26 completed, 8 recruiting, 2 active not recruiting, 2 not yet recruiting. 24 Phase 2, 12 Phase 3, 10 Phase 1, 1 Not applicable.
Follow pretomanid: new trials by email Literature Review of pretomanid trials Research Report on pretomanid
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Study of Combinations of Novel Promising Drugs for Pulmonary Tuberculosis TBAJ-587 50 mg, Pretomanid 200mg, Linezolid 600Mg Tab - Tuberculosis, Pulmonary | Phase 2 | Not yet recruiting | TASK Applied Science | 135 | 2026-09-25 | 2026-09-25 |
| Sorfequiline-based Regimens in Adults With Newly Diagnosed Drug-sensitive Pulmonary TB sorfequiline, Pretomanid, Linezolid - Tuberculosis, Pulmonary | Phase 2 | Recruiting | Global Alliance for TB Drug Development | 100 | 2026-07-09 | 2026-08-19 |
| Bactericidal Activity and Safety of Nicotinamide in Combination With Bedaquiline, Pretomanid, and Linezolid in Drug-susceptible Pulmonary Tuberculosis Bedaquiline, pretomanid, linezolid, Nicotinamide (NAM) - Drug Susceptible Pulmonary Tuberculosis | Phase 2 | Suspended | Gates Medical Research Institute | 165 | 2026-04-17 | 2026-08-10 |
| Bactericidal Activity of TBD09 in Combination With Other Drugs in Pulmonary Tuberculosis Bedaquiline, pretomanid and TBD09, Bedaquiline, pretomanid and linezolid - Drug Susceptible Pulmonary Tuberculosis | Phase 2 | Recruiting | Gates Medical Research Institute | 150 | 2026-04-14 | 2026-07-30 |
| A Study of Quabodepistat-containing Regimens for the Treatment of Drug-resistant Pulmonary Tuberculosis Bedaquiline, Quabodepistat, Pretomanid - Rifampicin-Resistant Pulmonary Tuberculosis, Multidrug-Resistant Pulmonary Tuberculosis | Phase 3 | Recruiting | Otsuka Pharmaceutical Development & Commercialization, Inc. | 532 | 2025-10-16 | 2026-10-26 |
| Program for Rifampicin-Resistant Disease With Stratified Medicine for Tuberculosis Bedaquiline, Linezolid, Pretomanid - Tuberculosis, Pulmonary, Tuberculosis, Multidrug-Resistant | Phase 2 / Phase 3 | Recruiting | University of California, San Francisco | 400 | 2025-10-03 | 2026-09-02 |
| A Study on the Short-course Treatment Regimen Containing Pretomanid for Drug-resistant Tuberculosis bedaquiline, Pretomanid (Pa), linezolid - Efficacy and Safety | Not applicable | Not yet recruiting | Wuhan Pulmonary Hospital | 200 | 2025-09-01 | 2025-08-17 |
| A PAN-USR TB Multi-Center Trial Bedaquiline (B), Sitafloxacin (S), Linezolid (L) - Pulmonary Tuberculosis | Phase 3 | Recruiting | Shenzhen Third People's Hospital | 610 | 2025-06-18 | 2025-12-01 |
| Trial of Novel Regimens for the Treatment of Pulmonary Tuberculosis Isoniazid, Rifampicin, Pyrazinamide - Pulmonary Tuberculosis | Phase 2 | Recruiting | National Institute of Allergy and Infectious Diseases (NIAID) | 315 | 2025-03-11 | 2026-10-19 |
| Single-Dose Study to Evaluate the PKs of Pretomanid in Participants With Renal Impairment Compared to Participants With Normal Renal Function PA-824 - Renal Impairment, Tuberculosis | Phase 1 | Completed | National Institute of Allergy and Infectious Diseases (NIAID) | 12 | 2024-04-17 | 2026-07-16 |
| Platform Assessing Regimens and Durations In a Global Multisite Consortium for TB Ganfeborole, BTZ-043, Bedaquiline (B) - Pulmonary Tuberculosis | Phase 2 | Recruiting | University College, London | 2500 | 2024-01-09 | 2026-10-15 |
| Phase 2 Trial Assessing TBAJ876 or Bedaquiline, With Pretomanid and Linezolid in Adults With Drug-sensitive Pulmonary Tuberculosis sorfequiline, Pretomanid, Linezolid - Pulmonary TB, Pulmonary Tuberculosis | Phase 2 | Active not recruiting | Global Alliance for TB Drug Development | 309 | 2023-10-31 | 2026-06-24 |
| Study of a Single Dose of Pretomanid Added to an Optimized Background Regimen in Children With Rifampicin-Resistant Tuberculosis Pretomanid, Optimized background regimen (OBR) for multidrug-resistant TB (MDR-TB) - Tuberculosis, Rifampicin Resistant Tuberculosis | Phase 1 | Completed | National Institute of Allergy and Infectious Diseases (NIAID) | 32 | 2023-10-03 | 2026-09-28 |
| A Pan-TB Regimen Targeting Host and Microbe Sutezolid, N-acetyl cysteine, Pretomanid - Tuberculosis | Phase 2 / Phase 3 | Active not recruiting | The Aurum Institute NPC | 352 | 2023-07-28 | 2025-05-28 |
