorded as —.", "old": null, "new": "—", "citation": null }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "TB-500 · Participants", "entity": "tb-500", "summary": "TB-500: Participants recorded as —.", "old": null, "new": "—", "citation": null }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "TB-500 · Pivotal trial", "entity": "tb-500", "summary": "TB-500: Pivotal trial recorded as —.", "old": null, "new": "—", "citation": null }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "TB-500 · Placebo-adjusted", "entity": "tb-500", "summary": "TB-500: Placebo-adjusted recorded as —.", "old": null, "new": "—", "citation": null }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "TB-500 · Placebo arm", "entity": "tb-500", "summary": "TB-500: Placebo arm recorded as —.", "old": null, "new": "—", "citation": null }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "TB-500 · Weight change", "entity": "tb-500", "summary": "TB-500: Weight change recorded as —.", "old": null, "new": "—", "citation": null }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "TB-500 · Randomised human evidence", "entity": "tb-500", "summary": "TB-500: Randomised human evidence recorded as none.", "old": null, "new": "none", "citation": null }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "BPC-157 · Duration", "entity": "bpc-157", "summary": "BPC-157: Duration recorded as —.", "old": null, "new": "—", "citation": null }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "BPC-157 · Participants", "entity": "bpc-157", "summary": "BPC-157: Participants recorded as —.", "old": null, "new": "—", "citation": null }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "BPC-157 · Pivotal trial", "entity": "bpc-157", "summary": "BPC-157: Pivotal trial recorded as —.", "old": null, "new": "—", "citation": null }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "BPC-157 · Placebo-adjusted", "entity": "bpc-157", "summary": "BPC-157: Placebo-adjusted recorded as —.", "old": null, "new": "—", "citation": null }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "BPC-157 · Placebo arm", "entity": "bpc-157", "summary": "BPC-157: Placebo arm recorded as —.", "old": null, "new": "—", "citation": null }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "BPC-157 · Weight change", "entity": "bpc-157", "summary": "BPC-157: Weight change recorded as —.", "old": null, "new": "—", "citation": null }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "BPC-157 · Randomised human evidence", "entity": "bpc-157", "summary": "BPC-157: Randomised human evidence recorded as none.", "old": null, "new": "none", "citation": null }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Petrelintide · Placebo-adjusted", "entity": "petrelintide", "summary": "Petrelintide: Placebo-adjusted recorded as -9.0 pp.", "old": null, "new": "-9.0 pp", "citation": { "title": "Petrelintide — Zealand Pharma / Roche", "url": "https://www.zealandpharma.com/pipeline/petrelintide/", "publisher": "Petrelintide", "kind": "press", "primary": false, "published_on": null, "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Petrelintide · Placebo arm", "entity": "petrelintide", "summary": "Petrelintide: Placebo arm recorded as -1.7 %.", "old": null, "new": "-1.7 %", "citation": { "title": "Petrelintide — Zealand Pharma / Roche", "url": "https://www.zealandpharma.com/pipeline/petrelintide/", "publisher": "Petrelintide", "kind": "press", "primary": false, "published_on": null, "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Petrelintide · Weight change", "entity": "petrelintide", "summary": "Petrelintide: Weight change recorded as -10.7 %.", "old": null, "new": "-10.7 %", "citation": { "title": "Petrelintide — Zealand Pharma / Roche", "url": "https://www.zealandpharma.com/pipeline/petrelintide/", "publisher": "Petrelintide", "kind": "press", "primary": false, "published_on": null, "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Petrelintide · Duration", "entity": "petrelintide", "summary": "Petrelintide: Duration recorded as 42 weeks.", "old": null, "new": "42 weeks", "citation": { "title": "Petrelintide — Zealand Pharma / Roche", "url": "https://www.zealandpharma.com/pipeline/petrelintide/", "publisher": "Petrelintide", "kind": "press", "primary": false, "published_on": null, "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Petrelintide · Participants", "entity": "petrelintide", "summary": "Petrelintide: Participants recorded as 493.", "old": null, "new": "493", "citation": { "title": "Petrelintide — Zealand Pharma / Roche", "url": "https://www.zealandpharma.com/pipeline/petrelintide/", "publisher": "Petrelintide", "kind": "press", "primary": false, "published_on": null, "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Petrelintide · Pivotal trial", "entity": "petrelintide", "summary": "Petrelintide: Pivotal trial recorded as ZUPREME-1.", "old": null, "new": "ZUPREME-1", "citation": { "title": "Petrelintide — Zealand Pharma / Roche", "url": "https://www.zealandpharma.com/pipeline/petrelintide/", "publisher": "Petrelintide", "kind": "press", "primary": false, "published_on": null, "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Petrelintide · Class", "entity": "petrelintide", "summary": "Petrelintide: Class recorded as Long-acting amylin analogue.", "old": null, "new": "Long-acting amylin analogue", "citation": { "title": "Petrelintide — Zealand Pharma / Roche", "url": "https://www.zealandpharma.com/pipeline/petrelintide/", "publisher": "Petrelintide", "kind": "press", "primary": false, "published_on": null, "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "VK2735 (oral) · Placebo-adjusted", "entity": "vk2735-oral", "summary": "VK2735 (oral): Placebo-adjusted recorded as -10.9 pp.", "old": null, "new": "-10.9 pp", "citation": { "title": "VK2735 (oral) — Viking Therapeutics", "url": "https://www.prnewswire.com/news-releases/viking-therapeutics-presents-data-from-its-13-week-phase-2-venture-oral-dosing-trial-of-vk2735-at-european-congress-on-obesity-eco-2026-302768959.html", "publisher": "VK2735 (oral)", "kind": "press", "primary": false, "published_on": null, "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "VK2735 (oral) · Placebo arm", "entity": "vk2735-oral", "summary": "VK2735 (oral): Placebo arm recorded as -1.3 %.", "old": null, "new": "-1.3 %", "citation": { "title": "VK2735 (oral) — Viking Therapeutics", "url": "https://www.prnewswire.com/news-releases/viking-therapeutics-presents-data-from-its-13-week-phase-2-venture-oral-dosing-trial-of-vk2735-at-european-congress-on-obesity-eco-2026-302768959.html", "publisher": "VK2735 (oral)", "kind": "press", "primary": false, "published_on": null, "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "VK2735 (oral) · Weight change", "entity": "vk2735-oral", "summary": "VK2735 (oral): Weight change recorded as -12.2 %.", "old": null, "new": "-12.2 %", "citation": { "title": "VK2735 (oral) — Viking Therapeutics", "url": "https://www.prnewswire.com/news-releases/viking-therapeutics-presents-data-from-its-13-week-phase-2-venture-oral-dosing-trial-of-vk2735-at-european-congress-on-obesity-eco-2026-302768959.html", "publisher": "VK2735 (oral)", "kind": "press", "primary": false, "published_on": null, "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "VK2735 (oral) · Duration", "entity": "vk2735-oral", "summary": "VK2735 (oral): Duration recorded as 13 weeks.", "old": null, "new": "13 weeks", "citation": { "title": "VK2735 (oral) — Viking Therapeutics", "url": "https://www.prnewswire.com/news-releases/viking-therapeutics-presents-data-from-its-13-week-phase-2-venture-oral-dosing-trial-of-vk2735-at-european-congress-on-obesity-eco-2026-302768959.html", "publisher": "VK2735 (oral)", "kind": "press", "primary": false, "published_on": null, "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "VK2735 (oral) · Participants", "entity": "vk2735-oral", "summary": "VK2735 (oral): Participants recorded as 280.", "old": null, "new": "280", "citation": { "title": "VK2735 (oral) — Viking Therapeutics", "url": "https://www.prnewswire.com/news-releases/viking-therapeutics-presents-data-from-its-13-week-phase-2-venture-oral-dosing-trial-of-vk2735-at-european-congress-on-obesity-eco-2026-302768959.html", "publisher": "VK2735 (oral)", "kind": "press", "primary": false, "published_on": null, "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "VK2735 (oral) · Pivotal trial", "entity": "vk2735-oral", "summary": "VK2735 (oral): Pivotal trial recorded as VENTURE-Oral.", "old": null, "new": "VENTURE-Oral", "citation": { "title": "VK2735 (oral) — Viking Therapeutics", "url": "https://www.prnewswire.com/news-releases/viking-therapeutics-presents-data-from-its-13-week-phase-2-venture-oral-dosing-trial-of-vk2735-at-european-congress-on-obesity-eco-2026-302768959.html", "publisher": "VK2735 (oral)", "kind": "press", "primary": false, "published_on": null, "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "VK2735 (oral) · Class", "entity": "vk2735-oral", "summary": "VK2735 (oral): Class recorded as Dual GLP-1 / GIP agonist.", "old": null, "new": "Dual GLP-1 / GIP agonist", "citation": { "title": "VK2735 (oral) — Viking Therapeutics", "url": "https://www.prnewswire.com/news-releases/viking-therapeutics-presents-data-from-its-13-week-phase-2-venture-oral-dosing-trial-of-vk2735-at-european-congress-on-obesity-eco-2026-302768959.html", "publisher": "VK2735 (oral)", "kind": "press", "primary": false, "published_on": null, "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Survodutide · Placebo-adjusted", "entity": "survodutide", "summary": "Survodutide: Placebo-adjusted recorded as -7.6 pp.", "old": null, "new": "-7.6 pp", "citation": { "title": "Survodutide — Boehringer Ingelheim / Zealand", "url": "https://pubmed.ncbi.nlm.nih.gov/42253238/", "publisher": "Survodutide", "kind": "journal", "primary": true, "published_on": null, "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Survodutide · Placebo arm", "entity": "survodutide", "summary": "Survodutide: Placebo arm recorded as -5.4 %.", "old": null, "new": "-5.4 %", "citation": { "title": "Survodutide — Boehringer Ingelheim / Zealand", "url": "https://pubmed.ncbi.nlm.nih.gov/42253238/", "publisher": "Survodutide", "kind": "journal", "primary": true, "published_on": null, "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Survodutide · Weight change", "entity": "survodutide", "summary": "Survodutide: Weight change recorded as -13.0 %.", "old": null, "new": "-13.0 %", "citation": { "title": "Survodutide — Boehringer Ingelheim / Zealand", "url": "https://pubmed.ncbi.nlm.nih.gov/42253238/", "publisher": "Survodutide", "kind": "journal", "primary": true, "published_on": null, "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Survodutide · Duration", "entity": "survodutide", "summary": "Survodutide: Duration recorded as 76 weeks.", "old": null, "new": "76 weeks", "citation": { "title": "Survodutide — Boehringer Ingelheim / Zealand", "url": "https://pubmed.ncbi.nlm.nih.gov/42253238/", "publisher": "Survodutide", "kind": "journal", "primary": true, "published_on": null, "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Survodutide · Participants", "entity": "survodutide", "summary": "Survodutide: Participants recorded as 725.", "old": null, "new": "725", "citation": { "title": "Survodutide — Boehringer Ingelheim / Zealand", "url": "https://pubmed.ncbi.nlm.nih.gov/42253238/", "publisher": "Survodutide", "kind": "journal", "primary": true, "published_on": null, "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Survodutide · Pivotal trial", "entity": "survodutide", "summary": "Survodutide: Pivotal trial recorded as SYNCHRONIZE-1.", "old": null, "new": "SYNCHRONIZE-1", "citation": { "title": "Survodutide — Boehringer Ingelheim / Zealand", "url": "https://pubmed.ncbi.nlm.nih.gov/42253238/", "publisher": "Survodutide", "kind": "journal", "primary": true, "published_on": null, "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Survodutide · Class", "entity": "survodutide", "summary": "Survodutide: Class recorded as Dual glucagon + GLP-1 agonist.", "old": null, "new": "Dual glucagon + GLP-1 agonist", "citation": { "title": "Survodutide — Boehringer Ingelheim / Zealand", "url": "https://pubmed.ncbi.nlm.nih.gov/42253238/", "publisher": "Survodutide", "kind": "journal", "primary": true, "published_on": null, "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "MariTide · Placebo-adjusted", "entity": "maritide", "summary": "MariTide: Placebo-adjusted recorded as -13.7 pp.", "old": null, "new": "-13.7 pp", "citation": { "title": "MariTide — Amgen", "url": "https://pubmed.ncbi.nlm.nih.gov/40549887/", "publisher": "MariTide", "kind": "journal", "primary": true, "published_on": null, "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "MariTide · Placebo arm", "entity": "maritide", "summary": "MariTide: Placebo arm recorded as -2.5 %.", "old": null, "new": "-2.5 %", "citation": { "title": "MariTide — Amgen", "url": "https://pubmed.ncbi.nlm.nih.gov/40549887/", "publisher": "MariTide", "kind": "journal", "primary": true, "published_on": null, "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "MariTide · Weight change", "entity": "maritide", "summary": "MariTide: Weight change recorded as -16.2 %.", "old": null, "new": "-16.2 %", "citation": { "title": "MariTide — Amgen", "url": "https://pubmed.ncbi.nlm.nih.gov/40549887/", "publisher": "MariTide", "kind": "journal", "primary": true, "published_on": null, "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "MariTide · Duration", "entity": "maritide", "summary": "MariTide: Duration recorded as 52 weeks.", "old": null, "new": "52 weeks", "citation": { "title": "MariTide — Amgen", "url": "https://pubmed.ncbi.nlm.nih.gov/40549887/", "publisher": "MariTide", "kind": "journal", "primary": true, "published_on": null, "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "MariTide · Participants", "entity": "maritide", "summary": "MariTide: Participants recorded as 592.", "old": null, "new": "592", "citation": { "title": "MariTide — Amgen", "url": "https://pubmed.ncbi.nlm.nih.gov/40549887/", "publisher": "MariTide", "kind": "journal", "primary": true, "published_on": null, "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "MariTide · Pivotal trial", "entity": "maritide", "summary": "MariTide: Pivotal trial recorded as —.", "old": null, "new": "—", "citation": null }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "MariTide · Class", "entity": "maritide", "summary": "MariTide: Class recorded as GIP receptor antagonist conjugated to a GLP-1 agonist.", "old": null, "new": "GIP receptor antagonist conjugated to a GLP-1 agonist", "citation": { "title": "MariTide — Amgen", "url": "https://pubmed.ncbi.nlm.nih.gov/40549887/", "publisher": "MariTide", "kind": "journal", "primary": true, "published_on": null, "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Aleniglipron · Placebo-adjusted", "entity": "aleniglipron", "summary": "Aleniglipron: Placebo-adjusted recorded as —.", "old": null, "new": "—", "citation": null }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Aleniglipron · Placebo arm", "entity": "aleniglipron", "summary": "Aleniglipron: Placebo arm recorded as —.", "old": null, "new": "—", "citation": null }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Aleniglipron · Weight change", "entity": "aleniglipron", "summary": "Aleniglipron: Weight change recorded as -16.3 %.", "old": null, "new": "-16.3 %", "citation": { "title": "Aleniglipron — Structure Therapeutics", "url": "https://ir.structuretx.com/news-releases/news-release-details/structure-therapeutics-reports-positive-topline-data-phase-2", "publisher": "Aleniglipron", "kind": "press", "primary": false, "published_on": null, "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Aleniglipron · Duration", "entity": "aleniglipron", "summary": "Aleniglipron: Duration recorded as 44 weeks.", "old": null, "new": "44 weeks", "citation": { "title": "Aleniglipron — Structure Therapeutics", "url": "https://ir.structuretx.com/news-releases/news-release-details/structure-therapeutics-reports-positive-topline-data-phase-2", "publisher": "Aleniglipron", "kind": "press", "primary": false, "published_on": null, "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Aleniglipron · Participants", "entity": "aleniglipron", "summary": "Aleniglipron: Participants recorded as 85.", "old": null, "new": "85", "citation": { "title": "Aleniglipron — Structure Therapeutics", "url": "https://ir.structuretx.com/news-releases/news-release-details/structure-therapeutics-reports-positive-topline-data-phase-2", "publisher": "Aleniglipron", "kind": "press", "primary": false, "published_on": null, "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Aleniglipron · Pivotal trial", "entity": "aleniglipron", "summary": "Aleniglipron: Pivotal trial recorded as ACCESS II.", "old": null, "new": "ACCESS II", "citation": { "title": "Aleniglipron — Structure Therapeutics", "url": "https://ir.structuretx.com/news-releases/news-release-details/structure-therapeutics-reports-positive-topline-data-phase-2", "publisher": "Aleniglipron", "kind": "press", "primary": false, "published_on": null, "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Aleniglipron · Class", "entity": "aleniglipron", "summary": "Aleniglipron: Class recorded as Oral small-molecule GLP-1 agonist.", "old": null, "new": "Oral small-molecule GLP-1 agonist", "citation": { "title": "Aleniglipron — Structure