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Pyrazinamide (PYRAZINAMIDE)
Pyrazinamide, marketed by Dava Pharms Inc, is a first-line antituberculosis agent used for the initial treatment of active tuberculosis. Its key strength lies in its mechanism of action, which effectively inhibits the growth of Mycobacterium tuberculosis, making it an essential component in combination therapy. The primary risk is the upcoming key patent expiry in 2028, which could lead to increased competition from generics.
At a glance
| Generic name | PYRAZINAMIDE |
|---|---|
| Sponsor | Dava Pharms Inc |
| Drug class | Antimycobacterial [EPC] |
| Target | Cytochrome P450 3A4 |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | FDA-approved |
| First approval | 1971 |
Approved indications
- Initial treatment of active tuberculosis
- Treatment of drug-resistant tuberculosis
- Treatment after failure with other primary drugs
Common side effects
- Hepatotoxicity
- Thrombocytopenia
- Sideroblastic anemia with erythroid hyperplasia
- Vacuolation of erythrocytes
- Increased serum iron concentration
- Adverse effects on blood clotting mechanisms
- Gout
- Fever
- Porphyria
- Dysuria
- Nausea
- Vomiting
Key clinical trials
- Safety and Tolerability of Metformin in People With Tuberculosis (TB) and Human Immunodeficiency Virus (HIV) (PHASE2)
- Shortened Regimen for Drug-susceptible TB in Children (PHASE3)
- Trial of Novel Regimens for the Treatment of Pulmonary Tuberculosis (PHASE2)
- Treatment of Tuberculosis Multidrug Resistance Treatment of Tuberculosis Multidrug Resistance
- AIPH-TB: AI-Optimised Pyrazinamide-Hydroxychloroquine vs Standard RIPE for Drug-Sensitive Pulmonary Tuberculosis - A Phase II RCT (PHASE2)
- Phase 2a Trial of Alpibectir Plus Ethionamide for Tuberculosis Meningitis (PHASE2)
- Digitally Facilitated, Integrated Community and Facility-Based Interventions: The HEART-TB Trial Protocol (NA)
- Ultra-Short Course Bedaquiline, Clofazimine, Pyrazinamide and Delamanid Versus Standard Therapy for Drug-Susceptible 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 |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| 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:
- Pyrazinamide CI brief — competitive landscape report
- Pyrazinamide updates RSS · CI watch RSS
- Dava Pharms Inc portfolio CI