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Isoniazid Oral Product
Isoniazid inhibits mycobacterial cell wall synthesis by blocking mycolic acid production, which is essential for Mycobacterium tuberculosis survival.
Isoniazid inhibits mycobacterial cell wall synthesis by blocking mycolic acid production, which is essential for Mycobacterium tuberculosis survival. Used for Tuberculosis (TB) - active disease treatment, Tuberculosis latent infection prevention.
At a glance
| Generic name | Isoniazid Oral Product |
|---|---|
| Also known as | INH |
| Sponsor | Wits Health Consortium (Pty) Ltd |
| Drug class | Antimycobacterial agent |
| Target | Enoyl-ACP reductase (InhA), Catalase-peroxidase (KatG) |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | Phase 3 |
Mechanism of action
Isoniazid is a prodrug that requires activation by the mycobacterial enzyme catalase-peroxidase (KatG) to form an isonicotinoyl radical. This activated form binds to mycobacterial enoyl-ACP reductase (InhA), inhibiting the synthesis of mycolic acids that are critical structural components of the mycobacterial cell wall. This disruption of cell wall integrity leads to bacterial death and is bactericidal against actively dividing M. tuberculosis.
Approved indications
- Tuberculosis (TB) - active disease treatment
- Tuberculosis latent infection prevention
Common side effects
- Peripheral neuropathy
- Hepatotoxicity
- Hypersensitivity reactions
- Drug-induced lupus
- Nausea and vomiting
- Headache
Key clinical trials
- Phase 2 Trial to Evaluate the Safety and Tolerability and Early Bactericidal Activity of RESP30TB in Tuberculosis (PHASE2)
- Pharmacokinetic Study of Antiretroviral Drugs and Related Drugs During and After Pregnancy
- PanACEA - STEP2C -01 (PHASE2)
- Pharmacokinetic and Pharmacodynamic Study of High-Dose Rifapentine and Moxifloxacin for Treatment of Tuberculosis (PHASE3)
- Short-course Regimens for the Treatment of Pulmonary Tuberculosis (PHASE2, PHASE3)
- Short-Course Regimen With Bedaquiline, Moxifloxacin and Pyrazinamide for Early Bactericidal Activity in Drug-Susceptible Tuberculosis (PHASE2)
- Evaluating the Early Bactericidal Activity, Safety and Tolerability of Nebulised RESP301 in Adults With Tuberculosis (PHASE2)
- Triage Test for All Oral DR-TB Regimen (TRiAD Study)
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:
- Isoniazid Oral Product CI brief — competitive landscape report
- Isoniazid Oral Product updates RSS · CI watch RSS
- Wits Health Consortium (Pty) Ltd portfolio CI