{"slug":"mazdutide","seoKey":"mazdutide","inn":"mazdutide","displayName":"Mazdutide","codes":["IBI362","IBI-362","LY3305677","LY-3305677"],"synonyms":["mazdutide [INN]","MAZDUTIDE [USAN]","oxyntomodulin analogue","dual glucagon (GCGR) and GLP-1 receptor agonist","approved as a prescription medicine in the People's Republic of China since June 2025 (an eighth market the registry does not track)"],"legalClass":"rx","identifiers":{"cas":"2259884-03-0","pubchemCid":167312357,"unii":"MB76Z4IBZ5","inchikey":"XRBYWQZGSZWYEJ-HMQIFOERSA-N","chemblId":"CHEMBL5095358","wikidataQid":"Q123248554","formula":"C207H317N45O65","molecularWeight":4476,"sequence":"HGQGTFTSDYSKYLDEKKAKEFVEWLLEGGPSSG"},"approvals":[{"market":"US","status":"investigational","note":"Not approved; investigational medicinal product. Three openFDA endpoints (Drugs@FDA, labelling, enforcement) returned no match on 2026-09-10, while a control query for semaglutide in the same run returned results. The only approval worldwide is held in China and has no legal effect in the United States.","source":"https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:mazdutide"},{"market":"EU","status":"investigational","note":"Not approved; no centralised marketing authorisation and no marketing authorisation application made public. The Community Register returned no entry on 2026-09-10, while a control search for semaglutide in the same document returned five. The approval granted in China has no legal effect in the European Union.","source":"https://ec.europa.eu/health/documents/community-register/html/reg_hum_act.htm"},{"market":"DE","status":"investigational","note":"Not approved; Germany follows the centralised EU authorisation, which does not exist for this substance, so no national authorisation exists either. A completed phase 1 trial conducted in Germany (NCT03928379) documents the investigational status. No entry found on 2026-09-10.","source":"https://ec.europa.eu/health/documents/community-register/html/reg_hum_act.htm"},{"market":"UK","status":"investigational","note":"Not approved; no marketing authorisation. The electronic medicines compendium returned no search results on 2026-09-10, while a control search for semaglutide returned twenty. The first two first-in-human trials took place in the United Kingdom as clinical trials, not as an authorisation.","source":"https://www.medicines.org.uk/emc/search?q=mazdutide"},{"market":"AU","status":"not_approved","note":"Not registered; no entry in the Australian Register of Therapeutic Goods found. Register not machine-queryable on 2026-09-10: the search page returned an empty shell for the control query as well, so this is an indirect negative finding. No Australian trial sites and no publicly announced application.","source":"https://www.tga.gov.au/resources/artg"},{"market":"CA","status":"not_approved","note":"Not approved; no drug identification number. The Health Canada Drug Product Database API returned an empty result for the active ingredient on 2026-09-10, while a control query for semaglutide in the same run returned several entries.","source":"https://health-products.canada.ca/api/drug/activeingredient/?ingredientname=mazdutide"},{"market":"CH","status":"not_approved","note":"No marketing authorisation found. Register not machine-queryable on 2026-09-10: the Swiss medicinal product information and the compendium are JavaScript applications and returned no substance data for the control query either, so this is an indirect negative finding.","source":"https://www.swissmedicinfo.ch/"}],"devStage":"approved","strongestEvidence":"rct_phase3","wada":{"status":"not_listed","listYear":2026,"source":"https://www.wada-ama.org/en/prohibited-list"},"trials":[{"nct":"NCT02972645","name":"First-in-human single ascending dose study in healthy adults","phase":"Phase 1","n":66,"status":"COMPLETED"},{"nct":"NCT03325387","name":"Multiple ascending dose study in healthy adults","phase":"Phase 1","n":56,"status":"COMPLETED"},{"nct":"NCT04440345","name":"Phase 1b multiple ascending dose study in overweight or obesity","phase":"Phase 1/Phase 2","n":60,"status":"COMPLETED"},{"nct":"NCT04466904","name":"Phase 1b study in type 2 diabetes","phase":"Phase 1/Phase 2","n":42,"status":"COMPLETED"},{"nct":"NCT04904913","name":"Two-part phase 2 obesity study","phase":"Phase 2","n":328,"status":"COMPLETED"},{"nct":"NCT04965506","name":"Phase 2 study in type 2 diabetes (active-controlled against dulaglutide)","phase":"Phase 2","n":252,"status":"COMPLETED"},{"nct":"NCT05623839","name":"Phase 1 high-dose study in overweight or obesity (United States)","phase":"Phase 1","n":32,"status":"COMPLETED"},{"nct":"NCT05606913","name":"DREAMS-2 (comparison against dulaglutide)","phase":"Phase 3","n":731,"status":"COMPLETED"},{"nct":"NCT05607680","name":"GLORY-1","phase":"Phase 3","n":610,"status":"COMPLETED"},{"nct":"NCT05628311","name":"DREAMS-1","phase":"Phase 3","n":319,"status":"COMPLETED"},{"nct":"NCT06124807","name":"Phase 2 obesity study in the United States","phase":"Phase 2","n":179,"status":"COMPLETED"},{"nct":"NCT06164873","name":"GLORY-2","phase":"Phase 3","n":462,"status":"UNKNOWN"}],"sameAs":["https://www.wikidata.org/wiki/Q123248554","https://pubchem.ncbi.nlm.nih.gov/compound/167312357","https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL5095358/","https://www.guidetopharmacology.org/services/ligands/13924"],"lastVerified":"2026-09-10","version":"1.0","published":true,"locale":"en","title":"Mazdutide: what the trials show, status and safety","summary":"Mazdutide is a weekly injected peptide that switches on the docking points for two hormones, GLP-1 and glucagon. In a 60-week trial in 461 Chinese adults, participants lost 16.65% of their body weight against 1.50% on placebo. China licensed it in 2025 for weight management and for type 2 diabetes; everywhere else it remains an experimental drug. Vomiting affected 53.1% of the treated group in that trial.","updated":"2026-09-10","url":"https://mypep.app/peptides/mazdutide"}