{"id":"tacrolimus-advagraf-once-daily-formulation","safety":{"commonSideEffects":[{"rate":"20-50","effect":"Tremor"},{"rate":"15-40","effect":"Headache"},{"rate":"30-50","effect":"Hypertension"},{"rate":"25-40","effect":"Nephrotoxicity/elevated creatinine"},{"rate":"15-30","effect":"Hyperglycemia/new-onset diabetes"},{"rate":"20-40","effect":"Infections"},{"rate":"10-20","effect":"Hyperkalemia"},{"rate":"10-20","effect":"Nausea"}]},"_chembl":null,"_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 prevents transcription of IL-2 and other cytokines essential for T-cell proliferation. Advagraf® is a once-daily extended-release formulation designed to improve patient adherence compared to twice-daily immediate-release tacrolimus.","oneSentence":"Tacrolimus inhibits calcineurin phosphatase, blocking T-cell activation and proliferation to suppress immune responses.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T00:10:52.875Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Prophylaxis of organ rejection in adult patients receiving allogeneic kidney, heart, or liver transplants"},{"name":"Rejection prophylaxis in pediatric transplant recipients"}]},"trialDetails":[{"nctId":"NCT01334333","phase":"PHASE4","title":"Comparison of Medication Adherence Between Once and Twice Daily Tacrolimus in Stable Renal Transplant Recipients","status":"COMPLETED","sponsor":"University of British Columbia","startDate":"2011-11-11","conditions":"Renal Disease, Renal Transplant","enrollment":46},{"nctId":"NCT02432833","phase":"PHASE4","title":"Multicentre, Open Label, Randomized, Two-arm, Parallel-group Study to Assess Efficacy and Safety of ENVARSUS® Compared With Tacrolimus Used as Per Current Clinical Practice in the Initial Maintenance Setting in de Novo Kidney Transplant Patients","status":"COMPLETED","sponsor":"Chiesi Farmaceutici S.p.A.","startDate":"2015-05","conditions":"End Stage Renal Disease","enrollment":428},{"nctId":"NCT01702207","phase":"PHASE4","title":"Evaluation Of Switching From Twice Daily Tacrolimus To Once Daily Formulation On Cardiovascular Risk","status":"COMPLETED","sponsor":"University of Saskatchewan","startDate":"2012-10","conditions":"Immunosuppression, Cardiovascular Diseases, Kidney Transplantation","enrollment":36},{"nctId":"NCT01092806","phase":"PHASE4","title":"Insulin Secretion and Advagraf","status":"COMPLETED","sponsor":"University of Oslo School of Pharmacy","startDate":"2009-10","conditions":"Post Transplant Diabetes Mellitus","enrollment":20},{"nctId":"NCT00282243","phase":"PHASE2","title":"A Study to Assess the Pharmacokinetics of a Modified-release Tacrolimus Based Immunosuppression Regimen in Stable Liver Transplant Patients","status":"COMPLETED","sponsor":"Astellas Pharma Inc","startDate":"2003-02","conditions":"Liver Transplantation","enrollment":70}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":22,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Advagraf®"],"phase":"marketed","status":"active","brandName":"Tacrolimus - Advagraf® once daily formulation","genericName":"Tacrolimus - Advagraf® once daily formulation","companyName":"University of British Columbia","companyId":"university-of-british-columbia","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Tacrolimus inhibits calcineurin phosphatase, blocking T-cell activation and proliferation to suppress immune responses. Used for Prophylaxis of organ rejection in adult patients receiving allogeneic kidney, heart, or liver transplants, Rejection prophylaxis in pediatric transplant recipients.","enrichmentLevel":3,"visitCount":2,"trialStats":{"total":1,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}