Therapeutics", "url": "https://ir.structuretx.com/news-releases/news-release-details/structure-therapeutics-reports-positive-topline-data-phase-2", "publisher": "Aleniglipron", "kind": "press", "primary": false, "published_on": null, "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Bimagrumab + semaglutide · Placebo-adjusted", "entity": "bimagrumab-semaglutide", "summary": "Bimagrumab + semaglutide: Placebo-adjusted recorded as —.", "old": null, "new": "—", "citation": null }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Bimagrumab + semaglutide · Placebo arm", "entity": "bimagrumab-semaglutide", "summary": "Bimagrumab + semaglutide: Placebo arm recorded as —.", "old": null, "new": "—", "citation": null }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Bimagrumab + semaglutide · Weight change", "entity": "bimagrumab-semaglutide", "summary": "Bimagrumab + semaglutide: Weight change recorded as -22.1 %.", "old": null, "new": "-22.1 %", "citation": { "title": "Bimagrumab + semaglutide — Eli Lilly", "url": "https://www.hcplive.com/view/believe-bimagrumab-semaglutide-combo-yields-substantial-fat-mass-weight-loss-preserves-lean-mass", "publisher": "Bimagrumab + semaglutide", "kind": "trade", "primary": false, "published_on": null, "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Bimagrumab + semaglutide · Duration", "entity": "bimagrumab-semaglutide", "summary": "Bimagrumab + semaglutide: Duration recorded as 72 weeks.", "old": null, "new": "72 weeks", "citation": { "title": "Bimagrumab + semaglutide — Eli Lilly", "url": "https://www.hcplive.com/view/believe-bimagrumab-semaglutide-combo-yields-substantial-fat-mass-weight-loss-preserves-lean-mass", "publisher": "Bimagrumab + semaglutide", "kind": "trade", "primary": false, "published_on": null, "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Bimagrumab + semaglutide · Participants", "entity": "bimagrumab-semaglutide", "summary": "Bimagrumab + semaglutide: Participants recorded as 507.", "old": null, "new": "507", "citation": { "title": "Bimagrumab + semaglutide — Eli Lilly", "url": "https://www.hcplive.com/view/believe-bimagrumab-semaglutide-combo-yields-substantial-fat-mass-weight-loss-preserves-lean-mass", "publisher": "Bimagrumab + semaglutide", "kind": "trade", "primary": false, "published_on": null, "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Bimagrumab + semaglutide · Pivotal trial", "entity": "bimagrumab-semaglutide", "summary": "Bimagrumab + semaglutide: Pivotal trial recorded as BELIEVE.", "old": null, "new": "BELIEVE", "citation": { "title": "Bimagrumab + semaglutide — Eli Lilly", "url": "https://www.hcplive.com/view/believe-bimagrumab-semaglutide-combo-yields-substantial-fat-mass-weight-loss-preserves-lean-mass", "publisher": "Bimagrumab + semaglutide", "kind": "trade", "primary": false, "published_on": null, "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Bimagrumab + semaglutide · Class", "entity": "bimagrumab-semaglutide", "summary": "Bimagrumab + semaglutide: Class recorded as Anti-activin receptor antibody, muscle-sparing, combined with a GLP-1.", "old": null, "new": "Anti-activin receptor antibody, muscle-sparing, combined with a GLP-1", "citation": { "title": "Bimagrumab + semaglutide — Eli Lilly", "url": "https://www.hcplive.com/view/believe-bimagrumab-semaglutide-combo-yields-substantial-fat-mass-weight-loss-preserves-lean-mass", "publisher": "Bimagrumab + semaglutide", "kind": "trade", "primary": false, "published_on": null, "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Amycretin · Placebo-adjusted", "entity": "amycretin", "summary": "Amycretin: Placebo-adjusted recorded as -24.0 pp.", "old": null, "new": "-24.0 pp", "citation": { "title": "Amycretin — Novo Nordisk", "url": "https://www.biospace.com/press-releases/novo-nordisk-to-advance-subcutaneous-and-oral-amycretin-for-weight-management-into-phase-3-clinical-development", "publisher": "Amycretin", "kind": "trade", "primary": false, "published_on": null, "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Amycretin · Placebo arm", "entity": "amycretin", "summary": "Amycretin: Placebo arm recorded as 2.0 %.", "old": null, "new": "2.0 %", "citation": { "title": "Amycretin — Novo Nordisk", "url": "https://www.biospace.com/press-releases/novo-nordisk-to-advance-subcutaneous-and-oral-amycretin-for-weight-management-into-phase-3-clinical-development", "publisher": "Amycretin", "kind": "trade", "primary": false, "published_on": null, "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Amycretin · Weight change", "entity": "amycretin", "summary": "Amycretin: Weight change recorded as -22.0 %.", "old": null, "new": "-22.0 %", "citation": { "title": "Amycretin — Novo Nordisk", "url": "https://www.biospace.com/press-releases/novo-nordisk-to-advance-subcutaneous-and-oral-amycretin-for-weight-management-into-phase-3-clinical-development", "publisher": "Amycretin", "kind": "trade", "primary": false, "published_on": null, "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Amycretin · Duration", "entity": "amycretin", "summary": "Amycretin: Duration recorded as 36 weeks.", "old": null, "new": "36 weeks", "citation": { "title": "Amycretin — Novo Nordisk", "url": "https://www.biospace.com/press-releases/novo-nordisk-to-advance-subcutaneous-and-oral-amycretin-for-weight-management-into-phase-3-clinical-development", "publisher": "Amycretin", "kind": "trade", "primary": false, "published_on": null, "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Amycretin · Participants", "entity": "amycretin", "summary": "Amycretin: Participants recorded as 125.", "old": null, "new": "125", "citation": { "title": "Amycretin — Novo Nordisk", "url": "https://www.biospace.com/press-releases/novo-nordisk-to-advance-subcutaneous-and-oral-amycretin-for-weight-management-into-phase-3-clinical-development", "publisher": "Amycretin", "kind": "trade", "primary": false, "published_on": null, "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Amycretin · Pivotal trial", "entity": "amycretin", "summary": "Amycretin: Pivotal trial recorded as —.", "old": null, "new": "—", "citation": null }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Amycretin · Class", "entity": "amycretin", "summary": "Amycretin: Class recorded as Single molecule acting on GLP-1 and amylin receptors.", "old": null, "new": "Single molecule acting on GLP-1 and amylin receptors", "citation": { "title": "Amycretin — Novo Nordisk", "url": "https://www.biospace.com/press-releases/novo-nordisk-to-advance-subcutaneous-and-oral-amycretin-for-weight-management-into-phase-3-clinical-development", "publisher": "Amycretin", "kind": "trade", "primary": false, "published_on": null, "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "CagriSema · Placebo-adjusted", "entity": "cagrisema", "summary": "CagriSema: Placebo-adjusted recorded as -17.4 pp.", "old": null, "new": "-17.4 pp", "citation": { "title": "CagriSema — Novo Nordisk", "url": "https://www.patientcareonline.com/view/cagrisema-achieves-23-weight-loss-but-misses-noninferiority-vs-tirzepatide-in-redefine-4", "publisher": "CagriSema", "kind": "trade", "primary": false, "published_on": null, "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "CagriSema · Placebo arm", "entity": "cagrisema", "summary": "CagriSema: Placebo arm recorded as -3.0 %.", "old": null, "new": "-3.0 %", "citation": { "title": "CagriSema — Novo Nordisk", "url": "https://www.patientcareonline.com/view/cagrisema-achieves-23-weight-loss-but-misses-noninferiority-vs-tirzepatide-in-redefine-4", "publisher": "CagriSema", "kind": "trade", "primary": false, "published_on": null, "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "CagriSema · Weight change", "entity": "cagrisema", "summary": "CagriSema: Weight change recorded as -20.4 %.", "old": null, "new": "-20.4 %", "citation": { "title": "CagriSema — Novo Nordisk", "url": "https://www.patientcareonline.com/view/cagrisema-achieves-23-weight-loss-but-misses-noninferiority-vs-tirzepatide-in-redefine-4", "publisher": "CagriSema", "kind": "trade", "primary": false, "published_on": null, "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "CagriSema · Duration", "entity": "cagrisema", "summary": "CagriSema: Duration recorded as 68 weeks.", "old": null, "new": "68 weeks", "citation": { "title": "CagriSema — Novo Nordisk", "url": "https://www.patientcareonline.com/view/cagrisema-achieves-23-weight-loss-but-misses-noninferiority-vs-tirzepatide-in-redefine-4", "publisher": "CagriSema", "kind": "trade", "primary": false, "published_on": null, "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "CagriSema · Participants", "entity": "cagrisema", "summary": "CagriSema: Participants recorded as 3 417.", "old": null, "new": "3 417", "citation": { "title": "CagriSema — Novo Nordisk", "url": "https://www.patientcareonline.com/view/cagrisema-achieves-23-weight-loss-but-misses-noninferiority-vs-tirzepatide-in-redefine-4", "publisher": "CagriSema", "kind": "trade", "primary": false, "published_on": null, "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "CagriSema · Pivotal trial", "entity": "cagrisema", "summary": "CagriSema: Pivotal trial recorded as REDEFINE 1.", "old": null, "new": "REDEFINE 1", "citation": { "title": "CagriSema — Novo Nordisk", "url": "https://www.patientcareonline.com/view/cagrisema-achieves-23-weight-loss-but-misses-noninferiority-vs-tirzepatide-in-redefine-4", "publisher": "CagriSema", "kind": "trade", "primary": false, "published_on": null, "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "CagriSema · Class", "entity": "cagrisema", "summary": "CagriSema: Class recorded as Amylin analogue + GLP-1 agonist.", "old": null, "new": "Amylin analogue + GLP-1 agonist", "citation": { "title": "CagriSema — Novo Nordisk", "url": "https://www.patientcareonline.com/view/cagrisema-achieves-23-weight-loss-but-misses-noninferiority-vs-tirzepatide-in-redefine-4", "publisher": "CagriSema", "kind": "trade", "primary": false, "published_on": null, "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Retatrutide · Placebo-adjusted", "entity": "retatrutide", "summary": "Retatrutide: Placebo-adjusted recorded as -26.1 pp.", "old": null, "new": "-26.1 pp", "citation": { "title": "Retatrutide — Eli Lilly", "url": "https://www.prnewswire.com/news-releases/lillys-triple-agonist-retatrutide-delivered-powerful-weight-loss-in-pivotal-phase-3-obesity-trial-302778859.html", "publisher": "Retatrutide", "kind": "press", "primary": false, "published_on": null, "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Retatrutide · Placebo arm", "entity": "retatrutide", "summary": "Retatrutide: Placebo arm recorded as -2.2 %.", "old": null, "new": "-2.2 %", "citation": { "title": "Retatrutide — Eli Lilly", "url": "https://www.prnewswire.com/news-releases/lillys-triple-agonist-retatrutide-delivered-powerful-weight-loss-in-pivotal-phase-3-obesity-trial-302778859.html", "publisher": "Retatrutide", "kind": "press", "primary": false, "published_on": null, "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Retatrutide · Weight change", "entity": "retatrutide", "summary": "Retatrutide: Weight change recorded as -28.3 %.", "old": null, "new": "-28.3 %", "citation": { "title": "Retatrutide — Eli Lilly", "url": "https://www.prnewswire.com/news-releases/lillys-triple-agonist-retatrutide-delivered-powerful-weight-loss-in-pivotal-phase-3-obesity-trial-302778859.html", "publisher": "Retatrutide", "kind": "press", "primary": false, "published_on": null, "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Retatrutide · Duration", "entity": "retatrutide", "summary": "Retatrutide: Duration recorded as 80 weeks.", "old": null, "new": "80 weeks", "citation": { "title": "Retatrutide — Eli Lilly", "url": "https://www.prnewswire.com/news-releases/lillys-triple-agonist-retatrutide-delivered-powerful-weight-loss-in-pivotal-phase-3-obesity-trial-302778859.html", "publisher": "Retatrutide", "kind": "press", "primary": false, "published_on": null, "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Retatrutide · Participants", "entity": "retatrutide", "summary": "Retatrutide: Participants recorded as 2 339.", "old": null, "new": "2 339", "citation": { "title": "Retatrutide — Eli Lilly", "url": "https://www.prnewswire.com/news-releases/lillys-triple-agonist-retatrutide-delivered-powerful-weight-loss-in-pivotal-phase-3-obesity-trial-302778859.html", "publisher": "Retatrutide", "kind": "press", "primary": false, "published_on": null, "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Retatrutide · Pivotal trial", "entity": "retatrutide", "summary": "Retatrutide: Pivotal trial recorded as TRIUMPH-1.", "old": null, "new": "TRIUMPH-1", "citation": { "title": "Retatrutide — Eli Lilly", "url": "https://www.prnewswire.com/news-releases/lillys-triple-agonist-retatrutide-delivered-powerful-weight-loss-in-pivotal-phase-3-obesity-trial-302778859.html", "publisher": "Retatrutide", "kind": "press", "primary": false, "published_on": null, "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Retatrutide · Class", "entity": "retatrutide", "summary": "Retatrutide: Class recorded as Triple GLP-1 / GIP / glucagon agonist.", "old": null, "new": "Triple GLP-1 / GIP / glucagon agonist", "citation": { "title": "Retatrutide — Eli Lilly", "url": "https://www.prnewswire.com/news-releases/lillys-triple-agonist-retatrutide-delivered-powerful-weight-loss-in-pivotal-phase-3-obesity-trial-302778859.html", "publisher": "Retatrutide", "kind": "press", "primary": false, "published_on": null, "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "approval", "generated": true, "subject": "Ecnoglutide · TGA", "entity": "ecnoglutide", "summary": "Ecnoglutide: TGA position recorded as not approved.", "old": null, "new": "not approved", "citation": null }, { "happened_on": "2026-08-21", "kind": "approval", "generated": true, "subject": "Ecnoglutide · Canada", "entity": "ecnoglutide", "summary": "Ecnoglutide: Canada position recorded as not approved.", "old": null, "new": "not approved", "citation": null }, { "happened_on": "2026-08-21", "kind": "approval", "generated": true, "subject": "Ecnoglutide · PMDA", "entity": "ecnoglutide", "summary": "Ecnoglutide: PMDA position recorded as not approved.", "old": null, "new": "not approved", "citation": null }, { "happened_on": "2026-08-21", "kind": "approval", "generated": true, "subject": "Ecnoglutide · ANVISA", "entity": "ecnoglutide", "summary": "Ecnoglutide: ANVISA position recorded as not approved.", "old": null, "new": "not approved", "citation": null }, { "happened_on": "2026-08-21", "kind": "approval", "generated": true, "subject": "Ecnoglutide · MHRA", "entity": "ecnoglutide", "summary": "Ecnoglutide: MHRA position recorded as not approved.", "old": null, "new": "not approved", "citation": null }, { "happened_on": "2026-08-21", "kind": "approval", "generated": true, "subject": "Ecnoglutide · EMA", "entity": "ecnoglutide", "summary": "Ecnoglutide: EMA position recorded as not approved.", "old": null, "new": "not approved", "citation": null }, { "happened_on": "2026-08-21", "kind": "approval", "generated": true, "subject": "Ecnoglutide · FDA", "entity": "ecnoglutide", "summary": "Ecnoglutide: FDA position recorded as not approved.", "old": null, "new": "not approved", "citation": null }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Ecnoglutide · Duration", "entity": "ecnoglutide", "summary": "Ecnoglutide: Duration recorded as 48 weeks.", "old": null, "new": "48 weeks", "citation": { "title": "Sciwind — NMPA approval of ecnoglutide", "url": "https://www.prnewswire.com/news-releases/sciwind-biosciences-announces-ecnoglutide-injection-approved-by-chinas-national-medical-products-administration-nmpa-for-chronic-weight-management-302706442.html", "publisher": "Sciwind", "kind": "press", "primary": false, "published_on": "2026-03-06", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Ecnoglutide · Participants", "entity": "ecnoglutide", "summary": "Ecnoglutide: Participants recorded as —.", "old": null, "new": "—", "citation": null }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Ecnoglutide · Pivotal trial", "entity": "ecnoglutide", "summary": "Ecnoglutide: Pivotal trial recorded as SLIMMER.", "old": null, "new": "SLIMMER", "citation": { "title": "Sciwind — NMPA approval of ecnoglutide", "url": "https://www.prnewswire.com/news-releases/sciwind-biosciences-announces-ecnoglutide-injection-approved-by-chinas-national-medical-products-administration-nmpa-for-chronic-weight-management-302706442.html", "publisher": "Sciwind", "kind": "press", "primary": false, "published_on": "2026-03-06", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Ecnoglutide · Placebo-adjusted", "entity": "ecnoglutide", "summary": "Ecnoglutide: Placebo-adjusted recorded as -15.1 pp.", "old": null, "new": "-15.1 pp", "citation": { "title": "Sciwind — NMPA approval of ecnoglutide", "url": "https://www.prnewswire.com/news-releases/sciwind-biosciences-announces-ecnoglutide-injection-approved-by-chinas-national-medical-products-administration-nmpa-for-chronic-weight-management-302706442.html", "publisher": "Sciwind", "kind": "press", "primary": false, "published_on": "2026-03-06", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Ecnoglutide · Placebo arm", "entity": "ecnoglutide", "summary": "Ecnoglutide: Placebo arm recorded as -0.3 %.", "old": null, "new": "-0.3 %", "citation": { "title": "Sciwind — NMPA approval of ecnoglutide", "url": "https://www.prnewswire.com/news-releases/sciwind-biosciences-announces-ecnoglutide-injection-approved-by-chinas-national-medical-products-administration-nmpa-for-chronic-weight-management-302706442.html", "publisher": "Sciwind", "kind": "press", "primary": false, "published_on": "2026-03-06", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Ecnoglutide · Weight change", "entity": "ecnoglutide", "summary": "Ecnoglutide: Weight change recorded as -15.4 %.", "old": null, "new": "-15.4 %", "citation": { "title": "Sciwind — NMPA approval of ecnoglutide", "url": "https://www.prnewswire.com/news-releases/sciwind-biosciences-announces-ecnoglutide-injection-approved-by-chinas-national-medical-products-administration-nmpa-for-chronic-weight-management-302706442.html", "publisher": "Sciwind", "kind": "press", "primary": false, "published_on": "2026-03-06", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Ecnoglutide · Stopped for side effects", "entity": "ecnoglutide", "summary": "Ecnoglutide: Stopped for side effects recorded as —.", "old": null, "new": "—", "citation": null }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Ecnoglutide · Dose", "entity": "ecnoglutide", "summary": "Ecnoglutide: Dose recorded as 2.4 mg weekly.", "old": null, "new": "2.4 mg weekly", "citation": { "title": "Sciwind — NMPA approval of ecnoglutide", "url": "https://www.prnewswire.com/news-releases/sciwind-biosciences-announces-ecnoglutide-injection-approved-by-chinas-national-medical-products-administration-nmpa-for-chronic-weight-management-302706442.html", "publisher": "Sciwind", "kind": "press", "primary": false, "published_on": "2026-03-06", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Ecnoglutide · Route", "entity": "ecnoglutide", "summary": "Ecnoglutide: Route recorded as Injection, weekly.", "old": null, "new": "Injection, weekly", "citation": { "title": "Sciwind — NMPA approval of ecnoglutide", "url": "https://www.prnewswire.com/news-releases/sciwind-biosciences-announces-ecnoglutide-injection-approved-by-chinas-national-medical-products-administration-nmpa-for-chronic-weight-management-302706442.html", "publisher": "Sciwind", "kind": "press", "primary": false, "published_on": "2026-03-06", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Ecnoglutide · Class", "entity": "ecnoglutide", "summary": "Ecnoglutide: Class recorded as cAMP-biased GLP-1 receptor agonist.", "old": null, "new": "cAMP-biased GLP-1 receptor agonist", "citation": { "title": "Sciwind — NMPA approval of ecnoglutide", "url": "https://www.prnewswire.com/news-releases/sciwind-biosciences-announces-ecnoglutide-injection-approved-by-chinas-national-medical-products-administration-nmpa-for-chronic-weight-management-302706442.html", "publisher": "Sciwind", "kind": "press", "primary": false, "published_on": "2026-03-06", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Ecnoglutide · Brand", "entity": "ecnoglutide", "summary": "Ecnoglutide: Brand recorded as Ecnoglutide (brand not disclosed).", "old": null, "new": "Ecnoglutide (brand not disclosed)", "citation": { "title": "Sciwind — NMPA approval of ecnoglutide", "url": "https://www.prnewswire.com/news-releases/sciwind-biosciences-announces-ecnoglutide-injection-approved-by-chinas-national-medical-products-administration-nmpa-for-chronic-weight-management-302706442.html", "publisher": "Sciwind", "kind": "press", "primary": false, "published_on": "2026-03-06", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "approval", "generated": true, "subject": "Mazdutide · TGA", "entity": "mazdutide", "summary": "Mazdutide: TGA position recorded as not approved.", "old": null, "new": "not approved", "citation": null }, { "happened_on": "2026-08-21", "kind": "approval", "generated": true, "subject": "Mazdutide · Canada", "entity": "mazdutide", "summary": "Mazdutide: Canada position recorded as not approved.", "old": null, "new": "not approved", "citation": null }, { "happened_on": "2026-08-21", "kind": "approval", "generated": true, "subject": "Mazdutide · PMDA", "entity": "mazdutide", "summary": "Mazdutide: PMDA position recorded as not approved.", "old": null, "new": "not approved", "citation": null }, { "happened_on": "2026-08-21", "kind": "approval", "generated": true, "subject": "Mazdutide · ANVISA", "entity": "mazdutide", "summary": "Mazdutide: ANVISA position recorded as not approved.", "old": null, "new": "not approved", "citation": null }, { "happened_on": "2026-08-21", "kind": "approval", "generated": true, "subject": "Mazdutide · MHRA", "entity": "mazdutide", "summary": "Mazdutide: MHRA position recorded as not approved.", "old": null, "new": "not approved", "citation": null }, { "happened_on": "2026-08-21", "kind": "approval", "generated": true, "subject": "Mazdutide · EMA", "entity": "mazdutide", "summary": "Mazdutide: EMA position recorded as not approved.", "old": null, "new": "not approved", "citation": null }, { "happened_on": "2026-08-21", "kind": "approval", "generated": true, "subject": "Mazdutide · FDA", "entity": "mazdutide", "summary": "Mazdutide: FDA position recorded as not approved.", "old": null, "new": "not approved", "citation": null }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Mazdutide · Duration", "entity": "mazdutide", "summary": "Mazdutide: Duration recorded as 48 weeks.", "old": null, "new": "48 weeks", "citation": { "title": "Mazdutide: First Approval, Drugs 2025 — PubMed 41028652", "url": "https://pubmed.ncbi.nlm.nih.gov/41028652/", "publisher": "Mazdutide: First Approval, Drugs 2025", "kind": "journal", "primary": true, "published_on": "2025-09-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Mazdutide · Participants", "entity": "mazdutide", "summary": "Mazdutide: Participants recorded as —.", "old": null, "new": "—", "citation": null }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Mazdutide · Pivotal trial", "entity": "mazdutide", "summary": "Mazdutide: Pivotal trial recorded as GLORY-1.", "old": null, "new": "GLORY-1", "citation": { "title": "Mazdutide: First Approval, Drugs 2025 — PubMed 41028652", "url": "https://pubmed.ncbi.nlm.nih.gov/41028652/", "publisher": "Mazdutide: First Approval, Drugs 2025", "kind": "journal", "primary": true, "published_on": "2025-09-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Mazdutide · Placebo-adjusted", "entity": "mazdutide", "summary": "Mazdutide: Placebo-adjusted recorded as -14.3 pp.", "old": null, "new": "-14.3 pp", "citation": { "title": "Mazdutide: First Approval, Drugs 2025 — PubMed 41028652", "url": "https://pubmed.ncbi.nlm.nih.gov/41028652/", "publisher": "Mazdutide: First Approval, Drugs 2025", "kind": "journal", "primary": true, "published_on": "2025-09-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Mazdutide · Placebo arm", "entity": "mazdutide", "summary": "Mazdutide: Placebo arm recorded as -0.5 %.", "old": null, "new": "-0.5 %", "citation": { "title": "Mazdutide: First Approval, Drugs 2025 — PubMed 41028652", "url": "https://pubmed.ncbi.nlm.nih.gov/41028652/", "publisher": "Mazdutide: First Approval, Drugs 2025", "kind": "journal", "primary": true, "published_on": "2025-09-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Mazdutide · Weight change", "entity": "mazdutide", "summary": "Mazdutide: Weight change recorded as -14.8 %.", "old": null, "new": "-14.8 %", "citation": { "title": "Mazdutide: First Approval, Drugs 2025 — PubMed 41028652", "url": "https://pubmed.ncbi.nlm.nih.gov/41028652/", "publisher": "Mazdutide: First Approval, Drugs 2025", "kind": "journal", "primary": true, "published_on": "2025-09-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Mazdutide · Stopped for side effects", "entity": "mazdutide", "summary": "Mazdutide: Stopped for side effects recorded as —.", "old": null, "new": "—", "citation": null }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Mazdutide · Dose", "entity": "mazdutide", "summary": "Mazdutide: Dose recorded as 4 mg or 6 mg weekly.", "old": null, "new": "4 mg or 6 mg weekly", "citation": { "title": "Innovent — NMPA approval for chronic weight management", "url": "https://www.prnewswire.com/news-releases/innovent-announces-mazdutide-first-dual-gcgglp-1-receptor-agonist-received-approval-from-chinas-nmpa-for-chronic-weight-management-302493152.html", "publisher": "Innovent", "kind": "press", "primary": false, "published_on": "2025-06-27", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Mazdutide · Route", "entity": "mazdutide", "summary": "Mazdutide: Route recorded as Injection, weekly.", "old": null, "new": "Injection, weekly", "citation": { "title": "Innovent — NMPA approval for chronic weight management", "url": "https://www.prnewswire.com/news-releases/innovent-announces-mazdutide-first-dual-gcgglp-1-receptor-agonist-received-approval-from-chinas-nmpa-for-chronic-weight-management-302493152.html", "publisher": "Innovent", "kind": "press", "primary": false, "published_on": "2025-06-27", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Mazdutide · Class", "entity": "mazdutide", "summary": "Mazdutide: Class recorded as Dual glucagon + GLP-1 receptor agonist.", "old": null, "new": "Dual glucagon + GLP-1 receptor agonist", "citation": { "title": "Innovent — NMPA approval for chronic weight management", "url": "https://www.prnewswire.com/news-releases/innovent-announces-mazdutide-first-dual-gcgglp-1-receptor-agonist-received-approval-from-chinas-nmpa-for-chronic-weight-management-302493152.html", "publisher": "Innovent", "kind": "press", "primary": false, "published_on": "2025-06-27", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Mazdutide · Brand", "entity": "mazdutide", "summary": "Mazdutide: Brand recorded as Xin Er Mei (信尔美).", "old": null, "new": "Xin Er Mei (信尔美)", "citation": { "title": "Innovent — NMPA approval for chronic weight management", "url": "https://www.prnewswire.com/news-releases/innovent-announces-mazdutide-first-dual-gcgglp-1-receptor-agonist-received-approval-from-chinas-nmpa-for-chronic-weight-management-302493152.html", "publisher": "Innovent", "kind": "press", "primary": false, "published_on": "2025-06-27", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "approval", "generated": true, "subject": "Metreleptin · TGA", "entity": "metreleptin", "summary": "Metreleptin: TGA position recorded as not approved.", "old": null, "new": "not approved", "citation": null }, { "happened_on": "2026-08-21", "kind": "approval", "generated": true, "subject": "Metreleptin · Canada", "entity": "metreleptin", "summary": "Metreleptin: Canada position recorded as not approved.", "old": null, "new": "not approved", "citation": null }, { "happened_on": "2026-08-21", "kind": "approval", "generated": true, "subject": "Metreleptin · NMPA", "entity": "metreleptin", "summary": "Metreleptin: NMPA position recorded as not approved.", "old": null, "new": "not approved", "citation": null }, { "happened_on": "2026-08-21", "kind": "approval", "generated": true, "subject": "Metreleptin · PMDA", "entity": "metreleptin", "summary": "Metreleptin: PMDA position recorded as approved.", "old": null, "new": "approved", "citation": null }, { "happened_on": "2026-08-21", "kind": "approval", "generated": true, "subject": "Metreleptin · ANVISA", "entity": "metreleptin", "summary": "Metreleptin: ANVISA position recorded as not approved.", "old": null, "new": "not approved", "citation": null }, { "happened_on": "2026-08-21", "kind": "approval", "generated": true, "subject": "Metreleptin · MHRA", "entity": "metreleptin", "summary": "Metreleptin: MHRA position recorded as approved.", "old": null, "new": "approved", "citation": null }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Metreleptin · Duration", "entity": "metreleptin", "summary": "Metreleptin: Duration recorded as —.", "old": null, "new": "—", "citation": null }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Metreleptin · Participants", "entity": "metreleptin", "summary": "Metreleptin: Participants recorded as 107.", "old": null, "new": "107", "citation": { "title": "FDA — Myalept label", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125390s004lbl.pdf", "publisher": "FDA", "kind": "regulator", "primary": true, "published_on": "2014-02-24", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Metreleptin · Pivotal trial", "entity": "metreleptin", "summary": "Metreleptin: Pivotal trial recorded as NIH open-label cohort.", "old": null, "new": "NIH open-label cohort", "citation": { "title": "FDA — Myalept label", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125390s004lbl.pdf", "publisher": "FDA", "kind": "regulator", "primary": true, "published_on": "2014-02-24", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Metreleptin · Placebo-adjusted", "entity": "metreleptin", "summary": "Metreleptin: Placebo-adjusted recorded as —.", "old": null, "new": "—", "citation": null }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Metreleptin · Placebo arm", "entity": "metreleptin", "summary": "Metreleptin: Placebo arm recorded as —.", "old": null, "new": "—", "citation": null }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Metreleptin · Weight change", "entity": "metreleptin", "summary": "Metreleptin: Weight change recorded as —.", "old": null, "new": "—", "citation": null }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Metreleptin · Stopped for side effects", "entity": "metreleptin", "summary": "Metreleptin: Stopped for side effects recorded as —.", "old": null, "new": "—", "citation": null }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Metreleptin · Dose", "entity": "metreleptin", "summary": "Metreleptin: Dose recorded as Up to 10 mg daily.", "old": null, "new": "Up to 10 mg daily", "citation": { "title": "FDA — Myalept label", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125390s004lbl.pdf", "publisher": "FDA", "kind": "regulator", "primary": true, "published_on": "2014-02-24", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Metreleptin · Route", "entity": "metreleptin", "summary": "Metreleptin: Route recorded as Injection, daily.", "old": null, "new": "Injection, daily", "citation": { "title": "FDA — Myalept label", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125390s004lbl.pdf", "publisher": "FDA", "kind": "regulator", "primary": true, "published_on": "2014-02-24", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Metreleptin · Class", "entity": "metreleptin", "summary": "Metreleptin: Class recorded as Recombinant leptin analogue.", "old": null, "new": "Recombinant leptin analogue", "citation": { "title": "FDA — Myalept label", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125390s004lbl.pdf", "publisher": "FDA", "kind": "regulator", "primary": true, "published_on": "2014-02-24", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Metreleptin · Brand", "entity": "metreleptin", "summary": "Metreleptin: Brand recorded as Myalept (US) / Myalepta (EU).", "old": null, "new": "Myalept (US) / Myalepta (EU)", "citation": { "title": "FDA — Myalept label", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125390s004lbl.pdf", "publisher": "FDA", "kind": "regulator", "primary": true, "published_on": "2014-02-24", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "approval", "generated": true, "subject": "Setmelanotide · TGA", "entity": "setmelanotide", "summary": "Setmelanotide: TGA position recorded as not approved.", "old": null, "new": "not approved", "citation": null }, { "happened_on": "2026-08-21", "kind": "approval", "generated": true, "subject": "Setmelanotide · Canada", "entity": "setmelanotide", "summary": "Setmelanotide: Canada position recorded as not approved.", "old": null, "new": "not approved", "citation": null }, { "happened_on": "2026-08-21", "kind": "approval", "generated": true, "subject": "Setmelanotide · NMPA", "entity": "setmelanotide", "summary": "Setmelanotide: NMPA position recorded as not approved.", "old": null, "new": "not approved", "citation": null }, { "happened_on": "2026-08-21", "kind": "approval", "generated": true, "subject": "Setmelanotide · PMDA", "entity": "setmelanotide", "summary": "Setmelanotide: PMDA position recorded as not approved.", "old": null, "new": "not approved", "citation": null }, { "happened_on": "2026-08-21", "kind": "approval", "generated": true, "subject": "Setmelanotide · ANVISA", "entity": "setmelanotide", "summary": "Setmelanotide: ANVISA position recorded as not approved.", "old": null, "new": "not approved", "citation": null }, { "happened_on": "2026-08-21", "kind": "approval", "generated": true, "subject": "Setmelanotide · MHRA", "entity": "setmelanotide", "summary": "Setmelanotide: MHRA position recorded as approved.", "old": null, "new": "approved", "citation": null }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Setmelanotide · Duration", "entity": "setmelanotide", "summary": "Setmelanotide: Duration recorded as 52 weeks.", "old": null, "new": "52 weeks", "citation": { "title": "EMA — Imcivree EPAR", "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/imcivree", "publisher": "EMA", "kind": "regulator", "primary": true, "published_on": "2026-08-20", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Setmelanotide · Participants", "entity": "setmelanotide", "summary": "Setmelanotide: Participants recorded as 142.", "old": null, "new": "142", "citation": { "title": "EMA — Imcivree EPAR", "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/imcivree", "publisher": "EMA", "kind": "regulator", "primary": true, "published_on": "2026-08-20", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Setmelanotide · Pivotal trial", "entity": "setmelanotide", "summary": "Setmelanotide: Pivotal trial recorded as TRANSCEND.", "old": null, "new": "TRANSCEND", "citation": { "title": "EMA — Imcivree