{"id":"rectal-tacrolimus","safety":{"commonSideEffects":[{"rate":null,"effect":"Local rectal irritation"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Abdominal discomfort"},{"rate":null,"effect":"Systemic immunosuppression (if absorbed)"}]},"_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 T-cell proliferation and cytokine production by preventing dephosphorylation of nuclear factor of activated T cells (NFAT). When administered rectally, it delivers high local concentrations to inflamed colonic tissue while minimizing systemic exposure, making it suitable for treating distal inflammatory bowel conditions.","oneSentence":"Tacrolimus suppresses local immune responses in the rectum by inhibiting calcineurin and reducing T-cell activation, helping to control inflammatory bowel disease.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T00:04:21.720Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Ulcerative colitis (rectal/distal disease)"},{"name":"Inflammatory bowel disease (IBD)"}]},"trialDetails":[{"nctId":"NCT05252754","phase":"PHASE3","title":"Rectal Indomethacin and Oral Tacrolimus Versus Combination to Prevent Post-ERCP Pancreatitis","status":"RECRUITING","sponsor":"Johns Hopkins University","startDate":"2023-01-18","conditions":"Post-ERCP Acute Pancreatitis","enrollment":4874},{"nctId":"NCT06867042","phase":"PHASE2","title":"Tacrolimus Lipid Suspension for Enema in Adult Subjects with Mild to Moderately Active Left-sided/Distal Ulcerative Colitis Who Had an Inadequate Response to the Treatment","status":"NOT_YET_RECRUITING","sponsor":"Jina Pharmaceuticals Inc.","startDate":"2025-04","conditions":"Ulcerative Colitis (UC), Ulcerative Colitis, Active Moderate","enrollment":150},{"nctId":"NCT00514982","phase":"PHASE2","title":"Medical Treatment of Colitis in Patients With Hermansky-Pudlak Syndrome","status":"WITHDRAWN","sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","startDate":"2007-08-07","conditions":"Hermanski-Pudlak Syndrome, Colitis, Cytokines","enrollment":""},{"nctId":"NCT01418131","phase":"PHASE4","title":"Rectal Tacrolimus in the Treatment of Resistant Ulcerative Proctitis","status":"COMPLETED","sponsor":"The University of Western Australia","startDate":"2012-10","conditions":"Ulcerative Colitis","enrollment":21},{"nctId":"NCT00987103","phase":"PHASE1","title":"Pharmacokinetic Study to Rectal and Sublingual Administration of Tacrolimus in Future Kidney Transplant Patients","status":"UNKNOWN","sponsor":"Maastricht University Medical Center","startDate":"2009-09","conditions":"Organ Transplantation","enrollment":18}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":5,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["calcineurin inhibitor"],"phase":"marketed","status":"active","brandName":"Rectal tacrolimus","genericName":"Rectal tacrolimus","companyName":"The University of Western Australia","companyId":"the-university-of-western-australia","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Tacrolimus suppresses local immune responses in the rectum by inhibiting calcineurin and reducing T-cell activation, helping to control inflammatory bowel disease. Used for Ulcerative colitis (rectal/distal disease), Inflammatory bowel disease (IBD).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}