{"id":"absk021","safety":{"commonSideEffects":[{"rate":"20-30%","effect":"Diarrhea"},{"rate":"15-25%","effect":"Fatigue"},{"rate":"10-20%","effect":"Nausea"}]},"_chembl":{"chemblId":"CHEMBL6068433","moleculeType":"Small molecule","molecularWeight":"474.95"},"_dailymed":null,"mechanism":{"_ai_source":"groq-llama-8b","explanation":"ABSK021 acts as a selective inhibitor of the PI3K/AKT/mTOR pathway, which is involved in cell proliferation and survival. This mechanism is relevant for treating various types of cancer.","oneSentence":"ABSK021 is a small molecule targeting the PI3K/AKT/mTOR pathway.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T02:28:27.417Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Metastatic non-small cell lung cancer"},{"name":"Metastatic breast cancer"}]},"trialDetails":[{"nctId":"NCT04192344","phase":"PHASE1","title":"A Study to Assess the Safety, Tolerability, and Pharmacokinetics of ABSK-021 in Patients With Advanced Solid Tumor","status":"RECRUITING","sponsor":"Abbisko Therapeutics Co, Ltd","startDate":"2020-01-20","conditions":"Neoplasms, Tenosynovial Giant Cell Tumor","enrollment":276},{"nctId":"NCT05804045","phase":"PHASE3","title":"Study of Pimicotinib (ABSK021) for Tenosynovial Giant Cell Tumor (MANEUVER)","status":"ACTIVE_NOT_RECRUITING","sponsor":"Abbisko Therapeutics Co, Ltd","startDate":"2023-04-27","conditions":"Tenosynovial Giant Cell Tumor, Pigmented Villonodular Synovitis, Giant Cell Tumor of Tendon Sheath","enrollment":90},{"nctId":"NCT06322706","phase":"PHASE1","title":"A Clinical Trial to Evaluate a High-Fat Meal and Omeprazole Enteric-coated Tablets on ASBK021","status":"COMPLETED","sponsor":"Abbisko Therapeutics Co, Ltd","startDate":"2024-03-22","conditions":"Healthy Subjects","enrollment":36},{"nctId":"NCT06186583","phase":"PHASE1","title":"A Mass Balance Study of [14C]ABSK021","status":"COMPLETED","sponsor":"Abbisko Therapeutics Co, Ltd","startDate":"2023-12-13","conditions":"Healthy Subjects","enrollment":6},{"nctId":"NCT06186804","phase":"PHASE2","title":"A Phase II Study Evaluating the Efficacy and Safety of ABSK021 (Pimicotinib)) in the Treatment of cGvHD Chronic Graft Versus Host Disease (cGvHD)","status":"ENROLLING_BY_INVITATION","sponsor":"Abbisko Therapeutics Co, Ltd","startDate":"2023-05-30","conditions":"cGvHD","enrollment":64},{"nctId":"NCT06089733","phase":"PHASE1","title":"A Clinical Trial to Evaluate the Effect of Itraconazole and Rifampicin on ABSK021","status":"COMPLETED","sponsor":"Abbisko Therapeutics Co, Ltd","startDate":"2023-04-11","conditions":"Healthy Subjects","enrollment":32},{"nctId":"NCT05280483","phase":"PHASE1","title":"ABSK021 Food Effect Study in Healthy Subjects","status":"COMPLETED","sponsor":"Abbisko Therapeutics Co, Ltd","startDate":"2022-07-23","conditions":"Neoplasms","enrollment":16},{"nctId":"NCT06111274","phase":"PHASE2","title":"A Phase 2 Study of ABSK021 in Patients With Advanced Pancreatic Cancer","status":"RECRUITING","sponsor":"Abbisko Therapeutics Co, Ltd","startDate":"2023-10-17","conditions":"Advanced Pancreatic Cancer","enrollment":82}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":1,"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_2","status":"active","brandName":"ABSK021","genericName":"ABSK021","companyName":"Abbisko Therapeutics Co, Ltd","companyId":"abbisko-therapeutics-co-ltd","modality":"Small molecule","firstApprovalDate":"","aiSummary":"ABSK021 is a small molecule targeting the PI3K/AKT/mTOR pathway. Used for Metastatic non-small cell lung cancer, Metastatic breast cancer.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}