EPAR", "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/imcivree", "publisher": "EMA", "kind": "regulator", "primary": true, "published_on": "2026-08-20", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Setmelanotide · Placebo-adjusted", "entity": "setmelanotide", "summary": "Setmelanotide: Placebo-adjusted recorded as -18.4 pp.", "old": null, "new": "-18.4 pp", "citation": { "title": "EMA — Imcivree EPAR", "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/imcivree", "publisher": "EMA", "kind": "regulator", "primary": true, "published_on": "2026-08-20", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Setmelanotide · Placebo arm", "entity": "setmelanotide", "summary": "Setmelanotide: Placebo arm recorded as 2.6 %.", "old": null, "new": "2.6 %", "citation": { "title": "EMA — Imcivree EPAR", "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/imcivree", "publisher": "EMA", "kind": "regulator", "primary": true, "published_on": "2026-08-20", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Setmelanotide · Weight change", "entity": "setmelanotide", "summary": "Setmelanotide: Weight change recorded as -15.8 %.", "old": null, "new": "-15.8 %", "citation": { "title": "EMA — Imcivree EPAR", "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/imcivree", "publisher": "EMA", "kind": "regulator", "primary": true, "published_on": "2026-08-20", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Setmelanotide · Stopped for side effects", "entity": "setmelanotide", "summary": "Setmelanotide: Stopped for side effects recorded as —.", "old": null, "new": "—", "citation": null }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Setmelanotide · Dose", "entity": "setmelanotide", "summary": "Setmelanotide: Dose recorded as Titrated by age and weight, up to 3 mg daily.", "old": null, "new": "Titrated by age and weight, up to 3 mg daily", "citation": { "title": "EMA — Imcivree EPAR", "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/imcivree", "publisher": "EMA", "kind": "regulator", "primary": true, "published_on": "2026-08-20", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Setmelanotide · Route", "entity": "setmelanotide", "summary": "Setmelanotide: Route recorded as Injection, daily.", "old": null, "new": "Injection, daily", "citation": { "title": "EMA — Imcivree EPAR", "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/imcivree", "publisher": "EMA", "kind": "regulator", "primary": true, "published_on": "2026-08-20", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Setmelanotide · Class", "entity": "setmelanotide", "summary": "Setmelanotide: Class recorded as MC4R agonist.", "old": null, "new": "MC4R agonist", "citation": { "title": "EMA — Imcivree EPAR", "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/imcivree", "publisher": "EMA", "kind": "regulator", "primary": true, "published_on": "2026-08-20", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Setmelanotide · Brand", "entity": "setmelanotide", "summary": "Setmelanotide: Brand recorded as Imcivree.", "old": null, "new": "Imcivree", "citation": { "title": "EMA — Imcivree EPAR", "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/imcivree", "publisher": "EMA", "kind": "regulator", "primary": true, "published_on": "2026-08-20", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "approval", "generated": true, "subject": "Phentermine · TGA", "entity": "phentermine", "summary": "Phentermine: TGA position recorded as approved.", "old": null, "new": "approved", "citation": null }, { "happened_on": "2026-08-21", "kind": "approval", "generated": true, "subject": "Phentermine · Canada", "entity": "phentermine", "summary": "Phentermine: Canada position recorded as approved.", "old": null, "new": "approved", "citation": null }, { "happened_on": "2026-08-21", "kind": "approval", "generated": true, "subject": "Phentermine · NMPA", "entity": "phentermine", "summary": "Phentermine: NMPA position recorded as not approved.", "old": null, "new": "not approved", "citation": null }, { "happened_on": "2026-08-21", "kind": "approval", "generated": true, "subject": "Phentermine · PMDA", "entity": "phentermine", "summary": "Phentermine: PMDA position recorded as not approved.", "old": null, "new": "not approved", "citation": null }, { "happened_on": "2026-08-21", "kind": "approval", "generated": true, "subject": "Phentermine · ANVISA", "entity": "phentermine", "summary": "Phentermine: ANVISA position recorded as not approved.", "old": null, "new": "not approved", "citation": null }, { "happened_on": "2026-08-21", "kind": "approval", "generated": true, "subject": "Phentermine · MHRA", "entity": "phentermine", "summary": "Phentermine: MHRA position recorded as not approved.", "old": null, "new": "not approved", "citation": null }, { "happened_on": "2026-08-21", "kind": "approval", "generated": true, "subject": "Phentermine · EMA", "entity": "phentermine", "summary": "Phentermine: EMA position recorded as not approved.", "old": null, "new": "not approved", "citation": null }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Phentermine · Duration", "entity": "phentermine", "summary": "Phentermine: Duration recorded as —.", "old": null, "new": "—", "citation": null }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Phentermine · Participants", "entity": "phentermine", "summary": "Phentermine: Participants recorded as —.", "old": null, "new": "—", "citation": null }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Phentermine · Pivotal trial", "entity": "phentermine", "summary": "Phentermine: Pivotal trial recorded as —.", "old": null, "new": "—", "citation": null }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Phentermine · Placebo-adjusted", "entity": "phentermine", "summary": "Phentermine: Placebo-adjusted recorded as —.", "old": null, "new": "—", "citation": null }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Phentermine · Placebo arm", "entity": "phentermine", "summary": "Phentermine: Placebo arm recorded as —.", "old": null, "new": "—", "citation": null }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Phentermine · Weight change", "entity": "phentermine", "summary": "Phentermine: Weight change recorded as —.", "old": null, "new": "—", "citation": null }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Phentermine · Stopped for side effects", "entity": "phentermine", "summary": "Phentermine: Stopped for side effects recorded as —.", "old": null, "new": "—", "citation": null }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Phentermine · Dose", "entity": "phentermine", "summary": "Phentermine: Dose recorded as 37.5 mg daily.", "old": null, "new": "37.5 mg daily", "citation": { "title": "FDA — Adipex-P label, rev. 01/2012", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/085128s065lbl.pdf", "publisher": "FDA", "kind": "regulator", "primary": true, "published_on": "2012-01-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Phentermine · Route", "entity": "phentermine", "summary": "Phentermine: Route recorded as Tablet, daily.", "old": null, "new": "Tablet, daily", "citation": { "title": "FDA — Adipex-P label, rev. 01/2012", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/085128s065lbl.pdf", "publisher": "FDA", "kind": "regulator", "primary": true, "published_on": "2012-01-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Phentermine · Class", "entity": "phentermine", "summary": "Phentermine: Class recorded as Sympathomimetic amine anorectic.", "old": null, "new": "Sympathomimetic amine anorectic", "citation": { "title": "FDA — Adipex-P label, rev. 01/2012", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/085128s065lbl.pdf", "publisher": "FDA", "kind": "regulator", "primary": true, "published_on": "2012-01-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Phentermine · Brand", "entity": "phentermine", "summary": "Phentermine: Brand recorded as Adipex-P, Lomaira, Duromine.", "old": null, "new": "Adipex-P, Lomaira, Duromine", "citation": { "title": "FDA — Adipex-P label, rev. 01/2012", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/085128s065lbl.pdf", "publisher": "FDA", "kind": "regulator", "primary": true, "published_on": "2012-01-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "approval", "generated": true, "subject": "Orlistat · Canada", "entity": "orlistat", "summary": "Orlistat: Canada position recorded as approved.", "old": null, "new": "approved", "citation": null }, { "happened_on": "2026-08-21", "kind": "approval", "generated": true, "subject": "Orlistat · NMPA", "entity": "orlistat", "summary": "Orlistat: NMPA position recorded as approved.", "old": null, "new": "approved", "citation": null }, { "happened_on": "2026-08-21", "kind": "approval", "generated": true, "subject": "Orlistat · ANVISA", "entity": "orlistat", "summary": "Orlistat: ANVISA position recorded as approved.", "old": null, "new": "approved", "citation": null }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Orlistat · Duration", "entity": "orlistat", "summary": "Orlistat: Duration recorded as 208 weeks.", "old": null, "new": "208 weeks", "citation": { "title": "FDA — Xenical label, rev. 11/2022", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020766s038lbl.pdf", "publisher": "FDA", "kind": "regulator", "primary": true, "published_on": "2022-11-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Orlistat · Participants", "entity": "orlistat", "summary": "Orlistat: Participants recorded as 3 305.", "old": null, "new": "3 305", "citation": { "title": "FDA — Xenical label, rev. 11/2022", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020766s038lbl.pdf", "publisher": "FDA", "kind": "regulator", "primary": true, "published_on": "2022-11-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Orlistat · Pivotal trial", "entity": "orlistat", "summary": "Orlistat: Pivotal trial recorded as XENDOS.", "old": null, "new": "XENDOS", "citation": { "title": "FDA — Xenical label, rev. 11/2022", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020766s038lbl.pdf", "publisher": "FDA", "kind": "regulator", "primary": true, "published_on": "2022-11-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Orlistat · Placebo-adjusted", "entity": "orlistat", "summary": "Orlistat: Placebo-adjusted recorded as -2.4 pp.", "old": null, "new": "-2.4 pp", "citation": { "title": "FDA — Xenical label, rev. 11/2022", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020766s038lbl.pdf", "publisher": "FDA", "kind": "regulator", "primary": true, "published_on": "2022-11-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Orlistat · Placebo arm", "entity": "orlistat", "summary": "Orlistat: Placebo arm recorded as -2.8 %.", "old": null, "new": "-2.8 %", "citation": { "title": "FDA — Xenical label, rev. 11/2022", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020766s038lbl.pdf", "publisher": "FDA", "kind": "regulator", "primary": true, "published_on": "2022-11-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Orlistat · Weight change", "entity": "orlistat", "summary": "Orlistat: Weight change recorded as -5.2 %.", "old": null, "new": "-5.2 %", "citation": { "title": "FDA — Xenical label, rev. 11/2022", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020766s038lbl.pdf", "publisher": "FDA", "kind": "regulator", "primary": true, "published_on": "2022-11-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Orlistat · Stopped for side effects", "entity": "orlistat", "summary": "Orlistat: Stopped for side effects recorded as —.", "old": null, "new": "—", "citation": null }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Orlistat · Dose", "entity": "orlistat", "summary": "Orlistat: Dose recorded as 120 mg with each fat-containing meal; 60 mg over the counter.", "old": null, "new": "120 mg with each fat-containing meal; 60 mg over the counter", "citation": { "title": "FDA — Xenical label, rev. 11/2022", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020766s038lbl.pdf", "publisher": "FDA", "kind": "regulator", "primary": true, "published_on": "2022-11-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Orlistat · Route", "entity": "orlistat", "summary": "Orlistat: Route recorded as Capsule, three times daily.", "old": null, "new": "Capsule, three times daily", "citation": { "title": "FDA — Xenical label, rev. 11/2022", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020766s038lbl.pdf", "publisher": "FDA", "kind": "regulator", "primary": true, "published_on": "2022-11-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Orlistat · Class", "entity": "orlistat", "summary": "Orlistat: Class recorded as Gastrointestinal lipase inhibitor.", "old": null, "new": "Gastrointestinal lipase inhibitor", "citation": { "title": "FDA — Xenical label, rev. 11/2022", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020766s038lbl.pdf", "publisher": "FDA", "kind": "regulator", "primary": true, "published_on": "2022-11-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Orlistat · Brand", "entity": "orlistat", "summary": "Orlistat: Brand recorded as Xenical (Rx) / alli (OTC).", "old": null, "new": "Xenical (Rx) / alli (OTC)", "citation": { "title": "FDA — Xenical label, rev. 11/2022", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020766s038lbl.pdf", "publisher": "FDA", "kind": "regulator", "primary": true, "published_on": "2022-11-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "approval", "generated": true, "subject": "Naltrexone / bupropion ER · Canada", "entity": "contrave", "summary": "Naltrexone / bupropion ER: Canada position recorded as approved.", "old": null, "new": "approved", "citation": null }, { "happened_on": "2026-08-21", "kind": "approval", "generated": true, "subject": "Naltrexone / bupropion ER · NMPA", "entity": "contrave", "summary": "Naltrexone / bupropion ER: NMPA position recorded as not approved.", "old": null, "new": "not approved", "citation": null }, { "happened_on": "2026-08-21", "kind": "approval", "generated": true, "subject": "Naltrexone / bupropion ER · PMDA", "entity": "contrave", "summary": "Naltrexone / bupropion ER: PMDA position recorded as not approved.", "old": null, "new": "not approved", "citation": null }, { "happened_on": "2026-08-21", "kind": "approval", "generated": true, "subject": "Naltrexone / bupropion ER · ANVISA", "entity": "contrave", "summary": "Naltrexone / bupropion ER: ANVISA position recorded as not approved.", "old": null, "new": "not approved", "citation": null }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Naltrexone / bupropion ER · Duration", "entity": "contrave", "summary": "Naltrexone / bupropion ER: Duration recorded as 56 weeks.", "old": null, "new": "56 weeks", "citation": { "title": "FDA — Contrave label, rev. 03/2021", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/200063s020lbl.pdf", "publisher": "FDA", "kind": "regulator", "primary": true, "published_on": "2021-03-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Naltrexone / bupropion ER · Participants", "entity": "contrave", "summary": "Naltrexone / bupropion ER: Participants recorded as 1 074.", "old": null, "new": "1 074", "citation": { "title": "FDA — Contrave label, rev. 03/2021", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/200063s020lbl.pdf", "publisher": "FDA", "kind": "regulator", "primary": true, "published_on": "2021-03-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Naltrexone / bupropion ER · Pivotal trial", "entity": "contrave", "summary": "Naltrexone / bupropion ER: Pivotal trial recorded as COR-I.", "old": null, "new": "COR-I", "citation": { "title": "FDA — Contrave label, rev. 03/2021", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/200063s020lbl.pdf", "publisher": "FDA", "kind": "regulator", "primary": true, "published_on": "2021-03-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Naltrexone / bupropion ER · Placebo-adjusted", "entity": "contrave", "summary": "Naltrexone / bupropion ER: Placebo-adjusted recorded as -4.1 pp.", "old": null, "new": "-4.1 pp", "citation": { "title": "FDA — Contrave label, rev. 03/2021", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/200063s020lbl.pdf", "publisher": "FDA", "kind": "regulator", "primary": true, "published_on": "2021-03-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Naltrexone / bupropion ER · Placebo arm", "entity": "contrave", "summary": "Naltrexone / bupropion ER: Placebo arm recorded as -1.3 %.", "old": null, "new": "-1.3 %", "citation": { "title": "FDA — Contrave label, rev. 03/2021", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/200063s020lbl.pdf", "publisher": "FDA", "kind": "regulator", "primary": true, "published_on": "2021-03-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Naltrexone / bupropion ER · Weight change", "entity": "contrave", "summary": "Naltrexone / bupropion ER: Weight change recorded as -5.4 %.", "old": null, "new": "-5.4 %", "citation": { "title": "FDA — Contrave label, rev. 03/2021", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/200063s020lbl.pdf", "publisher": "FDA", "kind": "regulator", "primary": true, "published_on": "2021-03-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Naltrexone / bupropion ER · Stopped for side effects", "entity": "contrave", "summary": "Naltrexone / bupropion ER: Stopped for side effects recorded as 24% vs 12% placebo — by far the highest of any approved agent.", "old": null, "new": "24% vs 12% placebo — by far the highest of any approved agent", "citation": { "title": "FDA — Contrave label, rev. 