14 completed, 3 active not recruiting, 2 recruiting, 2 terminated. 23 Phase 2, 2 Phase 1, 1 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 23 | Completed 14, Active not recruiting 3, Recruiting 2, Terminated 2, Not yet recruiting 1, Unknown 1 |
| Phase 1 | 2 | Completed 2 |
| Phase 3 | 1 | Active not recruiting 1 |
Follow OPC-67683: new trials by email Literature Review of OPC-67683 trials Research Report on OPC-67683
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 |
|---|---|---|---|---|---|---|
| A Phase 2b Clinical Study of JDB0131 Benzenesulfonate Tablets JDB0131 100mg, JDB0131 200mg, Delamanid (D) - Tuberculosis, Multidrug Resistant Pulmonary Tuberculosis | Phase 2 | Recruiting | WestVac Biopharma Co., Ltd. | 60 | 2025-09-19 | 2026-01-30 |
| Short-Course Regimen With Bedaquiline, Moxifloxacin and Pyrazinamide for Early Bactericidal Activity in Drug-Susceptible Tuberculosis Bedaquiline (B), Moxifloxacin, Pyrazinamide (PZA) - Tuberculosis, Pulmonary, Drug-Susceptible Pulmonary Tuberculosis | Phase 2 | Not yet recruiting | Shanghai Pulmonary Hospital, Shanghai, China | 45 | 2025-08-20 | 2025-08-19 |
| 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 |
| Ultra-Short Course Bedaquiline, Clofazimine, Pyrazinamide and Delamanid Versus Standard Therapy for Drug-Susceptible Tuberculosis Bedaquiline (BDQ), Clofazimine (CFZ), Pyrazinamide (PZA) - Tuberculosis, Pulmonary, HIV | Phase 2 | Active not recruiting | Brigham and Women's Hospital | 94 | 2023-11-24 | 2026-08-05 |
| Short-course Regimens for the Treatment of Pulmonary Tuberculosis Rifabutin, Delamanid, Bedaquiline - Tuberculosis, Pulmonary, Tuberculosis Infection | Phase 2 / Phase 3 | Active not recruiting | Centers for Disease Control and Prevention | 288 | 2023-11-21 | 2026-09-21 |
| Clinical Study of JDB0131 Benzenesulfonate Tablets in Patients With Drug-sensitive Pulmonary Tuberculosis JDB0131, Delamanid, Ethylpyrazine rifampicide (II) - Drug-resistant Tuberculosis | Phase 2 | Unknown | Beijing Chest Hospital | 52 | 2023-10-31 | 2024-01-25 |
| BTZ-043 Dose Evaluation in Combination and Selection BTZ-043, Bedaquiline, Delamanid - Tuberculosis, Pulmonary, Other Specified Pulmonary Tuberculosis | Phase 2 | Completed | Michael Hoelscher | 92 | 2023-09-21 | 2026-10-05 |
| 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 |
| Linezolid Dosing Strategies in Drug-Resistant TB Linezolid 600 mg, Linezolid 1200 mg (QD), Linezolid 1200 mg (TIW) - Tuberculosis, Multidrug-Resistant, Tuberculosis | Phase 2 | Completed | National Institute of Allergy and Infectious Diseases (NIAID) | 138 | 2022-09-27 | 2026-10-02 |
| 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 |
| Efficacy and Tolerability of Bedaquiline, Delamanid, Levofloxacin, Linezolid, and Clofazimine to Treat MDR-TB Delamanid, Levofloxacin, Bedaquiline - Tuberculosis, Multidrug-Resistant | Phase 2 | Active not recruiting | Boston University | 271 | 2022-06-07 | 2026-07-08 |
| Safety and Efficacy Evaluation of 4-month Regimen of OPC-167832, Delamanid and Bedaquiline in Participants With Drug-Susceptible Pulmonary TB Delamanid, Bedaquiline, RHEZ - Pulmonary TB | Phase 2 | Completed | Otsuka Pharmaceutical Development & Commercialization, Inc. | 122 | 2022-04-12 | 2026-08-12 |
