{"id":"hms5552","safety":{"commonSideEffects":[{"rate":null,"effect":"Hypoglycemia"},{"rate":null,"effect":"Gastrointestinal disorders"}]},"_chembl":{"chemblId":"CHEMBL4297508","moleculeType":"Small molecule","molecularWeight":"462.93"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"HMS5552 activates glucokinase, a key enzyme in glucose metabolism within pancreatic beta cells. By increasing glucokinase activity, the drug improves the glucose-sensing capacity of beta cells, leading to enhanced insulin secretion in response to elevated blood glucose levels. This mechanism helps restore more physiological insulin secretion patterns in patients with type 2 diabetes.","oneSentence":"HMS5552 is a glucokinase activator that enhances glucose sensing and insulin secretion in pancreatic beta cells.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T00:44:56.928Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Type 2 diabetes mellitus"}]},"trialDetails":[{"nctId":"NCT03790787","phase":"PHASE1","title":"Drug Interaction Study Between Dorzagliatin and Empagliflozin","status":"COMPLETED","sponsor":"Hua Medicine Limited","startDate":"2019-04-18","conditions":"Patients","enrollment":16},{"nctId":"NCT03790839","phase":"PHASE1","title":"Drug Interaction Study Between Dorzagliatin and Sitagliptin","status":"COMPLETED","sponsor":"Hua Medicine Limited","startDate":"2019-01-31","conditions":"Patients","enrollment":15},{"nctId":"NCT04426708","phase":"PHASE1","title":"A Clinical Study to Access the Pharmacokinetics of HMS5552 in Hepatic Impaired Subjects and Healthy Volunteers","status":"COMPLETED","sponsor":"Hua Medicine Limited","startDate":"2019-02-18","conditions":"Type 2 Diabetes Mellitus","enrollment":25},{"nctId":"NCT03173391","phase":"PHASE3","title":"Long-term Efficacy and Safety of HMS5552 in T2DM Subjects","status":"COMPLETED","sponsor":"Hua Medicine Limited","startDate":"2017-07-18","conditions":"Diabetes Mellitus, Type 2","enrollment":463},{"nctId":"NCT04091854","phase":"","title":"The Progress of Diabetes Mellitus After HMS5552 Treatment in Type 2 Diabetes Mellitus","status":"UNKNOWN","sponsor":"Majianhua","startDate":"2018-12-12","conditions":"Type2 Diabetes Mellitus","enrollment":24},{"nctId":"NCT03141073","phase":"PHASE3","title":"Long-term Efficacy and Safety of HMS5552 add-on to Metformin in T2DM Subjects","status":"COMPLETED","sponsor":"Hua Medicine Limited","startDate":"2017-10-15","conditions":"Diabetes Mellitus, Type 2","enrollment":767},{"nctId":"NCT04324424","phase":"PHASE1","title":"A Clinical Study to Access the Pharmacokinetics of HMS5552 in Renal Impaired Subjects and Healthy Volunteers","status":"COMPLETED","sponsor":"Hua Medicine Limited","startDate":"2019-04-23","conditions":"Type 2 Diabetes Mellitus","enrollment":17},{"nctId":"NCT02561338","phase":"PHASE2","title":"A Multi-center 12-week Study of HMS5552 in T2DM","status":"COMPLETED","sponsor":"Hua Medicine Limited","startDate":"2015-09","conditions":"Diabetes Mellitus, Type 2","enrollment":258},{"nctId":"NCT04080596","phase":"PHASE1","title":"DDI Study to Investigate the Impact of Itraconazole on the Pharmacokinetics of Dorzagliatin","status":"COMPLETED","sponsor":"Hua Medicine Limited","startDate":"2017-10-13","conditions":"Drug Interaction","enrollment":18},{"nctId":"NCT03158506","phase":"PHASE1","title":"Human Mass Balance Study of HMS5552 in Healthy Subjects","status":"COMPLETED","sponsor":"Hua Medicine Limited","startDate":"2017-03-29","conditions":"Healthy Subject","enrollment":6},{"nctId":"NCT01952535","phase":"PHASE1","title":"A Clinical Study to Evaluate Safety, Tolerability and Pharmacokinetics of Oral HMS5552 in Healthy Volunteers","status":"COMPLETED","sponsor":"Hua Medicine Limited","startDate":"2013-09","conditions":"Type II Diabetes Mellitus","enrollment":60},{"nctId":"NCT02077452","phase":"PHASE1","title":"Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HMS5552 in Patients With Type 2 Diabetes","status":"COMPLETED","sponsor":"Hua Medicine Limited","startDate":"2014-03","conditions":"Type 2 Diabetes Mellitus","enrollment":53},{"nctId":"NCT02597400","phase":"PHASE1","title":"Drug-Drug Interaction Study of Glucokinase Activator HMS5552 and Metformin in T2DM","status":"COMPLETED","sponsor":"Hua Medicine Limited","startDate":"2015-10","conditions":"Type 2 Diabetes Mellitus","enrollment":12},{"nctId":"NCT02386982","phase":"PHASE1","title":"Beta Cell Function and Related Pharmacodynamics of HMS5552 in T2DM Patients","status":"COMPLETED","sponsor":"Hua Medicine Limited","startDate":"2015-03","conditions":"Type 2 Diabetes","enrollment":24}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":5,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Glucokinase Activator (GKA)","Sinogliatin","GKA"],"phase":"phase_3","status":"active","brandName":"HMS5552","genericName":"HMS5552","companyName":"Hua Medicine Limited","companyId":"hua-medicine-limited","modality":"Small molecule","firstApprovalDate":"","aiSummary":"HMS5552 is a glucokinase activator that enhances glucose sensing and insulin secretion in pancreatic beta cells. Used for Type 2 diabetes mellitus.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":5,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}