{"id":"fk506mr","safety":{"commonSideEffects":[{"rate":null,"effect":"Nephrotoxicity"},{"rate":null,"effect":"Neurotoxicity"},{"rate":null,"effect":"Hypertension"},{"rate":null,"effect":"Hyperglycemia"},{"rate":null,"effect":"Infections"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Tacrolimus is a calcineurin inhibitor that binds to FKBP12 and blocks the dephosphorylation of NFAT, preventing T-cell proliferation and cytokine production. The modified-release (MR) formulation provides sustained drug exposure with potentially improved tolerability and reduced dosing frequency compared to immediate-release tacrolimus. This mechanism makes it suitable for immunosuppression in transplantation and autoimmune conditions.","oneSentence":"FK506MR is a modified-release formulation of tacrolimus that suppresses T-cell activation by inhibiting calcineurin phosphatase.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:12:41.684Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Organ transplant rejection prevention"},{"name":"Autoimmune and inflammatory conditions"}]},"trialDetails":[{"nctId":"NCT00459719","phase":"PHASE3","title":"A Study to Compare the Efficacy and Safety of FK506MR vs Prograf® in Patients Undergoing Liver Transplantation","status":"COMPLETED","sponsor":"Astellas Pharma Inc","startDate":"2007-03","conditions":"Liver Transplantation","enrollment":42},{"nctId":"NCT00619398","phase":"PHASE3","title":"A Study to Evaluate and Compare the Efficacy and Safety of FK506MR vs Prograf® in Stable Liver Transplantation Patients","status":"COMPLETED","sponsor":"Astellas Pharma Inc","startDate":"2008-01","conditions":"Liver Transplantation","enrollment":172},{"nctId":"NCT00481819","phase":"PHASE3","title":"A Study to Compare the Efficacy and Safety of FK506MR vs Prograf® in Patients Undergoing Kidney Transplantation","status":"COMPLETED","sponsor":"Astellas Pharma Inc","startDate":"2007-07","conditions":"Kidney Transplantation","enrollment":240},{"nctId":"NCT00481481","phase":"PHASE3","title":"Conversion Study From Cyclosporine to FK506MR Based Immunosuppression in Kidney Transplant Subjects","status":"COMPLETED","sponsor":"Astellas Pharma Inc","startDate":"2007-04","conditions":"Transplantation","enrollment":346},{"nctId":"NCT00719745","phase":"PHASE3","title":"A Study to Assess the Safety and Efficacy of Prograf and MR4 in Liver Transplant Recipients","status":"COMPLETED","sponsor":"Astellas Pharma Inc","startDate":"2006-02","conditions":"Liver Transplantation","enrollment":74},{"nctId":"NCT00720265","phase":"PHASE3","title":"A Study to Assess the Safety and Efficacy of Prograf and MR4 in Kidney Transplantation Patients","status":"COMPLETED","sponsor":"Astellas Pharma Inc","startDate":"2006-02","conditions":"Kidney Transplantation","enrollment":135}],"_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":["Advagraf","Tacrolimus modified-release","MR4","tacrolimus modified release capsule","Prograf XL"],"phase":"phase_3","status":"active","brandName":"FK506MR","genericName":"FK506MR","companyName":"Astellas Pharma Inc","companyId":"astellas-pharma-inc","modality":"Small molecule","firstApprovalDate":"","aiSummary":"FK506MR is a modified-release formulation of tacrolimus that suppresses T-cell activation by inhibiting calcineurin phosphatase. Used for Organ transplant rejection prevention, Autoimmune and inflammatory conditions.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}