{"id":"rhb-104","safety":{"commonSideEffects":[{"rate":null,"effect":"Gastrointestinal disturbances"},{"rate":null,"effect":"Nausea"},{"rate":null,"effect":"Abdominal pain"},{"rate":null,"effect":"Diarrhea"},{"rate":null,"effect":"Discoloration of skin/body fluids"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"anthropic-haiku","explanation":"RHB-104 combines antimicrobial agents with activity against intracellular bacteria, particularly MAP, which has been hypothesized to play a role in Crohn's disease pathogenesis. The triple-drug combination aims to achieve synergistic bacterial killing while minimizing resistance development. The rationale is based on the theory that MAP infection may trigger or perpetuate chronic intestinal inflammation in genetically susceptible individuals.","oneSentence":"RHB-104 is a combination of three antibiotics (clarithromycin, rifabutin, and clofazimine) designed to target Mycobacterium avium subspecies paratuberculosis (MAP) in Crohn's disease.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:32:01.212Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Crohn's disease (moderate to severe, MAP-positive or MAP-negative)"}]},"trialDetails":[{"nctId":"NCT03009396","phase":"PHASE3","title":"Open Label Efficacy and Safety of Anti-MAP (Mycobacterium Avium Ssp. Paratuberculosis) Therapy in Adult Crohn's Disease","status":"COMPLETED","sponsor":"RedHill Biopharma Limited","startDate":"2017-03-18","conditions":"Crohn Disease","enrollment":54},{"nctId":"NCT01951326","phase":"PHASE3","title":"Efficacy and Safety of Anti-MAP Therapy in Adult Crohn's Disease","status":"COMPLETED","sponsor":"RedHill Biopharma Limited","startDate":"2013-09","conditions":"Crohn's Disease","enrollment":331},{"nctId":"NCT01717664","phase":"PHASE2","title":"Proof of Concept Study of RHB-104 as Add-On Therapy to Interferon Beta-1a in Relapsing Remitting Multiple Sclerosis (RRMS)","status":"COMPLETED","sponsor":"RedHill Biopharma Limited","startDate":"2013-06","conditions":"Relapsing Remitting Multiple Sclerosis","enrollment":18}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":6,"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":"RHB-104","genericName":"RHB-104","companyName":"RedHill Biopharma Limited","companyId":"redhill-biopharma-limited","modality":"Small molecule","firstApprovalDate":"","aiSummary":"RHB-104 is a combination of three antibiotics (clarithromycin, rifabutin, and clofazimine) designed to target Mycobacterium avium subspecies paratuberculosis (MAP) in Crohn's disease. Used for Crohn's disease (moderate to severe, MAP-positive or MAP-negative).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}