{"slug":"brenipatide","seoKey":"brenipatide","inn":"brenipatide","displayName":"Brenipatide","codes":["LY3537031","LY-3537031"],"synonyms":["brenipatide [INN]","BRENIPATIDE [USAN]","LY3537031","dual GIP/GLP-1 receptor agonist"],"legalClass":"investigational","identifiers":{"cas":"2408921-49-1","unii":"C3939LZT6J","wikidataQid":"Q137841098","formula":"C228H354N46O72","molecularWeight":4891.5,"sequence":"YAEGTFTSDYSILLDKKAQAEFIEYLIAGGPSSGAPPPS-NH2"},"approvals":[{"market":"US","status":"investigational","note":"Not approved. Queries of the approval, labelling and enforcement endpoints on 2026-09-26 each returned no matches, and the labelling library and drug terminology held no entry, while a control substance queried in the same run returned hits everywhere. The substance registration code is an identifier only, not an approval. The substance is used in US trial sites under investigational status.","source":"https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:brenipatide"},{"market":"EU","status":"investigational","note":"Not approved. The official dataset of European public assessment reports, retrieved on 2026-09-26, contains neither the substance name nor the development code, while a control substance is present in the same file. No development support designation is known. Sites in several member states take part in the phase 2 and phase 3 trials.","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. The German medicines directory is an interactive application and was not queried by machine, so the finding is derived from the verified European negative. German sites take part in the alcohol use disorder, depression, asthma, COPD and bowel trials, 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 returned no result on 2026-09-26, while a control substance in the same run returned 6 results. The regulator's own product register is a JavaScript application and was not queryable server-side, not even for the control query. British sites take part in several phase 2 and phase 3 trials.","source":"https://www.medicines.org.uk/emc/search?q=brenipatide"},{"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 2026-09-26 with no match, while control substances in the same document were found. The register of therapeutic goods timed out on 2026-09-26, so the negative finding for that register is not directly evidenced. Australian sites take part in the two depression trials.","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 2026-09-26, while a control substance queried through the same endpoint returned several entries. Canadian sites take part in several trials under investigational status.","source":"https://health-products.canada.ca/api/drug/activeingredient/?ingredientname=brenipatide&type=json"},{"market":"CH","status":"not_approved","note":"Not approved. The official list of authorised human medicines with active-ingredient detail, retrieved on 2026-09-26, contains neither the substance name nor the development code, while a control substance appears 19 times in the same file.","source":"https://www.swissmedic.ch/dam/swissmedic/de/dokumente/internetlisten/erweiterte_ham_ind.xlsx.download.xlsx/Erweiterte_Arzneimittelliste%20HAM.xlsx"}],"devStage":"phase3","strongestEvidence":"rct_phase1","wada":{"status":"prohibited","section":"S0","listYear":2026,"source":"https://www.wada-ama.org/en/prohibited-list"},"trials":[{"nct":"NCT07219966","name":"RENEW-ALC-1 — moderate to severe alcohol use disorder","phase":"Phase 3","n":1100,"status":"RECRUITING"},{"nct":"NCT07219953","name":"RENEW-ALC-2 — alcohol use disorder","phase":"Phase 3","n":1100,"status":"RECRUITING"},{"nct":"NCT07412756","name":"RENEW-MDD-1 — relapse prevention in major depressive disorder","phase":"Phase 3","n":1000,"status":"RECRUITING"},{"nct":"NCT07775300","name":"RENEW-MDD-2 — relapse prevention in major depressive disorder","phase":"Phase 3","n":1000,"status":"NOT_YET_RECRUITING"},{"nct":"NCT07286175","name":"RENEW-Bipolar-1 — bipolar disorder","phase":"Phase 2","n":400,"status":"RECRUITING"},{"nct":"NCT07410507","name":"RENEW-Scz-1 — schizophrenia","phase":"Phase 2","n":450,"status":"RECRUITING"},{"nct":"NCT07420283","name":"RENEW-Op-1 — opioid use disorder","phase":"Phase 2","n":465,"status":"RECRUITING"},{"nct":"NCT07223840","name":"RENEW-Smk-1 — relapse prevention after quitting smoking","phase":"Phase 2","n":222,"status":"RECRUITING"},{"nct":"NCT07219173","name":"RENEW-Asthma — uncontrolled moderate to severe asthma","phase":"Phase 2","n":531,"status":"RECRUITING"},{"nct":"NCT07759245","name":"RENEW-COPD — moderate to severe COPD","phase":"Phase 2","n":606,"status":"RECRUITING"},{"nct":"NCT07545759","name":"RENEW-IBS-D — irritable bowel syndrome with diarrhoea","phase":"Phase 2","n":531,"status":"RECRUITING"},{"nct":"NCT07545772","name":"RENEW-IBS-C — irritable bowel syndrome with constipation","phase":"Phase 2","n":342,"status":"RECRUITING"},{"nct":"NCT06606106","name":"Multiple-ascending-dose study in overweight, obese and healthy participants","phase":"Phase 1","n":302,"status":"ACTIVE_NOT_RECRUITING"},{"nct":"NCT04648865","name":"First-in-human single-dose study, Japan","phase":"Phase 1","n":40,"status":"COMPLETED"},{"nct":"NCT07476118","name":"Pharmacodynamics in overweight or obesity","phase":"Phase 1","n":150,"status":"ACTIVE_NOT_RECRUITING"}],"sameAs":["https://www.wikidata.org/wiki/Q137841098","https://gsrs.ncats.nih.gov/ginas/app/beta/substances/759639ef-97c3-4baa-8cc3-86dd0b599eb6"],"lastVerified":"2026-09-26","version":"1.0","published":true,"locale":"en","title":"Brenipatide: what the trials show, status and safety","summary":"Brenipatide is an experimental weekly injection from Eli Lilly that activates two gut-hormone receptors, GIP and GLP-1, like tirzepatide. Unlike tirzepatide, it is being developed for addiction, depression and other psychiatric disorders, irritable bowel syndrome, asthma and COPD, not for obesity or type 2 diabetes. The only human results come from a conference poster on 212 volunteers: a half-life of 9.08 to 12.5 days and mostly mild side effects, with an unexplained skin-sensation signal in 15.2 per cent. There are no efficacy data in any target condition, and no country has approved it.","updated":"2026-09-26","url":"https://mypep.app/peptides/brenipatide"}