PRETOMANID
Pretomanid is an antimycobacterial indicated as part of a specific combination regimen with bedaquiline and linezolid (the BPaL regimen) for the treatment of adults with pulmonary tuberculosis (TB) exhibiting specific resistance profiles. It is indicated for patients with extensively drug-resistant (XDR) TB (resistant to isoniazid, rifamycins, a fluoroquinolone, and a second-line injectable) or those with multidrug-resistant (MDR) TB who are treatment-intolerant or nonresponsive to standard therapy. This drug was approved under the Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD) based on limited clinical data. It is not indicated for drug-sensitive TB, latent TB, extra-pulmonary TB, or MDR-TB that is responsive to standard therapy.
How PRETOMANID Works
Pretomanid is a nitroimidazooxazine prodrug that exhibits a dual mechanism of action against *Mycobacterium tuberculosis*. In aerobic (replicating) bacteria, it inhibits mycolic acid biosynthesis, thereby disrupting the formation of the bacterial cell wall. In anaerobic (non-replicating) conditions, pretomanid acts as a respiratory poison by releasing reactive nitrogen species, including nitric oxide, which leads to the poisoning of the bacterial respiratory chain and subsequent ATP depletion. This dual activity allows it to target both active and dormant populations of the bacilli.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2019-08-14
- Patent Cliff
- 2029
- Routes
- ORAL
- Dosage Forms
- TABLET
PRETOMANID Approval History
What PRETOMANID Treats
1 indicationsPRETOMANID is approved for 1 conditions since its original approval in 2019. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Tuberculosis
PRETOMANID Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to PRETOMANID
3 of 5FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
11 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05586230 | IMPAACT 2034 38754 | Ph 1 | completed | Study of a Single Dose of Pretomanid Added to an Optimized Background Regimen in Children With Rifampicin-Resistant Tuberculosis |
| NCT06192160 RAD-TB | A5409 DOH-27-032024-5399 | Ph 2 | recruiting | Trial of Novel Regimens for the Treatment of Pulmonary Tuberculosis |
| NCT06441006 PRISM-TB | 7200AA22CA00005 7200AA22CA00005 | Ph 2, Ph 3 | recruiting | Program for Rifampicin-Resistant Disease With Stratified Medicine for Tuberculosis |
| NCT05686356 panTB-HM | AUR1-1-312 24206, 6986 | Ph 2, Ph 3 | active not recruiting | A Pan-TB Regimen Targeting Host and Microbe |
| NCT06058299 | NC-009 | Ph 2 | active not recruiting | Phase 2 Trial Assessing TBAJ876 or Bedaquiline, with Pretomanid and Linezolid in Adults with Drug-sensitive Pulmonary Tuberculosis |
| NCT04179500 PaSEM results posted | Pa-824-CL-012 | Ph 2 | completed | A Trial to Evaluate the Male Reproductive Safety of Pretomanid in Adult Male Participants With Drug Resistant Pulmonary Tuberculosis |
| NCT04309656 results posted | Pa-824-CL-011 | Ph 1 | completed | Single-dose Study in Two Panels of Healthy Adult Participants to Assess Immediate-Release and Dispersible Formulations of Pretomanid |
| NCT02589782 TB-PRACTECAL | 1541 | Ph 2, Ph 3 | completed | Pragmatic Clinical Trial for a More Effective Concise and Less Toxic MDR-TB Treatment Regimen(s) |
| NCT04207112 PRACTECAL-EE | PRACTECAL-EE | Ph 2, Ph 3 | completed | Economic Evaluation of New MDR TB Regimens |
| NCT03338621 results posted | SimpliciTB (B-Pa-M-Z) NC-008 | Ph 2, Ph 3 | completed | Trial to Evaluate the Efficacy, Safety and Tolerability of BPaMZ in Drug-Sensitive (DS-TB) Adult Patients and Drug-Resistant (DR-TB) Adult Patients |
| NCT03086486 ZeNix results posted | ZeNix (B-Pa-L) NC-007 | Ph 3 | completed | Various Doses and Durations of Linezolid Plus Bedaquiline & Pretomanid in Participants With Drug Resistant Tuberculosis |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
PRETOMANID FDA Label Details
Indications & Usage
FDA Label (PDF)PRETOMANID is indicated for the treatment of Tuberculosis.
PRETOMANID Patents & Exclusivity
Exclusivity
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment