{"slug":"enicepatide","seoKey":"enicepatide","inn":"enicepatide","displayName":"Enicepatide","codes":["CT-388","CT388","RO7795068"],"synonyms":["enicepatide [INN]","ENICEPATIDE [USAN]","CT-388","RO7795068","dual GIP/GLP-1 receptor agonist"],"legalClass":"investigational","identifiers":{"cas":"2869147-44-2","unii":"MTP9QR7GYF","wikidataQid":"Q130632792","formula":"C226H345FN48O67","molecularWeight":4825.5,"sequence":"X-EGTFTSDYSI-X-LDKIAQKAFVQWLIAGGPSSGAPPPS-NH2"},"approvals":[{"market":"US","status":"investigational","note":"Not approved. Queries of the approval, labelling, product and enforcement datasets on 2026-09-26 each returned no match, while a control substance queried in the same run returned hits in all four. No Fast Track, Breakthrough Therapy or other development designation is documented; the developer's description of the compound as an internal 'fast-track asset' is a company prioritisation, not a regulatory status. US sites take part in both phase 2 trials and in the phase 3 programme, that is, under investigational status.","source":"https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:enicepatide"},{"market":"EU","status":"investigational","note":"Not approved. The official medicines dataset of the European Medicines Agency, retrieved on 2026-09-26, contains neither the name nor the development code, while a control substance is present in the same file; the dataset of committee opinions has no match either. The two phase 3 trials are registered in the EU clinical trials system (2025-523104-71-00 and 2025-523106-32-00), which is investigational status, not an authorisation.","source":"https://www.ema.europa.eu/en/documents/report/medicines-output-medicines_json-report_en.json"},{"market":"DE","status":"investigational","note":"Not approved. For this drug class the centralised European procedure applies, and no centralised authorisation exists; a national authorisation is not apparent. The German directories were not queried directly, so the finding is derived from the verified European negative. Germany hosts sites of both phase 3 trials, where use takes place exclusively within clinical trials.","source":"https://www.ema.europa.eu/en/documents/report/medicines-output-medicines_json-report_en.json"},{"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 six. The regulator's own product register is a JavaScript application and could not be queried server-side. British sites take part in both phase 3 trials, that is, under investigational status.","source":"https://www.medicines.org.uk/emc/search?q=enicepatide"},{"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 for the name or the development code, while control substances in the same document were found. The register of therapeutic goods could not be checked because its search timed out, so the negative finding for that register is indirect. The first-in-human single-dose study ran at an Australian site, and Australian sites take part in the phase 3 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 the phase 2 diabetes trial and in the phase 3 programme, that is, under investigational status.","source":"https://health-products.canada.ca/api/drug/activeingredient/?lang=en&type=json&ingredientname=enicepatide"},{"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 name nor the development code, while two control substances are present; the list of authorised preparations has no product either. The developer is headquartered in Switzerland, but Switzerland is not listed among the phase 3 trial locations.","source":"https://www.swissmedic.ch/dam/swissmedic/de/dokumente/internetlisten/erweiterte_ham_ind.xlsx.download.xlsx/Erweiterte_Arzneimittelliste%20HAM.xlsx"}],"devStage":"phase3","strongestEvidence":"rct_phase2","wada":{"status":"prohibited","section":"S0","listYear":2026,"source":"https://www.wada-ama.org/en/prohibited-list"},"trials":[{"nct":"NCT07351045","name":"ENITH-1 — obesity or overweight without type 2 diabetes, 72 weeks","phase":"Phase 3","n":2000,"status":"RECRUITING"},{"nct":"NCT07351058","name":"ENITH-2 — obesity or overweight with type 2 diabetes, 72 weeks","phase":"Phase 3","n":1600,"status":"RECRUITING"},{"nct":"NCT07670416","name":"Obesity or overweight with or without type 2 diabetes in China, 52 weeks","phase":"Phase 3","n":300,"status":"RECRUITING"},{"nct":"NCT06525935","name":"CT-388-103 — obesity or overweight without diabetes, 48 weeks","phase":"Phase 2","n":469,"status":"COMPLETED"},{"nct":"NCT06628362","name":"CT-388-104 — type 2 diabetes with overweight or obesity, 48 weeks","phase":"Phase 2","n":447,"status":"ACTIVE_NOT_RECRUITING"},{"nct":"NCT07589686","name":"ZYNERGY — combination with petrelintide, 40 weeks","phase":"Phase 2","n":486,"status":"NOT_YET_RECRUITING"},{"nct":"NCT04838405","name":"CT-388-101 — first-in-human single and multiple ascending doses, up to 24 weeks","phase":"Phase 1","n":129,"status":"COMPLETED"},{"nct":"NCT07626515","name":"Pharmacokinetics and safety in healthy Chinese adults","phase":"Phase 1","n":36,"status":"RECRUITING"}],"sameAs":["https://www.wikidata.org/wiki/Q130632792","https://gsrs.ncats.nih.gov/ginas/app/beta/substances/MTP9QR7GYF"],"lastVerified":"2026-09-26","version":"1.0","published":true,"locale":"en","title":"Enicepatide: what the trials show, status and safety","summary":"Enicepatide is an experimental injectable drug, developed by Roche, that activates two gut hormone receptors: GLP-1 and GIP. In a 48-week phase 2 trial in 467 adults with obesity, the trial reported a mean weight change in the highest dose arm 22.5 per cent larger than on placebo, assuming everyone stayed on treatment. Counting those who stopped, the difference was 18.3 per cent. Neither phase 2 trial has been published in full, stomach and bowel side effects were common, and the substance is approved nowhere.","updated":"2026-09-26","url":"https://mypep.app/peptides/enicepatide"}