{"id":"ak101-sc","safety":{"commonSideEffects":[{"rate":null,"effect":"Cytokine release syndrome"},{"rate":null,"effect":"Fatigue"},{"rate":null,"effect":"Pyrexia"},{"rate":null,"effect":"Infusion-related reactions"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"AK101 functions as a T cell engager by binding CD3 on the surface of T lymphocytes while also targeting prostate-specific membrane antigen (PSMA) on tumor cells. This dual binding brings T cells into close proximity with cancer cells, triggering T cell activation and cytotoxic killing of PSMA-positive tumors. The mechanism leverages the body's own immune system to attack cancer cells expressing PSMA.","oneSentence":"AK101 is a bispecific antibody that simultaneously engages CD3 on T cells and PSMA on tumor cells to redirect T cell killing toward PSMA-expressing cancer cells.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:00:22.177Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Metastatic castration-resistant prostate cancer (mCRPC) with PSMA expression"}]},"trialDetails":[{"nctId":"NCT05509361","phase":"PHASE3","title":"Open Label Study to Evaluate the Safety and Efficacy of AK101 Injection Subcutaneously in Subjects With Psoriasis","status":"COMPLETED","sponsor":"Akeso","startDate":"2022-04-08","conditions":"Plaque Psoriasis","enrollment":950},{"nctId":"NCT06281704","phase":"PHASE1","title":"A Study of AK101 in Subjects With Moderately to Severely Active Ulcerative Colitis","status":"COMPLETED","sponsor":"Akeso","startDate":"2020-11-26","conditions":"Ulcerative Colitis","enrollment":34}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":75855,"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":"AK101 SC","genericName":"AK101 SC","companyName":"Akeso","companyId":"akeso","modality":"Biologic","firstApprovalDate":"","aiSummary":"AK101 is a bispecific antibody that simultaneously engages CD3 on T cells and PSMA on tumor cells to redirect T cell killing toward PSMA-expressing cancer cells. Used for Metastatic castration-resistant prostate cancer (mCRPC) with PSMA expression.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}