|Systematic (IUPAC) name|
|Licence data||US FDA:|
|Pregnancy cat.||B (US)|
|Legal status||℞-only (US)|
|Synonyms||TMC207; R207910; AIDS222089|
|Mol. mass||555.5 g/mol|
Bedaquiline (trade name Sirturo, code names TMC207 and R207910) is a diarylquinoline anti-tuberculosis drug, which was discovered by a team led by Koen Andries at Janssen Pharmaceutica. It is the first new medicine to fight TB in more than forty years, and is specifically approved to treat multi-drug-resistant tuberculosis.
Mode of action
Clinical trials and approval
Bedaquiline was described for the first time in 2004 at the Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) meeting, after the drug had been in development for over seven years.
One of the first published trials of Bedaquiline was a Phase II trial of 47 patients, which showed that the drug was effective in reducing the time to TB-free sputum cultures. A subsequent phase II efficacy trial was published in 2010 and sponsored by Tibotec and the TB Alliance.
It is manufactured by Johnson & Johnson (J&J), who sought accelerated approval of the drug, a type of temporary approval for diseases lacking other viable treatment options. By gaining approval for a drug that treats a neglected disease, J&J is now able to request expedited FDA review of a future drug.
It was formally approved for use by the U.S. Food and Drug Administration (FDA) for use in tuberculosis (TB) treatment, as part of a fast-track approval for use only in cases of multi-drug-resistant tuberculosis, and the more resistant extensively drug resistant tuberculosis.
There is some controversy over the approval for the drug, as the FDA's ruling was based on a surrogate outcome (sputum cultures) as opposed to patient deaths. In the clinical trials used for approval, the patients taking bedaquiline were more likely to die, even though they had resolution of TB based on sputum cultures.
The most common side effects of bedaquiline in studies were nausea, joint and chest pain, and headache. The drug also has a black-box warning for arrhythmias, as it may induce long QT syndrome by blocking the hERG channel.
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- Drugs.com: Sirturo Side Effects
- Multi-drug-resistant tuberculosis (MDR-TB)