Pretomanid (PA-824) has been evaluated across numerous clinical trials spanning Phase 1 through Phase 3, primarily targeting pulmonary tuberculosis across drug-susceptible, multidrug-resistant, and extensively drug-resistant strains, as well as HIV co-infections. Supported by non-profit organizations, government entities, and academic medical centers, these studies range from completed safety and efficacy trials to actively recruiting platform evaluations. As a result, pretomanid remains a critical component of novel combination therapy regimens for mycobacterial therapeutics.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT06441006 | RECRUITING | Tuberculosis, Pulmonary; Tuberculosis, Multidrug-Resistant; Tuberculosis, MDR |
University of California, San Francisco |
2025-10-03 | PHASE2; PHASE3 |
| NCT06905522 | RECRUITING | Pulmonary Tuberculosis |
Shenzhen Third People's Hospital |
2025-06-18 | PHASE3 |
| NCT07773610 | NOT_YET_RECRUITING | Tuberculosis, Pulmonary |
TASK Applied Science |
2026-07-23 | PHASE2 |
| NCT05807399 | RECRUITING | Pulmonary Tuberculosis; Other Specified Pulmonary Tuberculosis |
Michael Hoelscher |
2023-04-14 | PHASE2 |
| NCT07126639 | NOT_YET_RECRUITING | Efficacy and Safety |
Wuhan Pulmonary Hospital |
2025-09-01 | |
| NCT07517445 | SUSPENDED | Drug Susceptible Pulmonary Tuberculosis |
Gates Medical Research Institute |
2026-04-17 | PHASE2 |
| NCT07672405 | RECRUITING | Tuberculosis, Pulmonary |
Global Alliance for TB Drug Development |
2026-07-09 | PHASE2 |
| NCT06114628 | RECRUITING | Pulmonary Tuberculosis |
University College, London |
2024-01-09 | PHASE2 |
| NCT06192160 | RECRUITING | Pulmonary Tuberculosis |
National Institute of Allergy and Infectious Diseases (NIAID) |
2025-03-11 | PHASE2 |
| NCT07525427 | RECRUITING | Drug Susceptible Pulmonary Tuberculosis |
Gates Medical Research Institute |
2026-04-14 | PHASE2 |
| NCT05586230 | COMPLETED | Tuberculosis; Rifampicin Resistant Tuberculosis |
National Institute of Allergy and Infectious Diseases (NIAID) |
2023-10-03 | PHASE1 |
| NCT05686356 | ACTIVE_NOT_RECRUITING | Tuberculosis |
The Aurum Institute NPC |
2023-07-28 | PHASE2; PHASE3 |
| NCT05382312 | COMPLETED | Tuberculosis |
GlaxoSmithKline |
2022-07-26 | PHASE2 |
| NCT05971602 | TERMINATED | Pulmonary Tuberculosis |
Gates Medical Research Institute |
2023-07-26 | PHASE2 |
| NCT05040126 | UNKNOWN | Pre-Extensively Drug-Resistant Pulmonary TB; Treatment Intolerant Multidrug-Resistant Pulmonary TB; Non-responsive Multidrug-Resistant Pulmonary TB |
Tuberculosis Research Centre, India |
2021-10-07 | PHASE3 |
| NCT06058299 | ACTIVE_NOT_RECRUITING | Pulmonary TB; Pulmonary Tuberculosis; Drug Sensitive Tuberculosis |
Global Alliance for TB Drug Development |
2023-10-31 | PHASE2 |
| NCT03896750 | COMPLETED | Renal Impairment; Tuberculosis |
National Institute of Allergy and Infectious Diseases (NIAID) |
2024-04-17 | PHASE1 |
| NCT02422524 | TERMINATED | Tuberculosis |
National Institute of Allergy and Infectious Diseases (NIAID) |
2018-03-29 | PHASE1 |
| NCT04179500 | COMPLETED | Tuberculosis, Pulmonary; Tuberculosis, Multidrug-Resistant; Tuberculosis, MDR; Tuberculosis; Drug-Resistant Tuberculosis |
Global Alliance for TB Drug Development |
2021-09-16 | PHASE2 |
| NCT04081077 | UNKNOWN | Multi-drug Resistant Tuberculosis; Extensively Drug-Resistant Tuberculosis; Pulmonary Tuberculosis |
Medecins Sans Frontieres, Netherlands |
2019-08-06 | PHASE2; PHASE3 |
| NCT04207112 | COMPLETED | Multi-drug Resistant Tuberculosis; Extensively Drug-Resistant Tuberculosis; Pulmonary Tuberculoses |
Medecins Sans Frontieres, Netherlands |
2020-10-20 | PHASE2; PHASE3 |
| NCT02589782 | COMPLETED | Tuberculosis, Multidrug-Resistant; Extensively Drug-Resistant Tuberculosis; Tuberculosis, Pulmonary |
Medecins Sans Frontieres, Netherlands |
2017-01 | PHASE2; PHASE3 |
| NCT02256696 | COMPLETED | Pulmonary Tuberculosis |
Johns Hopkins University |
2015-04-29 | PHASE2 |
| NCT03338621 | COMPLETED | Tuberculosis, Pulmonary; Tuberculosis, Multidrug-Resistant; Tuberculosis, MDR; Tuberculosis; Drug-Resistant Tuberculosis |
Global Alliance for TB Drug Development |
2018-07-30 | PHASE2; PHASE3 |
