{"id":"very-low-tacrolimus","safety":{"commonSideEffects":[{"rate":null,"effect":"Nephrotoxicity / renal impairment"},{"rate":null,"effect":"Neurotoxicity (tremor, headache, confusion)"},{"rate":null,"effect":"Hyperglycemia / new-onset diabetes"},{"rate":null,"effect":"Hypertension"},{"rate":null,"effect":"Infection"},{"rate":null,"effect":"Hyperkalemia"}]},"_chembl":{"chemblId":"CHEMBL3989887","moleculeType":"Small molecule","molecularWeight":"822.05"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Tacrolimus is a calcineurin inhibitor that blocks the dephosphorylation of nuclear factor of activated T cells (NFAT), preventing T-cell proliferation and cytokine production. The 'Very Low' designation indicates a dosing strategy or formulation designed to achieve therapeutic immunosuppression at lower systemic exposures, potentially reducing nephrotoxicity, neurotoxicity, and metabolic complications associated with standard tacrolimus dosing. This approach is used in solid organ transplantation to balance rejection prevention with tolerability.","oneSentence":"Very Low Tacrolimus is a reduced-dose formulation of tacrolimus that suppresses T-cell activation by inhibiting calcineurin, thereby reducing transplant rejection while minimizing immunosuppressive toxicity.","_ai_confidence":"low"},"_scrapedAt":"2026-03-27T23:38:49.766Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Prevention of organ rejection in solid organ transplant recipients (kidney, heart, liver, pancreas)"}]},"trialDetails":[{"nctId":"NCT01810588","phase":"PHASE2","title":"Targeting the IPA and Matching for the Non-Inherited Maternal Antigen for Haplo-Cord Transplantation","status":"ACTIVE_NOT_RECRUITING","sponsor":"Weill Medical College of Cornell University","startDate":"2012-10-16","conditions":"Hematologic Malignancies","enrollment":270},{"nctId":"NCT03734601","phase":"PHASE2","title":"Total Body Irradiation +/- Total Lymphoid Irradiation & Anti-Thymocyte Globulin in Non-myeloablative Hematopoietic Cell Transplantation","status":"COMPLETED","sponsor":"Stanford University","startDate":"2018-11-05","conditions":"Acute Myeloid Leukemia, Myelodysplastic Syndromes, Myeloproliferative Disorder","enrollment":22},{"nctId":"NCT02084446","phase":"PHASE4","title":"Everolimus + Very Low Tacrolimus vs Enteric-coated Mycophenolate Sodium + Low Tacrolimus in de Novo Renal Transplant","status":"COMPLETED","sponsor":"Ronaldo de Matos Esmeraldo, MD","startDate":"2012-12","conditions":"Transplantation Infection, Cytomegalovirus Infections","enrollment":120},{"nctId":"NCT00369161","phase":"PHASE4","title":"A Twelve-month, Multicenter, Open-label, Randomized Study of the Safety, Tolerability and Efficacy of Everolimus With Basiliximab, Corticosteroids and Two Different Exposure Levels of Tacrolimus in de Novo Renal Transplant Recipients","status":"COMPLETED","sponsor":"Novartis","startDate":"2006-06","conditions":"Renal Transplantation","enrollment":228}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":3,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Very low Prograf"],"phase":"marketed","status":"active","brandName":"Very Low Tacrolimus","genericName":"Very Low Tacrolimus","companyName":"Ronaldo de Matos Esmeraldo, MD","companyId":"ronaldo-de-matos-esmeraldo-md","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Very Low Tacrolimus is a reduced-dose formulation of tacrolimus that suppresses T-cell activation by inhibiting calcineurin, thereby reducing transplant rejection while minimizing immunosuppressive toxicity. Used for Prevention of organ rejection in solid organ transplant recipients (kidney, heart, liver, pancreas).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}