{"id":"gilteritinib-gilt","safety":{"commonSideEffects":[{"rate":"30-40","effect":"Febrile neutropenia"},{"rate":"25-35","effect":"Thrombocytopenia"},{"rate":"20-30","effect":"Anemia"},{"rate":"15-25","effect":"Nausea"},{"rate":"10-20","effect":"Diarrhea"},{"rate":"10-15","effect":"Vomiting"},{"rate":"15-25","effect":"Fatigue"},{"rate":"5-10","effect":"QT prolongation"}]},"_chembl":{"chemblId":"CHEMBL3301622","moleculeType":"Small molecule","molecularWeight":"552.72"},"_dailymed":{"setId":"b5ff59aa-9c0d-49a8-9053-1f179b482383","title":"XOSPATA (GILTERITINIB) TABLET [ASTELLAS PHARMA US, INC.]"},"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Gilteritinib binds to and inhibits FLT3, a receptor tyrosine kinase that is frequently mutated or overexpressed in acute myeloid leukemia (AML). By blocking FLT3 signaling, the drug suppresses the growth and survival of leukemic blasts. It has activity against both FLT3-ITD (internal tandem duplication) and FLT3-TKD (tyrosine kinase domain) mutations.","oneSentence":"Gilteritinib is a tyrosine kinase inhibitor that selectively targets FLT3 (FMS-like tyrosine kinase 3) to inhibit proliferation of acute myeloid leukemia cells.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T04:01:02.784Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Acute myeloid leukemia (AML) with FLT3 mutation, relapsed or refractory"},{"name":"Acute myeloid leukemia (AML) with FLT3 mutation, newly diagnosed (in combination with chemotherapy)"}]},"trialDetails":[{"nctId":"NCT06696183","phase":"PHASE2","title":"Gilteritinib in Combination With Venetoclax and Azacitidine for AML Patients With FLT3 Mutations Ineligible for Intensive Treatment","status":"RECRUITING","sponsor":"Technische Universität Dresden","startDate":"2025-04-25","conditions":"AML - Acute Myeloid Leukemia","enrollment":60}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":6,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"marketed","status":"active","brandName":"Gilteritinib (GILT)","genericName":"Gilteritinib (GILT)","companyName":"Technische Universität Dresden","companyId":"technische-universit-t-dresden","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Gilteritinib is a tyrosine kinase inhibitor that selectively targets FLT3 (FMS-like tyrosine kinase 3) to inhibit proliferation of acute myeloid leukemia cells. Used for Acute myeloid leukemia (AML) with FLT3 mutation, relapsed or refractory, Acute myeloid leukemia (AML) with FLT3 mutation, newly diagnosed (in combination with chemotherapy).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}