{"id":"bedaquiline-oral-tablet","safety":{"commonSideEffects":[{"rate":null,"effect":"QT prolongation"},{"rate":null,"effect":"Hepatotoxicity"},{"rate":null,"effect":"Nausea"},{"rate":null,"effect":"Arthralgia"},{"rate":null,"effect":"Photosensitivity"}]},"_chembl":{"chemblId":"CHEMBL2105700","moleculeType":"Small molecule","molecularWeight":"671.59"},"_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 drug-resistant TB strains. It represents a novel class of anti-TB agents with activity against organisms resistant to first-line and second-line TB medications.","oneSentence":"Bedaquiline inhibits bacterial ATP synthase, disrupting energy production in Mycobacterium tuberculosis.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T01:03:49.234Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Multidrug-resistant tuberculosis (MDR-TB)"},{"name":"Extensively drug-resistant tuberculosis (XDR-TB)"}]},"trialDetails":[{"nctId":"NCT07486024","phase":"PHASE3","title":"Feasibility of the Application of a New Six-month Treatment for Multidrug-resistant Tuberculosis (MDR-TB) Patients in France (FAST-MDR)","status":"NOT_YET_RECRUITING","sponsor":"Assistance Publique - Hôpitaux de Paris","startDate":"2026-04","conditions":"MDR-TB, Tuberculosis Multi Drug Resistant Active, Antibiotic Resistance","enrollment":55},{"nctId":"NCT07485010","phase":"PHASE2","title":"Testing a Novel Combination Treatment (Arm D) Versus Standard of Care for Intensive Phase Treatment for Mycobacterium Abscessus Pulmonary Disease in People With or Without Cystic Fibrosis in the Finding the Optimal Regimen for Mycobacterium Abscessus Treatment (FORMaT) Adaptive Platform Trial","status":"NOT_YET_RECRUITING","sponsor":"The University of Queensland","startDate":"2027-04","conditions":"Mycobacterium Abscessus Pulmonary Disease, Mycobacterium Abscessus Infection, Non-Tuberculous Mycobacterial (NTM) Infections","enrollment":300},{"nctId":"NCT06192160","phase":"PHASE2","title":"Trial of Novel Regimens for the Treatment of Pulmonary Tuberculosis","status":"RECRUITING","sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","startDate":"2025-03-11","conditions":"Pulmonary Tuberculosis","enrollment":315},{"nctId":"NCT02354014","phase":"PHASE2","title":"Pharmacokinetic Study to Evaluate Anti-mycobacterial Activity of TMC207 in Combination With Background Regimen (BR) of Multidrug Resistant Tuberculosis (MDR-TB) Medications for Treatment of Children/Adolescents With Pulmonary MDR-TB","status":"RECRUITING","sponsor":"Janssen Research & Development, LLC","startDate":"2016-05-03","conditions":"Tuberculosis, Multidrug-Resistant","enrollment":60},{"nctId":"NCT07268664","phase":"PHASE3","title":"Innovating Shorter, All- Oral, Precised Treatment Regimen for Rifampicin Resistant Tuberculosis：BLMZ Chinese Cohort","status":"NOT_YET_RECRUITING","sponsor":"Beijing Chest Hospital","startDate":"2025-12-01","conditions":"Rifampicin Resistant Tuberculosis, Pulmonary Tuberculosis, Tuberculosis","enrollment":120},{"nctId":"NCT00042289","phase":"","title":"Pharmacokinetic Study of Antiretroviral Drugs and Related Drugs During and After Pregnancy","status":"COMPLETED","sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","startDate":"2003-06-09","conditions":"HIV Infections","enrollment":1578},{"nctId":"NCT07129629","phase":"PHASE2","title":"Short-Course Regimen With Bedaquiline, Moxifloxacin and Pyrazinamide for Early Bactericidal Activity in