| Efficacy and Safety Evaluation of Two to Four Months of Treatment With the Combination Regimens of DBOS and PBOS in Adults With Pulmonary Tuberculosis Delamanid, Bedaquiline, OPC-167832, and Sutezolid (DBOS), Pretomanid, Bedaquiline, OPC-167832, and Sutezolid (PBOS), Isoniazid, Rifampicin, Pyrazinamide, Ethambutol (HRZE) - Pulmonary Tuberculosis | Phase 2 | Terminated | Gates Medical Research Institute | 93 | 2023-07-26 | 2026-05-20 |
| PanACEA - STEP2C -01 BTZ-043, Rifampicin, Isoniazid - Pulmonary Tuberculosis, Other Specified Pulmonary Tuberculosis | Phase 2 | Recruiting | Michael Hoelscher | 390 | 2023-04-14 | 2025-10-07 |
| Early Bactericidal Activity, Safety & Tolerability of Oral GSK3036656 in a Dual Combination With Novel and Established Antitubercular Agents, or Standard of Care in Adults With Rifampicin Susceptible Pulmonary Tuberculosis GSK3036656, Bedaquiline, Delamanid - Tuberculosis | Phase 2 | Completed | GlaxoSmithKline | 127 | 2022-07-26 | 2026-06-17 |
| Modified BPaL Regimen for Managing Pre-XDR TB and MDR (TI/NR) TB in India Linezolid, Bedaquiline, Pretomanid - Pre-Extensively Drug-Resistant Pulmonary TB, Treatment Intolerant Multidrug-Resistant Pulmonary TB | Phase 3 | Unknown | Tuberculosis Research Centre, India | 400 | 2021-10-07 | 2024-01-03 |
| A Trial to Evaluate the Male Reproductive Safety of Pretomanid in Adult Male Participants With Drug Resistant Pulmonary Tuberculosis Pretomanid, Bedaquiline, moxifloxacin - Tuberculosis, Pulmonary, Tuberculosis, Multidrug-Resistant | Phase 2 | Completed | Global Alliance for TB Drug Development | 26 | 2021-09-16 | 2025-01-17 |
| Economic Evaluation of New MDR TB Regimens Bedaquiline, Pretomanid, Moxifloxacin - Multi-drug Resistant Tuberculosis, Extensively Drug-Resistant Tuberculosis | Phase 2 / Phase 3 | Completed | Medecins Sans Frontieres, Netherlands | 73 | 2020-10-20 | 2024-04-22 |
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Tuberculosis (24) · Tuberculosis, Pulmonary (23) · Tuberculosis, Multidrug-Resistant (14) · Extensively Drug-Resistant Tuberculosis (7) · HIV Infections (1) · Renal Insufficiency (1)
Global Alliance for TB Drug Development (18) · National Institute of Allergy and Infectious Diseases (NIAID) (7) · Medecins Sans Frontieres, Netherlands (4) · Gates Medical Research Institute (3) · GlaxoSmithKline (1) · Johns Hopkins University (1) · Michael Hoelscher (1) · Otsuka Pharmaceutical Development & Commercialization, Inc. (1) · Shenzhen Third People's Hospital (1) · TASK Applied Science (1) · The Aurum Institute NPC (1) · Tuberculosis Research Centre, India (1) · University College, London (1) · University of California, San Francisco (1) · Wuhan Pulmonary Hospital (1)
South Africa (29) · Tanzania (10) · United States (10) · Uganda (8) · Georgia (6) · Philippines (6) · Belarus (4) · Brazil (4) · India (3) · Moldova (3) · Peru (3) · Thailand (3) · Uzbekistan (3) · Vietnam (3) · Botswana (2)
Andreas Diacon, MD (3) · Rodney Dawson, MD (3) · Antonio Lombardi, MD (2) · Morounfolu Olugbosi, MD (2) · Andreas Diacon (1) · Bern Nyang'wa, MB BS, MPH (1) · Bern-Thomas Nyang'wa, MD (1) · Beverley Stringer (1) · C James Kissling, MD (1) · Ethel Weld (1) · Fairoez Ryklief, MBBChB (1) · Francesca Conradie (1) · Francesca Conradie, MD (1)
PMID 23979737, PMID 36053506, PMID 36546625, PMID 37980911, PMID 16470119, PMID 16988514, PMID 18366444, PMID 18795962, PMID 18989231, PMID 20002783, PMID 20632458, PMID 21283017, PMID 22083071, PMID 22129166, PMID 22430968, PMID 22828481, PMID 23305215, PMID 23392467, PMID 24957823, PMID 25162818, PMID 25261418, PMID 25407158, PMID 25622149, PMID 25795076, PMID 25950206, PMID 25959631, PMID 26038418, PMID 26104205, PMID 26202768, PMID 26918544, PMID 27540363, PMID 29369162, PMID 29520730, PMID 29528944, PMID 30134297, PMID 30358179, PMID 30530925, PMID 30715324, PMID 31489678, PMID 31732485, PMID 32015036, PMID 32130813, PMID 32451908, PMID 33229425, PMID 33252495, PMID 33318014, PMID 34076612, PMID 34489263, PMID 34489274, PMID 34604901