{"id":"high-dose-budesonide-rectal-foam","safety":{"commonSideEffects":[{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Abdominal pain"},{"rate":null,"effect":"Nausea"},{"rate":null,"effect":"Rectal irritation"},{"rate":null,"effect":"Flatulence"}]},"_chembl":{"chemblId":"CHEMBL1370","moleculeType":"Small molecule","molecularWeight":"430.54"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Budesonide is a synthetic glucocorticoid that exerts potent anti-inflammatory effects through activation of intracellular glucocorticoid receptors, leading to suppression of inflammatory mediators and immune cell activation in the rectal and colonic mucosa. The rectal foam formulation delivers high local concentrations directly to the distal colon and rectum while minimizing systemic absorption. This localized delivery reduces inflammation characteristic of ulcerative colitis and other inflammatory bowel conditions affecting the lower gastrointestinal tract.","oneSentence":"Budesonide is a corticosteroid that suppresses local inflammation in the colon and rectum by binding to glucocorticoid receptors and inhibiting pro-inflammatory cytokine production.","_ai_confidence":"high"},"_scrapedAt":"2026-03-27T23:47:38.729Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Ulcerative colitis (distal/left-sided disease)"},{"name":"Proctitis"},{"name":"Proctosigmoiditis"}]},"trialDetails":[{"nctId":"NCT05976802","phase":"PHASE4","title":"Dose Ranging Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Budesonide Rectal Foam in Pediatric Patients Aged 5 to 17 Years With Active, Mild to Moderate Distal Ulcerative Colitis","status":"NOT_YET_RECRUITING","sponsor":"Bausch Health Americas, Inc.","startDate":"2027-06","conditions":"Ulcerative Colitis","enrollment":100}],"_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":"High dose budesonide rectal foam","genericName":"High dose budesonide rectal foam","companyName":"Bausch Health Americas, Inc.","companyId":"bausch-health-americas-inc","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Budesonide is a corticosteroid that suppresses local inflammation in the colon and rectum by binding to glucocorticoid receptors and inhibiting pro-inflammatory cytokine production. Used for Ulcerative colitis (distal/left-sided disease), Proctitis, Proctosigmoiditis.","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}