Bedaquiline
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.
Developed by Janssen, In 2012, bedaquiline received conditional approved by the US FDA for the treatment of MDR-TB, in addition to the current second-line treatment regimen. A 2018 WHO Rapid Communication on MDR-TB treatment guidelines prioritized bedaquiline among the the drugs for treatment of MDR-TB.
Bedaquiline is used in many of the new TB and drug-resistant TB treatment regimens currently in development by TB Alliance, as well as in the FDA-approved BPaL regimen.
Peer Reviewed Publications
Clinical Trials
- A Study to Evaluate the Efficacy and Safety of TMC207 in Patients With Pulmonary Infection With Multi-drug Resistant Mycobacterium Tuberculosis
- Early Access of TMC207 in Patients With Extensively Drug Resistant or Pre-XDR Pulmonary Tuberculosis
- Evaluation of Early Bactericidal Activity in Pulmonary Tuberculosis With (J-M-Pa-Z)
- Evaluation of Early Bactericidal Activity in Pulmonary Tuberculosis With Clofazimine (C)-TMC207 (J)-PA-824 (Pa)-Pyrazinamide (Z) (NC-003)
- TMC207-TiDP13-C208: Anti-bacterial Activity, Safety, and Tolerability of TMC207 in Patients With Multi-drug Resistant Mycobacterium Tuberculosis (MDR-TB).
- To Evaluate the Safety, Tolerability, and Efficacy of TMC207 as Part of an Individualized Multi-drug Resistant Tuberculosis (MDR-TB) Treatment Regimen in Participants With Sputum Smear-positive Pulmonary MDR-TB
- Evaluation of Early Bactericidal Activity in Pulmonary Tuberculosis
- TMC207-C202: Study to Evaluate Bactericidal Activity of Multiple Oral Doses of TMC207 in Subjects With Sputum-Smear Positive Tuberculosis
- TMC207-TiDP13-C110: Interaction Study With Lopinavir/Ritonavir in Healthy Volunteer
- Safety, Tolerability, and Effect of TMC207 and Efavirenz in Healthy Volunteers
- TMC207-TiDP13-C117: Interaction Study in Human Immunodeficiency Virus-type 1 (HIV-1) Infected Patients With Nevirapine (NVP)
- A Study to Assess the Relative Bioavailability of TMC207 Following Single-Dose Administrations of Two Pediatric Formulations in Healthy Adult Participants
- A Study to Determine the Relative Oral Bioavailability of Single Dose Administration of TMC207, Under Fed and Fasted Conditions in Healthy Participants
- TMC207 +/- Rifabutin/Rifampin
- A Study of TMC207 in Patients With Moderately Impaired Hepatic Function
- TMC207TBC1003 - A Study in Healthy Volunteers Investigating the Effect of Single-dose TMC207 on the QT/QTc Interval Under Fed Conditions