{"id":"bpal","safety":{"commonSideEffects":[{"rate":null,"effect":"Peripheral neuropathy"},{"rate":null,"effect":"Optic neuropathy"},{"rate":null,"effect":"QT prolongation"},{"rate":null,"effect":"Hepatotoxicity"},{"rate":null,"effect":"Anemia"},{"rate":null,"effect":"Gastrointestinal disturbances"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Bedaquiline inhibits mycobacterial ATP synthase, disrupting energy production in Mycobacterium tuberculosis. Pretomanid is a prodrug that generates reactive nitrogen species to damage mycobacterial DNA and proteins. Linezolid inhibits bacterial protein synthesis by targeting the ribosome. Together, these agents provide synergistic bactericidal activity against multidrug-resistant and extensively drug-resistant tuberculosis.","oneSentence":"BPaL is a three-drug combination regimen (bedaquiline, pretomanid, and linezolid) that inhibits mycobacterial ATP synthase and protein synthesis to kill drug-resistant tuberculosis bacteria.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T01:42:13.239Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Multidrug-resistant tuberculosis (MDR-TB)"},{"name":"Extensively drug-resistant tuberculosis (XDR-TB)"}]},"trialDetails":[{"nctId":"NCT07477119","phase":"PHASE4","title":"Linezolid Tolerance During the BPaL Regimen With Dosage Personalization Based on Therapeutic Drug Monitoring (TDM) During Multidrug-Resistant Tuberculosis Treatment","status":"NOT_YET_RECRUITING","sponsor":"Marco Schiuma","startDate":"2026-03","conditions":"Linezolid, Tuberculosis Multi Drug Resistant Active, Therapeutic Drug Monitoring (TDM)","enrollment":150},{"nctId":"NCT07209761","phase":"PHASE3","title":"A Study of Quabodepistat-containing Regimens for the Treatment of Drug-resistant Pulmonary Tuberculosis","status":"RECRUITING","sponsor":"Otsuka Pharmaceutical Development & Commercialization, Inc.","startDate":"2025-10-16","conditions":"Pulmonary Tuberculosis","enrollment":532},{"nctId":"NCT06058299","phase":"PHASE2","title":"Phase 2 Trial Assessing TBAJ876 or Bedaquiline, with Pretomanid and Linezolid in Adults with Drug-sensitive Pulmonary Tuberculosis","status":"ACTIVE_NOT_RECRUITING","sponsor":"Global Alliance for TB Drug Development","startDate":"2023-10-24","conditions":"Pulmonary TB, Pulmonary Tuberculosis, Drug Sensitive Tuberculosis","enrollment":309},{"nctId":"NCT05381194","phase":"PHASE4","title":"BPaL(M) Regimen for the Treatment of MDR/RR-TB","status":"RECRUITING","sponsor":"Asan Medical Center","startDate":"2022-12-13","conditions":"Multidrug- and Rifampicin-resistant Tuberculosis","enrollment":80},{"nctId":"NCT05040126","phase":"PHASE3","title":"Modified BPaL Regimen for Managing Pre-XDR TB and MDR (TI/NR) TB in India","status":"UNKNOWN","sponsor":"Tuberculosis Research Centre, India","startDate":"2021-10-07","conditions":"Pre-Extensively Drug-Resistant Pulmonary TB, Treatment Intolerant Multidrug-Resistant Pulmonary TB, Non-responsive Multidrug-Resistant Pulmonary TB","enrollment":400}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":144,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Bedaquiline, Pretomanid, Linezolid"],"phase":"phase_3","status":"active","brandName":"BPaL","genericName":"BPaL","companyName":"Otsuka Pharmaceutical Development & Commercialization, Inc.","companyId":"otsuka-pharmaceutical-development-commercialization-inc","modality":"Small molecule","firstApprovalDate":"","aiSummary":"BPaL is a three-drug combination regimen (bedaquiline, pretomanid, and linezolid) that inhibits mycobacterial ATP synthase and protein synthesis to kill drug-resistant tuberculosis bacteria. 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}}