bedaquiline: Clinical Trials

79 trials of bedaquiline, newest first

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46 completed, 11 recruiting, 7 active not recruiting, 7 not yet recruiting. 44 Phase 2, 27 Phase 3, 12 Phase 1, 3 Not applicable, 1 Early Phase 1.

By phase and status

PhaseTrialsStatus
Phase 244Completed 27, Recruiting 6, Active not recruiting 5, Not yet recruiting 2, Suspended 2, Terminated 1, Unknown 1
Phase 327Completed 12, Recruiting 7, Active not recruiting 4, Not yet recruiting 2, Unknown 2
Phase 112Completed 10, Enrolling by invitation 1, Not yet recruiting 1
Not applicable3Not yet recruiting 2, Completed 1
Early Phase 11Completed 1
Phase 41Unknown 1

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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.

TrialPhaseStatusSponsorEnrollmentStartUpdated
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
Sulbactam 25mg/kg -Durlobactam 25mg/kg (Every 6 hours), Ceftriaxone for Injection, Amoxicillin - Mycobacterium Abscessus Pulmonary Disease, Mycobacterium Abscessus Infection
Phase 2Not yet recruitingThe University of Queensland3002027-04-012026-03-20
A 6-Month MDR-END Plus Regimen for Rifampicin-Resistant Tuberculosis
MDR-END Plus regimen, Standard-of-care (SoC) treatment - Rifampicin-Resistant Tuberculosis
Phase 3Not yet recruitingSeoul National University Hospital2942026-10-012026-06-30
Feasibility of the Application of a New Six-month Treatment for Multidrug-resistant Tuberculosis (MDR-TB) Patients in France (FAST-MDR)
Bedaquiline Oral Tablet - MDR-TB, Tuberculosis Multi Drug Resistant Active
Phase 3RecruitingAssistance Publique - Hôpitaux de Paris552026-09-112026-09-16
Bedaquiline Roll-out Evidence in Contacts and People Living With HIV to Prevent TB
Bedaquiline, Isoniazid, rifapentine, Levofloxacin - Tuberculosis, Latent
Phase 2 / Phase 3RecruitingJohns Hopkins University25302026-05-082026-10-20
Bactericidal Activity and Safety of Nicotinamide in Combination With Bedaquiline, Pretomanid, and Linezolid in Drug-susceptible Pulmonary Tuberculosis
Bedaquiline, pretomanid, linezolid, Nicotinamide (NAM) - Drug Susceptible Pulmonary Tuberculosis
Phase 2SuspendedGates Medical Research Institute1652026-04-172026-08-10
Bactericidal Activity of TBD09 in Combination With Other Drugs in Pulmonary Tuberculosis
Bedaquiline, pretomanid and TBD09, Bedaquiline, pretomanid and linezolid - Drug Susceptible Pulmonary Tuberculosis
Phase 2RecruitingGates Medical Research Institute1502026-04-142026-07-30
Pharmacokinetics of Antituberculosis Drugs in Breastfeeding Women
Standard dose rifampicin, High dose rifampicin, Standard dose isoniazid - Tuberculosis Infection, Healthy Volunteer
Phase 1Not yet recruitingMcGill University Health Centre/Research Institute of the McGill University Health Centre602026-04-012026-02-10
Bacteriophage Therapy for Mycobacterium Abscessus Pulmonary Infection
Mycobacteriophage Muddy_HRMN0052, Amikacin Injection, Clofazimine - Non-Tuberculous Mycobacterial (NTM) Pneumonia, Mycobacterium Abscessus Infection
Phase 1Enrolling by invitationVancouver Coastal Health12026-01-112026-06-03
A Study of Quabodepistat-containing Regimens for the Treatment of Drug-resistant Pulmonary Tuberculosis
BPaQM, BPaLM, BPaQ - Pulmonary Tuberculosis
Phase 3RecruitingOtsuka Pharmaceutical Development & Commercialization, Inc.5322025-10-162026-05-06
Program for Rifampicin-Resistant Disease With Stratified Medicine for Tuberculosis
Bedaquiline, Linezolid, Pretomanid - Tuberculosis, Pulmonary, Tuberculosis, Multidrug-Resistant
Phase 2 / Phase 3RecruitingUniversity of California, San Francisco4002025-10-032026-09-02
6 Months of Bedaquiline(BDQ), Delamanid(DLM), Linezolid(LZD) and Levofloxacin(LFX) in RR-TB Patients in Hubei Province
bedaquiline, Delamanid (DLM), Linezolid (LZD) - Treat to Target, Treatment Duration
Not applicableNot yet recruitingWuhan Pulmonary Hospital522025-09-302025-09-30
A Study on the Short-course Treatment Regimen Containing Pretomanid for Drug-resistant Tuberculosis
bedaquiline, Pretomanid (Pa), linezolid - Efficacy and Safety
Not applicableNot yet recruitingWuhan Pulmonary Hospital2002025-09-012025-08-17
Short-Course Regimen With Bedaquiline, Moxifloxacin and Pyrazinamide for Early Bactericidal Activity in Drug-Susceptible Tuberculosis
Bedaquiline (B), Moxifloxacin, Pyrazinamide (PZA) - Tuberculosis, Pulmonary, Drug-Susceptible Pulmonary Tuberculosis
Phase 2Not yet recruitingShanghai Pulmonary Hospital, Shanghai, China452025-08-202025-08-19
Ultra-Short Regimen for Elderly DS-TB
Bedaquiline (B), Sitafloxacin (S), Linezolid (L) - Pulmonary Tuberculosis
Phase 3Not yet recruitingShenzhen Third People's Hospital3002025-07-252025-07-22
A PAN-USR TB Multi-Center Trial
Bedaquiline (B), Sitafloxacin (S), Linezolid (L) - Pulmonary Tuberculosis
Phase 3RecruitingShenzhen Third People's Hospital6102025-06-182025-12-01
Trial of Novel Regimens for the Treatment of Pulmonary Tuberculosis
Isoniazid, Rifampicin, Pyrazinamide - Pulmonary Tuberculosis
Phase 2RecruitingNational Institute of Allergy and Infectious Diseases (NIAID)3152025-03-112026-10-19
Innovating Shorter, All- Oral, Precised Treatment Regimen for Rifampicin Resistant Tuberculosis:BDLL Chinese Cohort
bedaquiline, delamanid, linezolid - Drug-resistant Tuberculosis, Pulmonary Tuberculosis
Phase 3Active not recruitingHuashan Hospital1202024-11-272025-09-02
Platform Assessing Regimens and Durations In a Global Multisite Consortium for TB
Ganfeborole, BTZ-043, Bedaquiline (B) - Pulmonary Tuberculosis
Phase 2RecruitingUniversity College, London25002024-01-092026-10-15
Innovating Shorter, All- Oral, Precised, Individualized Treatment Regimen for Rifampicin Resistant Tuberculosis:Contezolid, Delamanid and Bedaquiline Cohort
Bedaquiline, Delamanid, Contezolid - Pulmonary Tuberculosis, Rifampicin-resistant Tuberculosis
Phase 3Active not recruitingBeijing Chest Hospital1862023-12-222025-04-01
Ultra-Short Course Bedaquiline, Clofazimine, Pyrazinamide and Delamanid Versus Standard Therapy for Drug-Susceptible Tuberculosis
Bedaquiline (BDQ), Clofazimine (CFZ), Pyrazinamide (PZA) - Tuberculosis, Pulmonary, HIV
Phase 2Active not recruitingBrigham and Women's Hospital942023-11-242026-08-05

