{"id":"bpi-16350","safety":{"commonSideEffects":[{"rate":null,"effect":"Hyperphosphatemia"},{"rate":null,"effect":"Diarrhea"},{"rate":null,"effect":"Fatigue"},{"rate":null,"effect":"Nausea"},{"rate":null,"effect":"Stomatitis"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"BPI-16350 targets FGFR mutations and fusions that drive proliferation in certain solid tumors. By inhibiting FGFR kinase activity, the drug suppresses downstream signaling pathways critical for tumor cell survival and growth. This mechanism is particularly relevant in cancers with FGFR alterations, including cholangiocarcinoma and other FGFR-driven malignancies.","oneSentence":"BPI-16350 is a selective inhibitor of fibroblast growth factor receptor (FGFR) that blocks aberrant FGFR signaling in cancer cells.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:42:13.221Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Cholangiocarcinoma with FGFR2 fusion or rearrangement"},{"name":"Other FGFR-altered solid tumors"}]},"trialDetails":[{"nctId":"NCT03791112","phase":"PHASE1","title":"A Phase I Study of BPI-16350 in Patients with Advanced Solid Tumor","status":"ACTIVE_NOT_RECRUITING","sponsor":"Betta Pharmaceuticals Co., Ltd.","startDate":"2019-07-18","conditions":"Advanced Solid Cancer","enrollment":54},{"nctId":"NCT05433480","phase":"PHASE3","title":"A Study of BPI-16350 in Combination With Fulvestrant in Patients With HR+ and HER2- Locally Advanced, Recurrent or Metastatic Breast Cancer","status":"UNKNOWN","sponsor":"Betta Pharmaceuticals Co., Ltd.","startDate":"2022-05-25","conditions":"Breast Cancer","enrollment":274},{"nctId":"NCT05316259","phase":"PHASE1","title":"A Food-Effect Study of BPI-16350 in Healthy Subjects","status":"COMPLETED","sponsor":"Betta Pharmaceuticals Co., Ltd.","startDate":"2022-04-15","conditions":"Healthy","enrollment":24}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":2,"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":"BPI-16350","genericName":"BPI-16350","companyName":"Betta Pharmaceuticals Co., Ltd.","companyId":"betta-pharmaceuticals-co-ltd","modality":"Small molecule","firstApprovalDate":"","aiSummary":"BPI-16350 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":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}