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isoniazide
isoniazide is a Small molecule drug developed by Bridge BioResearch Ltd.. It is currently in Phase 2 development for Acute tuberculosis, Inactive tuberculosis, Pulmonary tuberculosis.
Isoniazid is a small molecule antibiotic used for the treatment of tuberculosis, including active and latent forms, as well as multidrug-resistant tuberculosis. It is typically taken orally, but may also be administered by injection, and is often used in combination with other medications such as rifampicin, pyrazinamide, and either streptomycin or ethambutol.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Anti-infectives pathway favourability
+2.0pp
Microbiological endpoints + non-inferiority designs raise approval rates above baseline.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | isoniazide |
|---|---|
| Sponsor | Bridge BioResearch Ltd. |
| Target | Myeloperoxidase, Cytochrome P450 3A4, Cytochrome P450 3A5 |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | Phase 2 |
Approved indications
- Acute tuberculosis
- Inactive tuberculosis
- Pulmonary tuberculosis
Common side effects
Key clinical trials
- Treatment of Tuberculosis Multidrug Resistance Treatment of Tuberculosis Multidrug Resistance
- The Effectivity of Anti Tuberculosis Therapy in Idiopathic Uveitis with Positive IGRA (PHASE2)
- Evaluation of the Early Bactericidal Activity of Tedizolid and Linezolide Against Mycobacterium Tuberculosis (TEDITUB) (PHASE2)
- Analysis of Liver Injury Risk Factors in a Multiethnic Population Treated With Antituberculosis Drugs
- Rifampicin Resistance in S. Aureus During and After Treatment for Latent Tuberculosis
- New Strategies for Assessment of the Persistence of Viable Bacilli in Latent and Active Tuberculosis
- An Evaluation of the Pharmacological Interaction of Lopinavir/r and Rifampin (PHASE4)
- Safety and Efficacy of Oral Immunomodulator in Tuberculosis (TB) and TB/HIV Patients (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 |
|---|---|
| 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:
- isoniazide CI brief — competitive landscape report
- isoniazide updates RSS · CI watch RSS
- Bridge BioResearch Ltd. portfolio CI
Frequently asked questions about isoniazide
What is isoniazide?
What is isoniazide used for?
Who makes isoniazide?
What development phase is isoniazide in?
What does isoniazide target?
Related
- Target: All drugs targeting Myeloperoxidase, Cytochrome P450 3A4, Cytochrome P450 3A5
- Manufacturer: Bridge BioResearch Ltd. — full pipeline
- Therapeutic area: All drugs in Infectious Disease
- Indication: Drugs for Acute tuberculosis
- Indication: Drugs for Inactive tuberculosis
- Indication: Drugs for Pulmonary tuberculosis
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing