{"id":"delayed-and-extended-release-mesalazine","safety":{"commonSideEffects":[{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Abdominal pain"},{"rate":null,"effect":"Diarrhea"},{"rate":null,"effect":"Nausea"},{"rate":null,"effect":"Mesalamine-induced acute intolerance syndrome"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Mesalazine is a topical anti-inflammatory agent that acts locally in the gastrointestinal tract. The delayed and extended release formulation allows the drug to be released in the distal small intestine and colon, where it exerts its anti-inflammatory effects by suppressing inflammatory mediators and reducing immune cell activation in the mucosa.","oneSentence":"Mesalazine (5-aminosalicylic acid) reduces intestinal inflammation by inhibiting prostaglandin and leukotriene production and scavenging reactive oxygen species in the colon.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T01:08:58.141Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Ulcerative colitis (induction and maintenance of remission)"},{"name":"Crohn's disease (colonic involvement)"}]},"trialDetails":[{"nctId":"NCT00545389","phase":"PHASE2","title":"Phase II Dose-Ranging Study in Subjects With Mild to Moderate Ulcerative Colitis Treated With SPD476","status":"COMPLETED","sponsor":"Shire","startDate":"2003-02-10","conditions":"Colitis, Ulcerative","enrollment":38},{"nctId":"NCT00503243","phase":"PHASE3","title":"Safety and Efficacy of SPD476 (Mesalazine) Given Twice Daily (2.4 g/Day) vs SPD476 Given as a Single Dose (4.8 g/Day) in Subjects With Acute Mild to Moderate Ulcerative Colitis","status":"COMPLETED","sponsor":"Shire","startDate":"2003-09-30","conditions":"Colitis, Ulcerative","enrollment":280},{"nctId":"NCT00548574","phase":"PHASE3","title":"Efficacy and Safety of Two Doses of SPD476 (Mesalazine) 2.4g and 4.8g Once Daily, With Reference to Asacol 0.8g Three Times Daily in Subjects With Acute, Mild to Moderate Ulcerative Colitis","status":"COMPLETED","sponsor":"Shire","startDate":"2003-12-04","conditions":"Ulcerative Colitis","enrollment":343}],"_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":"phase_3","status":"active","brandName":"Delayed and extended release mesalazine","genericName":"Delayed and extended release mesalazine","companyName":"Shire","companyId":"shire","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Mesalazine (5-aminosalicylic acid) reduces intestinal inflammation by inhibiting prostaglandin and leukotriene production and scavenging reactive oxygen species in the colon. Used for Ulcerative colitis (induction and maintenance of remission), Crohn's disease (colonic involvement).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}