03/2021", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/200063s020lbl.pdf", "publisher": "FDA", "kind": "regulator", "primary": true, "published_on": "2021-03-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Naltrexone / bupropion ER · Dose", "entity": "contrave", "summary": "Naltrexone / bupropion ER: Dose recorded as 32 mg / 360 mg daily.", "old": null, "new": "32 mg / 360 mg daily", "citation": { "title": "FDA — Contrave label, rev. 03/2021", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/200063s020lbl.pdf", "publisher": "FDA", "kind": "regulator", "primary": true, "published_on": "2021-03-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Naltrexone / bupropion ER · Route", "entity": "contrave", "summary": "Naltrexone / bupropion ER: Route recorded as Tablet, twice daily.", "old": null, "new": "Tablet, twice daily", "citation": { "title": "FDA — Contrave label, rev. 03/2021", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/200063s020lbl.pdf", "publisher": "FDA", "kind": "regulator", "primary": true, "published_on": "2021-03-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Naltrexone / bupropion ER · Class", "entity": "contrave", "summary": "Naltrexone / bupropion ER: Class recorded as Opioid antagonist + aminoketone antidepressant.", "old": null, "new": "Opioid antagonist + aminoketone antidepressant", "citation": { "title": "FDA — Contrave label, rev. 03/2021", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/200063s020lbl.pdf", "publisher": "FDA", "kind": "regulator", "primary": true, "published_on": "2021-03-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Naltrexone / bupropion ER · Brand", "entity": "contrave", "summary": "Naltrexone / bupropion ER: Brand recorded as Contrave (US) / Mysimba (EU).", "old": null, "new": "Contrave (US) / Mysimba (EU)", "citation": { "title": "FDA — Contrave label, rev. 03/2021", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/200063s020lbl.pdf", "publisher": "FDA", "kind": "regulator", "primary": true, "published_on": "2021-03-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "approval", "generated": true, "subject": "Phentermine / topiramate ER · TGA", "entity": "qsymia", "summary": "Phentermine / topiramate ER: TGA position recorded as not approved.", "old": null, "new": "not approved", "citation": null }, { "happened_on": "2026-08-21", "kind": "approval", "generated": true, "subject": "Phentermine / topiramate ER · Canada", "entity": "qsymia", "summary": "Phentermine / topiramate ER: Canada position recorded as not approved.", "old": null, "new": "not approved", "citation": null }, { "happened_on": "2026-08-21", "kind": "approval", "generated": true, "subject": "Phentermine / topiramate ER · NMPA", "entity": "qsymia", "summary": "Phentermine / topiramate ER: NMPA position recorded as not approved.", "old": null, "new": "not approved", "citation": null }, { "happened_on": "2026-08-21", "kind": "approval", "generated": true, "subject": "Phentermine / topiramate ER · PMDA", "entity": "qsymia", "summary": "Phentermine / topiramate ER: PMDA position recorded as not approved.", "old": null, "new": "not approved", "citation": null }, { "happened_on": "2026-08-21", "kind": "approval", "generated": true, "subject": "Phentermine / topiramate ER · ANVISA", "entity": "qsymia", "summary": "Phentermine / topiramate ER: ANVISA position recorded as not approved.", "old": null, "new": "not approved", "citation": null }, { "happened_on": "2026-08-21", "kind": "approval", "generated": true, "subject": "Phentermine / topiramate ER · MHRA", "entity": "qsymia", "summary": "Phentermine / topiramate ER: MHRA position recorded as not approved.", "old": null, "new": "not approved", "citation": null }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Phentermine / topiramate ER · Duration", "entity": "qsymia", "summary": "Phentermine / topiramate ER: Duration recorded as 56 weeks.", "old": null, "new": "56 weeks", "citation": { "title": "FDA — Qsymia label, rev. 09/2024", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022580s026lbl.pdf", "publisher": "FDA", "kind": "regulator", "primary": true, "published_on": "2024-09-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Phentermine / topiramate ER · Participants", "entity": "qsymia", "summary": "Phentermine / topiramate ER: Participants recorded as 2 487.", "old": null, "new": "2 487", "citation": { "title": "FDA — Qsymia label, rev. 09/2024", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022580s026lbl.pdf", "publisher": "FDA", "kind": "regulator", "primary": true, "published_on": "2024-09-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Phentermine / topiramate ER · Pivotal trial", "entity": "qsymia", "summary": "Phentermine / topiramate ER: Pivotal trial recorded as CONQUER.", "old": null, "new": "CONQUER", "citation": { "title": "FDA — Qsymia label, rev. 09/2024", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022580s026lbl.pdf", "publisher": "FDA", "kind": "regulator", "primary": true, "published_on": "2024-09-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Phentermine / topiramate ER · Placebo-adjusted", "entity": "qsymia", "summary": "Phentermine / topiramate ER: Placebo-adjusted recorded as -8.6 pp.", "old": null, "new": "-8.6 pp", "citation": { "title": "FDA — Qsymia label, rev. 09/2024", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022580s026lbl.pdf", "publisher": "FDA", "kind": "regulator", "primary": true, "published_on": "2024-09-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Phentermine / topiramate ER · Placebo arm", "entity": "qsymia", "summary": "Phentermine / topiramate ER: Placebo arm recorded as -1.2 %.", "old": null, "new": "-1.2 %", "citation": { "title": "FDA — Qsymia label, rev. 09/2024", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022580s026lbl.pdf", "publisher": "FDA", "kind": "regulator", "primary": true, "published_on": "2024-09-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Phentermine / topiramate ER · Weight change", "entity": "qsymia", "summary": "Phentermine / topiramate ER: Weight change recorded as -9.8 %.", "old": null, "new": "-9.8 %", "citation": { "title": "FDA — Qsymia label, rev. 09/2024", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022580s026lbl.pdf", "publisher": "FDA", "kind": "regulator", "primary": true, "published_on": "2024-09-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Phentermine / topiramate ER · Stopped for side effects", "entity": "qsymia", "summary": "Phentermine / topiramate ER: Stopped for side effects recorded as Label reports only all-cause withdrawal of 31–40%, which is not comparable to other drugs' figures.", "old": null, "new": "Label reports only all-cause withdrawal of 31–40%, which is not comparable to other drugs' figures", "citation": { "title": "FDA — Qsymia label, rev. 09/2024", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022580s026lbl.pdf", "publisher": "FDA", "kind": "regulator", "primary": true, "published_on": "2024-09-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Phentermine / topiramate ER · Dose", "entity": "qsymia", "summary": "Phentermine / topiramate ER: Dose recorded as 7.5/46 mg or 15/92 mg daily.", "old": null, "new": "7.5/46 mg or 15/92 mg daily", "citation": { "title": "FDA — Qsymia label, rev. 09/2024", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022580s026lbl.pdf", "publisher": "FDA", "kind": "regulator", "primary": true, "published_on": "2024-09-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Phentermine / topiramate ER · Route", "entity": "qsymia", "summary": "Phentermine / topiramate ER: Route recorded as Tablet, daily.", "old": null, "new": "Tablet, daily", "citation": { "title": "FDA — Qsymia label, rev. 09/2024", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022580s026lbl.pdf", "publisher": "FDA", "kind": "regulator", "primary": true, "published_on": "2024-09-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Phentermine / topiramate ER · Class", "entity": "qsymia", "summary": "Phentermine / topiramate ER: Class recorded as Sympathomimetic + anticonvulsant combination.", "old": null, "new": "Sympathomimetic + anticonvulsant combination", "citation": { "title": "FDA — Qsymia label, rev. 09/2024", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022580s026lbl.pdf", "publisher": "FDA", "kind": "regulator", "primary": true, "published_on": "2024-09-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Phentermine / topiramate ER · Brand", "entity": "qsymia", "summary": "Phentermine / topiramate ER: Brand recorded as Qsymia.", "old": null, "new": "Qsymia", "citation": { "title": "FDA — Qsymia label, rev. 09/2024", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022580s026lbl.pdf", "publisher": "FDA", "kind": "regulator", "primary": true, "published_on": "2024-09-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "approval", "generated": true, "subject": "Liraglutide 3.0 mg · Canada", "entity": "liraglutide", "summary": "Liraglutide 3.0 mg: Canada position recorded as approved.", "old": null, "new": "approved", "citation": null }, { "happened_on": "2026-08-21", "kind": "approval", "generated": true, "subject": "Liraglutide 3.0 mg · NMPA", "entity": "liraglutide", "summary": "Liraglutide 3.0 mg: NMPA position recorded as not approved.", "old": null, "new": "not approved", "citation": null }, { "happened_on": "2026-08-21", "kind": "approval", "generated": true, "subject": "Liraglutide 3.0 mg · PMDA", "entity": "liraglutide", "summary": "Liraglutide 3.0 mg: PMDA position recorded as not approved.", "old": null, "new": "not approved", "citation": null }, { "happened_on": "2026-08-21", "kind": "approval", "generated": true, "subject": "Liraglutide 3.0 mg · ANVISA", "entity": "liraglutide", "summary": "Liraglutide 3.0 mg: ANVISA position recorded as approved.", "old": null, "new": "approved", "citation": null }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Liraglutide 3.0 mg · Duration", "entity": "liraglutide", "summary": "Liraglutide 3.0 mg: Duration recorded as 56 weeks.", "old": null, "new": "56 weeks", "citation": { "title": "SCALE, NEJM 2015;373:11", "url": "https://www.nejm.org/doi/full/10.1056/NEJMoa1411892", "publisher": "nejm.org", "kind": "journal", "primary": true, "published_on": "2015-07-02", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Liraglutide 3.0 mg · Participants", "entity": "liraglutide", "summary": "Liraglutide 3.0 mg: Participants recorded as 3 731.", "old": null, "new": "3 731", "citation": { "title": "SCALE, NEJM 2015;373:11", "url": "https://www.nejm.org/doi/full/10.1056/NEJMoa1411892", "publisher": "nejm.org", "kind": "journal", "primary": true, "published_on": "2015-07-02", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Liraglutide 3.0 mg · Pivotal trial", "entity": "liraglutide", "summary": "Liraglutide 3.0 mg: Pivotal trial recorded as SCALE Obesity and Prediabetes.", "old": null, "new": "SCALE Obesity and Prediabetes", "citation": { "title": "SCALE, NEJM 2015;373:11", "url": "https://www.nejm.org/doi/full/10.1056/NEJMoa1411892", "publisher": "nejm.org", "kind": "journal", "primary": true, "published_on": "2015-07-02", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Liraglutide 3.0 mg · Placebo-adjusted", "entity": "liraglutide", "summary": "Liraglutide 3.0 mg: Placebo-adjusted recorded as -5.4 pp.", "old": null, "new": "-5.4 pp", "citation": { "title": "SCALE, NEJM 2015;373:11", "url": "https://www.nejm.org/doi/full/10.1056/NEJMoa1411892", "publisher": "nejm.org", "kind": "journal", "primary": true, "published_on": "2015-07-02", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Liraglutide 3.0 mg · Placebo arm", "entity": "liraglutide", "summary": "Liraglutide 3.0 mg: Placebo arm recorded as -2.6 %.", "old": null, "new": "-2.6 %", "citation": { "title": "SCALE, NEJM 2015;373:11", "url": "https://www.nejm.org/doi/full/10.1056/NEJMoa1411892", "publisher": "nejm.org", "kind": "journal", "primary": true, "published_on": "2015-07-02", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Liraglutide 3.0 mg · Weight change", "entity": "liraglutide", "summary": "Liraglutide 3.0 mg: Weight change recorded as -8.0 %.", "old": null, "new": "-8.0 %", "citation": { "title": "SCALE, NEJM 2015;373:11", "url": "https://www.nejm.org/doi/full/10.1056/NEJMoa1411892", "publisher": "nejm.org", "kind": "journal", "primary": true, "published_on": "2015-07-02", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Liraglutide 3.0 mg · Stopped for side effects", "entity": "liraglutide", "summary": "Liraglutide 3.0 mg: Stopped for side effects recorded as —.", "old": null, "new": "—", "citation": null }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Liraglutide 3.0 mg · Dose", "entity": "liraglutide", "summary": "Liraglutide 3.0 mg: Dose recorded as 3.0 mg daily.", "old": null, "new": "3.0 mg daily", "citation": { "title": "EMA — Saxenda EPAR", "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/saxenda", "publisher": "EMA", "kind": "regulator", "primary": true, "published_on": "2026-08-20", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Liraglutide 3.0 mg · Route", "entity": "liraglutide", "summary": "Liraglutide 3.0 mg: Route recorded as Injection, daily.", "old": null, "new": "Injection, daily", "citation": { "title": "EMA — Saxenda EPAR", "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/saxenda", "publisher": "EMA", "kind": "regulator", "primary": true, "published_on": "2026-08-20", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Liraglutide 3.0 mg · Class", "entity": "liraglutide", "summary": "Liraglutide 3.0 mg: Class recorded as GLP-1 receptor agonist.", "old": null, "new": "GLP-1 receptor agonist", "citation": { "title": "EMA — Saxenda EPAR", "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/saxenda", "publisher": "EMA", "kind": "regulator", "primary": true, "published_on": "2026-08-20", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Liraglutide 3.0 mg · Brand", "entity": "liraglutide", "summary": "Liraglutide 3.0 mg: Brand recorded as Saxenda + generics.", "old": null, "new": "Saxenda + generics", "citation": { "title": "EMA — Saxenda EPAR", "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/saxenda", "publisher": "EMA", "kind": "regulator", "primary": true, "published_on": "2026-08-20", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "approval", "generated": true, "subject": "Orforglipron · TGA", "entity": "orforglipron", "summary": "Orforglipron: TGA position recorded as not approved.", "old": null, "new": "not approved", "citation": null }, { "happened_on": "2026-08-21", "kind": "approval", "generated": true, "subject": "Orforglipron · Canada", "entity": "orforglipron", "summary": "Orforglipron: Canada position recorded as not approved.", "old": null, "new": "not approved", "citation": null }, { "happened_on": "2026-08-21", "kind": "approval", "generated": true, "subject": "Orforglipron · NMPA", "entity": "orforglipron", "summary": "Orforglipron: NMPA position recorded as not approved.", "old": null, "new": "not approved", "citation": null }, { "happened_on": "2026-08-21", "kind": "approval", "generated": true, "subject": "Orforglipron · PMDA", "entity": "orforglipron", "summary": "Orforglipron: PMDA position recorded as not approved.", "old": null, "new": "not approved", "citation": null }, { "happened_on": "2026-08-21", "kind": "approval", "generated": true, "subject": "Orforglipron · ANVISA", "entity": "orforglipron", "summary": "Orforglipron: ANVISA position recorded as not approved.", "old": null, "new": "not approved", "citation": null }, { "happened_on": "2026-08-21", "kind": "approval", "generated": true, "subject": "Orforglipron · MHRA", "entity": "orforglipron", "summary": "Orforglipron: MHRA position recorded as not approved.", "old": null, "new": "not approved", "citation": null }, { "happened_on": "2026-08-21", "kind": "approval", "generated": true, "subject": "Orforglipron · EMA", "entity": "orforglipron", "summary": "Orforglipron: EMA position recorded as not approved.", "old": null, "new": "not approved", "citation": null }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Orforglipron · Duration", "entity": "orforglipron", "summary": "Orforglipron: Duration recorded as 72 weeks.", "old": null, "new": "72 weeks", "citation": { "title": "FDA — Foundayo label, rev. 04/2026", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/220934Orig1s000lbl.pdf", "publisher": "FDA", "kind": "regulator", "primary": true, "published_on": "2026-04-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Orforglipron · Participants", "entity": "orforglipron", "summary": "Orforglipron: Participants recorded as 3 127.", "old": null, "new": "3 127", "citation": { "title": "FDA — Foundayo label, rev. 04/2026", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/220934Orig1s000lbl.pdf", "publisher": "FDA", "kind": "regulator", "primary": true, "published_on": "2026-04-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Orforglipron · Pivotal trial", "entity": "orforglipron", "summary": "Orforglipron: Pivotal trial recorded as ATTAIN-1.", "old": null, "new": "ATTAIN-1", "citation": { "title": "FDA — Foundayo label, rev. 04/2026", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/220934Orig1s000lbl.pdf", "publisher": "FDA", "kind": "regulator", "primary": true, "published_on": "2026-04-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Orforglipron · Placebo-adjusted", "entity": "orforglipron", "summary": "Orforglipron: Placebo-adjusted recorded as -9.0 pp.", "old": null, "new": "-9.0 pp", "citation": { "title": "FDA — Foundayo label, rev. 