{"id":"hmpl-306","safety":{"commonSideEffects":[{"rate":null,"effect":"Hyperphosphatemia"},{"rate":null,"effect":"Diarrhea"},{"rate":null,"effect":"Fatigue"},{"rate":null,"effect":"Nausea"},{"rate":null,"effect":"Stomatitis"}]},"_chembl":{"chemblId":"CHEMBL4650297","moleculeType":"Unknown"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"HMPL-306 selectively targets FGFR kinases, which are frequently dysregulated in various solid tumors through mutations, amplifications, or translocations. By inhibiting FGFR-mediated signaling pathways, the drug suppresses tumor cell proliferation and survival in FGFR-dependent cancers. This mechanism is particularly relevant in tumors with FGFR alterations where the pathway drives oncogenic growth.","oneSentence":"HMPL-306 is a selective inhibitor of fibroblast growth factor receptor (FGFR) that blocks aberrant FGFR signaling in cancer cells.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T00:44:43.807Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Cholangiocarcinoma with FGFR2 fusion or rearrangement"},{"name":"Other FGFR-altered solid tumors"}]},"trialDetails":[{"nctId":"NCT04762602","phase":"PHASE1","title":"A Study of HMPL-306 in Advanced Solid Tumors With IDH Mutations","status":"TERMINATED","sponsor":"Hutchmed","startDate":"2021-02-28","conditions":"Isocitrate Dehydrogenase Gene Mutation","enrollment":42},{"nctId":"NCT04764474","phase":"PHASE1","title":"A Study of HMPL-306 in Advanced Hematological Malignancies With mIDH","status":"TERMINATED","sponsor":"Hutchmed","startDate":"2021-04-12","conditions":"Isocitrate Dehydrogenase Gene Mutation","enrollment":46},{"nctId":"NCT06387069","phase":"PHASE3","title":"A Study to Evaluate HMPL-306 in Patients With IDH1or IDH2-mutated Acute Myeloid Leukemia","status":"RECRUITING","sponsor":"Hutchmed","startDate":"2024-04-26","conditions":"Acute Myeloid Leukemia","enrollment":316},{"nctId":"NCT07025018","phase":"PHASE1","title":"Phase I Study of HMPL-306 for the Treatment of Gliomas With IDH1 and/or IDH2 Mutations","status":"RECRUITING","sponsor":"Hutchmed","startDate":"2025-07-15","conditions":"Gliomas Harboring IDH1 and/or IDH2 Mutations","enrollment":52},{"nctId":"NCT06671873","phase":"PHASE1","title":"Study on Mass Balance of [14C]HMPL-306（Isocitrate Dehydrogenase Inhibitor） in Healthy Chinese Adult Male Subjects","status":"COMPLETED","sponsor":"Hutchmed","startDate":"2024-11-26","conditions":"Mass Balance Study","enrollment":6},{"nctId":"NCT04272957","phase":"PHASE1","title":"A Study of HMPL-306 in Patients With IDH1 and/or IDH2 Mutation of Relapsed/Refractory Myeloid Leukemia/Neoplasms","status":"UNKNOWN","sponsor":"Hutchison Medipharma Limited","startDate":"2020-05-14","conditions":"Acute Myeloid Leukemia","enrollment":75}],"_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":"HMPL-306","genericName":"HMPL-306","companyName":"Hutchison Medipharma Limited","companyId":"hutchison-medipharma-limited","modality":"Small molecule","firstApprovalDate":"","aiSummary":"HMPL-306 is a selective inhibitor of fibroblast growth factor receptor (FGFR) that blocks aberrant FGFR signaling in cancer cells. Used for Cholangiocarcinoma with FGFR2 fusion or rearrangement, Other FGFR-altered solid tumors.","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":3,"withResults":2},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}