{"id":"tofacitinib-plus-mesalamine","safety":{"commonSideEffects":[{"rate":"15-25","effect":"Infections (upper respiratory, urinary tract)"},{"rate":"10-15","effect":"Headache"},{"rate":"5-10","effect":"Diarrhea"},{"rate":"5-10","effect":"Nausea"},{"rate":"10-20","effect":"Elevated cholesterol"},{"rate":"5-10","effect":"Elevated liver enzymes"}]},"_chembl":{"chemblId":"CHEMBL2103743","moleculeType":"Small molecule","molecularWeight":"504.50"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Tofacitinib is a JAK inhibitor that suppresses T-cell activation and pro-inflammatory cytokine production systemically. Mesalamine (5-aminosalicylic acid) provides local anti-inflammatory effects in the intestinal mucosa. The combination targets both systemic and local inflammation in inflammatory bowel disease.","oneSentence":"Tofacitinib inhibits JAK kinases to reduce inflammatory signaling, while mesalamine acts as a topical anti-inflammatory in the colon.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T00:13:04.027Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Ulcerative colitis"}]},"trialDetails":[{"nctId":"NCT04259138","phase":"PHASE4","title":"Determination of the Optimal Treatment Target in Ulcerative Colitis","status":"ACTIVE_NOT_RECRUITING","sponsor":"Alimentiv Inc.","startDate":"2020-02-18","conditions":"Colitis, Ulcerative","enrollment":672},{"nctId":"NCT03591770","phase":"PHASE4","title":"Shingrix Vaccine in Patients With Moderate to Severe Ulcerative Colitis on Tofacitinib","status":"TERMINATED","sponsor":"Boston Medical Center","startDate":"2019-07-31","conditions":"Inflammatory Bowel Diseases","enrollment":15},{"nctId":"NCT06625450","phase":"PHASE4","title":"TOFACITINIB vs TOFACITINIB WITH MESALAMINE IN ULCERATIVE COLITIS","status":"NOT_YET_RECRUITING","sponsor":"Post Graduate Institute of Medical Education and Research, Chandigarh","startDate":"2024-10","conditions":"Ulcerative Colitis","enrollment":75}],"_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":[],"phase":"marketed","status":"active","brandName":"Tofacitinib plus mesalamine","genericName":"Tofacitinib plus mesalamine","companyName":"Post Graduate Institute of Medical Education and Research, Chandigarh","companyId":"post-graduate-institute-of-medical-education-and-research-chandigarh","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Tofacitinib plus mesalamine is being studied as a treatment for ulcerative colitis and other inflammatory bowel diseases. A clinical trial, NCT06625450, is comparing the effectiveness of tofacitinib alone versus tofacitinib in combination with mesalamine for maintaining remission in ulcerative colitis.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}