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BPaL
BPaL is a three-drug combination regimen (bedaquiline, pretomanid, and linezolid) that inhibits mycobacterial ATP synthase and protein synthesis to kill drug-resistant tuberculosis bacteria.
BPaL is a three-drug combination regimen (bedaquiline, pretomanid, and linezolid) that inhibits mycobacterial ATP synthase and protein synthesis to kill drug-resistant tuberculosis bacteria. Used for Multidrug-resistant tuberculosis (MDR-TB), Extensively drug-resistant tuberculosis (XDR-TB).
At a glance
| Generic name | BPaL |
|---|---|
| Also known as | Bedaquiline, Pretomanid, Linezolid |
| Sponsor | Otsuka Pharmaceutical Development & Commercialization, Inc. |
| Drug class | Antituberculous combination therapy |
| Target | Mycobacterial ATP synthase (bedaquiline), mycobacterial DNA/proteins (pretomanid), bacterial ribosome (linezolid) |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | Phase 3 |
Mechanism of action
Bedaquiline inhibits mycobacterial ATP synthase, disrupting energy production in Mycobacterium tuberculosis. Pretomanid is a prodrug that generates reactive nitrogen species to damage mycobacterial DNA and proteins. Linezolid inhibits bacterial protein synthesis by targeting the ribosome. Together, these agents provide synergistic bactericidal activity against multidrug-resistant and extensively drug-resistant tuberculosis.
Approved indications
- Multidrug-resistant tuberculosis (MDR-TB)
- Extensively drug-resistant tuberculosis (XDR-TB)
Common side effects
- Peripheral neuropathy
- Optic neuropathy
- QT prolongation
- Hepatotoxicity
- Anemia
- Gastrointestinal disturbances
Key clinical trials
- Linezolid Tolerance During the BPaL Regimen With Dosage Personalization Based on Therapeutic Drug Monitoring (TDM) During Multidrug-Resistant Tuberculosis Treatment (PHASE4)
- A Study of Quabodepistat-containing Regimens for the Treatment of Drug-resistant Pulmonary Tuberculosis (PHASE3)
- Phase 2 Trial Assessing TBAJ876 or Bedaquiline, with Pretomanid and Linezolid in Adults with Drug-sensitive Pulmonary Tuberculosis (PHASE2)
- BPaL(M) Regimen for the Treatment of MDR/RR-TB (PHASE4)
- Modified BPaL Regimen for Managing Pre-XDR TB and MDR (TI/NR) TB in India (PHASE3)
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:
- BPaL CI brief — competitive landscape report
- BPaL updates RSS · CI watch RSS
- Otsuka Pharmaceutical Development & Commercialization, Inc. portfolio CI