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Pretomanid (Pa)
Pretomanid (Pa) is a nitroimidazole Small molecule drug developed by Wuhan Pulmonary Hospital. It is currently in Phase 3 development for Multidrug-resistant tuberculosis (MDR-TB) and extensively drug-resistant tuberculosis (XDR-TB).
Pretomanid is a prodrug that is converted into its active form, which inhibits the enzyme dihydrofolate reductase (DHFR) in Mycobacterium tuberculosis.
Pretomanid is a prodrug that is converted into its active form, which inhibits the enzyme dihydrofolate reductase (DHFR) in Mycobacterium tuberculosis. Used for Multidrug-resistant tuberculosis (MDR-TB) and extensively drug-resistant tuberculosis (XDR-TB).
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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 | Pretomanid (Pa) |
|---|---|
| Sponsor | Wuhan Pulmonary Hospital |
| Drug class | nitroimidazole |
| Target | dihydrofolate reductase (DHFR) |
| Modality | Small molecule |
| Therapeutic area | Infectious Diseases |
| Phase | Phase 3 |
Mechanism of action
This inhibition prevents the synthesis of tetrahydrofolate, a necessary precursor for DNA synthesis and repair in the bacteria. As a result, the bacteria are unable to replicate and eventually die. Pretomanid has been shown to be effective against drug-resistant strains of tuberculosis.
Approved indications
- Multidrug-resistant tuberculosis (MDR-TB) and extensively drug-resistant tuberculosis (XDR-TB)
Common side effects
- Nausea
- Vomiting
- Diarrhea
- Abdominal pain
Key clinical trials
- Study of a Single Dose of Pretomanid Added to an Optimized Background Regimen in Children With Rifampicin-Resistant Tuberculosis (PHASE1)
- Trial of Novel Regimens for the Treatment of Pulmonary Tuberculosis (PHASE2)
- A PAN-USR TB Multi-Center Trial (PHASE3)
- PanACEA - STEP2C -01 (PHASE2)
- Platform Assessing Regimens and Durations In a Global Multisite Consortium for TB (PHASE2)
- A Phase 3 Trial Assessing Safety and Efficacy of B-Pa-L in Participants With DR-TB (PHASE3)
- A Study on the Short-course Treatment Regimen Containing Pretomanid for Drug-resistant Tuberculosis (NA)
- A Trial to Evaluate the Male Reproductive Safety of Pretomanid in Adult Male Participants With Drug Resistant Pulmonary Tuberculosis (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:
- Pretomanid (Pa) CI brief — competitive landscape report
- Pretomanid (Pa) updates RSS · CI watch RSS
- Wuhan Pulmonary Hospital portfolio CI
Frequently asked questions about Pretomanid (Pa)
What is Pretomanid (Pa)?
How does Pretomanid (Pa) work?
What is Pretomanid (Pa) used for?
Who makes Pretomanid (Pa)?
What drug class is Pretomanid (Pa) in?
What development phase is Pretomanid (Pa) in?
What are the side effects of Pretomanid (Pa)?
What does Pretomanid (Pa) target?
Related
- Drug class: All nitroimidazole drugs
- Target: All drugs targeting dihydrofolate reductase (DHFR)
- Manufacturer: Wuhan Pulmonary Hospital — full pipeline
- Therapeutic area: All drugs in Infectious Diseases
- Indication: Drugs for Multidrug-resistant tuberculosis (MDR-TB) and extensively drug-resistant tuberculosis (XDR-TB)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing