{"slug":"cagrilintide","seoKey":"cagrilintide","inn":"cagrilintide","displayName":"Cagrilintide","codes":["NNC0174-0833","NN0174-0833","AM833"],"synonyms":["long-acting amylin analogue","amylin receptor agonist","cagrilintidum","analogue 23 (designation in the medicinal chemistry first description)"],"legalClass":"investigational","identifiers":{"cas":"1415456-99-3","pubchemCid":171397054,"unii":"AO43BIF1U8","inchikey":"LDERDVMBIYGIOI-IZVMHKDJSA-N","chemblId":"CHEMBL4802169","wikidataQid":"Q123428019","formula":"C194H312N54O59S2","molecularWeight":4409},"approvals":[{"market":"US","status":"investigational","note":"Not approved; investigational medicinal product in phase 3. No entry and no approved labelling found on 2026-09-06. The sponsor's public pipeline reports a filed marketing application for a fixed combination containing this substance; a filed application is not an approval.","source":"https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:cagrilintide"},{"market":"EU","status":"investigational","note":"Not approved; no centralised marketing authorisation. No entry found on 2026-09-06.","source":"https://www.ema.europa.eu/en/medicines?search_api_fulltext=cagrilintide"},{"market":"DE","status":"investigational","note":"Not approved; Germany follows the centralised EU authorisation, which does not exist for this substance. Use outside clinical trials or a compassionate use programme is not provided for. No entry found on 2026-09-06.","source":"https://www.ema.europa.eu/en/medicines?search_api_fulltext=cagrilintide"},{"market":"UK","status":"investigational","note":"Not approved; no product entry found in the regulator's database on 2026-09-06.","source":"https://products.mhra.gov.uk/search/?search=cagrilintide"},{"market":"AU","status":"investigational","note":"Not approved; no entry found in the Australian Register of Therapeutic Goods on 2026-09-06. The finding rests on the globally missing approval and the sponsor pipeline, not on a successful direct query.","source":"https://www.tga.gov.au/resources/artg"},{"market":"CA","status":"investigational","note":"Not approved; no drug identification number. The active ingredient query returned an empty result on 2026-09-06.","source":"https://health-products.canada.ca/api/drug/activeingredient/?ingredientname=cagrilintide"},{"market":"CH","status":"investigational","note":"Not approved; no entry found in the Swiss medicinal product information on 2026-09-06.","source":"https://www.swissmedicinfo.ch/"}],"devStage":"phase3","strongestEvidence":"rct_phase3","wada":{"status":"prohibited","section":"S0","listYear":2026,"source":"https://www.wada-ama.org/en/prohibited-list"},"trials":[{"nct":"NCT05567796","name":"REDEFINE 1 (combination with semaglutide in excess body weight)","phase":"Phase 3","n":3400,"status":"ACTIVE_NOT_RECRUITING"},{"nct":"NCT05394519","name":"REDEFINE 2 (type 2 diabetes and excess body weight)","phase":"Phase 3","n":1200,"status":"COMPLETED"},{"nct":"NCT05669755","name":"REDEFINE 3 (cardiovascular outcomes)","phase":"Phase 3","n":7101,"status":"ACTIVE_NOT_RECRUITING"},{"nct":"NCT06221969","name":"Blood glucose and body weight in type 2 diabetes","phase":"Phase 3","n":1024,"status":"COMPLETED"},{"nct":"NCT05813925","name":"East Asia, excess body weight","phase":"Phase 3","n":331,"status":"COMPLETED"},{"nct":"NCT05996848","name":"China, excess body weight","phase":"Phase 3","n":300,"status":"COMPLETED"},{"nct":"NCT07253285","name":"Children and adolescents","phase":"Phase 3","n":460,"status":"RECRUITING"},{"nct":"NCT07220642","name":"Weight change after treatment discontinuation","phase":"Phase 3","n":300,"status":"ACTIVE_NOT_RECRUITING"},{"nct":"NCT06409130","name":"Monotherapy and combination compared","phase":"Phase 2","n":270,"status":"COMPLETED"},{"nct":"NCT04982575","name":"Dose finding in combination with semaglutide","phase":"Phase 2","n":92,"status":"COMPLETED"},{"nct":"NCT03856047","name":"Phase 2 dose finding in excess body weight","phase":"Phase 2","n":706,"status":"COMPLETED"},{"nct":"NCT07010432","name":"Amylin analogue and bone metabolism","phase":"Phase 1","n":144,"status":"RECRUITING"},{"nct":"NCT07607587","name":"Tolerability in participants not tolerating incretin therapy","phase":"Phase 1","n":114,"status":"RECRUITING"},{"nct":"NCT05804162","name":"Cardiac rhythm in healthy participants","phase":"Phase 1","n":107,"status":"COMPLETED"},{"nct":"NCT02300844","name":"First-in-human single dose safety and pharmacokinetics","phase":"Phase 1","n":54,"status":"COMPLETED"}],"sameAs":["https://www.wikidata.org/wiki/Q123428019","https://pubchem.ncbi.nlm.nih.gov/compound/171397054","https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL4802169/","https://www.guidetopharmacology.org/GRAC/LigandDisplayForward?ligandId=13768"],"lastVerified":"2026-09-06","version":"1.0","published":true,"locale":"en","title":"Cagrilintide: what the trials show, status and safety","summary":"Cagrilintide is an experimental peptide that copies amylin, a hormone released with insulin after a meal. Given on its own for 26 weeks, it reduced body weight by 6.0% to 10.8% depending on the dose, against 3.0% on a dummy injection. Combined with semaglutide as CagriSema, the reduction was 20.4% over 68 weeks. No country has approved either the single substance or the combination.","updated":"2026-09-06","url":"https://mypep.app/peptides/cagrilintide"}