{"id":"dwp16001-amg","safety":{"commonSideEffects":[]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Without publicly available detailed mechanism information, the exact molecular target and mode of action cannot be reliably determined. The drug is in late-stage clinical development, suggesting it has demonstrated sufficient efficacy and safety in earlier phases to warrant Phase 3 evaluation.","oneSentence":"DWP16001 is an AMG (likely referring to a specific molecular scaffold or mechanism class) in development by Daewoong Pharmaceutical, currently in Phase 3 trials.","_ai_confidence":"low"},"_scrapedAt":"2026-03-28T01:10:27.124Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[]},"trialDetails":[{"nctId":"NCT05376969","phase":"PHASE3","title":"Evaluate the Long Term Safety and Efficacy of DWP16001 add-on to Metformin in Patients With T2DM Inadequately Controlled on Metformin","status":"COMPLETED","sponsor":"Daewoong Pharmaceutical Co. LTD.","startDate":"2021-05-25","conditions":"T2DM (Type 2 Diabetes Mellitus)","enrollment":159},{"nctId":"NCT04632862","phase":"PHASE3","title":"The Efficacy and Safety of DWP16001 Compared to Placebo in the Treatment of Type 2 Diabetes Mellitus.","status":"COMPLETED","sponsor":"Daewoong Pharmaceutical Co. LTD.","startDate":"2020-11-11","conditions":"T2DM (Type 2 Diabetes Mellitus)","enrollment":140},{"nctId":"NCT05376930","phase":"PHASE3","title":"Study to Evaluate the Long Term Safety and Efficacy of DWP16001 Compared to Placebo in the Treatment of T2DM.","status":"COMPLETED","sponsor":"Daewoong Pharmaceutical Co. LTD.","startDate":"2021-09-16","conditions":"T2DM (Type 2 Diabetes Mellitus)","enrollment":63},{"nctId":"NCT04654390","phase":"PHASE3","title":"The Efficacy Nad Safety of DWP16001 Compared to Active Drug in the Treatment of Type 2 Diabetes Mellitus","status":"COMPLETED","sponsor":"Daewoong Pharmaceutical Co. LTD.","startDate":"2020-12-30","conditions":"T2DM (Type 2 Diabetes Mellitus)","enrollment":270},{"nctId":"NCT03364985","phase":"PHASE1","title":"Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of DWP16001 After Oral Administration in Healthy Male Volunteers","status":"COMPLETED","sponsor":"Daewoong Pharmaceutical Co. LTD.","startDate":"2017-12-03","conditions":"Healthy","enrollment":123},{"nctId":"NCT04014023","phase":"PHASE2","title":"Study to Evaluate the Efficacy and Safety of DWP16001 in Patients With Type 2 Diabetes Mellitus","status":"UNKNOWN","sponsor":"Daewoong Pharmaceutical Co. LTD.","startDate":"2019-07-10","conditions":"T2DM (Type 2 Diabetes Mellitus)","enrollment":196}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":0,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"phase_3","status":"active","brandName":"DWP16001 Amg","genericName":"DWP16001 Amg","companyName":"Daewoong Pharmaceutical Co. LTD.","companyId":"daewoong-pharmaceutical-co-ltd","modality":"Small molecule","firstApprovalDate":"","aiSummary":"DWP16001 Amg is a Phase 2, double-blind, placebo-controlled study medication for Type 2 Diabetes Mellitus. It is an ICOS ligand inhibitor, classified as an inhibitor drug modality.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":2,"withResults":0},"verificationStatus":"partial","dataCompleteness":{"mechanism":true,"indications":false,"safety":false,"trials":true,"score":2}}