{"id":"conversion-to-extended-release-tacrolimus","_chembl":{"chemblId":"CHEMBL3989887","moleculeType":"Small molecule","molecularWeight":"822.05"},"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=Conversion to extended-release tacrolimus","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T02:11:52.101755+00:00"},"aiSummary":{"url":"","method":"ai_extraction","source":"AI Strategic Summary","aiModel":"featherless","rawText":"","confidence":0.9,"sourceType":"ai_extraction","retrievedAt":"2026-04-20T02:12:09.428239+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T02:11:59.772100+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=Conversion to extended-release tacrolimus","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T02:12:00.615396+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: FK506-binding protein 1A inhibitor","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T02:12:01.723996+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL3989887/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T02:12:01.623254+00:00"}},"_dailymed":null,"aiSummary":"Conversion to extended-release tacrolimus, marketed by Massachusetts General Hospital, holds a position in the immunosuppressive drug market with a key composition patent expiring in 2028. The drug's key strength lies in its extended-release formulation, which may offer improved patient compliance and reduced dosing frequency compared to immediate-release alternatives. The primary risk is the potential for increased competition as the key patent expires in 2028, potentially leading to generic entry and market share erosion.","_scrapedAt":"2026-03-27T23:43:50.866Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"_validation":{"fieldsValidated":1,"lastValidatedAt":"2026-04-20T02:12:09.428772+00:00","fieldsConflicting":0,"overallConfidence":0.95},"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":"NCT03769298","phase":"PHASE2, PHASE3","title":"CIRTEN-Simultaneous Pancreas-Kidney Transplant Recipients","status":"RECRUITING","sponsor":"University of Wisconsin, Madison","startDate":"2019-02-27","conditions":"Kidney Pancreas Transplantation","enrollment":20},{"nctId":"NCT03410654","phase":"EARLY_PHASE1","title":"Assessment of Cognitive Function Before and After Conversion From Immediate Release Tacrolimus to Envarsus XR.","status":"COMPLETED","sponsor":"Yale University","startDate":"2018-10-24","conditions":"Kidney Transplant; Complications","enrollment":28},{"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":""},{"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":"NCT04420195","phase":"PHASE2","title":"Envarsus XR in Lung Transplant","status":"COMPLETED","sponsor":"NYU Langone Health","startDate":"2020-10-23","conditions":"Lung Transplant","enrollment":41},{"nctId":"NCT04496401","phase":"PHASE4","title":"PK Study in Diabetic Transplant récipients : From Twice-daily Tacrolimus to Once-daily Extended-release Tacrolimus","status":"COMPLETED","sponsor":"Nantes University Hospital","startDate":"2020-09-28","conditions":"Kidney Transplantation, Pancreas Transplantation, Diabetes","enrollment":25},{"nctId":"NCT03762473","phase":"PHASE2","title":"Conversion to Envarsus Post Kidney Transplant Protects Against BK Infection","status":"COMPLETED","sponsor":"University of Alabama at Birmingham","startDate":"2019-05-09","conditions":"Renal Transplant Infection","enrollment":89},{"nctId":"NCT04917718","phase":"PHASE4","title":"Renal Tubular Injury and Transplant Outcomes in Cardiac Recipients Converting From IR Tacrolimus to XR Tacrolimus","status":"UNKNOWN","sponsor":"Loyola University","startDate":"2021-08-16","conditions":"Chronic Kidney Diseases, Heart Transplant","enrollment":42},{"nctId":"NCT01958190","phase":"PHASE4","title":"Study Comparing in Livertransplantation Recipients With Tacrolimus Alone Versus Tacrolimus&Sirolimus","status":"COMPLETED","sponsor":"Foundation for Liver Research","startDate":"2011-02-07","conditions":"Liver Disease","enrollment":196},{"nctId":"NCT03380936","phase":"EARLY_PHASE1","title":"Pilot Study of Treatment for Subclinical AMR (Antibody-mediated Rejection) in Kidney Transplant Recipients","status":"TERMINATED","sponsor":"University of Colorado, Denver","startDate":"2018-01-17","conditions":"Kidney Transplant Rejection","enrollment":4},{"nctId":"NCT03751332","phase":"PHASE4","title":"The Vienna Prograf and Endothelial Progenitor Cell Extension Study","status":"COMPLETED","sponsor":"Medical University of Vienna","startDate":"2008-03","conditions":"Immunosuppression, Renal Failure","enrollment":87},{"nctId":"NCT02545972","phase":"PHASE4","title":"Once-a-day Tacrolimus Conversion Study: The OneTAC Trial","status":"UNKNOWN","sponsor":"Newark Beth Israel Medical Center","startDate":"2016-02","conditions":"Heart Failure","enrollment":100},{"nctId":"NCT01964014","phase":"PHASE4","title":"Once-a-day Immunosuppression(CISECON_a_day)","status":"COMPLETED","sponsor":"Ajou University School of Medicine","startDate":"2013-10","conditions":"Chronic Renal Disease","enrollment":160},{"nctId":"NCT01410162","phase":"PHASE4","title":"Advagraf/Prograf Conversion Trial","status":"COMPLETED","sponsor":"Norman Muirhead","startDate":"2010-12","conditions":"Renal Transplant, Kidney Pancreas Transplant","enrollment":53},{"nctId":"NCT01476488","phase":"PHASE2, PHASE3","title":"Conversion of Prograf to Advagraf in Pediatric Renal Transplant Recipients","status":"COMPLETED","sponsor":"Seoul National University Hospital","startDate":"2011-07","conditions":"Kidney Transplantation, Pediatric Patients, Maintenance With Tacrolimus","enrollment":""},{"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":[],"crossReferences":{"chemblId":"CHEMBL3989887"},"_approvalHistory":[],"publicationCount":39,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Envarsus XR"],"phase":"marketed","status":"active","brandName":"Conversion to extended-release tacrolimus","genericName":"Conversion to extended-release tacrolimus","companyName":"Massachusetts General Hospital","companyId":"massachusetts-general-hospital","modality":"Small molecule","firstApprovalDate":"","enrichmentLevel":3,"visitCount":1,"regulatoryByCountry":[{"country_code":"CA","regulator":"Health Canada","status":"approved","approval_date":null,"mah":"","brand_name_local":"","application_number":""},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null}],"trialStats":{"total":0,"withResults":0},"validation":{"fieldsValidated":1,"lastValidatedAt":"2026-04-20T02:12:09.428772+00:00","fieldsConflicting":0,"overallConfidence":0.95},"verificationStatus":"enriching","dataCompleteness":{"mechanism":false,"indications":false,"safety":false,"trials":true,"score":1}}