{"id":"tacrobell-sr-cap","safety":{"commonSideEffects":[{"rate":null,"effect":"Nephrotoxicity"},{"rate":null,"effect":"Neurotoxicity (tremor, headache)"},{"rate":null,"effect":"Hypertension"},{"rate":null,"effect":"Hyperglycemia"},{"rate":null,"effect":"Infection"},{"rate":null,"effect":"Gastrointestinal disturbances"}]},"_chembl":{"chemblId":"CHEMBL4591082","moleculeType":"Unknown","molecularWeight":"622.79"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Tacrolimus binds to the immunophilin FKBP12 and inhibits calcineurin, a phosphatase required for dephosphorylation and nuclear translocation of NFAT (nuclear factor of activated T cells). This prevents IL-2 and other cytokine gene transcription, thereby suppressing T-cell mediated immune responses. The SR (sustained-release) formulation provides prolonged drug exposure with potentially improved tolerability and compliance compared to immediate-release formulations.","oneSentence":"TacroBell SR is a sustained-release formulation of tacrolimus that suppresses T-cell activation and proliferation by inhibiting calcineurin phosphatase.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T00:10:43.676Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Organ transplant rejection prophylaxis (renal, cardiac, hepatic)"},{"name":"Autoimmune and inflammatory conditions (atopic dermatitis, psoriasis)"}]},"trialDetails":[{"nctId":"NCT03749356","phase":"PHASE4","title":"Study to Evaluate the Efficacy and Safety of Once-Daily Tacrolimus in Kidney Transplant Recipients","status":"COMPLETED","sponsor":"Chong Kun Dang Pharmaceutical","startDate":"2018-09-05","conditions":"Kidney Transplant","enrollment":141},{"nctId":"NCT04224350","phase":"PHASE4","title":"Study to Evaluate the Efficacy and Safety of Tacrolimus in Kidney Transplant Recipients (BLOSSOM)","status":"UNKNOWN","sponsor":"Chong Kun Dang Pharmaceutical","startDate":"2018-12-17","conditions":"Kidney Transplant","enrollment":184},{"nctId":"NCT04069065","phase":"PHASE4","title":"Efficacy and Safety of Once-Daily Tacrolimus in Liver Transplant Recipients (SOUL)","status":"UNKNOWN","sponsor":"Chong Kun Dang Pharmaceutical","startDate":"2019-07-31","conditions":"Liver Transplant","enrollment":146}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":0,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Tacrolimus SR cap."],"phase":"marketed","status":"active","brandName":"TacroBell SR cap.","genericName":"TacroBell SR cap.","companyName":"Chong Kun Dang Pharmaceutical","companyId":"chong-kun-dang-pharmaceutical","modality":"Small molecule","firstApprovalDate":"","aiSummary":"TacroBell SR cap is a formulation of tacrolimus used in kidney and liver transplant patients. It is compared to tacrolimus capsules and conversion to once-daily tacrolimus in clinical trials for efficacy and safety.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":2,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}