{"id":"spd476-2-4-g","safety":{"commonSideEffects":[{"rate":null,"effect":"Hypertension"},{"rate":null,"effect":"Insomnia"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Nausea"},{"rate":null,"effect":"Dizziness"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"SPD476 works by inhibiting monoamine oxidase enzymes, which are responsible for breaking down neurotransmitters. By blocking this degradation, the drug increases synaptic concentrations of dopamine, norepinephrine, and serotonin, thereby enhancing monoaminergic neurotransmission. This mechanism is intended to improve symptoms in conditions characterized by monoamine deficiency.","oneSentence":"SPD476 is a monoamine oxidase inhibitor that increases levels of dopamine, norepinephrine, and serotonin in the central nervous system.","_ai_confidence":"low"},"_scrapedAt":"2026-03-28T01:35:43.858Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Major depressive disorder"}]},"trialDetails":[{"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":"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}],"_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":["Lialda, MMX™ mesalazine"],"phase":"phase_3","status":"active","brandName":"SPD476 (2.4 g)","genericName":"SPD476 (2.4 g)","companyName":"Shire","companyId":"shire","modality":"Small molecule","firstApprovalDate":"","aiSummary":"SPD476 is a small molecule mesalazine formulation used to treat conditions such as ulcerative colitis and diverticulitis. It is available in delayed and extended release forms, including a 2.4 g dose, which has been studied for safety and efficacy in clinical trials.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}