Drug name
Last update: Jul 2026Bedaquiline
Developer(s)
Drug information
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Bedaquiline
Sirturo
Small molecule
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Bedaquiline (BDQ), also known as TMC207, is a diarylquinoline used for the treatment of pulmonary multidrug-resistant Mycobacterium tuberculosis (MDR-TB) as part of multifactorial treatment regimen in adult patients. BDQ inhibits mycobacterial F1F0-ATP synthase in a species-specific manner and displays potent bactericidal activity against both susceptible and MDR strains of TB. Due to possible serious adverse effects, the prescribing of BDQ requires close monitoring by experts in MDR-TB management, as its use is not recommended for all patients. BDQ is postulated to have suitable profile for long-acting injectable formulation, as it has an extended half-life (164 days), high lipophilicity (logP 7.25) and displays a low M. tuberculosis specific minimum inhibitory concentration (~0.03μg/ml).
Unknown
Unknown
Therapeutic area(s)
- TB
- Treatment
Administration route
Oral, Intramuscular, Subcutaneous, Intravenous
Associated long-acting platforms
Polymer-based particles, In-situ forming gel/implant, Based on other organic particles
Use of drug
- Administered by a nurse
- Administered by a specialty health worker
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Dosage
long acting formulation is being investigated
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Associated compounds, formulations and regimens
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Associated technologies
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Additional information
Developer(s)
Johnson & Johnson
Janssen Pharmaceuticals is a subsidiary company of Johnson & Johnson headquartered in Beerse, Belgium. They focus on manufacturing and developing pharmaceutical products for use in areas such as, Immunology, Infectious Diseases & Vaccines, Pulmonary Hypertension, Cardiovascular & Metabolism, Oncology, and Neuroscience.
Drug structure
Scale-up and manufacturing prospects
Formulations for long-acting Bedaquiline are currently in pre-clinical development, and therefore detailed scale-up information is unavailable. Several promising long-acting formulation approaches have been reported, including: (1) nanoemulsion-based chitosan nanocapsules, (2) lipid nanoparticles, and (3) a PLGA in-situ forming gel.
Detailed information regarding industrial manufacturing requirements and/or equipment lists is currently not available as long-acting bedaquiline formulations have only been produced at small-scale for preclinical research use.
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Excipients & delivery device(s)
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No delivery device
Safety, Efficacy and Evidence Summary
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