{"id":"low-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":"Diarrhea"}]},"_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 on the colonic mucosa. When applied as a rectal foam at low dose, it reduces inflammation by suppressing T-cell activation, decreasing production of inflammatory mediators (IL-1, IL-6, TNF-α), and stabilizing mast cells. The rectal formulation delivers the drug locally to affected tissue while minimizing systemic absorption and adverse effects.","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":"2026-03-27T23:53:15.515Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Ulcerative colitis (distal/left-sided disease)"},{"name":"Mild to moderate active ulcerative colitis"}]},"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":"Low dose budesonide rectal foam","genericName":"Low 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), Mild to moderate active ulcerative colitis.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}