{"id":"change-from-prograf-to-envarsus-xr","safety":{"commonSideEffects":[{"rate":null,"effect":"Tremor"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Hypertension"},{"rate":null,"effect":"Nephrotoxicity"},{"rate":null,"effect":"Hyperglycemia"},{"rate":null,"effect":"Infection"},{"rate":null,"effect":"Gastrointestinal disturbances"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Tacrolimus is a calcineurin inhibitor that binds to FKBP12 and blocks calcineurin phosphatase activity, preventing dephosphorylation of NFAT and subsequent T-cell cytokine production. Envarsus XR is a once-daily extended-release formulation designed to improve bioavailability and reduce dosing frequency compared to immediate-release Prograf (tacrolimus), while maintaining immunosuppressive efficacy in transplant recipients.","oneSentence":"Envarsus XR is an extended-release formulation of tacrolimus that suppresses the immune system by inhibiting calcineurin and T-cell activation to prevent organ transplant rejection.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T00:17:53.887Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Prevention of organ rejection in adult kidney transplant recipients"},{"name":"Prevention of organ rejection in adult heart transplant recipients"},{"name":"Prevention of organ rejection in adult liver transplant recipients"}]},"trialDetails":[{"nctId":"NCT06751992","phase":"PHASE4","title":"Neurocognitive Function Changes With Extended-Release Tacrolimus Among Older Kidney Transplant Recipients","status":"RECRUITING","sponsor":"Massachusetts General Hospital","startDate":"2026-03-17","conditions":"Kidney Transplant Recipients, Old Age","enrollment":92},{"nctId":"NCT03841097","phase":"PHASE4","title":"Pulse Wave Velocity, Tacrolimus Time in Therapeutic Range and CV in African American Kidney Transplants","status":"ACTIVE_NOT_RECRUITING","sponsor":"Roy D. Bloom, MD","startDate":"2019-11-11","conditions":"Kidney Transplant; Complications","enrollment":60},{"nctId":"NCT04838288","phase":"PHASE4","title":"Cognitive Outcomes in Stable Renal Transplant Patients Switched FromTacrolimus to Envarsus XR™","status":"ACTIVE_NOT_RECRUITING","sponsor":"Vanderbilt University Medical Center","startDate":"2021-06-22","conditions":"Renal Transplant","enrollment":60},{"nctId":"NCT04711291","phase":"NA","title":"Efficacy of Envarsus XR and Digital Health Technology in Reducing Tacrolimus Fluctuation and Frequency of Dose Changes","status":"WITHDRAWN","sponsor":"Beth Israel Deaconess Medical Center","startDate":"2017-06-01","conditions":"Medication Adherence, Renal Transplant","enrollment":""}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":1,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Change from Tacrolimus to Envarsus XR"],"phase":"marketed","status":"active","brandName":"Change from Prograf to Envarsus XR","genericName":"Change from Prograf to Envarsus XR","companyName":"Vanderbilt University Medical Center","companyId":"vanderbilt-university-medical-center","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Envarsus XR is an extended-release formulation of tacrolimus that suppresses the immune system by inhibiting calcineurin and T-cell activation to prevent organ transplant rejection. Used for Prevention of organ rejection in adult kidney transplant recipients, Prevention of organ rejection in adult heart transplant recipients, Prevention of organ rejection in adult liver transplant recipients.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}