{"id":"tacrolimus-sustained-release-capsule","safety":{"commonSideEffects":[{"rate":"10-30","effect":"Nephrotoxicity (renal dysfunction)"},{"rate":"20-40","effect":"Hypertension"},{"rate":"10-25","effect":"Hyperglycemia/new-onset diabetes"},{"rate":"10-20","effect":"Neurotoxicity (tremor, headache)"},{"rate":"15-30","effect":"Infections"},{"rate":"5-15","effect":"Hyperkalemia"},{"rate":"5-15","effect":"Gastrointestinal disturbances"}]},"_chembl":{"chemblId":"CHEMBL3989887","moleculeType":"Small molecule","molecularWeight":"822.05"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Tacrolimus binds to the immunophilin FKBP12, and this complex inhibits calcineurin, a key phosphatase required for dephosphorylation and nuclear translocation of NFAT (nuclear factor of activated T cells). This blocks the transcription of IL-2 and other cytokines essential for T-cell proliferation and immune response. The sustained-release formulation provides prolonged drug exposure with potentially improved tolerability and more stable immunosuppression compared to immediate-release formulations.","oneSentence":"Tacrolimus inhibits calcineurin phosphatase, suppressing T-cell activation and proliferation to prevent organ rejection and treat autoimmune conditions.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T00:10:45.723Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Prophylaxis of organ rejection in allogeneic kidney, heart, and liver transplant recipients"},{"name":"Atopic dermatitis (eczema)"},{"name":"Autoimmune conditions requiring immunosuppression"}]},"trialDetails":[{"nctId":"NCT06183892","phase":"NA","title":"Prospective, Multicenter Clinical Study of Prolonged-release Tacrolimus in Stable Pediatric Liver Transplant Recipients","status":"RECRUITING","sponsor":"RenJi Hospital","startDate":"2024-03-04","conditions":"Liver Transplant","enrollment":80},{"nctId":"NCT02706678","phase":"PHASE4","title":"Efficacy and Safety Study of the Switch From Cyclosporin to Tacrolimus in Renal Transplant Recipients","status":"COMPLETED","sponsor":"Astellas Pharma China, Inc.","startDate":"2010-12-29","conditions":"Renal Transplant Recipients","enrollment":105},{"nctId":"NCT06147648","phase":"PHASE4","title":"Early Conversion of Prolonged-release Tacrolimus in Liver Transplantation.","status":"NOT_YET_RECRUITING","sponsor":"Beijing Tsinghua Chang Gung Hospital","startDate":"2023-12-01","conditions":"Liver Transplantation","enrollment":352},{"nctId":"NCT01288664","phase":"PHASE3","title":"Efficacy and Safety of Tacrolimus Sustained-release Capsules in Induction Phase Treatment in Lupus Nephritis","status":"WITHDRAWN","sponsor":"Sun Yat-sen University","startDate":"2011-01","conditions":"Lupus Nephritis","enrollment":""},{"nctId":"NCT01328834","phase":"PHASE3","title":"Efficacy and Safety of Tacrolimus Sustained-release Capsules in Induction Treatment in Refractory Lupus Nephritis","status":"COMPLETED","sponsor":"Sun Yat-sen University","startDate":"2011-01","conditions":"Nephritis, Lupus","enrollment":20},{"nctId":"NCT01309477","phase":"PHASE3","title":"The Efficacy and Tolerance of Tacrolimus Sustained-release Capsules on Refractory Nephrotic Syndrome (RNS)","status":"COMPLETED","sponsor":"Sun Yat-sen University","startDate":"2011-01","conditions":"Nephrotic Syndrome","enrollment":20}],"_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":["FK506"],"phase":"marketed","status":"active","brandName":"Tacrolimus sustained-release capsule","genericName":"Tacrolimus sustained-release capsule","companyName":"Astellas Pharma China, Inc.","companyId":"astellas-pharma-china-inc","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Tacrolimus sustained-release capsule is used to treat conditions such as renal transplant rejection, liver transplant rejection, and nephrotic syndrome. It works by inhibiting calcineurin, a protein involved in the activation of T-lymphocytes, according to its mechanism of action as recorded in ChEMBL.","enrichmentLevel":3,"visitCount":2,"trialStats":{"total":1,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}