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Tuberculosis treatment
Tuberculosis treatment is a Antitubercular Small molecule drug developed by National Institute of Allergy and Infectious Diseases (NIAID). It is currently in Phase 3 development for Treatment of tuberculosis, Prophylaxis of tuberculosis.
Isoniazid works by inhibiting the synthesis of mycolic acid in Mycobacterium tuberculosis, thereby inhibiting bacterial growth and replication.
Tuberculosis treatment typically involves the use of small molecule inhibitors that target Mycobacterium tuberculosis H37Rv. The exact treatment plan for TB can vary depending on the specific condition being treated, but it often includes a combination of medications.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% 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 | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +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 | Tuberculosis treatment |
|---|---|
| Sponsor | National Institute of Allergy and Infectious Diseases (NIAID) |
| Drug class | Antitubercular |
| Target | InhA |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | Phase 3 |
Mechanism of action
Isoniazid is a prodrug that is activated by the enzyme catalase-peroxidase in M. tuberculosis. Once activated, it inhibits the enzyme enoyl-acyl carrier protein reductase (InhA), which is essential for the synthesis of mycolic acid. This leads to the accumulation of mycolic acid precursors and the inhibition of bacterial growth and replication.
Approved indications
- Treatment of tuberculosis
- Prophylaxis of tuberculosis
Common side effects
- Peripheral neuropathy
- Hepatotoxicity
- Rash
- Gastrointestinal upset
Key clinical trials
- Parent Study Name: Pulmonary Rehabilitation to Reduce Post-Tuberculosis Morbidity (TB Pure) (NA)
- Safety and Tolerability of Metformin in People With Tuberculosis (TB) and Human Immunodeficiency Virus (HIV) (PHASE2)
- The DECIDE-TB Trial; Validation of Treatment Decision Algorithms for Childhood Tuberculosis (NA)
- Study of a Single Dose of Pretomanid Added to an Optimized Background Regimen in Children With Rifampicin-Resistant Tuberculosis (PHASE1)
- Development of a Clinical-epidemiological Score Predictive of Tuberculosis.
- Feasibility of the Application of a New Six-month Treatment for Multidrug-resistant Tuberculosis (MDR-TB) Patients in France (FAST-MDR) (PHASE3)
- Peer-led Implementation of TB-HIV Education and Adherence Counseling in Uganda (NA)
- Effects of the Active Cycle of Breathing Technique With and Without Balloon Blowing Therapy in Tuberculosis (NA)
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:
- Tuberculosis treatment CI brief — competitive landscape report
- Tuberculosis treatment updates RSS · CI watch RSS
- National Institute of Allergy and Infectious Diseases (NIAID) portfolio CI
Frequently asked questions about Tuberculosis treatment
What is Tuberculosis treatment?
How does Tuberculosis treatment work?
What is Tuberculosis treatment used for?
Who makes Tuberculosis treatment?
What drug class is Tuberculosis treatment in?
What development phase is Tuberculosis treatment in?
What are the side effects of Tuberculosis treatment?
What does Tuberculosis treatment target?
Related
- Drug class: All Antitubercular drugs
- Target: All drugs targeting InhA
- Manufacturer: National Institute of Allergy and Infectious Diseases (NIAID) — full pipeline
- Therapeutic area: All drugs in Infectious Disease
- Indication: Drugs for Treatment of tuberculosis
- Indication: Drugs for Prophylaxis of tuberculosis
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing