{"id":"be-pep-bedaquiline","safety":{"commonSideEffects":[{"rate":null,"effect":"QT prolongation"},{"rate":null,"effect":"Hepatotoxicity"},{"rate":null,"effect":"Peripheral neuropathy"},{"rate":null,"effect":"Gastrointestinal disturbances"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Bedaquiline is a diarylquinoline that binds to the ATP synthase enzyme of tuberculosis bacteria, blocking ATP synthesis and causing rapid bactericidal activity. This mechanism is distinct from existing TB drugs and is effective against both drug-susceptible and multidrug-resistant tuberculosis strains. BE-PEP likely refers to a bedaquiline-containing combination regimen being evaluated in Phase 3 trials.","oneSentence":"Bedaquiline inhibits bacterial ATP synthase, disrupting energy production in Mycobacterium tuberculosis.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:03:52.012Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Multidrug-resistant tuberculosis (MDR-TB)"},{"name":"Extensively drug-resistant tuberculosis (XDR-TB)"}]},"trialDetails":[{"nctId":"NCT05406479","phase":"PHASE2","title":"Bedaquiline Enhanced Post ExpOsure Prophylaxis for Leprosy (Phase 2)","status":"COMPLETED","sponsor":"Institute of Tropical Medicine, Belgium","startDate":"2022-07-14","conditions":"Leprosy","enrollment":313},{"nctId":"NCT05597280","phase":"PHASE3","title":"Bedaquiline Enhanced Post ExpOsure Prophylaxis for Leprosy","status":"RECRUITING","sponsor":"Institute of Tropical Medicine, Belgium","startDate":"2023-03-22","conditions":"Leprosy","enrollment":124000}],"_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":"BE-PEP Bedaquiline","genericName":"BE-PEP Bedaquiline","companyName":"Institute of Tropical Medicine, Belgium","companyId":"institute-of-tropical-medicine-belgium","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Bedaquiline inhibits bacterial ATP synthase, disrupting energy production in Mycobacterium tuberculosis. Used for Multidrug-resistant tuberculosis (MDR-TB), Extensively drug-resistant tuberculosis (XDR-TB).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}