NDAORALTABLETPriority Review
Approved
Aug 2019
Lifecycle
Post-LOE
Competitive Pressure
35/100
Clinical Trials
8
Data completeness
4/8 — Partial
Priority Review
PRETOMANID (pretomanid) by Viatris (2) is organic anion transporter 3 inhibitors [moa]. First approved in 2019.
Drug data last refreshed 5h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Pretomanid is an oral antimycobacterial tablet approved in 2019 that works by inhibiting organic anion transporter 3, disrupting bacterial energy metabolism. It is indicated for drug-resistant tuberculosis as part of combination therapy. The drug represents a novel mechanism class for treating difficult-to-treat mycobacterial infections.
$0.056BPart D
Post-LOEPost-LOEProduct has entered post-LOE phase with minimal Part D spending, indicating small commercial team and limited growth opportunities in U.S. markets.
Mechanism of Action
Organic Anion Transporter 3 Inhibitors
Pharmacologic Class:
Antimycobacterial
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (8)
Bactericidal Activity and Safety of Nicotinamide in Combination With Bedaquiline, Pretomanid, and Linezolid in Drug-susceptible Pulmonary Tuberculosis
Started Apr 2026
165 enrolled
Drug Susceptible Pulmonary Tuberculosis
Single-Dose Study to Evaluate the PKs of Pretomanid in Participants With Renal Impairment Compared to Participants With Normal Renal Function
Started Apr 2024
12 enrolled
Renal ImpairmentTuberculosis
Phase 2 Trial Assessing TBAJ876 or Bedaquiline, with Pretomanid and Linezolid in Adults with Drug-sensitive Pulmonary Tuberculosis
Started Oct 2023
309 enrolled
Pulmonary TBPulmonary TuberculosisDrug Sensitive Tuberculosis
Study of a Single Dose of Pretomanid Added to an Optimized Background Regimen in Children With Rifampicin-Resistant Tuberculosis
Started Oct 2023
32 enrolled
TuberculosisRifampicin Resistant Tuberculosis
A Trial to Evaluate the Male Reproductive Safety of Pretomanid in Adult Male Participants With Drug Resistant Pulmonary Tuberculosis
Started Sep 2021
26 enrolled
Tuberculosis, PulmonaryTuberculosis, Multidrug-ResistantTuberculosis, MDR+2 more
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.