{"id":"ak102","safety":{"commonSideEffects":[{"rate":null,"effect":"Immune-related adverse events (irAEs)"},{"rate":null,"effect":"Fatigue"},{"rate":null,"effect":"Diarrhea"},{"rate":null,"effect":"Rash"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"AK102 functions as a bispecific monoclonal antibody designed to bind both PD-1 and CTLA-4, two key immune checkpoint molecules. By engaging both pathways simultaneously, it aims to provide superior T-cell activation and anti-tumor immunity compared to single-checkpoint inhibitors. This dual mechanism is intended to overcome resistance to monotherapy and improve clinical outcomes in solid tumors.","oneSentence":"AK102 is a bispecific antibody that simultaneously engages PD-1 on immune cells and CTLA-4 to enhance anti-tumor immune responses.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:00:24.054Z","_scrapedBy":"cloudflare-swarm","_wikipedia":{"url":"https://en.wikipedia.org/wiki/AK-102","title":"AK-102","extract":"The AK-102 is a shortened carbine version of the AK-101 rifle, which was derived from the original AK-47 design and its AK-74 successor."},"indications":{"approved":[{"name":"Advanced or metastatic solid tumors (Phase 3 development)"}]},"trialDetails":[{"nctId":"NCT05255094","phase":"PHASE3","title":"A Study to Evaluate the Efficacy and Safety of AK102 in Patients With Hyperlipidemia","status":"COMPLETED","sponsor":"Akeso","startDate":"2021-11-03","conditions":"Hyperlipidemia","enrollment":464},{"nctId":"NCT05260411","phase":"PHASE3","title":"A Study to Evaluate the Efficacy and Safety of AK102 Q6W in Patients With Hyperlipidemia","status":"COMPLETED","sponsor":"Akeso","startDate":"2022-01-26","conditions":"Hyperlipidemia","enrollment":246},{"nctId":"NCT05255458","phase":"PHASE3","title":"A Study to Evaluate the Long-term Efficacy and Safety of AK102 in Patients With Hyperlipidemia","status":"COMPLETED","sponsor":"Akeso","startDate":"2021-11-04","conditions":"Hyperlipidemia","enrollment":122},{"nctId":"NCT04169386","phase":"PHASE1","title":"A Study of PCSK9 Inhibitor AK102 in Healthy Subjects","status":"COMPLETED","sponsor":"Akeso","startDate":"2018-05-23","conditions":"Hypercholesterolaemia","enrollment":32},{"nctId":"NCT03933293","phase":"PHASE2","title":"A Study to Evaluate the Safety and Efficacy of the PCSK9 Inhibitor AK102 in Patients With HoFH","status":"COMPLETED","sponsor":"Akeso","startDate":"2019-05-13","conditions":"Homozygous Familial Hypercholesterolemia","enrollment":10},{"nctId":"NCT04173403","phase":"PHASE2","title":"A Long-term Study of AK102 in Patients With Hypercholesterolemia","status":"COMPLETED","sponsor":"Akeso","startDate":"2019-11-04","conditions":"Hypercholesterolemia","enrollment":796},{"nctId":"NCT04173793","phase":"PHASE2","title":"A Study of PCSK9 Inhibitor AK102 in Patients With Heterozygous Familial Hypercholesterolemia (HeFH)","status":"COMPLETED","sponsor":"Akeso","startDate":"2019-11-18","conditions":"Heterozygous Familial Hypercholesterolemia","enrollment":109},{"nctId":"NCT04358432","phase":"PHASE2","title":"A Study of PCSK9 Inhibitor AK102 in Patients With Hypercholesterolemia","status":"COMPLETED","sponsor":"Akeso","startDate":"2020-05-13","conditions":"Hypercholesterolemia","enrollment":262},{"nctId":"NCT02774486","phase":"NA","title":"Efficacy and Safety of IQP-AK-102 in Reducing Appetite","status":"COMPLETED","sponsor":"InQpharm Group","startDate":"2016-05-01","conditions":"Appetite Regulation, Appetite Suppression, Energy Intake","enrollment":36},{"nctId":"NCT01905956","phase":"PHASE3","title":"Safety and Efficacy of IQP- AK-102 in Reducing Body Weight","status":"COMPLETED","sponsor":"InQpharm Group","startDate":"2013-07","conditions":"Weight Loss","enrollment":119},{"nctId":"NCT02041754","phase":"PHASE3","title":"Safety and Efficacy of IQP-AK-102 in Reducing Appetite","status":"COMPLETED","sponsor":"InQpharm Group","startDate":"2014-01","conditions":"Weight Loss, Appetite Modulation (Focus of Study)","enrollment":40}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":3,"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":"AK102","genericName":"AK102","companyName":"Akeso","companyId":"akeso","modality":"Small molecule","firstApprovalDate":"","aiSummary":"AK102 is a bispecific antibody that simultaneously engages PD-1 on immune cells and CTLA-4 to enhance anti-tumor immune responses. Used for Advanced or metastatic solid tumors (Phase 3 development).","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":5,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}