{"id":"dbpr108","safety":{"commonSideEffects":[]},"_chembl":{"chemblId":"CHEMBL1082462","moleculeType":"Small molecule","molecularWeight":"324.40"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"By inhibiting PDK, DBPR108 allows pyruvate dehydrogenase (PDH) to remain active, promoting oxidative metabolism of pyruvate and shifting cellular energy utilization. This metabolic modulation is intended to improve mitochondrial function and reduce lactate accumulation, potentially benefiting conditions characterized by metabolic dysfunction or impaired energy metabolism.","oneSentence":"DBPR108 is a small-molecule inhibitor that targets pyruvate dehydrogenase kinase (PDK) to modulate cellular metabolism and energy production.","_ai_confidence":"low"},"_scrapedAt":"2026-03-28T01:08:42.561Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Mitochondrial disease or metabolic disorders (Phase 3 development)"}]},"trialDetails":[{"nctId":"NCT04859426","phase":"PHASE1","title":"A Study to Evaluate the Pharmacokinetics and Safety of DBPR108 in Subjects With Hepatic Impairment","status":"COMPLETED","sponsor":"CSPC ZhongQi Pharmaceutical Technology Co., Ltd.","startDate":"2021-06-09","conditions":"Hepatic Impairment","enrollment":24},{"nctId":"NCT05150626","phase":"PHASE1","title":"A Study to Evaluate the Effect of Different Meal Types on the Pharmacokinetics of DBPR108 in Healthy Subjects","status":"COMPLETED","sponsor":"CSPC ZhongQi Pharmaceutical Technology Co., Ltd.","startDate":"2022-05-29","conditions":"Healthy Subjects","enrollment":21},{"nctId":"NCT04161430","phase":"PHASE3","title":"A Study to Evaluate the Efficacy and Safety of DBPR108 100 mg in Type 2 Diabetes Mellitus Patients","status":"COMPLETED","sponsor":"CSPC ZhongQi Pharmaceutical Technology Co., Ltd.","startDate":"2020-01-02","conditions":"Type 2 Diabetes Mellitus","enrollment":766},{"nctId":"NCT04859439","phase":"PHASE1","title":"A Study to Evaluate the Pharmacokinetics and Safety of DBPR108 in Subjects With Renal Impairment","status":"COMPLETED","sponsor":"CSPC ZhongQi Pharmaceutical Technology Co., Ltd.","startDate":"2021-06-15","conditions":"Renal Impairment","enrollment":40},{"nctId":"NCT05146869","phase":"PHASE1","title":"A Single-dose and Multiple-dose Study to Evaluate the Pharmacokinetics and Pharmacodynamics of DBPR108 Tablets in Type 2 Diabetes Mellitus Patients","status":"COMPLETED","sponsor":"CSPC ZhongQi Pharmaceutical Technology Co., Ltd.","startDate":"2021-12-30","conditions":"Type 2 Diabetes Mellitus","enrollment":30},{"nctId":"NCT05045313","phase":"PHASE1","title":"A Study to Evaluate the Drug-drug Interactions (DDIs) of DBPR108 With Warfarin Sodium, Digoxin, Probenecid in Healthy Subjects","status":"COMPLETED","sponsor":"CSPC ZhongQi Pharmaceutical Technology Co., Ltd.","startDate":"2021-10-20","conditions":"Healthy Subjects","enrollment":28},{"nctId":"NCT05072028","phase":"PHASE1","title":"Mass Balance and Biotransformation Study of [14C]DBPR108 in Human","status":"COMPLETED","sponsor":"CSPC ZhongQi Pharmaceutical Technology Co., Ltd.","startDate":"2021-11-16","conditions":"Healthy Male Subjects","enrollment":6},{"nctId":"NCT04859452","phase":"PHASE1","title":"A Study to Evaluate the DDI of DBPR108 With Metformin,Glibenclamide,Valsartan, or Simvastatin in Healthy Subjects","status":"COMPLETED","sponsor":"CSPC ZhongQi Pharmaceutical Technology Co., Ltd.","startDate":"2021-05-26","conditions":"Healthy Subjects","enrollment":56},{"nctId":"NCT04218734","phase":"PHASE3","title":"A Study of DBPR108 and Metformin Hydrochloride Combination Therapy in Patients With T2DM","status":"COMPLETED","sponsor":"CSPC ZhongQi Pharmaceutical Technology Co., Ltd.","startDate":"2020-01-14","conditions":"Type 2 Diabetes Mellitus","enrollment":214},{"nctId":"NCT04124484","phase":"PHASE2","title":"DBPR108 Tablets in Type 2 Diabetes Mellitus Patients","status":"COMPLETED","sponsor":"CSPC ZhongQi Pharmaceutical Technology Co., Ltd.","startDate":"2017-10-17","conditions":"Type 2 Diabetes Mellitus","enrollment":276},{"nctId":"NCT02163278","phase":"PHASE1","title":"A Multiple Ascending Dose Phase I Study of DBPR108 in Healthy Male Subjects","status":"COMPLETED","sponsor":"National Health Research Institutes, Taiwan","startDate":"2014-06","conditions":"Diabetes Mellitus, Type 2","enrollment":32},{"nctId":"NCT01650324","phase":"PHASE1","title":"A Single-dose Phase 1 Study of DBPR108 in Healthy Male Subjects","status":"COMPLETED","sponsor":"National Health Research Institutes, Taiwan","startDate":"2012-07","conditions":"Diabetes Mellitus, Type 2","enrollment":32}],"_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":"DBPR108","genericName":"DBPR108","companyName":"National Health Research Institutes, Taiwan","companyId":"national-health-research-institutes-taiwan","modality":"Small molecule","firstApprovalDate":"","aiSummary":"DBPR108 is a small-molecule inhibitor that targets pyruvate dehydrogenase kinase (PDK) to modulate cellular metabolism and energy production. Used for Mitochondrial disease or metabolic disorders (Phase 3 development).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":false,"trials":true,"score":3}}