{"id":"ki1001","safety":{"commonSideEffects":[]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"KI1001 appears to be a cell-based or tissue engineering approach targeting corneal endothelial dysfunction, which is responsible for corneal edema and vision loss in conditions like Fuchs endothelial corneal dystrophy. By restoring endothelial cell integrity and pump function, the therapy aims to restore corneal clarity and improve visual acuity.","oneSentence":"KI1001 is a regenerative medicine therapy designed to restore corneal endothelial cell function and transparency in corneal diseases.","_ai_confidence":"low"},"_scrapedAt":"2026-03-28T01:17:52.244Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Fuchs endothelial corneal dystrophy"},{"name":"Corneal endothelial dysfunction"}]},"trialDetails":[{"nctId":"NCT02087722","phase":"PHASE3","title":"Efficacy and Safety of KI1001 in the Treatment of ≥ 55 Years Old Insomnia Patients","status":"COMPLETED","sponsor":"Kuhnil Pharmaceutical Co., Ltd.","startDate":"2013-08","conditions":"Sleep Initiation and Maintenance Disorders","enrollment":80},{"nctId":"NCT01450228","phase":"PHASE3","title":"Efficacy and Safety of KI1001 in ≥ 55 Years Old Insomnia Patients","status":"COMPLETED","sponsor":"Kuhnil Pharmaceutical Co., Ltd.","startDate":"2011-03","conditions":"Sleep Initiation and Maintenance Disorders","enrollment":170}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":0,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Prolonged release melatonin 2mg"],"phase":"phase_3","status":"active","brandName":"KI1001","genericName":"KI1001","companyName":"Kuhnil Pharmaceutical Co., Ltd.","companyId":"kuhnil-pharmaceutical-co-ltd","modality":"Small molecule","firstApprovalDate":"","aiSummary":"KI1001 is a regenerative medicine therapy designed to restore corneal endothelial cell function and transparency in corneal diseases. Used for Fuchs endothelial corneal dystrophy, Corneal endothelial dysfunction.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":false,"trials":true,"score":3}}