04/2026", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/220934Orig1s000lbl.pdf", "publisher": "FDA", "kind": "regulator", "primary": true, "published_on": "2026-04-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Orforglipron · Placebo arm", "entity": "orforglipron", "summary": "Orforglipron: Placebo arm recorded as -2.1 %.", "old": null, "new": "-2.1 %", "citation": { "title": "FDA — Foundayo label, rev. 04/2026", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/220934Orig1s000lbl.pdf", "publisher": "FDA", "kind": "regulator", "primary": true, "published_on": "2026-04-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Orforglipron · Weight change", "entity": "orforglipron", "summary": "Orforglipron: Weight change recorded as -11.1 %.", "old": null, "new": "-11.1 %", "citation": { "title": "FDA — Foundayo label, rev. 04/2026", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/220934Orig1s000lbl.pdf", "publisher": "FDA", "kind": "regulator", "primary": true, "published_on": "2026-04-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Orforglipron · Stopped for side effects", "entity": "orforglipron", "summary": "Orforglipron: Stopped for side effects recorded as 8% vs 3% placebo — the highest of the GLP-1 agents.", "old": null, "new": "8% vs 3% placebo — the highest of the GLP-1 agents", "citation": { "title": "FDA — Foundayo label, rev. 04/2026", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/220934Orig1s000lbl.pdf", "publisher": "FDA", "kind": "regulator", "primary": true, "published_on": "2026-04-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Orforglipron · Dose", "entity": "orforglipron", "summary": "Orforglipron: Dose recorded as Up to 17.2 mg daily, no food or water restrictions.", "old": null, "new": "Up to 17.2 mg daily, no food or water restrictions", "citation": { "title": "FDA — Foundayo label, rev. 04/2026", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/220934Orig1s000lbl.pdf", "publisher": "FDA", "kind": "regulator", "primary": true, "published_on": "2026-04-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Orforglipron · Route", "entity": "orforglipron", "summary": "Orforglipron: Route recorded as Tablet, daily.", "old": null, "new": "Tablet, daily", "citation": { "title": "FDA — Foundayo label, rev. 04/2026", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/220934Orig1s000lbl.pdf", "publisher": "FDA", "kind": "regulator", "primary": true, "published_on": "2026-04-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Orforglipron · Class", "entity": "orforglipron", "summary": "Orforglipron: Class recorded as Small-molecule (non-peptide) GLP-1 receptor agonist.", "old": null, "new": "Small-molecule (non-peptide) GLP-1 receptor agonist", "citation": { "title": "FDA — Foundayo label, rev. 04/2026", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/220934Orig1s000lbl.pdf", "publisher": "FDA", "kind": "regulator", "primary": true, "published_on": "2026-04-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Orforglipron · Brand", "entity": "orforglipron", "summary": "Orforglipron: Brand recorded as Foundayo.", "old": null, "new": "Foundayo", "citation": { "title": "FDA — Foundayo label, rev. 04/2026", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/220934Orig1s000lbl.pdf", "publisher": "FDA", "kind": "regulator", "primary": true, "published_on": "2026-04-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Tirzepatide · Duration", "entity": "tirzepatide", "summary": "Tirzepatide: Duration recorded as 72 weeks.", "old": null, "new": "72 weeks", "citation": { "title": "SURMOUNT-1 — PubMed 35658024", "url": "https://pubmed.ncbi.nlm.nih.gov/35658024/", "publisher": "SURMOUNT-1", "kind": "journal", "primary": true, "published_on": "2022-06-04", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Tirzepatide · Participants", "entity": "tirzepatide", "summary": "Tirzepatide: Participants recorded as 2 539.", "old": null, "new": "2 539", "citation": { "title": "SURMOUNT-1 — PubMed 35658024", "url": "https://pubmed.ncbi.nlm.nih.gov/35658024/", "publisher": "SURMOUNT-1", "kind": "journal", "primary": true, "published_on": "2022-06-04", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Tirzepatide · Pivotal trial", "entity": "tirzepatide", "summary": "Tirzepatide: Pivotal trial recorded as SURMOUNT-1.", "old": null, "new": "SURMOUNT-1", "citation": { "title": "SURMOUNT-1 — PubMed 35658024", "url": "https://pubmed.ncbi.nlm.nih.gov/35658024/", "publisher": "SURMOUNT-1", "kind": "journal", "primary": true, "published_on": "2022-06-04", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Tirzepatide · Placebo-adjusted", "entity": "tirzepatide", "summary": "Tirzepatide: Placebo-adjusted recorded as -17.8 pp.", "old": null, "new": "-17.8 pp", "citation": { "title": "SURMOUNT-1 — PubMed 35658024", "url": "https://pubmed.ncbi.nlm.nih.gov/35658024/", "publisher": "SURMOUNT-1", "kind": "journal", "primary": true, "published_on": "2022-06-04", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Tirzepatide · Placebo arm", "entity": "tirzepatide", "summary": "Tirzepatide: Placebo arm recorded as -3.1 %.", "old": null, "new": "-3.1 %", "citation": { "title": "SURMOUNT-1 — PubMed 35658024", "url": "https://pubmed.ncbi.nlm.nih.gov/35658024/", "publisher": "SURMOUNT-1", "kind": "journal", "primary": true, "published_on": "2022-06-04", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Tirzepatide · Weight change", "entity": "tirzepatide", "summary": "Tirzepatide: Weight change recorded as -20.9 %.", "old": null, "new": "-20.9 %", "citation": { "title": "SURMOUNT-1 — PubMed 35658024", "url": "https://pubmed.ncbi.nlm.nih.gov/35658024/", "publisher": "SURMOUNT-1", "kind": "journal", "primary": true, "published_on": "2022-06-04", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Tirzepatide · Stopped for side effects", "entity": "tirzepatide", "summary": "Tirzepatide: Stopped for side effects recorded as 4.8–6.7% vs 3.4% placebo.", "old": null, "new": "4.8–6.7% vs 3.4% placebo", "citation": { "title": "FDA — Zepbound label, rev. 01/2026", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/217806s037lbl.pdf", "publisher": "FDA", "kind": "regulator", "primary": true, "published_on": "2026-01-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Tirzepatide · Dose", "entity": "tirzepatide", "summary": "Tirzepatide: Dose recorded as 5, 10 or 15 mg weekly.", "old": null, "new": "5, 10 or 15 mg weekly", "citation": { "title": "FDA — Zepbound label, rev. 01/2026", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/217806s037lbl.pdf", "publisher": "FDA", "kind": "regulator", "primary": true, "published_on": "2026-01-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Tirzepatide · Route", "entity": "tirzepatide", "summary": "Tirzepatide: Route recorded as Injection, weekly.", "old": null, "new": "Injection, weekly", "citation": { "title": "FDA — Zepbound label, rev. 01/2026", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/217806s037lbl.pdf", "publisher": "FDA", "kind": "regulator", "primary": true, "published_on": "2026-01-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Tirzepatide · Class", "entity": "tirzepatide", "summary": "Tirzepatide: Class recorded as Dual GIP + GLP-1 receptor agonist.", "old": null, "new": "Dual GIP + GLP-1 receptor agonist", "citation": { "title": "FDA — Zepbound label, rev. 01/2026", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/217806s037lbl.pdf", "publisher": "FDA", "kind": "regulator", "primary": true, "published_on": "2026-01-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Tirzepatide · Brand", "entity": "tirzepatide", "summary": "Tirzepatide: Brand recorded as Zepbound (US) / Mounjaro.", "old": null, "new": "Zepbound (US) / Mounjaro", "citation": { "title": "FDA — Zepbound label, rev. 01/2026", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/217806s037lbl.pdf", "publisher": "FDA", "kind": "regulator", "primary": true, "published_on": "2026-01-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "approval", "generated": true, "subject": "Semaglutide 25 mg, oral · TGA", "entity": "oral-semaglutide", "summary": "Semaglutide 25 mg, oral: TGA position recorded as not approved.", "old": null, "new": "not approved", "citation": null }, { "happened_on": "2026-08-21", "kind": "approval", "generated": true, "subject": "Semaglutide 25 mg, oral · Canada", "entity": "oral-semaglutide", "summary": "Semaglutide 25 mg, oral: Canada position recorded as not approved.", "old": null, "new": "not approved", "citation": null }, { "happened_on": "2026-08-21", "kind": "approval", "generated": true, "subject": "Semaglutide 25 mg, oral · NMPA", "entity": "oral-semaglutide", "summary": "Semaglutide 25 mg, oral: NMPA position recorded as not approved.", "old": null, "new": "not approved", "citation": null }, { "happened_on": "2026-08-21", "kind": "approval", "generated": true, "subject": "Semaglutide 25 mg, oral · PMDA", "entity": "oral-semaglutide", "summary": "Semaglutide 25 mg, oral: PMDA position recorded as not approved.", "old": null, "new": "not approved", "citation": null }, { "happened_on": "2026-08-21", "kind": "approval", "generated": true, "subject": "Semaglutide 25 mg, oral · ANVISA", "entity": "oral-semaglutide", "summary": "Semaglutide 25 mg, oral: ANVISA position recorded as under review.", "old": null, "new": "under review", "citation": null }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Semaglutide 25 mg, oral · Duration", "entity": "oral-semaglutide", "summary": "Semaglutide 25 mg, oral: Duration recorded as 64 weeks.", "old": null, "new": "64 weeks", "citation": { "title": "OASIS 4 — PubMed 40934115", "url": "https://pubmed.ncbi.nlm.nih.gov/40934115/", "publisher": "OASIS 4", "kind": "journal", "primary": true, "published_on": "2025-09-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Semaglutide 25 mg, oral · Participants", "entity": "oral-semaglutide", "summary": "Semaglutide 25 mg, oral: Participants recorded as 307.", "old": null, "new": "307", "citation": { "title": "OASIS 4 — PubMed 40934115", "url": "https://pubmed.ncbi.nlm.nih.gov/40934115/", "publisher": "OASIS 4", "kind": "journal", "primary": true, "published_on": "2025-09-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Semaglutide 25 mg, oral · Pivotal trial", "entity": "oral-semaglutide", "summary": "Semaglutide 25 mg, oral: Pivotal trial recorded as OASIS 4.", "old": null, "new": "OASIS 4", "citation": { "title": "OASIS 4 — PubMed 40934115", "url": "https://pubmed.ncbi.nlm.nih.gov/40934115/", "publisher": "OASIS 4", "kind": "journal", "primary": true, "published_on": "2025-09-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Semaglutide 25 mg, oral · Placebo-adjusted", "entity": "oral-semaglutide", "summary": "Semaglutide 25 mg, oral: Placebo-adjusted recorded as -12.0 pp.", "old": null, "new": "-12.0 pp", "citation": { "title": "OASIS 4 — PubMed 40934115", "url": "https://pubmed.ncbi.nlm.nih.gov/40934115/", "publisher": "OASIS 4", "kind": "journal", "primary": true, "published_on": "2025-09-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Semaglutide 25 mg, oral · Placebo arm", "entity": "oral-semaglutide", "summary": "Semaglutide 25 mg, oral: Placebo arm recorded as -2.0 %.", "old": null, "new": "-2.0 %", "citation": { "title": "OASIS 4 — PubMed 40934115", "url": "https://pubmed.ncbi.nlm.nih.gov/40934115/", "publisher": "OASIS 4", "kind": "journal", "primary": true, "published_on": "2025-09-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Semaglutide 25 mg, oral · Weight change", "entity": "oral-semaglutide", "summary": "Semaglutide 25 mg, oral: Weight change recorded as -14.0 %.", "old": null, "new": "-14.0 %", "citation": { "title": "OASIS 4 — PubMed 40934115", "url": "https://pubmed.ncbi.nlm.nih.gov/40934115/", "publisher": "OASIS 4", "kind": "journal", "primary": true, "published_on": "2025-09-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Semaglutide 25 mg, oral · Stopped for side effects", "entity": "oral-semaglutide", "summary": "Semaglutide 25 mg, oral: Stopped for side effects recorded as 7% vs 6% placebo.", "old": null, "new": "7% vs 6% placebo", "citation": { "title": "FDA — Wegovy tablets label, rev. 12/2025", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/218316Orig1s000lbl.pdf", "publisher": "FDA", "kind": "regulator", "primary": true, "published_on": "2025-12-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Semaglutide 25 mg, oral · Dose", "entity": "oral-semaglutide", "summary": "Semaglutide 25 mg, oral: Dose recorded as 25 mg daily, on an empty stomach with ≤120 ml water, then nothing for 30 minutes.", "old": null, "new": "25 mg daily, on an empty stomach with ≤120 ml water, then nothing for 30 minutes", "citation": { "title": "FDA — Wegovy tablets label, rev. 12/2025", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/218316Orig1s000lbl.pdf", "publisher": "FDA", "kind": "regulator", "primary": true, "published_on": "2025-12-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Semaglutide 25 mg, oral · Route", "entity": "oral-semaglutide", "summary": "Semaglutide 25 mg, oral: Route recorded as Tablet, daily.", "old": null, "new": "Tablet, daily", "citation": { "title": "FDA — Wegovy tablets label, rev. 12/2025", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/218316Orig1s000lbl.pdf", "publisher": "FDA", "kind": "regulator", "primary": true, "published_on": "2025-12-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Semaglutide 25 mg, oral · Class", "entity": "oral-semaglutide", "summary": "Semaglutide 25 mg, oral: Class recorded as GLP-1 receptor agonist.", "old": null, "new": "GLP-1 receptor agonist", "citation": { "title": "FDA — Wegovy tablets label, rev. 12/2025", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/218316Orig1s000lbl.pdf", "publisher": "FDA", "kind": "regulator", "primary": true, "published_on": "2025-12-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Semaglutide 25 mg, oral · Brand", "entity": "oral-semaglutide", "summary": "Semaglutide 25 mg, oral: Brand recorded as Wegovy tablets.", "old": null, "new": "Wegovy tablets", "citation": { "title": "FDA — Wegovy tablets label, rev. 12/2025", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/218316Orig1s000lbl.pdf", "publisher": "FDA", "kind": "regulator", "primary": true, "published_on": "2025-12-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "approval", "generated": true, "subject": "Semaglutide 7.2 mg · TGA", "entity": "semaglutide-72", "summary": "Semaglutide 7.2 mg: TGA position recorded as not approved.", "old": null, "new": "not approved", "citation": null }, { "happened_on": "2026-08-21", "kind": "approval", "generated": true, "subject": "Semaglutide 7.2 mg · Canada", "entity": "semaglutide-72", "summary": "Semaglutide 7.2 mg: Canada position recorded as not approved.", "old": null, "new": "not approved", "citation": null }, { "happened_on": "2026-08-21", "kind": "approval", "generated": true, "subject": "Semaglutide 7.2 mg · NMPA", "entity": "semaglutide-72", "summary": "Semaglutide 7.2 mg: NMPA position recorded as not approved.", "old": null, "new": "not approved", "citation": null }, { "happened_on": "2026-08-21", "kind": "approval", "generated": true, "subject": "Semaglutide 7.2 mg · PMDA", "entity": "semaglutide-72", "summary": "Semaglutide 7.2 mg: PMDA position recorded as not approved.", "old": null, "new": "not approved", "citation": null }, { "happened_on": "2026-08-21", "kind": "approval", "generated": true, "subject": "Semaglutide 7.2 mg · ANVISA", "entity": "semaglutide-72", "summary": "Semaglutide 7.2 mg: ANVISA position recorded as not approved.", "old": null, "new": "not approved", "citation": null }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Semaglutide 7.2 mg · Duration", "entity": "semaglutide-72", "summary": "Semaglutide 7.2 mg: Duration recorded as 72 weeks.", "old": null, "new": "72 weeks", "citation": { "title": "ClinicalTrials.gov NCT05646706 — posted results including the placebo arm", "url": "https://clinicaltrials.gov/study/NCT05646706", "publisher": "ClinicalTrials.gov NCT05646706", "kind": "journal", "primary": true, "published_on": "2026-08-20", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Semaglutide 7.2 mg · Participants", "entity": "semaglutide-72", "summary": "Semaglutide 7.2 mg: Participants recorded as —.", "old": null, "new": "—", "citation": null }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Semaglutide 7.2 mg · Pivotal trial", "entity": "semaglutide-72", "summary": "Semaglutide 7.2 mg: Pivotal trial recorded as STEP UP.", "old": null, "new": "STEP UP", "citation": { "title": "ClinicalTrials.gov NCT05646706 — posted results including the placebo arm", "url": "https://clinicaltrials.gov/study/NCT05646706", "publisher": "ClinicalTrials.gov NCT05646706", "kind": "journal", "primary": true, "published_on": "2026-08-20", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Semaglutide 7.2 mg · Placebo-adjusted", "entity": "semaglutide-72", "summary": "Semaglutide 7.2 mg: Placebo-adjusted recorded as -15.7 pp.", "old": null, "new": "-15.7 pp", "citation": { "title": "ClinicalTrials.gov NCT05646706 — posted results including the placebo arm", "url": "https://clinicaltrials.gov/study/NCT05646706", "publisher": "ClinicalTrials.gov NCT05646706", "kind": "journal", "primary": true, "published_on": "2026-08-20", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Semaglutide 7.2 mg · Placebo arm", "entity": "semaglutide-72", "summary": "Semaglutide 7.2 mg: Placebo arm recorded as -3.8 %.", "old": null, "new": "-3.8 %", "citation": { "title": "ClinicalTrials.gov NCT05646706 — posted results including the placebo arm", "url": "https://clinicaltrials.gov/study/NCT05646706", "publisher": "ClinicalTrials.gov NCT05646706", "kind": "journal", "primary": true, "published_on": "2026-08-20", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Semaglutide 7.2 mg · Weight change", "entity": "semaglutide-72", "summary": "Semaglutide 7.2 mg: Weight change recorded as -19.5 %.", "old": null, "new": "-19.5 %", "citation": { "title": "ClinicalTrials.gov NCT05646706 — posted results including the placebo arm", "url": "https://clinicaltrials.gov/study/NCT05646706", "publisher": "ClinicalTrials.gov NCT05646706", "kind": "journal", "primary": true, "published_on": "2026-08-20", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Semaglutide 7.2 mg · Stopped for side effects", "entity": "semaglutide-72", "summary": "Semaglutide 7.2 mg: Stopped for side effects recorded as —.", "old": null, "new": "—", "citation": null }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Semaglutide 7.2 mg · Dose", "entity": "semaglutide-72", "summary": "Semaglutide 7.2 mg: Dose recorded as 7.2 mg weekly, escalated from 2.4 mg.", "old": null, "new": "7.2 mg weekly, escalated from 2.4 mg", "citation": { "title": "ClinicalTrials.gov NCT05646706 — posted results including the placebo arm", "url": "https://clinicaltrials.gov/study/NCT05646706", "publisher": "ClinicalTrials.gov NCT05646706", "kind": "journal", "primary": true, "published_on": "2026-08-20", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Semaglutide 7.2 mg · Route", "entity": "semaglutide-72", "summary": "Semaglutide 7.2 mg: Route recorded as Injection, weekly.", "old": null, "new": "Injection, weekly", "citation": { "title": "ClinicalTrials.gov NCT05646706 — posted results including the placebo arm", "url": "https://clinicaltrials.gov/study/NCT05646706", "publisher": "ClinicalTrials.gov NCT05646706", "kind": "journal", "primary": true, "published_on": "2026-08-20", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Semaglutide 7.2 mg · Class", "entity": "semaglutide-72", "summary": "Semaglutide 7.2 mg: Class recorded as GLP-1 receptor agonist.", "old": null, "new": "GLP-1 receptor agonist", "citation": { "title": "ClinicalTrials.gov NCT05646706 — posted results including the placebo arm", "url": "https://clinicaltrials.gov/study/NCT05646706", "publisher": "ClinicalTrials.gov NCT05646706", "kind": "journal", "primary": true, "published_on": "2026-08-20", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Semaglutide 7.2 mg · Brand", "entity": "semaglutide-72", "summary": "Semaglutide 7.2 mg: Brand recorded as Wegovy HD.", "old": null, "new": "Wegovy HD", "citation": { "title": "ClinicalTrials.gov NCT05646706 — posted results including the placebo arm", "url": "https://clinicaltrials.gov/study/NCT05646706", "publisher": "ClinicalTrials.gov NCT05646706", "kind": "journal", "primary": true, "published_on": "2026-08-20", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Semaglutide 2.4 mg · Duration", "entity": "semaglutide-24", "summary": "Semaglutide 2.4 mg: Duration recorded as 68 weeks.", "old": null, "new": "68 weeks", "citation": { "title": "SELECT trial summary, NEJM 2023;389:2221", "url": "https://www.acc.org/latest-in-cardiology/clinical-trials/2023/11/09/15/04/select", "publisher": "acc.org", "kind": "journal", "primary": true, "published_on": "2023-11-11", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Semaglutide 2.4 mg · Participants", "entity": "semaglutide-24", "summary": "Semaglutide 2.4 mg: Participants recorded as 1 961.", "old": null, "new": "1 961", "citation": { "title": "SELECT trial summary, NEJM 2023;389:2221", "url": "https://www.acc.org/latest-in-cardiology/clinical-trials/2023/11/09/15/04/select", "publisher": "acc.org", "kind": "journal", "primary": true, "published_on": "2023-11-11", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Semaglutide 2.4 mg · Pivotal trial", "entity": "semaglutide-24", "summary": "Semaglutide 2.4 mg: Pivotal trial recorded as STEP 1.", "old": null, "new": "STEP 1", "citation": { "title": "SELECT trial summary, NEJM 2023;389:2221", "url": "https://www.acc.org/latest-in-cardiology/clinical-trials/2023/11/09/15/04/select", "publisher": "acc.org", "kind": "journal", "primary": true, "published_on": "2023-11-11", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Semaglutide 2.4 mg · Placebo-adjusted", "entity": "semaglutide-24", "summary": "Semaglutide 2.4 mg: Placebo-adjusted recorded as -12.5 pp.", "old": null, "new": "-12.5 pp", "citation": { "title": "SELECT trial summary, NEJM 2023;389:2221", "url": "https://www.acc.org/latest-in-cardiology/clinical-trials/2023/11/09/15/04/select", "publisher": "acc.org", "kind": "journal", "primary": true, "published_on": "2023-11-11", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Semaglutide 2.4 mg · Placebo arm", "entity": "semaglutide-24", "summary": "Semaglutide 2.4 mg: Placebo arm recorded as -2.4 %.", "old": null, "new": "-2.4 %", "citation": { "title": "SELECT trial summary, NEJM 2023;389:2221", "url": "https://www.acc.org/latest-in-cardiology/clinical-trials/2023/11/09/15/04/select", "publisher": "acc.org", "kind": "journal", "primary": true, "published_on": "2023-11-11", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Semaglutide 2.4 mg · Weight change", "entity": "semaglutide-24", "summary": "Semaglutide 2.4 mg: Weight change recorded as -14.9 %.", "old": null, "new": "-14.9 %", "citation": { "title": "SELECT trial summary, NEJM 2023;389:2221", "url": "https://www.acc.org/latest-in-cardiology/clinical-trials/2023/11/09/15/04/select", "publisher": "acc.org", "kind": "journal", "primary": true, "published_on": "2023-11-11", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Semaglutide 2.4 mg · Stopped for side effects", "entity": "semaglutide-24", "summary": "Semaglutide 2.4 mg: Stopped for side effects recorded as 6.8% vs 3.2% placebo.", "old": null, "new": "6.8% vs 3.2% placebo", "citation": { "title": "FDA — Wegovy label, rev. 03/2026", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/215256s029lbl.pdf", "publisher": "FDA", "kind": "regulator", "primary": true, "published_on": "2026-03-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Semaglutide 2.4 mg · Dose", "entity": "semaglutide-24", "summary": "Semaglutide 2.4 mg: Dose recorded as 2.4 mg weekly after a 16-week escalation.", "old": null, "new": "2.4 mg weekly after a 16-week escalation", "citation": { "title": "FDA — Wegovy label, rev. 03/2026", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/215256s029lbl.pdf", "publisher": "FDA", "kind": "regulator", "primary": true, "published_on": "2026-03-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Semaglutide 2.4 mg · Route", "entity": "semaglutide-24", "summary": "Semaglutide 2.4 mg: Route recorded as Injection, weekly.", "old": null, "new": "Injection, weekly", "citation": { "title": "FDA — Wegovy label, rev. 03/2026", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/215256s029lbl.pdf", "publisher": "FDA", "kind": "regulator", "primary": true, "published_on": "2026-03-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Semaglutide 2.4 mg · Class", "entity": "semaglutide-24", "summary": "Semaglutide 2.4 mg: Class recorded as GLP-1 receptor agonist.", "old": null, "new": "GLP-1 receptor agonist", "citation": { "title": "FDA — Wegovy label, rev. 03/2026", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/215256s029lbl.pdf", "publisher": "FDA", "kind": "regulator", "primary": true, "published_on": "2026-03-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-21", "kind": "spec", "generated": true, "subject": "Semaglutide 2.4 mg · Brand", "entity": "semaglutide-24", "summary": "Semaglutide 2.4 mg: Brand recorded as Wegovy.", "old": null, "new": "Wegovy", "citation": { "title": "FDA — Wegovy label, rev. 03/2026", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/215256s029lbl.pdf", "publisher": "FDA", "kind": "regulator", "primary": true, "published_on": "2026-03-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-20", "kind": "new", "generated": false, "subject": "This page", "entity": null, "summary": "First publication. Fourteen approved medicines, nine investigational compounds, six failures and ten unapproved peptides, each checked against regulator primary sources rather than press coverage.", "old": null, "new": null, "citation": { "title": "This page — 2026-08-20", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/", "publisher": "This page", "kind": "regulator", "primary": true, "published_on": null, "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-20", "kind": "correction", "generated": false, "subject": "Mazdutide · Ecnoglutide · Imcivree · Sevmia", "entity": null, "summary": "Four dates downgraded after an independent verification pass. The Chinese approval dates for mazdutide and ecnoglutide are sponsor announcement dates, not regulator-confirmed — NMPA's database is not machine-accessible. Imcivree's European extension now shows the CHMP opinion date of 27 Mar 2026, because the Commission decision date is not published. And Sevmia is described as the first generic semaglutide indicated for weight management, not the first generic semaglutide in Canada, which it is not.", "old": null, "new": null, "citation": { "title": "Mazdutide · Ecnoglutide · Imcivree · Sevmia — 2026-08-20", "url": "https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=107181", "publisher": "Mazdutide · Ecnoglutide · Imcivree · Sevmia", "kind": "regulator", "primary": true, "published_on": null, "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-20", "kind": "correction", "generated": false, "subject": "Semaglutide 7.2 mg (Wegovy HD)", "entity": "semaglutide-72", "summary": "CORRECTION, same day as publication. We first recorded that the STEP UP placebo arm had never been published, and showed no placebo-adjusted figure. That was wrong: full tabular results have been posted on ClinicalTrials.gov all along, giving −19.5% against a −3.8% placebo arm — a placebo-adjusted difference of 15.7 points. The error came from relying on press coverage and the paywalled journal article instead of the registry. The row now carries the registry figures, and the note explains why the company's −20.7% headline differs.", "old": "—", "new": "-15.7 pp", "citation": { "title": "ClinicalTrials.gov NCT05646706 — posted results including the placebo arm", "url": "https://clinicaltrials.gov/study/NCT05646706", "publisher": "ClinicalTrials.gov NCT05646706", "kind": "journal", "primary": true, "published_on": "2026-08-20", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-08-17", "kind": "status", "generated": false, "subject": "Semaglutide", "entity": null, "summary": "ANVISA approved the first Brazilian-made generic semaglutide (EMS, with Germed the same day). Brazil becomes the second country with a generic, after Canada.", "old": null, "new": null, "citation": { "title": "Semaglutide — 2026-08-17", "url": "https://www.poder360.com.br/poder-saude/anvisa-aprova-1o-generico-de-semaglutida-fabricado-no-brasil/", "publisher": "Semaglutide", "kind": "trade", "primary": false, "published_on": null, "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-07-23", "kind": "status", "generated": false, "subject": "Retatrutide", "entity": "retatrutide", "summary": "Lilly confirmed the filing has slipped to 2027. Recorded as a delay, not a failure — but it means the most effective compound on this page is at least two years from any pharmacy.", "old": null, "new": null, "citation": { "title": "Retatrutide — 2026-07-23", "url": "https://www.cnbc.com/2026/07/23/eli-lilly-will-file-for-approval-of-retatrutide-obesity-drug-in-2027.html", "publisher": "Retatrutide", "kind": "trade", "primary": false, "published_on": null, "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-07-23", "kind": "correction", "generated": false, "subject": "Unapproved peptides", "entity": null, "summary": "An FDA advisory panel voted narrowly in favour of allowing six peptides to be compounded — BPC-157, KPV and TB-500 at 8–6 with one abstention, MOTS-c at 7–5 with two. Emideltide was rejected. This will be widely reported as legalisation. It is not: the votes are non-binding, rulemaking has not started, the last comparable cycle took over two years, and FDA's own briefing said the studies were too short and too small to establish safety or effectiveness.", "old": null, "new": null, "citation": { "title": "Unapproved peptides — 2026-07-23", "url": "https://www.ajmc.com/view/fda-panel-backs-6-peptides-for-compounding", "publisher": "Unapproved peptides", "kind": "trade", "primary": false, "published_on": null, "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-07-15", "kind": "approval", "generated": true, "subject": "Semaglutide 25 mg, oral · EMA", "entity": "oral-semaglutide", "summary": "Semaglutide 25 mg, oral: EMA position recorded as approved · 15 Jul 2026.", "old": null, "new": "approved · 15 Jul 2026", "citation": null }, { "happened_on": "2026-07-15", "kind": "approval", "generated": true, "subject": "Semaglutide 7.2 mg · EMA", "entity": "semaglutide-72", "summary": "Semaglutide 7.2 mg: EMA position recorded as approved · 15 Jul 2026.", "old": null, "new": "approved · 15 Jul 2026", "citation": null }, { "happened_on": "2026-06-29", "kind": "status", "generated": false, "subject": "Semaglutide", "entity": null, "summary": "Health Canada authorised Apotex's Sevmia, the first generic semaglutide indicated for chronic weight management. Trade reporting attributes the early entry to a lapsed patent maintenance fee; Health Canada's own release does not say that, so we record it as reported rather than established.", "old": null, "new": null, "citation": { "title": "Health Canada — first generic semaglutide approved", "url": "https://www.canada.ca/en/health-canada/news/2026/06/canada-approves-first-generic-semaglutide-for-weight-loss.html", "publisher": "Health Canada", "kind": "regulator", "primary": true, "published_on": "2026-06-29", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-06-11", "kind": "approval", "generated": true, "subject": "Semaglutide 25 mg, oral · MHRA", "entity": "oral-semaglutide", "summary": "Semaglutide 25 mg, oral: MHRA position recorded as approved · 11 Jun 2026.", "old": null, "new": "approved · 11 Jun 2026", "citation": { "title": "Pharmaceutical Journal — MHRA approves oral semaglutide", "url": "https://pharmaceutical-journal.com/article/news/mhra-approves-semaglutide-oral-tablets-for-weight-loss", "publisher": "Pharmaceutical Journal", "kind": "trade", "primary": false, "published_on": "2026-06-11", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-04-30", "kind": "status", "generated": false, "subject": "Compounded GLP-1s", "entity": null, "summary": "FDA proposed permanently excluding semaglutide, tirzepatide and liraglutide from the 503B bulks list, which would close bulk compounding of all three for good.", "old": null, "new": null, "citation": { "title": "Compounded GLP-1s — 2026-04-30", "url": "https://www.pharmacytimes.com/view/fda-moves-to-permanently-close-the-door-on-compounded-glp-1s", "publisher": "Compounded GLP-1s", "kind": "trade", "primary": false, "published_on": null, "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-04-01", "kind": "new", "generated": false, "subject": "Orforglipron", "entity": "orforglipron", "summary": "Approved by FDA as Foundayo — the first small-molecule oral GLP-1. Reviewed in 50 days under the National Priority Voucher programme. Added to the list; the “there is no pill” argument for grey-market buying is now materially weaker.", "old": null, "new": null, "citation": { "title": "FDA — first NME approved under the National Priority Voucher programme", "url": "https://www.fda.gov/news-events/press-announcements/fda-approves-first-new-molecular-entity-under-national-priority-voucher-program", "publisher": "FDA", "kind": "regulator", "primary": true, "published_on": "2026-04-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-04-01", "kind": "approval", "generated": true, "subject": "Orforglipron · FDA", "entity": "orforglipron", "summary": "Orforglipron: FDA position recorded as approved · April 2026.", "old": null, "new": "approved · April 2026", "citation": { "title": "FDA — Foundayo label, rev. 04/2026", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/220934Orig1s000lbl.pdf", "publisher": "FDA", "kind": "regulator", "primary": true, "published_on": "2026-04-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-03-27", "kind": "approval", "generated": true, "subject": "Setmelanotide · EMA", "entity": "setmelanotide", "summary": "Setmelanotide: EMA position recorded as approved · 27 Mar 2026.", "old": null, "new": "approved · 27 Mar 2026", "citation": { "title": "EMA — Imcivree EPAR", "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/imcivree", "publisher": "EMA", "kind": "regulator", "primary": true, "published_on": "2026-08-20", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-03-19", "kind": "approval", "generated": true, "subject": "Semaglutide 7.2 mg · FDA", "entity": "semaglutide-72", "summary": "Semaglutide 7.2 mg: FDA position recorded as approved · 19 Mar 2026.", "old": null, "new": "approved · 19 Mar 2026", "citation": null }, { "happened_on": "2026-03-06", "kind": "new", "generated": false, "subject": "Ecnoglutide", "entity": "ecnoglutide", "summary": "Approved by China's NMPA. Added with the caveat that its pivotal trial has no published