{"id":"ibp-9414","safety":{"commonSideEffects":[]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"IBP-9414 is a rationally selected consortium of commensal bacteria intended to establish or restore healthy microbial communities in infants. By introducing specific bacterial strains, the therapeutic aims to promote normal microbiome development and prevent dysbiosis-related complications. This approach leverages the critical role of early-life microbiota in immune system development and disease prevention.","oneSentence":"IBP-9414 is a live biotherapeutic product designed to restore beneficial bacterial populations in the infant microbiome.","_ai_confidence":"low"},"_scrapedAt":"2026-03-28T01:15:24.166Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Microbiome restoration in infants (specific indication under investigation in Phase 3)"}]},"trialDetails":[{"nctId":"NCT03978000","phase":"PHASE3","title":"IBP-9414 for the Prevention of Necrotizing Enterocolitis - The Connection Study","status":"ACTIVE_NOT_RECRUITING","sponsor":"Infant Bacterial Therapeutics","startDate":"2019-07-04","conditions":"Necrotizing Enterocolitis","enrollment":2158},{"nctId":"NCT02472769","phase":"PHASE2","title":"IBP-9414 for the Prevention of Necrotizing Enterocolitis","status":"COMPLETED","sponsor":"Infant Bacterial Therapeutics","startDate":"2016-05-27","conditions":"Necrotizing Enterocolitis","enrollment":120}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":2,"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":"IBP-9414","genericName":"IBP-9414","companyName":"Infant Bacterial Therapeutics","companyId":"infant-bacterial-therapeutics","modality":"Small molecule","firstApprovalDate":"","aiSummary":"IBP-9414 is a live biotherapeutic product designed to restore beneficial bacterial populations in the infant microbiome. Used for Microbiome restoration in infants (specific indication under investigation in Phase 3).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":false,"trials":true,"score":3}}