{"id":"tas6417","safety":{"commonSideEffects":[{"rate":null,"effect":"Fatigue"},{"rate":null,"effect":"Nausea"},{"rate":null,"effect":"Diarrhea"},{"rate":null,"effect":"Anemia"}]},"_chembl":{"chemblId":"CHEMBL4650281","moleculeType":"Small molecule","molecularWeight":"396.45"},"_dailymed":null,"mechanism":{"_ai_source":"anthropic-haiku","explanation":"TAS6417 selectively inhibits ALK5 (activin receptor-like kinase 5), a key component of TGF-β receptor signaling. By blocking this pathway, the drug aims to reduce TGF-β-mediated immunosuppression in tumors, thereby enhancing anti-tumor immune responses. This mechanism is being explored in combination with checkpoint inhibitors to improve anti-cancer efficacy.","oneSentence":"TAS6417 is a small-molecule inhibitor of TGF-β signaling that blocks the TGF-β receptor pathway to reduce immunosuppression in the tumor microenvironment.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:37:34.260Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Advanced or metastatic solid tumors (in combination with checkpoint inhibitors, Phase 3 development)"}]},"trialDetails":[{"nctId":"NCT05973773","phase":"PHASE3","title":"REZILIENT3 (REsearching ZIpaLertinib In Egfr Non-small Cell Lung Cancer Tumors)","status":"ACTIVE_NOT_RECRUITING","sponsor":"Taiho Oncology, Inc.","startDate":"2023-12-18","conditions":"Advanced or Metastatic NSCLS With Exon 20 Insertion Mutation","enrollment":285},{"nctId":"NCT05967689","phase":"PHASE2","title":"A Study of Zipalertinib in Patients With Advanced Non-Small Cell Lung Cancer With Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertions or Other Uncommon Mutation.","status":"RECRUITING","sponsor":"Taiho Oncology, Inc.","startDate":"2023-07-31","conditions":"Advanced or Metastatic NSCLC Harboring Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertion (ex20ins) Mutations","enrollment":220},{"nctId":"NCT07229339","phase":"PHASE2","title":"Zipalertinib With Carboplatin and Pemetrexed for the Treatment of Resectable, Stage II-IIIB, Non-Small Cell Lung Cancer","status":"NOT_YET_RECRUITING","sponsor":"Jonsson Comprehensive Cancer Center","startDate":"2027-06-01","conditions":"Lung Non-Squamous Non-Small Cell Carcinoma","enrollment":16},{"nctId":"NCT07128199","phase":"PHASE3","title":"A Study to Assess the Efficacy and Safety of Zipalertinib Versus Placebo for Adjuvant Treatment in Participants With Stage IB-IIIA NSCLC With Uncommon EGFR Mutations, Following Complete Tumor Resection","status":"RECRUITING","sponsor":"Taiho Oncology, Inc.","startDate":"2025-12-22","conditions":"NSCLC, Stage IB-IIIA, Lung Cancer, Adjuvant","enrollment":360},{"nctId":"NCT04036682","phase":"PHASE1, PHASE2","title":"A Phase 1/2 Trial of CLN-081 in Patients With Non-Small Cell Lung Cancer","status":"ACTIVE_NOT_RECRUITING","sponsor":"Cullinan Therapeutics Inc.","startDate":"2019-10-31","conditions":"Non Small Cell Lung Cancer, EGFR Exon 20 Mutation","enrollment":284}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":9,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Zipalertinib","CLN-081","zipalertinib"],"phase":"phase_3","status":"active","brandName":"TAS6417","genericName":"TAS6417","companyName":"Taiho Oncology, Inc.","companyId":"taiho-oncology-inc","modality":"Small molecule","firstApprovalDate":"","aiSummary":"TAS6417 is a small-molecule inhibitor of TGF-β signaling that blocks the TGF-β receptor pathway to reduce immunosuppression in the tumor microenvironment. Used for Advanced or metastatic solid tumors (in combination with checkpoint inhibitors, Phase 3 development).","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":1,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}