sample size and no peer-reviewed publication.", "old": null, "new": null, "citation": { "title": "Sciwind — NMPA approval of ecnoglutide", "url": "https://www.prnewswire.com/news-releases/sciwind-biosciences-announces-ecnoglutide-injection-approved-by-chinas-national-medical-products-administration-nmpa-for-chronic-weight-management-302706442.html", "publisher": "Sciwind", "kind": "press", "primary": false, "published_on": "2026-03-06", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-03-06", "kind": "approval", "generated": true, "subject": "Ecnoglutide · NMPA", "entity": "ecnoglutide", "summary": "Ecnoglutide: NMPA position recorded as approved · 6 Mar 2026.", "old": null, "new": "approved · 6 Mar 2026", "citation": { "title": "Sciwind — NMPA approval of ecnoglutide", "url": "https://www.prnewswire.com/news-releases/sciwind-biosciences-announces-ecnoglutide-injection-approved-by-chinas-national-medical-products-administration-nmpa-for-chronic-weight-management-302706442.html", "publisher": "Sciwind", "kind": "press", "primary": false, "published_on": "2026-03-06", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-02-23", "kind": "correction", "generated": false, "subject": "CagriSema", "entity": "cagrisema", "summary": "REDEFINE 4 missed its primary endpoint: CagriSema was not shown non-inferior to tirzepatide head to head. Recorded prominently because consumer coverage of CagriSema has largely omitted it.", "old": null, "new": null, "citation": { "title": "CagriSema — Novo Nordisk", "url": "https://www.patientcareonline.com/view/cagrisema-achieves-23-weight-loss-but-misses-noninferiority-vs-tirzepatide-in-redefine-4", "publisher": "CagriSema", "kind": "trade", "primary": false, "published_on": null, "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2026-01-01", "kind": "approval", "generated": true, "subject": "Semaglutide 7.2 mg · MHRA", "entity": "semaglutide-72", "summary": "Semaglutide 7.2 mg: MHRA position recorded as approved · January 2026.", "old": null, "new": "approved · January 2026", "citation": null }, { "happened_on": "2025-12-22", "kind": "new", "generated": false, "subject": "Oral semaglutide 25 mg", "entity": null, "summary": "FDA approved the first oral GLP-1 for weight management. Note the estimand gap: the company cites 16.6%, the NEJM primary endpoint is about 14%.", "old": null, "new": null, "citation": { "title": "FDA — Wegovy tablets label, rev. 12/2025", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/218316Orig1s000lbl.pdf", "publisher": "FDA", "kind": "regulator", "primary": true, "published_on": "2025-12-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2025-12-22", "kind": "approval", "generated": true, "subject": "Semaglutide 25 mg, oral · FDA", "entity": "oral-semaglutide", "summary": "Semaglutide 25 mg, oral: FDA position recorded as approved · 22 Dec 2025.", "old": null, "new": "approved · 22 Dec 2025", "citation": { "title": "FDA — Wegovy tablets label, rev. 12/2025", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/218316Orig1s000lbl.pdf", "publisher": "FDA", "kind": "regulator", "primary": true, "published_on": "2025-12-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2025-12-01", "kind": "approval", "generated": true, "subject": "Liraglutide 3.0 mg · TGA", "entity": "liraglutide", "summary": "Liraglutide 3.0 mg: TGA position recorded as withdrawn · December 2025.", "old": null, "new": "withdrawn · December 2025", "citation": null }, { "happened_on": "2025-06-27", "kind": "approval", "generated": true, "subject": "Mazdutide · NMPA", "entity": "mazdutide", "summary": "Mazdutide: NMPA position recorded as approved · 27 Jun 2025.", "old": null, "new": "approved · 27 Jun 2025", "citation": { "title": "Innovent — NMPA approval for chronic weight management", "url": "https://www.prnewswire.com/news-releases/innovent-announces-mazdutide-first-dual-gcgglp-1-receptor-agonist-received-approval-from-chinas-nmpa-for-chronic-weight-management-302493152.html", "publisher": "Innovent", "kind": "press", "primary": false, "published_on": "2025-06-27", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2025-06-09", "kind": "approval", "generated": true, "subject": "Tirzepatide · ANVISA", "entity": "tirzepatide", "summary": "Tirzepatide: ANVISA position recorded as approved · 9 Jun 2025.", "old": null, "new": "approved · 9 Jun 2025", "citation": { "title": "Agência Brasil — ANVISA approves Mounjaro for weight loss", "url": "https://agenciabrasil.ebc.com.br/saude/noticia/2025-06/anvisa-aprova-uso-do-medicamento-mounjaro-para-perda-de-peso", "publisher": "Agência Brasil", "kind": "trade", "primary": false, "published_on": "2025-06-09", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2025-05-13", "kind": "approval", "generated": true, "subject": "Tirzepatide · Canada", "entity": "tirzepatide", "summary": "Tirzepatide: Canada position recorded as approved · 13 May 2025.", "old": null, "new": "approved · 13 May 2025", "citation": null }, { "happened_on": "2025-04-14", "kind": "death", "generated": false, "subject": "Danuglipron", "entity": "danuglipron", "summary": "Pfizer discontinued its oral GLP-1 after a possible drug-induced liver injury — the company's second oral GLP-1 killed by a liver signal.", "old": null, "new": null, "citation": { "title": "Danuglipron", "url": "https://www.biopharmadive.com/news/pfizer-discontinue-obesity-pill-danuglipron/745235/", "publisher": "biopharmadive.com", "kind": "trade", "primary": false, "published_on": null, "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2024-12-01", "kind": "approval", "generated": true, "subject": "Tirzepatide · PMDA", "entity": "tirzepatide", "summary": "Tirzepatide: PMDA position recorded as approved · December 2024.", "old": null, "new": "approved · December 2024", "citation": null }, { "happened_on": "2024-07-19", "kind": "approval", "generated": true, "subject": "Tirzepatide · NMPA", "entity": "tirzepatide", "summary": "Tirzepatide: NMPA position recorded as approved · 19 Jul 2024.", "old": null, "new": "approved · 19 Jul 2024", "citation": null }, { "happened_on": "2024-06-01", "kind": "approval", "generated": true, "subject": "Semaglutide 2.4 mg · NMPA", "entity": "semaglutide-24", "summary": "Semaglutide 2.4 mg: NMPA position recorded as approved · June 2024.", "old": null, "new": "approved · June 2024", "citation": null }, { "happened_on": "2024-01-01", "kind": "approval", "generated": true, "subject": "Semaglutide 2.4 mg · TGA", "entity": "semaglutide-24", "summary": "Semaglutide 2.4 mg: TGA position recorded as approved · January 2024.", "old": null, "new": "approved · January 2024", "citation": null }, { "happened_on": "2023-11-08", "kind": "approval", "generated": true, "subject": "Tirzepatide · FDA", "entity": "tirzepatide", "summary": "Tirzepatide: FDA position recorded as approved · 8 Nov 2023.", "old": null, "new": "approved · 8 Nov 2023", "citation": { "title": "FDA — Zepbound label, rev. 01/2026", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/217806s037lbl.pdf", "publisher": "FDA", "kind": "regulator", "primary": true, "published_on": "2026-01-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2023-11-01", "kind": "approval", "generated": true, "subject": "Tirzepatide · MHRA", "entity": "tirzepatide", "summary": "Tirzepatide: MHRA position recorded as approved · November 2023.", "old": null, "new": "approved · November 2023", "citation": null }, { "happened_on": "2023-11-01", "kind": "approval", "generated": true, "subject": "Semaglutide 2.4 mg · MHRA", "entity": "semaglutide-24", "summary": "Semaglutide 2.4 mg: MHRA position recorded as approved · November 2023.", "old": null, "new": "approved · November 2023", "citation": null }, { "happened_on": "2023-03-10", "kind": "approval", "generated": true, "subject": "Semaglutide 2.4 mg · PMDA", "entity": "semaglutide-24", "summary": "Semaglutide 2.4 mg: PMDA position recorded as approved · 10 Mar 2023.", "old": null, "new": "approved · 10 Mar 2023", "citation": null }, { "happened_on": "2023-01-01", "kind": "approval", "generated": true, "subject": "Orlistat · PMDA", "entity": "orlistat", "summary": "Orlistat: PMDA position recorded as approved · January 2023.", "old": null, "new": "approved · January 2023", "citation": null }, { "happened_on": "2023-01-01", "kind": "approval", "generated": true, "subject": "Tirzepatide · TGA", "entity": "tirzepatide", "summary": "Tirzepatide: TGA position recorded as approved · January 2023.", "old": null, "new": "approved · January 2023", "citation": null }, { "happened_on": "2023-01-01", "kind": "approval", "generated": true, "subject": "Semaglutide 2.4 mg · ANVISA", "entity": "semaglutide-24", "summary": "Semaglutide 2.4 mg: ANVISA position recorded as approved · January 2023.", "old": null, "new": "approved · January 2023", "citation": null }, { "happened_on": "2022-09-15", "kind": "approval", "generated": true, "subject": "Tirzepatide · EMA", "entity": "tirzepatide", "summary": "Tirzepatide: EMA position recorded as approved · 15 Sep 2022.", "old": null, "new": "approved · 15 Sep 2022", "citation": null }, { "happened_on": "2022-01-06", "kind": "approval", "generated": true, "subject": "Semaglutide 2.4 mg · EMA", "entity": "semaglutide-24", "summary": "Semaglutide 2.4 mg: EMA position recorded as approved · 6 Jan 2022.", "old": null, "new": "approved · 6 Jan 2022", "citation": { "title": "EMA — Wegovy EPAR", "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/wegovy", "publisher": "EMA", "kind": "regulator", "primary": true, "published_on": "2026-08-20", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2021-11-25", "kind": "approval", "generated": true, "subject": "Semaglutide 2.4 mg · Canada", "entity": "semaglutide-24", "summary": "Semaglutide 2.4 mg: Canada position recorded as approved · 25 Nov 2021.", "old": null, "new": "approved · 25 Nov 2021", "citation": { "title": "Health Canada — first generic semaglutide approved", "url": "https://www.canada.ca/en/health-canada/news/2026/06/canada-approves-first-generic-semaglutide-for-weight-loss.html", "publisher": "Health Canada", "kind": "regulator", "primary": true, "published_on": "2026-06-29", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2021-06-04", "kind": "approval", "generated": true, "subject": "Semaglutide 2.4 mg · FDA", "entity": "semaglutide-24", "summary": "Semaglutide 2.4 mg: FDA position recorded as approved · 4 Jun 2021.", "old": null, "new": "approved · 4 Jun 2021", "citation": { "title": "FDA — Wegovy label, rev. 03/2026", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/215256s029lbl.pdf", "publisher": "FDA", "kind": "regulator", "primary": true, "published_on": "2026-03-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2020-11-25", "kind": "approval", "generated": true, "subject": "Setmelanotide · FDA", "entity": "setmelanotide", "summary": "Setmelanotide: FDA position recorded as approved · 25 Nov 2020.", "old": null, "new": "approved · 25 Nov 2020", "citation": null }, { "happened_on": "2019-01-01", "kind": "approval", "generated": true, "subject": "Naltrexone / bupropion ER · TGA", "entity": "contrave", "summary": "Naltrexone / bupropion ER: TGA position recorded as approved · January 2019.", "old": null, "new": "approved · January 2019", "citation": null }, { "happened_on": "2018-07-30", "kind": "approval", "generated": true, "subject": "Metreleptin · EMA", "entity": "metreleptin", "summary": "Metreleptin: EMA position recorded as approved · 30 Jul 2018.", "old": null, "new": "approved · 30 Jul 2018", "citation": { "title": "EMA — Myalepta EPAR", "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/myalepta", "publisher": "EMA", "kind": "regulator", "primary": true, "published_on": "2026-08-20", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2015-03-26", "kind": "approval", "generated": true, "subject": "Naltrexone / bupropion ER · MHRA", "entity": "contrave", "summary": "Naltrexone / bupropion ER: MHRA position recorded as approved · 26 Mar 2015.", "old": null, "new": "approved · 26 Mar 2015", "citation": null }, { "happened_on": "2015-03-26", "kind": "approval", "generated": true, "subject": "Naltrexone / bupropion ER · EMA", "entity": "contrave", "summary": "Naltrexone / bupropion ER: EMA position recorded as approved · 26 Mar 2015.", "old": null, "new": "approved · 26 Mar 2015", "citation": { "title": "EMA — Mysimba EPAR", "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/mysimba", "publisher": "EMA", "kind": "regulator", "primary": true, "published_on": "2026-08-20", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2015-03-23", "kind": "approval", "generated": true, "subject": "Liraglutide 3.0 mg · MHRA", "entity": "liraglutide", "summary": "Liraglutide 3.0 mg: MHRA position recorded as approved · 23 Mar 2015.", "old": null, "new": "approved · 23 Mar 2015", "citation": null }, { "happened_on": "2015-03-23", "kind": "approval", "generated": true, "subject": "Liraglutide 3.0 mg · EMA", "entity": "liraglutide", "summary": "Liraglutide 3.0 mg: EMA position recorded as approved · 23 Mar 2015.", "old": null, "new": "approved · 23 Mar 2015", "citation": { "title": "EMA — Saxenda EPAR", "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/saxenda", "publisher": "EMA", "kind": "regulator", "primary": true, "published_on": "2026-08-20", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2014-12-23", "kind": "approval", "generated": true, "subject": "Liraglutide 3.0 mg · FDA", "entity": "liraglutide", "summary": "Liraglutide 3.0 mg: FDA position recorded as approved · 23 Dec 2014.", "old": null, "new": "approved · 23 Dec 2014", "citation": null }, { "happened_on": "2014-09-10", "kind": "approval", "generated": true, "subject": "Naltrexone / bupropion ER · FDA", "entity": "contrave", "summary": "Naltrexone / bupropion ER: FDA position recorded as approved · 10 Sep 2014.", "old": null, "new": "approved · 10 Sep 2014", "citation": { "title": "FDA — Contrave label, rev. 03/2021", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/200063s020lbl.pdf", "publisher": "FDA", "kind": "regulator", "primary": true, "published_on": "2021-03-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2014-02-24", "kind": "approval", "generated": true, "subject": "Metreleptin · FDA", "entity": "metreleptin", "summary": "Metreleptin: FDA position recorded as approved · 24 Feb 2014.", "old": null, "new": "approved · 24 Feb 2014", "citation": { "title": "FDA — Myalept label", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125390s004lbl.pdf", "publisher": "FDA", "kind": "regulator", "primary": true, "published_on": "2014-02-24", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2013-02-21", "kind": "approval", "generated": true, "subject": "Phentermine / topiramate ER · EMA", "entity": "qsymia", "summary": "Phentermine / topiramate ER: EMA position recorded as refused · 21 Feb 2013.", "old": null, "new": "refused · 21 Feb 2013", "citation": { "title": "EMA — Qsiva refusal question-and-answer document", "url": "https://www.ema.europa.eu/en/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-qsiva-phentermine-topiramate_en.pdf", "publisher": "EMA", "kind": "regulator", "primary": true, "published_on": "2013-02-21", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2012-07-17", "kind": "approval", "generated": true, "subject": "Phentermine / topiramate ER · FDA", "entity": "qsymia", "summary": "Phentermine / topiramate ER: FDA position recorded as approved · 17 Jul 2012.", "old": null, "new": "approved · 17 Jul 2012", "citation": { "title": "FDA — Qsymia label, rev. 09/2024", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022580s026lbl.pdf", "publisher": "FDA", "kind": "regulator", "primary": true, "published_on": "2024-09-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "2000-01-01", "kind": "approval", "generated": true, "subject": "Orlistat · TGA", "entity": "orlistat", "summary": "Orlistat: TGA position recorded as approved · January 2000.", "old": null, "new": "approved · January 2000", "citation": null }, { "happened_on": "1999-04-26", "kind": "approval", "generated": true, "subject": "Orlistat · FDA", "entity": "orlistat", "summary": "Orlistat: FDA position recorded as approved · 26 Apr 1999.", "old": null, "new": "approved · 26 Apr 1999", "citation": { "title": "FDA — Xenical label, rev. 11/2022", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020766s038lbl.pdf", "publisher": "FDA", "kind": "regulator", "primary": true, "published_on": "2022-11-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } }, { "happened_on": "1998-07-29", "kind": "approval", "generated": true, "subject": "Orlistat · MHRA", "entity": "orlistat", "summary": "Orlistat: MHRA position recorded as approved · 29 Jul 1998.", "old": null, "new": "approved · 29 Jul 1998", "citation": null }, { "happened_on": "1998-07-29", "kind": "approval", "generated": true, "subject": "Orlistat · EMA", "entity": "orlistat", "summary": "Orlistat: EMA position recorded as approved · 29 Jul 1998.", "old": null, "new": "approved · 29 Jul 1998", "citation": null }, { "happened_on": "1959-01-01", "kind": "approval", "generated": true, "subject": "Phentermine · FDA", "entity": "phentermine", "summary": "Phentermine: FDA position recorded as approved · January 1959.", "old": null, "new": "approved · January 1959", "citation": { "title": "FDA — Adipex-P label, rev. 01/2012", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/085128s065lbl.pdf", "publisher": "FDA", "kind": "regulator", "primary": true, "published_on": "2012-01-01", "retrieved_at": "2026-08-20T00:00:00+00:00" } } ] }