Drug-Susceptible Tuberculosis","status":"NOT_YET_RECRUITING","sponsor":"Shanghai Pulmonary Hospital, Shanghai, China","startDate":"2025-08-20","conditions":"Tuberculosis, Pulmonary, Drug-Susceptible Pulmonary Tuberculosis","enrollment":45},{"nctId":"NCT05007821","phase":"PHASE2","title":"Linezolid Dosing Strategies in Drug-Resistant TB","status":"ACTIVE_NOT_RECRUITING","sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","startDate":"2022-08-11","conditions":"Tuberculosis, Multidrug-Resistant, Tuberculosis, Tuberculosis, Pulmonary","enrollment":138},{"nctId":"NCT05824871","phase":"PHASE3","title":"A Phase III Study of Oral Sudapyridine (WX-081) Tablets in Rifampicin-Resistant Pulmonary Tuberculosis Patients","status":"RECRUITING","sponsor":"Shanghai Jiatan Pharmatech Co., Ltd","startDate":"2022-09-02","conditions":"Rifampin-Resistant Pulmonary Tuberculosis, Tuberculosis, Multidrug-Resistant (MDR-TB)","enrollment":450},{"nctId":"NCT05221502","phase":"PHASE2","title":"Safety and Efficacy Evaluation of 4-month Regimen of OPC-167832, Delamanid and Bedaquiline in Participants With Drug-Susceptible Pulmonary TB","status":"COMPLETED","sponsor":"Otsuka Pharmaceutical Development & Commercialization, Inc.","startDate":"2022-04-12","conditions":"Pulmonary TB","enrollment":122},{"nctId":"NCT05388448","phase":"PHASE2","title":"EBA, Safety and Tolerability of Sanfetrinem Cilexetil","status":"COMPLETED","sponsor":"TASK Applied Science","startDate":"2022-04-21","conditions":"Tuberculosis, Pulmonary","enrollment":54},{"nctId":"NCT03896685","phase":"PHASE3","title":"Evaluating Newly Approved Drugs in Combination Regimens for Multidrug-Resistant TB With Fluoroquinolone Resistance (endTB-Q)","status":"COMPLETED","sponsor":"Médecins Sans Frontières, France","startDate":"2020-04-06","conditions":"Tuberculosis, Multidrug-Resistant, Tuberculosis, Pulmonary Tuberculoses","enrollment":323},{"nctId":"NCT03800550","phase":"PHASE1","title":"A Study to Assess the Drug-Drug Interaction Between Bedaquiline and Clarithromycin in Healthy Adult Participants","status":"COMPLETED","sponsor":"Janssen Research & Development, LLC","startDate":"2019-02-13","conditions":"Healthy","enrollment":16},{"nctId":"NCT04087759","phase":"PHASE1","title":"A Study of Bedaquiline 100 Milligram (mg) Tablets Administered as Different Test Formulations Compared to the Commercial Tablet Formulation (F001) in Healthy Adult Participants","status":"COMPLETED","sponsor":"Janssen Research & Development, LLC","startDate":"2019-09-16","conditions":"Healthy","enrollment":36},{"nctId":"NCT04062201","phase":"PHASE3","title":"Building Evidence for Advancing New Treatment for Rifampicin Resistant Tuberculosis (RR-TB) Comparing a Short Course of Treatment (Containing Bedaquiline, Delamanid and Linezolid) With the Current South African Standard of Care","status":"COMPLETED","sponsor":"Wits Health Consortium (Pty) Ltd","startDate":"2019-08-22","conditions":"Tuberculosis, Pre-XDR-TB, Extensively Drug-Resistant Tuberculosis","enrollment":402},{"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},{"nctId":"NCT05926466","phase":"PHASE2","title":"BTZ-043 Dose Evaluation in Combination and Selection","status":"UNKNOWN","sponsor":"Michael Hoelscher","startDate":"2023-09-21","conditions":"Tuberculosis, Pulmonary, Other Specified Pulmonary Tuberculosis","enrollment":90},{"nctId":"NCT03678688","phase":"PHASE1, PHASE2","title":"A Phase 1/2 Trial of Multiple