Clinical Trials

Numerous clinical trials evaluate bedaquiline fumarate from Early Phase 1 to Phase 4, focusing primarily on drug-susceptible, multidrug-resistant, and extensively drug-resistant pulmonary tuberculosis, as well as non-tuberculous mycobacterial infections, multibacillary leprosy, latent tuberculosis, and TB/HIV co-infections. These studies, which encompass active, recruiting, and completed trials, assess outcomes ranging from early bactericidal activity to novel combination regimens. They are supported by diverse sponsors, including government institutes, research organizations, academic centers, non-profits, and pharmaceutical companies such as Janssen.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07675954 NOT_YET_RECRUITING
Rifampicin-Resistant Tuberculosis
Seoul National University Hospital
 2026-10-01 PHASE3
NCT06441006 RECRUITING
Tuberculosis, Pulmonary; Tuberculosis, Multidrug-Resistant; Tuberculosis, MDR
University of California, San Francisco
 2025-10-03 PHASE2; PHASE3
NCT07485010 NOT_YET_RECRUITING
Mycobacterium Abscessus Pulmonary Disease; Mycobacterium Abscessus Infection; Non-Tuberculous Mycobacterial (NTM) Infections; Non-Tuberculous Mycobacteria Pulmonary Disease
The University of Queensland
 2027-04 PHASE2
NCT07486024 NOT_YET_RECRUITING
MDR-TB; Tuberculosis Multi Drug Resistant Active; Antibiotic Resistance; Mycobacterium Tuberculosis
Assistance Publique - Hôpitaux de Paris
 2026-04 PHASE3
NCT07076225 NOT_YET_RECRUITING
Pulmonary Tuberculosis
Shenzhen Third People's Hospital
 2025-07-25 PHASE3
NCT04310930 RECRUITING
Pulmonary Disease Due to Mycobacteria (Diagnosis)
The University of Queensland
 2020-03-02 PHASE2; PHASE3
NCT06905522 RECRUITING
Pulmonary Tuberculosis
Shenzhen Third People's Hospital
 2025-06-18 PHASE3
NCT07228702 ENROLLING_BY_INVITATION
Non-Tuberculous Mycobacterial (NTM) Pneumonia; Mycobacterium Abscessus Infection
Vancouver Coastal Health
 2026-01-11 PHASE1
NCT07198685 NOT_YET_RECRUITING
Treat to Target; Treatment Duration
Wuhan Pulmonary Hospital
 2025-09-30
NCT07126639 NOT_YET_RECRUITING
Efficacy and Safety
Wuhan Pulmonary Hospital
 2025-09-01
NCT06568484 RECRUITING
Tuberculosis, Latent
Johns Hopkins University
 2026-05-08 PHASE2; PHASE3
NCT07517445 SUSPENDED
Drug Susceptible Pulmonary Tuberculosis
Gates Medical Research Institute
 2026-04-17 PHASE2
NCT03828201 ACTIVE_NOT_RECRUITING
Tuberculosis, Multidrug-Resistant
Boston University
 2022-06-07 PHASE2
NCT05597280 RECRUITING
Leprosy
Institute of Tropical Medicine, Belgium
 2023-03-22 PHASE3
NCT06649721 ACTIVE_NOT_RECRUITING
Drug-resistant Tuberculosis; Pulmonary Tuberculosis; Rifampin-resistant Tuberculosis
Huashan Hospital
 2024-11-27 PHASE3
NCT06114628 RECRUITING
Pulmonary Tuberculosis
University College, London
 2024-01-09 PHASE2
NCT02354014 RECRUITING
Tuberculosis, Multidrug-Resistant
Janssen Research & Development, LLC
 2016-05-03 PHASE2
NCT07129629 NOT_YET_RECRUITING
Tuberculosis, Pulmonary; Drug-Susceptible Pulmonary Tuberculosis
Shanghai Pulmonary Hospital, Shanghai, China
 2025-08-20 PHASE2
NCT05766267 ACTIVE_NOT_RECRUITING
Tuberculosis, Pulmonary; Tuberculosis Infection
Centers for Disease Control and Prevention
 2023-11-21 PHASE2; PHASE3
NCT06192160 RECRUITING
Pulmonary Tuberculosis
National Institute of Allergy and Infectious Diseases (NIAID)
 2025-03-11 PHASE2
NCT07525427 RECRUITING
