{"id":"ranirestat-as-3201","safety":{"commonSideEffects":[{"rate":null,"effect":"Hepatotoxicity / elevated liver enzymes"},{"rate":null,"effect":"Gastrointestinal disturbances"},{"rate":null,"effect":"Rash / dermatological reactions"}]},"_chembl":{"chemblId":"CHEMBL334830","moleculeType":"Small molecule","molecularWeight":"420.19"},"_dailymed":null,"mechanism":{"_ai_source":"anthropic-haiku","explanation":"Ranirestat is an aldose reductase inhibitor that blocks the conversion of glucose to sorbitol via the polyol pathway. By reducing sorbitol accumulation in tissues, it aims to prevent or slow the progression of diabetic microvascular complications such as peripheral neuropathy, retinopathy, and nephropathy. This mechanism addresses a key metabolic pathway implicated in diabetes-related tissue damage.","oneSentence":"Ranirestat inhibits aldose reductase, the first enzyme in the polyol pathway, to reduce sorbitol accumulation and prevent diabetic complications.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:31:15.282Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Diabetic peripheral neuropathy"},{"name":"Diabetic complications (retinopathy, nephropathy)"}]},"trialDetails":[{"nctId":"NCT00927914","phase":"PHASE2, PHASE3","title":"Evaluating the Efficacy and Safety of Oral Ranirestat (40 and 80 mg) in Mild to Moderate Diabetic Sensorimotor Polyneuropathy","status":"COMPLETED","sponsor":"Eisai Inc.","startDate":"2009-07","conditions":"Mild to Moderate Diabetic Sensorimotor Polyneuropathy","enrollment":800},{"nctId":"NCT00101426","phase":"PHASE3","title":"Safety and Efficacy of AS-3201 in the Treatment of Diabetic Sensorimotor Polyneuropathy","status":"COMPLETED","sponsor":"Sumitomo Pharma Co., Ltd.","startDate":"2004-10","conditions":"Diabetic Neuropathy","enrollment":500}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":1,"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":"ranirestat, (AS-3201)","genericName":"ranirestat, (AS-3201)","companyName":"Sumitomo Pharma Co., Ltd.","companyId":"sumitomo-pharma-co-ltd","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Ranirestat inhibits aldose reductase, the first enzyme in the polyol pathway, to reduce sorbitol accumulation and prevent diabetic complications. Used for Diabetic peripheral neuropathy, Diabetic complications (retinopathy, nephropathy).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}