{"id":"gut-directed-budesonide-and-soc","safety":{"commonSideEffects":[{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Nausea"},{"rate":null,"effect":"Abdominal pain"},{"rate":null,"effect":"Systemic corticosteroid effects (with prolonged use)"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Budesonide is a corticosteroid with high topical potency and low systemic bioavailability when formulated for gut delivery. The gut-directed formulation targets intestinal inflammation directly while minimizing systemic exposure. This combination approach with standard of care aims to improve efficacy in inflammatory bowel conditions.","oneSentence":"Gut-directed budesonide delivers a corticosteroid locally to the intestinal tract to reduce inflammation, combined with standard of care management.","_ai_confidence":"low"},"_scrapedAt":"2026-03-27T23:31:37.659Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Inflammatory bowel disease (IBD) — likely Crohn's disease or ulcerative colitis"}]},"trialDetails":[{"nctId":"NCT06676384","phase":"PHASE4","title":"Which of the Commonly Available and Approved Drugs in Addition to Standard of Care Can Significantly Improve the Slope of Estimated Glomerular Filtration Rate at Two Years When Compared to Standard of Care Alone in South-Asian Kidney Biopsy-proven Adult (≥18 Years) Primary IgA Nephropathy?","status":"RECRUITING","sponsor":"Christian Medical College, Vellore, India","startDate":"2025-02-15","conditions":"IgA Nephropathy, Renal Insufficiency, Chronic, IgA Vasculitis","enrollment":585}],"_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":["IgANEF® by MediART Life Sciences Pvt. Ltd."],"phase":"marketed","status":"active","brandName":"Gut-directed budesonide and SoC","genericName":"Gut-directed budesonide and SoC","companyName":"Christian Medical College, Vellore, India","companyId":"christian-medical-college-vellore-india","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Gut-directed budesonide delivers a corticosteroid locally to the intestinal tract to reduce inflammation, combined with standard of care management. Used for Inflammatory bowel disease (IBD) — likely Crohn's disease or ulcerative colitis.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}