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Bedaquiline Oral Tablet
Bedaquiline inhibits bacterial ATP synthase, disrupting energy production in Mycobacterium tuberculosis.
Bedaquiline inhibits bacterial ATP synthase, disrupting energy production in Mycobacterium tuberculosis. Used for Multidrug-resistant tuberculosis (MDR-TB), Extensively drug-resistant tuberculosis (XDR-TB).
At a glance
| Generic name | Bedaquiline Oral Tablet |
|---|---|
| Also known as | Sirturo |
| Sponsor | Wits Health Consortium (Pty) Ltd |
| Drug class | ATP synthase inhibitor |
| Target | Mycobacterial ATP synthase |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | Phase 3 |
Mechanism of action
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.
Approved indications
- Multidrug-resistant tuberculosis (MDR-TB)
- Extensively drug-resistant tuberculosis (XDR-TB)
Common side effects
- QT prolongation
- Hepatotoxicity
- Nausea
- Arthralgia
- Photosensitivity
Key clinical trials
- Feasibility of the Application of a New Six-month Treatment for Multidrug-resistant Tuberculosis (MDR-TB) Patients in France (FAST-MDR) (PHASE3)
- 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 (PHASE2)
- Trial of Novel Regimens for the Treatment of Pulmonary Tuberculosis (PHASE2)
- 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 (PHASE2)
- Innovating Shorter, All- Oral, Precised Treatment Regimen for Rifampicin Resistant Tuberculosis：BLMZ Chinese Cohort (PHASE3)
- Pharmacokinetic Study of Antiretroviral Drugs and Related Drugs During and After Pregnancy
- Short-Course Regimen With Bedaquiline, Moxifloxacin and Pyrazinamide for Early Bactericidal Activity in Drug-Susceptible Tuberculosis (PHASE2)
- Linezolid Dosing Strategies in Drug-Resistant TB (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Bedaquiline Oral Tablet CI brief — competitive landscape report
- Bedaquiline Oral Tablet updates RSS · CI watch RSS
- Wits Health Consortium (Pty) Ltd portfolio CI