{"id":"tacrolimus-prograf-twice-daily-formulation","safety":{"commonSideEffects":[{"rate":"20-40","effect":"Nephrotoxicity"},{"rate":"30-50","effect":"Hypertension"},{"rate":"15-30","effect":"Hyperglycemia/new-onset diabetes"},{"rate":"10-25","effect":"Neurotoxicity (tremor, headache)"},{"rate":"20-40","effect":"Infection"},{"rate":"10-20","effect":"Hyperkalemia"},{"rate":"5-15","effect":"Gum hyperplasia"}]},"_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 serine/threonine phosphatase critical for dephosphorylating NFAT (nuclear factor of activated T cells). By preventing NFAT translocation to the nucleus, tacrolimus blocks the transcription of IL-2 and other cytokines essential for T-cell proliferation and immune activation. This potent immunosuppressive effect makes it valuable in transplantation and autoimmune conditions.","oneSentence":"Tacrolimus inhibits calcineurin phosphatase, blocking T-cell activation and proliferation to suppress the immune response.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T00:10:43.525Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Organ transplant rejection prophylaxis (kidney, heart, liver, pancreas)"},{"name":"Atopic dermatitis"},{"name":"Autoimmune conditions (off-label use in various settings)"}]},"trialDetails":[{"nctId":"NCT03656926","phase":"PHASE3","title":"Efficacy + Safety of Liposome Cyclosporine A to Treat Bronchiolitis Obliterans Post Double Lung Transplant (BOSTON-2)","status":"COMPLETED","sponsor":"Zambon SpA","startDate":"2019-03-26","conditions":"Bronchiolitis Obliterans, Chronic Rejection of Lung Transplant, Lung Transplant Rejection","enrollment":169},{"nctId":"NCT03657342","phase":"PHASE3","title":"Efficacy + Safety of Liposome Cyclosporine A to Treat Bronchiolitis Obliterans Post Single Lung Transplant (BOSTON-1)","status":"COMPLETED","sponsor":"Zambon SpA","startDate":"2019-03-26","conditions":"Bronchiolitis Obliterans, Chronic Rejection of Lung Transplant, Lung Transplant Rejection","enrollment":62},{"nctId":"NCT06960824","phase":"","title":"Real-word Study of the de NOVO Extended-release tacrolimuS in Kidney Transplantation Using an ARTificial Intelligence","status":"NOT_YET_RECRUITING","sponsor":"Chiesi SAS","startDate":"2025-05","conditions":"Chronic Renal Disease","enrollment":165},{"nctId":"NCT05396898","phase":"PHASE4","title":"Tacrolimus Formulation and Glucose Metabolism After Kidney Transplantation (TAGLUMET Trial)","status":"COMPLETED","sponsor":"University Hospital Tuebingen","startDate":"2020-12-16","conditions":"Posttransplant Diabetes Mellitus","enrollment":44},{"nctId":"NCT03266393","phase":"PHASE4","title":"Envarsus XR® in Adolescent Renal Transplant Recipients","status":"ACTIVE_NOT_RECRUITING","sponsor":"University of California, Los Angeles","startDate":"2019-01-15","conditions":"Kidney Transplantation, Renal Transplantation, Grafting, Kidney","enrollment":28},{"nctId":"NCT03152019","phase":"PHASE2","title":"Efficacy and Safety of a 0.1% Tacrolimus Nasal Ointment as a Treatment for Epistaxis in Hemorrhagic Hereditary Telangiectasia (HHT)","status":"COMPLETED","sponsor":"Hospices Civils de Lyon","startDate":"2017-05-22","conditions":"Hemorrhagic Hereditary Telangiectasia (HHT)","enrollment":50},{"nctId":"NCT02961608","phase":"PHASE4","title":"Conversion Pharmacodynamic Study in Stable Renal Transplant Patients Receiving Tacrolimus Two Times a Day to a New Formulation of Tacrolimus - LCP Tacro - 1 Time a Day.","status":"COMPLETED","sponsor":"Hospital Universitari de Bellvitge","startDate":"2016-05","conditions":"Kidney Transplant; Complications","enrollment":25},{"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":28,"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":"Tacrolimus - Prograf® twice daily formulation","genericName":"Tacrolimus - Prograf® twice 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 the immune response. Used for Organ transplant rejection prophylaxis (kidney, heart, liver, pancreas), Atopic dermatitis, Autoimmune conditions (off-label use in various settings).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}