{"id":"branded-tacrolimus","safety":{"commonSideEffects":[{"rate":"10-50","effect":"Nephrotoxicity/renal impairment"},{"rate":"30-50","effect":"Hypertension"},{"rate":"10-30","effect":"Hyperglycemia/new-onset diabetes"},{"rate":"10-25","effect":"Neurotoxicity (tremor, headache, paresthesia)"},{"rate":"20-40","effect":"Infection"},{"rate":"10-20","effect":"Hyperkalemia"},{"rate":"5-15","effect":"Gastrointestinal disturbances"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Tacrolimus binds to the immunophilin FKBP12, and this complex inhibits calcineurin phosphatase activity. By blocking calcineurin, it prevents dephosphorylation and nuclear translocation of NFAT (nuclear factor of activated T cells), thereby suppressing the transcription of IL-2 and other pro-inflammatory cytokines essential for T-cell activation and proliferation. This potent immunosuppression makes it effective in preventing organ rejection and treating autoimmune conditions.","oneSentence":"Tacrolimus is a calcineurin inhibitor that suppresses T-cell activation by blocking the phosphatase calcineurin, preventing IL-2 production and T-cell proliferation.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T00:22:17.955Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Prevention of organ rejection in transplant recipients (kidney, heart, liver, pancreas)"},{"name":"Atopic dermatitis"},{"name":"Severe rheumatoid arthritis"},{"name":"Autoimmune uveitis"}]},"trialDetails":[{"nctId":"NCT03978494","phase":"PHASE1","title":"Study to Compare Pharmacokinetics of Tacrolimus Prolonged-release (PR) Capsules and Advagraf® PR Capsules in Stable Kidney Transplant Patients.","status":"WITHDRAWN","sponsor":"Sandoz","startDate":"2019-09-02","conditions":"Kidney Transplant","enrollment":""},{"nctId":"NCT01256294","phase":"PHASE4","title":"Pharmacokinetics of Generic to Brand Tacrolimus in Stable Renal Transplant Patients","status":"COMPLETED","sponsor":"Novartis","startDate":"2010-10","conditions":"Renal Transplant","enrollment":71}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":4,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Prograf"],"phase":"marketed","status":"active","brandName":"Branded Tacrolimus","genericName":"Branded Tacrolimus","companyName":"Novartis","companyId":"novartis","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Tacrolimus is a calcineurin inhibitor that suppresses T-cell activation by blocking the phosphatase calcineurin, preventing IL-2 production and T-cell proliferation. Used for Prevention of organ rejection in transplant recipients (kidney, heart, liver, pancreas), Atopic dermatitis, Severe rheumatoid arthritis.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}