{"id":"cgt9486","safety":{"commonSideEffects":[{"rate":null,"effect":"Nausea"},{"rate":null,"effect":"Diarrhea"},{"rate":null,"effect":"Vomiting"},{"rate":null,"effect":"Fatigue"},{"rate":null,"effect":"Thrombocytopenia"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"CGT9486 selectively inhibits FLT3 (Fms-like tyrosine kinase 3) signaling, which is frequently activated in acute myeloid leukemia (AML) through internal tandem duplications (ITD) or point mutations. By blocking FLT3-mediated proliferation and survival signals, the drug aims to reduce leukemic cell growth and induce apoptosis in FLT3-driven malignancies.","oneSentence":"CGT9486 is a selective tyrosine kinase inhibitor that targets FLT3, a receptor implicated in acute myeloid leukemia and other hematologic malignancies.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:05:27.094Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Acute myeloid leukemia (AML) with FLT3 mutations"}]},"trialDetails":[{"nctId":"NCT06915766","phase":"","title":"Expanded Access to Bezuclastinib for Patients With NonAdvanced Systemic Mastocytosis or Advanced Systemic Mastocytosis","status":"AVAILABLE","sponsor":"Cogent Biosciences, Inc.","startDate":"","conditions":"Systemic Mastocytoses, Indolent, Systemic Mastocytoses, Aggressive","enrollment":""},{"nctId":"NCT05186753","phase":"PHASE2","title":"(Summit) A Study to Evaluate the Efficacy and Safety of CGT9486 Versus Placebo in Patients With Indolent or Smoldering Systemic Mastocytosis","status":"ACTIVE_NOT_RECRUITING","sponsor":"Cogent Biosciences, Inc.","startDate":"2022-06-27","conditions":"SSM, Mastocytosis, Indolent, Mastocytosis, Systemic","enrollment":237},{"nctId":"NCT05208047","phase":"PHASE3","title":"(Peak) A Phase 3 Randomized Trial of CGT9486+Sunitinib vs. Sunitinib in Subjects With Gastrointestinal Stromal Tumors","status":"ACTIVE_NOT_RECRUITING","sponsor":"Cogent Biosciences, Inc.","startDate":"2022-04-14","conditions":"Advanced Gastrointestinal Stromal Tumors, Metastatic Cancer","enrollment":442},{"nctId":"NCT04996875","phase":"PHASE2","title":"(Apex) Bezuclastinib in Patients With Advanced Systemic Mastocytosis","status":"RECRUITING","sponsor":"Cogent Biosciences, Inc.","startDate":"2021-11-09","conditions":"Advanced Systemic Mastocytosis (AdvSM), SM With an Associated Hematologic Neoplasm (SM-AHN), Mast Cell Leukemia (MCL)","enrollment":140},{"nctId":"NCT02401815","phase":"PHASE1, PHASE2","title":"CGT9486 (Formerly Known as PLX9486) as a Single Agent and in Combination With PLX3397 (Pexidartinib) or Sunitinib in Participants With Advanced Solid Tumors","status":"COMPLETED","sponsor":"Cogent Biosciences, Inc.","startDate":"2015-03-06","conditions":"Gastrointestinal Stromal Tumors","enrollment":51}],"_emaApprovals":[],"_faersSignals":[{"count":1,"reaction":"BILIRUBIN CONJUGATED INCREASED"},{"count":1,"reaction":"BLOOD ALKALINE PHOSPHATASE INCREASED"},{"count":1,"reaction":"BLOOD BILIRUBIN INCREASED"},{"count":1,"reaction":"ERYSIPELAS"},{"count":1,"reaction":"ESCHERICHIA BACTERAEMIA"},{"count":1,"reaction":"LIVER FUNCTION TEST INCREASED"}],"_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":"CGT9486","genericName":"CGT9486","companyName":"Cogent Biosciences, Inc.","companyId":"cogent-biosciences-inc","modality":"Small molecule","firstApprovalDate":"","aiSummary":"CGT9486 is a selective tyrosine kinase inhibitor that targets FLT3, a receptor implicated in acute myeloid leukemia and other hematologic malignancies. Used for Acute myeloid leukemia (AML) with FLT3 mutations.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":1},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}