Product Description
Bedaquiline is a member of the diarylquinoline class of drugs and has a unique mechanism of action, targeting the adenosine triphosphate (ATP) synthase enzyme of the TB mycobacteria. ATP-synthase is used in the process by which M.tb generates its energy supply. It is active against both M.tb and the drug-resistant TB bacteria that cause MDR-TB. Laboratory tests and clinical trials have shown it to have strong bactericidal and sterilizing properties. (Sourced from: https://www.tballiance.org/portfolio/compound/bedaquiline)
Mechanisms of Action: ATP Inhibitor
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: None *
Approval Status: Approved
Approved Countries: Austria | Belgium | Brazil | Cyprus | Czech | Estonia | European Medicines Agency | Finland | France | Greece | Hong Kong | Hungary | Iceland | India | Indonesia | Ireland | Israel | Japan | Korea | Latvia | Lithuania | Luxembourg | Malaysia | Mexico | Netherlands | New Zealand | Peru | Philippines | Poland | Portugal | Romania | Russia | Slovakia | Slovenia | South Africa | Spain | Sweden | Taiwan | Turkey | Ukraine | United Kingdom | United States | Uruguay
Approved Indications: Tuberculosis | Tuberculosis, Pulmonary
Known Adverse Events: Abdominal Pain | Chest Pain | Headache | Pain Unspecified | Arthralgia | Hemoptysis
Company: Johnson & Johnson
Company Location: NEW BRUNSWICK NJ 08933
Company CEO: Joaquin Duato
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic: Belarus, Brazil, Japan, Korea, Philippines, South Africa, Taiwan, Uzbekistan, Vietnam
Active Clinical Trial Count: 8
Highest Development Phases
Phase 3: Extensively Drug-Resistant Tuberculosis|Latent Tuberculosis|Mycobacterium Infections|Mycobacterium avium-intracellulare Infection|Other|Tuberculosis, Multidrug-Resistant|Tuberculosis, Pulmonary
Phase 2: Leprosy, Multibacillary
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| BREACH-TB | P3 |
Not yet recruiting |
Latent Tuberculosis |
2027-11-01 |
|
| DRAMATIC | P2 |
Recruiting |
Tuberculosis, Multidrug-Resistant |
2027-05-01 |
|
| jRCT2031200268 | P3 |
Recruiting |
Other |
2026-02-10 |
|
| MAC-LD | P3 |
Active, not recruiting |
Mycobacterium avium-intracellulare Infection|Mycobacterium Infections |
2025-07-17 |