{"slug":"survodutide","seoKey":"survodutide","inn":"survodutide","displayName":"Survodutide","codes":["BI 456906","BI-456906","BI456906"],"synonyms":["survodutide [INN]","SURVODUTIDE [USAN]","BI 456906","dual glucagon/GLP-1 receptor agonist"],"legalClass":"investigational","identifiers":{"cas":"2805997-46-8","pubchemCid":171378821,"unii":"2ALA66NS64","inchikey":"MEDXQFAHWBMVIM-PCLHIQTFSA-N","chemblId":"CHEMBL5314776","wikidataQid":"Q123907235","formula":"C192H289N47O61","molecularWeight":4232,"sequence":"H-X-QGTFTSDYSKYLDERAAKDFIKWLESA-NH2"},"approvals":[{"market":"US","status":"investigational","note":"Not approved. No entry in the drug approval records and no approved labelling: queries of the approval, labelling and enforcement endpoints on 2026-09-17 each returned no matches, while a control substance queried in the same run returned hits in all three. A Breakthrough Therapy designation was granted in September 2024 for adults with non-cirrhotic steatohepatitis and moderate to advanced fibrosis; that designation accelerates development and is not an approval. The agency separately names the substance among the compounds sold illegally to consumers under a research label, and warned one seller by name on 24 August 2026.","source":"https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:survodutide"},{"market":"EU","status":"investigational","note":"Not approved. The official dataset of European public assessment reports, retrieved on 2026-09-17, contains neither the substance name nor the development code, while a control substance is present in the same file. Conversely the development code is listed in the official register of medicines currently in the PRIME scheme (EMA/521657/2016, status 10 August 2026) as a chemical medicinal product in gastroenterology and hepatology for steatohepatitis with fibrosis; PRIME is a development support programme entered in November 2023 and is expressly not an approval. No ATC code has been assigned, an index query on 2026-09-17 returning no match.","source":"https://www.ema.europa.eu/system/files/documents/other/medicines_output_european_public_assessment_reports_en.xlsx"},{"market":"DE","status":"investigational","note":"Not approved. For this drug class the centralised European procedure applies, and no centralised authorisation exists; no national authorisation is apparent either. The German medicines directories are JavaScript applications and returned no machine-readable result on 2026-09-17, not even for the control query, so the finding is derived from the verified European negative rather than from a national register. Germany is the developer's home country and hosts trial sites, where use takes place exclusively within clinical trials.","source":"https://www.ema.europa.eu/system/files/documents/other/medicines_output_european_public_assessment_reports_en.xlsx"},{"market":"UK","status":"investigational","note":"Not approved. A search of the electronic medicines compendium, the register of summaries of product characteristics, returned no result at all on 2026-09-17, while a control substance in the same run returned 20 results. The regulator's own product register is a JavaScript application and was not queryable server-side, returning only a loading placeholder even for the control query. British sites took part in the phase 3 obesity trial and in the phase 2 liver trial, that is, under investigational status.","source":"https://www.medicines.org.uk/emc/search?q=survodutide"},{"market":"AU","status":"not_approved","note":"Not approved and not named in the Poisons Standard; the full text of the June 2026 instrument was searched on 2026-09-17 with no match, while control substances in the same document were found. The register of therapeutic goods could not be checked: the search was unreachable both by direct request and by page retrieval, timing out on 2026-09-17, so the negative finding for that register is not directly evidenced. Absence of a scheduling entry does not make the substance freely available, since unapproved therapeutic goods remain regulated and unapproved injectable peptides are treated as prescription substances in