{"id":"sunitinib-malate-capsules-reference-product","safety":{"commonSideEffects":["Fatigue","Diarrhea","Nausea","Hypertension","Hand-foot syndrome","Decreased appetite","Mucositis"]},"_chembl":null,"modality":"Small molecule","_dailymed":null,"mechanism":{"target":"VEGFR, PDGFR, KIT, FLT3, RET","explanation":"Sunitinib inhibits multiple receptor tyrosine kinases including vascular endothelial growth factor receptors (VEGFR1-3), platelet-derived growth factor receptors (PDGFR-α and PDGFR-β), KIT, FLT3, and RET. By blocking these pathways, it inhibits tumor angiogenesis and directly suppresses tumor cell proliferation.","oneSentence":"Multi-targeted receptor tyrosine kinase inhibitor that blocks VEGFR, PDGFR, KIT, FLT3, and RET signaling pathways involved in tumor growth and angiogenesis."},"_scrapedAt":"2026-03-28T04:46:37.880Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"_claudeStub":{"ts":1779123033,"model":"claude-sonnet-4-5-20250929"},"competitors":[{"name":"Pazopanib","brand":"Votrient","company":"Novartis","rationale":"Multi-kinase inhibitor for advanced RCC"},{"name":"Cabozantinib","brand":"Cabometyx","company":"Exelixis","rationale":"Multi-kinase inhibitor for advanced RCC and other solid tumors"},{"name":"Regorafenib","brand":"Stivarga","company":"Bayer","rationale":"Multi-kinase inhibitor for GIST after imatinib and sunitinib failure"}],"description":"Sunitinib malate capsules reference product is being developed by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. as a generic or biosimilar version of the multi-targeted receptor tyrosine kinase inhibitor used in oncology. Currently in Phase 1 development, it targets multiple pathways involved in tumor growth and angiogenesis.","indications":{"approved":[{"status":"investigational","condition":"Gastrointestinal stromal tumor (GIST)","patientPopulation":"Adults with disease progression on or intolerance to imatinib"},{"status":"investigational","condition":"Renal cell carcinoma (RCC)","patientPopulation":"Adults with advanced disease"},{"status":"investigational","condition":"Pancreatic neuroendocrine tumors (pNET)","patientPopulation":"Adults with progressive, well-differentiated disease"}]},"trialDetails":[{"nctId":"NCT05800106","phase":"PHASE1","title":"A Bioequivalence Study of Sunitinib Malate Capsules.","status":"COMPLETED","sponsor":"Chia Tai Tianqing Pharmaceutical Group Co., Ltd.","startDate":"2018-12-04","conditions":"Gastrointestinal Stromal Tumors, Renal Cell Carcinoma, Pancreatic Neuroendocrine Tumor","enrollment":24},{"nctId":"NCT05218616","phase":"PHASE1","title":"The Bioequivalence Study of Two Sunitinib Products in Capsules 50 mg in Healthy Volunteers Under Fasting Conditions","status":"UNKNOWN","sponsor":"JLLC NatiVita","startDate":"2022-01-21","conditions":"Bioequivalence","enrollment":22}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":0,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"phase_1","status":"active","brandName":"Sunitinib malate capsules reference product","genericName":"Sunitinib malate capsules reference product","companyName":"Chia Tai Tianqing Pharmaceutical Group Co., Ltd.","companyId":"chia-tai-tianqing-pharmaceutical-group-co-ltd","firstApprovalDate":"","aiSummary":"Sunitinib malate capsules are a small molecule used to treat conditions such as gastrointestinal stromal tumors, renal cell carcinoma, and pancreatic neuroendocrine tumors. The bioequivalence of sunitinib malate capsules has been studied in a clinical trial, comparing them to the reference product Sutent.","enrichmentLevel":3,"visitCount":2,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}