{"id":"spd476-mesalazine","safety":{"commonSideEffects":[{"rate":"10-20%","effect":"Diarrhea"},{"rate":"5-10%","effect":"Nausea"},{"rate":"5-10%","effect":"Headache"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"groq-llama-8b","explanation":"Mesalazine, the active ingredient in SPD476, is a locally acting anti-inflammatory agent that inhibits the enzyme aminopeptidase N, thereby reducing the production of pro-inflammatory peptides in the gut. This action helps to reduce inflammation and alleviate symptoms associated with inflammatory bowel disease.","oneSentence":"SPD476 (mesalazine) works by inhibiting the enzyme aminopeptidase N to reduce inflammation in the gut.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T01:35:44.109Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Ulcerative colitis"},{"name":"Crohn's disease"}]},"trialDetails":[{"nctId":"NCT00151944","phase":"PHASE3","title":"Safety and Tolerability of SPD476 in Maintaining Remission in Patients With Ulcerative Colitis.","status":"COMPLETED","sponsor":"Shire","startDate":"2003-11-26","conditions":"Colitis, Ulcerative","enrollment":400},{"nctId":"NCT01130844","phase":"PHASE1","title":"Safety and Pharmacokinetics of MMX Mesalamine in Children and Adolescents With Ulcerative Colitis","status":"COMPLETED","sponsor":"Shire","startDate":"2010-10-08","conditions":"Ulcerative Colitis","enrollment":52},{"nctId":"NCT00545740","phase":"PHASE3","title":"Prevention of Recurrence of Diverticulitis","status":"COMPLETED","sponsor":"Shire","startDate":"2007-11-28","conditions":"Diverticulitis","enrollment":590},{"nctId":"NCT00151892","phase":"PHASE3","title":"Efficacy and Safety of SPD476 in Maintaining Remission in Patients With Ulcerative Colitis","status":"COMPLETED","sponsor":"Shire","startDate":"2005-04-08","conditions":"Ulcerative Colitis","enrollment":829},{"nctId":"NCT00545103","phase":"PHASE3","title":"Prevention of Recurrence of Diverticulitis","status":"COMPLETED","sponsor":"Shire","startDate":"2007-12-06","conditions":"Diverticulitis","enrollment":592},{"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":1,"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":"SPD476 (mesalazine)","genericName":"SPD476 (mesalazine)","companyName":"Shire","companyId":"shire","modality":"Small molecule","firstApprovalDate":"","aiSummary":"SPD476 (mesalazine) works by inhibiting the enzyme aminopeptidase N to reduce inflammation in the gut. Used for Ulcerative colitis, Crohn's disease.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}