NDAORALTABLETPriority Review
Approved
Aug 2019
Lifecycle
Post-LOE
Competitive Pressure
35/100
Clinical Trials
5
Mechanism of Action
Organic Anion Transporter 3 Inhibitors
Pharmacologic Class:
Antimycobacterial
Clinical Trials (5)
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
72 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
Single-dose Study in Two Panels of Healthy Adult Participants to Assess Immediate-Release and Dispersible Formulations of Pretomanid
Started Jan 2020
48 enrolled
Multi-drug Resistant Tuberculosis
Various Doses and Durations of Linezolid Plus Bedaquiline & Pretomanid in Participants With Drug Resistant Tuberculosis
Started Nov 2017
181 enrolled
Tuberculosis, PulmonaryTuberculosis, Multidrug-ResistantTuberculosis, MDR+4 more
Loss of Exclusivity
LOE Date
Aug 14, 2024
19 months ago
Exclusivity Expiry
Aug 14, 2029