{"id":"custodiol-n","safety":{"commonSideEffects":[]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Custodiol-N is a histidine-tryptophan-ketoglutarate (HTK) based preservation solution designed to protect donor organs during cold storage before transplantation. It maintains intracellular electrolyte composition, provides metabolic substrates, and buffers against acidosis to minimize reperfusion injury and extend organ preservation time.","oneSentence":"Custodiol-N is an organ preservation solution that maintains cellular viability and reduces ischemic injury during organ transplantation by providing essential electrolytes, substrates, and buffering capacity.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:08:13.101Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Cold preservation of donor organs for transplantation (kidney, liver, heart, pancreas)"}]},"trialDetails":[{"nctId":"NCT07381530","phase":"PHASE2","title":"Study of Cardioplegia in Cardiac Surgery Due to Congenital Heart Malformation in Children","status":"SUSPENDED","sponsor":"Dr. F. Köhler Chemie GmbH","startDate":"2024-12-05","conditions":"Congenital Heart Malformations","enrollment":100},{"nctId":"NCT06032195","phase":"PHASE2","title":"Study of Organ Perfusion in Heart Transplantation in Children","status":"RECRUITING","sponsor":"Dr. F. Köhler Chemie GmbH","startDate":"2023-08-15","conditions":"Heart Transplantation","enrollment":15},{"nctId":"NCT03627013","phase":"PHASE3","title":"Custodiol-N Solution Compared With Custodiol Solution in Organ Transplantation (Kidney, Liver and Pancreas)","status":"RECRUITING","sponsor":"Dr. F. Köhler Chemie GmbH","startDate":"2019-05-23","conditions":"Kidney Failure, Liver Failure, Chronic, Kidney-Pancreas Failure","enrollment":362},{"nctId":"NCT02869022","phase":"PHASE3","title":"Study of Organ Perfusion With Custodiol-N Solution Compared With Custodiol Solution in Heart Transplantation","status":"COMPLETED","sponsor":"Dr. F. Köhler Chemie GmbH","startDate":"2016-07","conditions":"Heart Failure","enrollment":105},{"nctId":"NCT02098772","phase":"PHASE3","title":"Phase III Study Comparing Two Methods of Cardioplegia in Aortic Valve Surgery Custodiol-N Versus Custodiol","status":"COMPLETED","sponsor":"Dr. F. Köhler Chemie GmbH","startDate":"2014-05","conditions":"Aortic Valve Disease, Coronary Artery Disease (CAD)","enrollment":530},{"nctId":"NCT01444235","phase":"PHASE2","title":"Phase III Study Comparing Two Methods of Cardioplegia in Coronary Artery Bypass Surgery","status":"COMPLETED","sponsor":"Dr. F. Köhler Chemie GmbH","startDate":"2011-03","conditions":"Coronary Artery Disease (CAD)","enrollment":102}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":32,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Solution for organ preservation in transplantation"],"phase":"phase_3","status":"active","brandName":"Custodiol-N","genericName":"Custodiol-N","companyName":"Dr. F. Köhler Chemie GmbH","companyId":"dr-f-k-hler-chemie-gmbh","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Custodiol-N is an organ preservation solution that maintains cellular viability and reduces ischemic injury during organ transplantation by providing essential electrolytes, substrates, and buffering capacity. Used for Cold preservation of donor organs for transplantation (kidney, liver, heart, pancreas).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":false,"trials":true,"score":3}}