{"id":"fyu-981","safety":{"commonSideEffects":[]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Limited publicly available information exists regarding the specific mechanism of action for FYU-981. As a phase 3 candidate from Fuji Yakuhin, it represents an advanced-stage investigational compound, but detailed mechanistic data has not been widely disclosed in accessible literature.","oneSentence":"FYU-981 is an investigational therapeutic agent in phase 3 development by Fuji Yakuhin Co., Ltd.","_ai_confidence":"low"},"_scrapedAt":"2026-03-28T00:47:06.026Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[]},"trialDetails":[{"nctId":"NCT05007392","phase":"PHASE3","title":"A Study to Evaluate Efficacy of Dotinurad and Febuxostat for the Treatment of Participants With Gout","status":"COMPLETED","sponsor":"Eisai Co., Ltd.","startDate":"2021-12-21","conditions":"Gout","enrollment":451},{"nctId":"NCT05278676","phase":"PHASE1","title":"A Single and Multiple Dose Study of Dotinurad in Chinese Healthy Participants","status":"COMPLETED","sponsor":"Eisai Co., Ltd.","startDate":"2022-07-01","conditions":"Healthy Volunteers","enrollment":26},{"nctId":"NCT03350386","phase":"PHASE1","title":"Drug-drug Interaction Study of FYU-981 and Oxaprozin","status":"COMPLETED","sponsor":"Mochida Pharmaceutical Company, Ltd.","startDate":"2017-11-02","conditions":"Healthy","enrollment":12},{"nctId":"NCT03006445","phase":"PHASE3","title":"Study of FYU-981 in Hyperuricemia With or Without Gout","status":"COMPLETED","sponsor":"Fuji Yakuhin Co., Ltd.","startDate":"2016-12","conditions":"Hyperuricemia With or Without Gout","enrollment":330},{"nctId":"NCT03100318","phase":"PHASE3","title":"Benzbromarone-Controlled, Double-Blind, Comparative Study of FYU-981 in Hyperuricemia With or Without Gout","status":"COMPLETED","sponsor":"Fuji Yakuhin Co., Ltd.","startDate":"2017-04-01","conditions":"Hyperuricemia With or Without Gout","enrollment":201},{"nctId":"NCT03372200","phase":"PHASE3","title":"Febuxostat-Controlled, Double-Blind, Comparative Study of FYU-981 in Hyperuricemia With or Without Gout","status":"COMPLETED","sponsor":"Mochida Pharmaceutical Company, Ltd.","startDate":"2018-01-09","conditions":"Hyperuricemia With or Without Gout","enrollment":203},{"nctId":"NCT03375632","phase":"PHASE1","title":"Study of FYU-981 in Hyperuricemic Outpatients With or Without Gout (Effect on Two Hyperuricemic Types)","status":"COMPLETED","sponsor":"Mochida Pharmaceutical Company, Ltd.","startDate":"2018-01-04","conditions":"Hyperuricemia With or Without Gout","enrollment":26},{"nctId":"NCT03306667","phase":"PHASE1","title":"Clinical Pharmacology of FYU-981 (Subjects With Hepatic Insufficiency)","status":"COMPLETED","sponsor":"Mochida Pharmaceutical Company, Ltd.","startDate":"2017-10-06","conditions":"Hepatic Insufficiency, Healthy","enrollment":24},{"nctId":"NCT02901366","phase":"PHASE2","title":"Mass Balance Study of FYU-981","status":"COMPLETED","sponsor":"Fuji Yakuhin Co., Ltd.","startDate":"2016-09","conditions":"Healthy Male Subjects","enrollment":6},{"nctId":"NCT02837198","phase":"PHASE2","title":"Study of FYU-981 in Hyperuricemia (Effect on Two Hyperuricemic Types)","status":"COMPLETED","sponsor":"Fuji Yakuhin Co., Ltd.","startDate":"2016-07","conditions":"Hyperuricemia","enrollment":24},{"nctId":"NCT03350373","phase":"PHASE1","title":"Clinical Pharmacology of FYU-981 (Final Formulation)","status":"COMPLETED","sponsor":"Mochida Pharmaceutical Company, Ltd.","startDate":"2017-11-06","conditions":"Healthy","enrollment":12},{"nctId":"NCT02515864","phase":"PHASE2","title":"Clinical Pharmacology of FYU-981 (Effect on QT/QTc Interval)","status":"COMPLETED","sponsor":"Fuji Yakuhin Co., Ltd.","startDate":"2015-08","conditions":"Healthy","enrollment":48},{"nctId":"NCT02416167","phase":"PHASE2","title":"Study of FYU-981 in Hyperuricemia With or Without Gout","status":"COMPLETED","sponsor":"Fuji Yakuhin Co., Ltd.","startDate":"2015-05","conditions":"Hyperuricemia","enrollment":200},{"nctId":"NCT02347046","phase":"PHASE1","title":"Clinical Pharmacology of FYU-981 (Subjects With Renal Insufficiency)","status":"COMPLETED","sponsor":"Fuji Yakuhin Co., Ltd.","startDate":"2015-01","conditions":"Renal Insufficiency, Healthy","enrollment":18},{"nctId":"NCT02348307","phase":"PHASE1","title":"Single Dose Phase I Study of FYU-981","status":"COMPLETED","sponsor":"Fuji Yakuhin Co., Ltd.","startDate":"2013-03","conditions":"Healthy","enrollment":54},{"nctId":"NCT02348333","phase":"PHASE1","title":"Repeated Dose Phase I Study of FYU-981","status":"COMPLETED","sponsor":"Fuji Yakuhin Co., Ltd.","startDate":"2013-09","conditions":"Healthy","enrollment":18},{"nctId":"NCT02344875","phase":"PHASE1","title":"Clinical Pharmacology of FYU-981 (Elder Subjects)","status":"COMPLETED","sponsor":"Fuji Yakuhin Co., Ltd.","startDate":"2014-05","conditions":"Healthy","enrollment":24},{"nctId":"NCT02344862","phase":"PHASE2","title":"Study of FYU-981 in Hyperuricemia With or Without Gout","status":"COMPLETED","sponsor":"Fuji Yakuhin Co., Ltd.","startDate":"2014-01","conditions":"Hyperuricemia","enrollment":80}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":12,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Final formulation of FYU-981"],"phase":"phase_3","status":"active","brandName":"FYU-981","genericName":"FYU-981","companyName":"Fuji Yakuhin Co., Ltd.","companyId":"fuji-yakuhin-co-ltd","modality":"Small molecule","firstApprovalDate":"","aiSummary":"","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":6,"withResults":0},"verificationStatus":"partial","dataCompleteness":{"mechanism":true,"indications":false,"safety":false,"trials":true,"score":2}}