Drug Susceptible Pulmonary Tuberculosis
Gates Medical Research Institute
 2026-04-14 PHASE2
NCT07069582 NOT_YET_RECRUITING
Tuberculosis Infection; Healthy Volunteer; Breastfeeding
McGill University Health Centre/Research Institute of the McGill University Health Centre
 2026-04-01 PHASE1
NCT06081361 ACTIVE_NOT_RECRUITING
Pulmonary Tuberculosis; Rifampicin-resistant Tuberculosis
Beijing Chest Hospital
 2023-12-22 PHASE3
NCT05686356 ACTIVE_NOT_RECRUITING
Tuberculosis
The Aurum Institute NPC
 2023-07-28 PHASE2; PHASE3
NCT05824871 RECRUITING
Rifampin-Resistant Pulmonary Tuberculosis; Tuberculosis, Multidrug-Resistant (MDR-TB)
Shanghai Jiatan Pharmatech Co., Ltd
 2022-09-02 PHASE3
NCT05306223 UNKNOWN
Tuberculosis, Multidrug-Resistant
Beijing Chest Hospital
 2022-05-10 PHASE4
NCT05556746 ACTIVE_NOT_RECRUITING
Tuberculosis, Pulmonary; HIV
Brigham and Women's Hospital
 2023-11-24 PHASE2
NCT06476210 UNKNOWN
Pulmonary Tuberculosis
Beijing Chest Hospital
 2024-06 PHASE4
NCT05382312 COMPLETED
Tuberculosis
GlaxoSmithKline
 2022-07-26 PHASE2
NCT05007821 COMPLETED
Tuberculosis, Multidrug-Resistant; Tuberculosis; Tuberculosis, Pulmonary
National Institute of Allergy and Infectious Diseases (NIAID)
 2022-09-27 PHASE2
NCT05971602 TERMINATED
Pulmonary Tuberculosis
Gates Medical Research Institute
 2023-07-26 PHASE2
NCT05040126 UNKNOWN
Pre-Extensively Drug-Resistant Pulmonary TB; Treatment Intolerant Multidrug-Resistant Pulmonary TB; Non-responsive Multidrug-Resistant Pulmonary TB
Tuberculosis Research Centre, India
 2021-10-07 PHASE3
NCT06058299 ACTIVE_NOT_RECRUITING
Pulmonary TB; Pulmonary Tuberculosis; Drug Sensitive Tuberculosis
Global Alliance for TB Drug Development
 2023-10-31 PHASE2
NCT04630145 COMPLETED
Treatment-refractory Mycobacterium Avium Complex-lung Disease (MAC-LD)
Janssen Pharmaceutical K.K.
 2021-01-08 PHASE2; PHASE3
NCT03896685 COMPLETED
Tuberculosis, Multidrug-Resistant; Tuberculosis; Pulmonary Tuberculoses; Mycobacterial Infections; Bacterial Infections; Gram-Positive Bacterial Infections
Médecins Sans Frontières, France
 2020-04-06 PHASE3
NCT05926466 UNKNOWN
Tuberculosis, Pulmonary; Other Specified Pulmonary Tuberculosis
Michael Hoelscher
 2023-09-21 PHASE2
NCT04717908 COMPLETED
Multidrug Resistant Tuberculosis
Huashan Hospital
 2021-01-20
NCT04062201 COMPLETED
Tuberculosis; Pre-XDR-TB; Extensively Drug-Resistant Tuberculosis; Multi Drug Resistant Tuberculosis; Rifampicin Resistant Tuberculosis
Wits Health Consortium (Pty) Ltd
 2019-08-22 PHASE3
NCT05221502 COMPLETED
Pulmonary TB
Otsuka Pharmaceutical Development & Commercialization, Inc.
 2022-04-12 PHASE2
NCT02906007 COMPLETED
Tuberculosis; HIV
National Institute of Allergy and Infectious Diseases (NIAID)
 2017-09-21 PHASE1; PHASE2
NCT04179500 COMPLETED
Tuberculosis, Pulmonary; Tuberculosis, Multidrug-Resistant; Tuberculosis, MDR; Tuberculosis; Drug-Resistant Tuberculosis
Global Alliance for TB Drug Development
 2021-09-16 PHASE2
NCT02754765 COMPLETED
Tuberculosis, Multidrug-Resistant; Infection, Bacterial; Pulmonary Tuberculoses
Médecins Sans Frontières, France
 2016-12 PHASE3
NCT05406479 COMPLETED
Leprosy
Institute of Tropical Medicine, Belgium
 2022-07-14 PHASE2
NCT03384641 COMPLETED
Leprosy, Multibacillary
Janssen Research & Development, LLC
 2018-09-26 PHASE2
NCT04550832 COMPLETED
Infections and Infestations; Pulmonary Tuberculosis
LigaChem Biosciences, Inc.