| NCT03086486 | COMPLETED | Tuberculosis, Pulmonary; Tuberculosis, Multidrug-Resistant; Tuberculosis, MDR; Tuberculosis; Extensively Drug-Resistant Tuberculosis; Pre-XDR-TB; XDR-TB |
Global Alliance for TB Drug Development |
2017-11-21 | PHASE3 |
| NCT04309656 | COMPLETED | Multi-drug Resistant Tuberculosis |
Global Alliance for TB Drug Development |
2020-01-14 | PHASE1 |
| NCT02333799 | COMPLETED | Pulmonary Tuberculosis |
Global Alliance for TB Drug Development |
2015-03 | PHASE3 |
| NCT02342886 | COMPLETED | Tuberculosis, Pulmonary, Drug Sensitive; Tuberculosis, Pulmonary, Multi Drug-resistant |
Global Alliance for TB Drug Development |
2015-02 | PHASE3 |
| NCT02193776 | COMPLETED | Tuberculosis |
Global Alliance for TB Drug Development |
2014-10-23 | PHASE2 |
| NCT02333799 | Completed | Pulmonary Tuberculosis |
Global Alliance for TB Drug Development |
2015-03 | Phase 3 |
| NCT01571414 | COMPLETED | Tuberculosis |
National Institute of Allergy and Infectious Diseases (NIAID) |
2012-05 | PHASE1 |
| NCT01691534 | COMPLETED | Pulmonary Tuberculosis |
Global Alliance for TB Drug Development |
2012-10 | PHASE2 |
| NCT01498419 | COMPLETED | Pulmonary Tuberculosis |
Global Alliance for TB Drug Development |
2012-03 | PHASE2 |
| NCT01674218 | COMPLETED | Tuberculosis |
National Institute of Allergy and Infectious Diseases (NIAID) |
2012-09 | PHASE1 |
| NCT01674218 | Completed | Tuberculosis |
National Institute of Allergy and Infectious Diseases (NIAID) |
2012-09 | Phase 1 |
| NCT01215851 | COMPLETED | Pulmonary Tuberculosis |
Global Alliance for TB Drug Development |
2010-10 | PHASE2 |
| NCT01768273 | COMPLETED | Tuberculosis |
Global Alliance for TB Drug Development |
2009-12 | PHASE1 |
| NCT01830439 | COMPLETED | Tuberculosis |
Global Alliance for TB Drug Development |
2009-09 | PHASE1 |
| NCT00944021 | COMPLETED | Pulmonary Tuberculosis |
Global Alliance for TB Drug Development |
2009-08 | PHASE2 |
| NCT01768273 | Completed | Tuberculosis |
Global Alliance for TB Drug Development |
2009-12 | Phase 1 |
| NCT00567840 | COMPLETED | Pulmonary Tuberculosis |
Global Alliance for TB Drug Development |
2007-08 | PHASE2 |
| NCT01828827 | COMPLETED | Tuberculosis |
Global Alliance for TB Drug Development |
2007-03 | PHASE1 |
| NCT03202693 | COMPLETED | Tuberculosis |
Global Alliance for TB Drug Development |
2006-03 | PHASE1 |
| NCT03202693 | Completed | Tuberculosis |
Global Alliance for TB Drug Development |
2006-03 | Phase 1 |
(data from https://clinicaltrials.gov, updated on 2026-09-02)
Check the
Pretomanid (PA-824)
product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.
Mechanism and Biochemical Profile
Appendix RUO and cGMP Quality Standards
| Quality Dimension | RUO (Research Use Only) | cGMP (Current Good Manufacturing Practice) |
|---|---|---|
| Clinical Applicability | Prohibited in human clinical trials or medical diagnostics. | Mandatory for human clinical trials (Phase I–III) and therapies. |
| Regulatory Status | Non-regulated grade; exempt from drug manufacturing laws. | Legally enforced by health authorities (e.g., FDA, EMA, NMPA). |
| Facility Environment | Unclassified analytical or research laboratories. | Validated Cleanrooms (ISO Class 5–8) with continuous monitoring. |
| Quality Control | Basic purity and activity testing. | Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma). |
| Process Validation | Basic equipment calibration; no process validation required. | Full qualification (IQ/OQ/PQ) and complete batch records. |
| Quality Assurance | Vendor self-declared without required formal QMS. | Mandatory QA/QC unit, Change Control, CAPA, and vendor audits. |
| Regulatory Impact | High risk of IND rejection if used as a critical raw material. | Required for IND/NDA filings, supported by Drug Master Files (DMF). |
Footnotes
Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).
- Pretomanid (PA-824) Solubility in DMSO
- Pretomanid (PA-824) Stock Solution
- Pretomanid (PA-824) Storage
- Pretomanid (PA-824) Stability
- Pretomanid (PA-824) Molecular Weight
- Pretomanid (PA-824) SMILES
- Pretomanid (PA-824) CAS Number
- Pretomanid (PA-824) Chemical Structure (2D and 3D)
- Pretomanid (PA-824) SDS｜MSDS
Note: Technical data last updated: Sep 1, 2026.