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Conditions studied

Tuberculosis (36)  ·  Tuberculosis, Pulmonary (34)  ·  Tuberculosis, Multidrug-Resistant (28)  ·  Extensively Drug-Resistant Tuberculosis (9)  ·  HIV Infections (4)  ·  Latent Tuberculosis (3)  ·  Mycobacterium Infections, Nontuberculous (3)  ·  Bacterial Infections (2)  ·  Gram-Positive Bacterial Infections (2)  ·  Infections (2)  ·  Lung Diseases (2)  ·  Breast Feeding (1)  ·  Disease (1)  ·  Leprosy (1)  ·  Leprosy, Multibacillary (1)

Sponsors

Global Alliance for TB Drug Development (10)  ·  National Institute of Allergy and Infectious Diseases (NIAID) (7)  ·  Tibotec BVBA (5)  ·  Janssen Research & Development, LLC (4)  ·  Medecins Sans Frontieres, Netherlands (4)  ·  Gates Medical Research Institute (3)  ·  Janssen Infectious Diseases BVBA (3)  ·  Beijing Chest Hospital (2)  ·  Huashan Hospital (2)  ·  Janssen Pharmaceutical K.K. (2)  ·  Michael Hoelscher (2)  ·  Médecins Sans Frontières, France (2)  ·  Otsuka Pharmaceutical Development & Commercialization, Inc. (2)  ·  Shanghai Jiatan Pharmatech Co., Ltd (2)  ·  Shenzhen Third People's Hospital (2)

Countries

South Africa (42)  ·  Philippines (11)  ·  Uganda (11)  ·  China (10)  ·  Peru (10)  ·  Tanzania (10)  ·  Georgia (7)  ·  India (7)  ·  Brazil (6)  ·  Russia (6)  ·  Thailand (6)  ·  Vietnam (6)  ·  Haiti (5)  ·  United States (5)  ·  Belarus (4)

Top investigators

Andreas Diacon (2)  ·  Carole Mitnick, Sc.D (2)  ·  Kelly Dooley, MD (2)  ·  Kelly Dooley, MD, PhD (2)  ·  Lorenzo Guglielmetti, MD (2)  ·  Morounfolu Olugbosi, MD (2)  ·  A-Dong Shen, Master (1)  ·  Andreas Diacon, MD (1)  ·  Andrew Nunn, PhD (1)  ·  Anneke Hesseling, M.D., Ph.D. (1)  ·  Anthony Garcia-Pratts, MD (1)

Results publications

PMID 36808186, PMID 25114140, PMID 26647431, PMID 36053506, PMID 36546625, PMID 37035978, PMID 37980911, PMID 38768617, PMID 16470119, PMID 16988514, PMID 18366444, PMID 18505852, PMID 18795962, PMID 18989231, PMID 19494215, PMID 20002783, PMID 20632458, PMID 21283017, PMID 22083071, PMID 22129166, PMID 22828481, PMID 23305215, PMID 23392467, PMID 25140958, PMID 25162818, PMID 25261418, PMID 25407158, PMID 25512422, PMID 25622149, PMID 25950206, PMID 25959631, PMID 26038418, PMID 26104205, PMID 26202768, PMID 26918544, PMID 26929418, PMID 27540363, PMID 29061739, PMID 29369162, PMID 29520730, PMID 29528944, PMID 30024924, PMID 30102705, PMID 30134297, PMID 30358179, PMID 30530925, PMID 30715324, PMID 30865791, PMID 31489678, PMID 31676905

NIH funding

2018 (2), 2008 (1), 2009 (1), 2014 (1), U01AI152980 (1), U01AI170426 (1)