 2021-10-28 PHASE2
NCT04545788 UNKNOWN
Tuberculosis
Beijing Chest Hospital
 2020-08-01
NCT04081077 UNKNOWN
Multi-drug Resistant Tuberculosis; Extensively Drug-Resistant Tuberculosis; Pulmonary Tuberculosis
Medecins Sans Frontieres, Netherlands
 2019-08-06 PHASE2; PHASE3
NCT03959566 COMPLETED
Pulmonary Tuberculosis; Other Specified Pulmonary Tuberculosis
Michael Hoelscher
 2021-05-06 PHASE2
NCT04207112 COMPLETED
Multi-drug Resistant Tuberculosis; Extensively Drug-Resistant Tuberculosis; Pulmonary Tuberculoses
Medecins Sans Frontieres, Netherlands
 2020-10-20 PHASE2; PHASE3
NCT02589782 COMPLETED
Tuberculosis, Multidrug-Resistant; Extensively Drug-Resistant Tuberculosis; Tuberculosis, Pulmonary
Medecins Sans Frontieres, Netherlands
 2017-01 PHASE2; PHASE3
NCT02409290 COMPLETED
MDR-TB
IUATLD, Inc
 2016-03 PHASE3
NCT04608955 COMPLETED
Pulmonary Tuberculosis
Shanghai Jiatan Pharmatech Co., Ltd
 2020-10-16 PHASE2
NCT03474198 COMPLETED
Tuberculosis, Pulmonary
University College, London
 2018-03-21 PHASE2; PHASE3
NCT03338621 COMPLETED
Tuberculosis, Pulmonary; Tuberculosis, Multidrug-Resistant; Tuberculosis, MDR; Tuberculosis; Drug-Resistant Tuberculosis
Global Alliance for TB Drug Development
 2018-07-30 PHASE2; PHASE3
NCT04629378 COMPLETED
Tuberculosis
TASK Applied Science
 2020-08-17 PHASE2
NCT03086486 COMPLETED
Tuberculosis, Pulmonary; Tuberculosis, Multidrug-Resistant; Tuberculosis, MDR; Tuberculosis; Extensively Drug-Resistant Tuberculosis; Pre-XDR-TB; XDR-TB
Global Alliance for TB Drug Development
 2017-11-21 PHASE3
NCT02454205 COMPLETED
Tuberculosis; Multidrug Resistant Tuberculosis; Extensively-drug Resistant Tuberculosis
University of Cape Town
 2015-11-12 PHASE2; PHASE3
NCT04087759 COMPLETED
Healthy
Janssen Research & Development, LLC
 2019-09-16 PHASE1
NCT03800550 COMPLETED
Healthy
Janssen Research & Development, LLC
 2019-02-13 PHASE1
NCT02333799 COMPLETED
Pulmonary Tuberculosis
Global Alliance for TB Drug Development
 2015-03 PHASE3
NCT02583048 COMPLETED
Tuberculosis; HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 2016-08-15 PHASE2
NCT02365623 COMPLETED
Tuberculosis, Multidrug-Resistant
Janssen Pharmaceutical K.K.
 2015-02-18 PHASE2
NCT03032367 COMPLETED
Tuberculosis
International Maternal Pediatric Adolescent AIDS Clinical Trials Group
 2016-11-10 EARLY_PHASE1
NCT02193776 COMPLETED
Tuberculosis
Global Alliance for TB Drug Development
 2014-10-23 PHASE2
NCT01341184 Completed
Tuberculosis
National Institute of Allergy and Infectious Diseases (NIAID)
 2011-10-21 Phase 1
NCT01215110 Completed
Pulmonary Tuberculosis
Global Alliance for TB Drug Development
 2010-04 Phase 2
NCT02216331 Completed
Tuberculosis
Global Alliance for TB Drug Development
 2010-03 Phase 1

(data from https://clinicaltrials.gov, updated on 2026-06-30)

Check the Bedaquiline fumarate product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Bedaquiline fumarate selectively binds to subunit c of bacterial proton-translocating ATP synthase, blocking the enzyme's essential proton-pumping mechanism and arresting cellular ATP synthesis. This disruption of mycobacterial bioenergetics leads to rapid bacterial cell death, driving its clinical efficacy in eradicating multidrug-resistant pulmonary tuberculosis and related mycobacterial infections.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.