practice.","source":"https://www.legislation.gov.au/F2026L00633/asmade/2026-05-28/text/original/epub/OEBPS/document_1/document_1.html"},{"market":"CA","status":"not_approved","note":"Not approved. The drug product database returned an empty result for the active ingredient on 2026-09-17, while a control substance queried through the same endpoint in the same run returned several ingredient entries. The negative finding is therefore verified. Canadian sites took part in two phase 3 trials and in the phase 2 obesity trial, that is, under investigational status.","source":"https://health-products.canada.ca/api/drug/activeingredient/?ingredientname=survodutide&type=json"},{"market":"CH","status":"not_approved","note":"Not approved. The official list of authorised human medicines with active-ingredient detail, retrieved on 2026-09-17, contains neither the substance name nor the development code, while two control substances are present in the same file. The companion list of authorised preparations likewise contains no product, while three control preparations are listed. The negative finding is therefore verified twice over.","source":"https://www.swissmedic.ch/dam/swissmedic/de/dokumente/internetlisten/erweiterte_ham_ind.xlsx.download.xlsx/Erweiterte_Arzneimittelliste%20HAM.xlsx"}],"devStage":"phase3","strongestEvidence":"rct_phase3","wada":{"status":"prohibited","section":"S0","listYear":2026,"source":"https://www.wada-ama.org/en/prohibited-list"},"trials":[{"nct":"NCT06066515","name":"SYNCHRONIZE-1 — obesity without type 2 diabetes, 76 weeks","phase":"Phase 3","n":726,"status":"COMPLETED"},{"nct":"NCT06066528","name":"SYNCHRONIZE-2 — obesity with type 2 diabetes, 76 weeks","phase":"Phase 3","n":755,"status":"COMPLETED"},{"nct":"NCT06077864","name":"SYNCHRONIZE-CVOT — cardiovascular safety, to week 114","phase":"Phase 3","n":5531,"status":"COMPLETED"},{"nct":"NCT06309992","name":"SYNCHRONIZE-MASLD — obesity with at-risk steatotic liver disease, 48 weeks","phase":"Phase 3","n":218,"status":"COMPLETED"},{"nct":"NCT06214741","name":"SYNCHRONIZE-CN — obesity or overweight in Chinese adults","phase":"Phase 3","n":307,"status":"COMPLETED"},{"nct":"NCT06176365","name":"SYNCHRONIZE-JP — obesity disease in Japanese adults","phase":"Phase 3","n":274,"status":"COMPLETED"},{"nct":"NCT06632444","name":"LIVERAGE — steatohepatitis with moderate to advanced fibrosis","phase":"Phase 3","n":1800,"status":"RECRUITING"},{"nct":"NCT06632457","name":"LIVERAGE-Cirrhosis — compensated cirrhosis in steatohepatitis","phase":"Phase 3","n":1590,"status":"RECRUITING"},{"nct":"NCT07754461","name":"Glycaemic control in type 2 diabetes","phase":"Phase 3","n":600,"status":"RECRUITING"},{"nct":"NCT04667377","name":"Dose-finding in overweight or obesity, 46 weeks","phase":"Phase 2","n":387,"status":"COMPLETED"},{"nct":"NCT04771273","name":"Dose-finding in steatohepatitis with fibrosis F1-F3, 48 weeks","phase":"Phase 2","n":295,"status":"COMPLETED"},{"nct":"NCT07206290","name":"ARTIST-CKD — albuminuria in chronic kidney disease","phase":"Phase 2","n":120,"status":"NOT_YET_RECRUITING"},{"nct":"NCT05296733","name":"Pharmacokinetics and tolerability in hepatic impairment and cirrhosis","phase":"Phase 1","n":82,"status":"COMPLETED"},{"nct":"NCT06352411","name":"Pharmacokinetics in renal impairment","phase":"Phase 1","n":42,"status":"COMPLETED"}],"sameAs":["https://pubchem.ncbi.nlm.nih.gov/compound/171378821","https://www.wikidata.org/wiki/Q123907235","https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL5314776/"],"lastVerified":"2026-09-17","version":"1.0","published":true,"locale":"en","title":"Survodutide: what the trials show, status and safety","summary":"Survodutide is an experimental injection that switches on two receptors at once: the GLP-1 receptor, which curbs appetite, and the glucagon receptor, which raises energy expenditure. In the largest published trial, people lost 12.2 to 13.0 per cent of their body weight over 76 weeks, against 5.4 per cent on placebo. Stomach and bowel side effects reached almost 90 per cent in one group, and no country has approved it. The American medicines agency names it among the substances sold illegally under a research label.","updated":"2026-09-17","url":"https://mypep.app/peptides/survodutide"}