33 completed, 2 active not recruiting, 2 recruiting, 2 terminated. 19 Phase 2, 16 Phase 1, 8 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 19 | Completed 13, Active not recruiting 2, Recruiting 2, Terminated 1, Unknown 1 |
| Phase 1 | 16 | Completed 15, Terminated 1 |
| Phase 3 | 8 | Completed 6, Active not recruiting 1, Unknown 1 |
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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 |
|---|---|---|---|---|---|---|
| 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 |
| Telacebec (T) Treatment in Adults With Buruli Ulcer (BU). (TREAT BU) Telacebec - Buruli Ulcer | Phase 2 | Recruiting | Barwon Health | 200 | 2024-07-09 | 2026-06-30 |
| 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 |
| A Phase 1, Drug-Drug Interaction Study of TBAJ-876 in Healthy Adults TBAJ-876, Midazolam, Digoxin - Pulmonary Disease, Tuberculosis, Pulmonary | Phase 1 | Completed | Global Alliance for TB Drug Development | 28 | 2022-06-30 | 2024-10-08 |
| Triage Test for All Oral DR-TB Regimen (TRiAD Study) Xpert® MTB/XDR - Drug Resistant Tuberculosis, MDR-TB | Completed | Centre for the AIDS Programme of Research in South Africa | 786 | 2022-05-26 | 2025-06-26 | |
| 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 |
| Pharmacokinetic Study of Linezolid for TB Meningitis Linezolid - Tuberculosis, Meningeal, Linezolid | Phase 2 | Completed | Universitas Padjadjaran | 36 | 2021-06-21 | 2023-09-06 |
| Study to Evaluate Safety, Tolerability, and the PK Profile of TBI-223 in Healthy Subjects TBI-223 1800 mg, TBI-223 2400mg, TBI-223 Placebo - Tuberculosis, Tuberculosis, Pulmonary | Phase 1 | Completed | Global Alliance for TB Drug Development | 28 | 2021-02-03 | 2025-06-05 |
| Evaluation of the Safety, Tolerability, PK of TBAJ-587 in Healthy Adults TBAJ-587, Placebo - Tuberculosis | Phase 1 | Completed | Global Alliance for TB Drug Development | 106 | 2020-12-01 | 2023-05-19 |
| Evaluate Safety, Tolerability, PK of TBAJ-876 in Healthy Adults TBAJ-876 suspension, Placebo suspension, TBAJ-876 100 mg tablet - Pulmonary Disease, Tuberculosis, Pulmonary | Phase 1 | Completed | Global Alliance for TB Drug Development | 137 | 2020-06-08 | 2025-06-04 |
| Single-dose Study in Two Panels of Healthy Adult Participants to Assess Immediate-Release and Dispersible Formulations of Pretomanid Pretomanid - Multi-drug Resistant Tuberculosis | Phase 1 | Completed | Global Alliance for TB Drug Development | 48 | 2020-01-14 | 2024-07-24 |
| PRACTECAL-PKPD Sub Study Bedaquiline, Pretomanid, Moxifloxacin - Multi-drug Resistant Tuberculosis, Extensively Drug-Resistant Tuberculosis | Phase 2 / Phase 3 | Unknown | Medecins Sans Frontieres, Netherlands | 240 | 2019-08-06 | 2021-05-14 |
| A Phase 1 Study to Evaluate Safety, Tolerability, and Pharmacokinetics of TBI-223 in Healthy Adults TBI-223 oral suspension, TBI-223 enteric capsule, TBI-223 SR Tablet Prototype 1 - Tuberculosis, Tuberculosis, Pulmonary | Phase 1 | Completed | Global Alliance for TB Drug Development | 86 | 2019-01-16 | 2024-12-09 |
| Trial to Evaluate the Efficacy, Safety and Tolerability of BPaMZ in Drug-Sensitive (DS-TB) Adult Patients and Drug-Resistant (DR-TB) Adult Patients Pretomanid, Bedaquiline, Moxifloxacin - Tuberculosis, Pulmonary, Tuberculosis, Multidrug-Resistant | Phase 2 / Phase 3 | Completed | Global Alliance for TB Drug Development | 455 | 2018-07-30 | 2026-08-27 |
| Various Doses and Durations of Linezolid Plus Bedaquiline & Pretomanid in Participants With Drug Resistant Tuberculosis Pretomanid, Linezolid, Bedaquiline - Tuberculosis, Pulmonary, Tuberculosis, Multidrug-Resistant | Phase 3 | Completed | Global Alliance for TB Drug Development | 181 | 2017-11-21 | 2023-06-29 |
| Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Sutezolid Sutezolid, Placebo - Tuberculosis, Tuberculosis, Pulmonary | Phase 1 | Completed | Global Alliance for TB Drug Development | 32 | 2017-09-26 | 2018-02-08 |
| A Phase 1 Study to Evaluate Safety, Tolerability, PK, and PK Interactions of TBA-7371 TBA-7371, Placebo - Tuberculosis, Tuberculosis, Pulmonary | Phase 1 | Completed | Global Alliance for TB Drug Development | 74 | 2017-08-29 | 2018-10-17 |
Showing 20 of 40. Sign in to see all of them.
Tuberculosis (30) · Tuberculosis, Pulmonary (25) · Tuberculosis, Multidrug-Resistant (13) · Extensively Drug-Resistant Tuberculosis (7) · Lung Diseases (2) · Buruli Ulcer (1) · Tuberculosis, Meningeal (1) · Ulcer (1)
pretomanid (23) · bedaquiline (14) · Pyrazinamide (11) · Moxifloxacin (10) · Linezolid (8) · Isoniazid (7) · Rifampin (7) · Ethambutol (5) · TBAJ-876 (4) · Clofazimine (3) · Midazolam (3) · PNU-100480 (3) · TBA-354 (2) · Acetylcysteine (1) · Bupropion (1)
South Africa (22) · United States (14) · Tanzania (8) · Georgia (5) · Uganda (5) · Philippines (4) · Brazil (3) · Malaysia (3) · Belarus (2) · Kenya (2) · Russia (2) · Thailand (2) · Zambia (2) · Australia (1) · Canada (1)
Antonio Lombardi, MD (4) · Andreas Diacon, MD (3) · Rodney Dawson, MD (3) · Andreas Diacon (2) · Jerry Nedelman (2) · Morounfolu Olugbosi, MD (2) · Scott Rasmussen, MD (2) · A K Jain, MBBS FICA (1) · Adreas Diacon (1) · Ahmad R Ganiem, MD, PhD (1) · Alexander Pym, MB BMRCP PhD (1) · Ali Zumla, BSc MBChB MSc PhD (1) · Andreas Diacon, BM MD (1) · Andrew Nunn, BSc MSc (1) · Angela Crook (1)
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