Oral Doses of OPC-167832 for Uncomplicated Pulmonary Tuberculosis","status":"COMPLETED","sponsor":"Otsuka Pharmaceutical Development & Commercialization, Inc.","startDate":"2018-10-18","conditions":"Pulmonary TB","enrollment":122},{"nctId":"NCT05306223","phase":"PHASE4","title":"A Study of an Oral Short-course Regimen Including Bedaquiline for the Treatment of Participants With Multidrug-resistant Tuberculosis in China","status":"UNKNOWN","sponsor":"Beijing Chest Hospital","startDate":"2022-05-10","conditions":"Tuberculosis, Multidrug-Resistant","enrollment":212},{"nctId":"NCT02583048","phase":"PHASE2","title":"Evaluating the Safety, Tolerability, and Pharmacokinetics of Bedaquiline and Delamanid, Alone and in Combination, For Drug-Resistant Pulmonary Tuberculosis","status":"COMPLETED","sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","startDate":"2016-08-15","conditions":"Tuberculosis, HIV Infections","enrollment":84},{"nctId":"NCT04629378","phase":"PHASE2","title":"Evaluating the EBA of Meropenem With Amoxicillin/Clavulanate and Pyrazinamide or Bedaquiline in Adults With PTB","status":"COMPLETED","sponsor":"TASK Applied Science","startDate":"2020-08-17","conditions":"Tuberculosis","enrollment":22},{"nctId":"NCT02193776","phase":"PHASE2","title":"A Phase 2 to Evaluate the Efficacy, Safety and Tolerability of Combinations of Bedaquiline, Moxifloxacin, PA-824 and Pyrazinamide in Adult Subjects With Drug-Sensitive or Multi Drug-Resistant Pulmonary Tuberculosis.","status":"COMPLETED","sponsor":"Global Alliance for TB Drug Development","startDate":"2014-10-23","conditions":"Tuberculosis","enrollment":240},{"nctId":"NCT03032367","phase":"EARLY_PHASE1","title":"TASK-002: Bioequivalence of Bedaquiline 400mg Administered in Crushed Form Compared to Tablet Form in Healthy Male and Female Adults Under Fed Conditions (BDQ Crush Study)","status":"COMPLETED","sponsor":"International Maternal Pediatric Adolescent AIDS Clinical Trials Group","startDate":"2016-11-10","conditions":"Tuberculosis","enrollment":24},{"nctId":"NCT01600963","phase":"PHASE3","title":"A Study to Evaluate the Efficacy and Safety of TMC207 in Patients With Pulmonary Infection With Multi-drug Resistant Mycobacterium Tuberculosis","status":"WITHDRAWN","sponsor":"Janssen Infectious Diseases BVBA","startDate":"2014-03","conditions":"Multi-drug Resistant Tuberculosis","enrollment":""},{"nctId":"NCT01803373","phase":"PHASE1","title":"A Study to Assess the Relative Bioavailability of TMC207 Following Single-Dose Administrations of Two Pediatric Formulations in Healthy Adult Participants","status":"COMPLETED","sponsor":"Janssen Infectious Diseases BVBA","startDate":"2013-04","conditions":"Healthy, Biological Availability","enrollment":36},{"nctId":"NCT00946842","phase":"PHASE1","title":"A Study to Determine the Relative Oral Bioavailability of Single Dose Administration of TMC207, Under Fed and Fasted Conditions in Healthy Participants","status":"COMPLETED","sponsor":"Tibotec BVBA","startDate":"2009-08","conditions":"Healthy","enrollment":28}],"_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":["Sirturo"],"phase":"phase_3","status":"active","brandName":"Bedaquiline Oral Tablet","genericName":"Bedaquiline Oral Tablet","companyName":"Wits Health Consortium (Pty) Ltd","companyId":"wits-health-consortium-pty-ltd","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":1,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}