| PanACEA DElpazolid Dose-finding and COmbination DEvelopment (DECODE) Delpazolid, Bedaquiline, Delamanid, Moxifloxacin - Infections and Infestations, Pulmonary Tuberculosis | Phase 2 | Completed | LigaChem Biosciences, Inc. | 76 | 2021-10-28 | 2025-09-16 |
| PanACEA Sutezolid Dose-finding and Combination Evaluation Sutezolid, Bedaquiline, Delamanid, Moxifloxacin, Midazolam oral solution - Pulmonary Tuberculosis, Other Specified Pulmonary Tuberculosis | Phase 2 | Completed | Michael Hoelscher | 75 | 2021-05-06 | 2023-05-01 |
| Evaluating the Pharmacokinetics, Safety, and Tolerability of Delamanid in Combination With Optimized Multidrug Background Regimen (OBR) for Multidrug-Resistant Tuberculosis (MDR-TB) in Children With MDR-TB With and Without HIV Delamanid, Optimized multidrug background regimen (OBR) for children with MDR-TB - Tuberculosis, HIV Infections | Phase 1 / Phase 2 | Completed | National Institute of Allergy and Infectious Diseases (NIAID) | 37 | 2019-02-18 | 2026-06-25 |
| A Phase 1/2 Trial of Multiple Oral Doses of OPC-167832 for Uncomplicated Pulmonary Tuberculosis 10 mg OPC-167832, 30 mg OPC-167832, 90 mg OPC-167832 - Pulmonary TB | Phase 1 / Phase 2 | Completed | Otsuka Pharmaceutical Development & Commercialization, Inc. | 122 | 2018-10-18 | 2023-11-18 |
| Evaluating the Safety, Tolerability, and Pharmacokinetics of Bedaquiline and Delamanid, Alone and in Combination, For Drug-Resistant Pulmonary Tuberculosis Bedaquiline, Delamanid, Dolutegravir - Tuberculosis, HIV Infections | Phase 2 | Completed | National Institute of Allergy and Infectious Diseases (NIAID) | 84 | 2016-08-15 | 2022-01-27 |
| Treatment Shortening of MDR-TB Using Existing and New Drugs Linezolid, Delamanid, Levofloxacin - Tuberculosis, Multidrug-Resistant | Phase 2 | Completed | Seoul National University Hospital | 214 | 2016-01-01 | 2025-01-03 |
| A 6-Month Safety, Efficacy, and Pharmacokinetic (PK) Trial of Delamanid in Pediatric Participants With Multidrug Resistant Tuberculosis (MDR-TB) Delamanid, Delamanid Pediatric Formulation (DPF), Optimized Background Regimen (OBR) - Multidrug Resistant Tuberculosis | Phase 2 | Completed | Otsuka Pharmaceutical Development & Commercialization, Inc. | 37 | 2013-07-20 | 2020-11-23 |
| Safety and Pharmacokinetics (PK) in Multidrug-Resistant (MDR) Refractive Tuberculosis Delamanid, Optimized Background Regimen (OBR) - Tuberculosis | Phase 2 | Terminated | Otsuka Pharmaceutical Development & Commercialization, Inc. | 10 | 2010-02-19 | 2021-11-11 |
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Tuberculosis, Pulmonary (14) · Tuberculosis (10) · Tuberculosis, Multidrug-Resistant (9) · HIV Infections (2) · Bacterial Infections (1) · Extensively Drug-Resistant Tuberculosis (1) · Gram-Positive Bacterial Infections (1) · Infections (1) · Latent Tuberculosis (1) · Mycobacterium Infections (1)
Otsuka Pharmaceutical Development & Commercialization, Inc. (6) · National Institute of Allergy and Infectious Diseases (NIAID) (3) · Michael Hoelscher (2) · Beijing Chest Hospital (1) · Boston University (1) · Brigham and Women's Hospital (1) · Centers for Disease Control and Prevention (1) · Gates Medical Research Institute (1) · GlaxoSmithKline (1) · LigaChem Biosciences, Inc. (1) · Otsuka Frankfurt Research Institute GmbH (1) · Seoul National University Hospital (1) · Shanghai Pulmonary Hospital, Shanghai, China (1) · University College, London (1) · WestVac Biopharma Co., Ltd. (1)
South Africa (15) · Philippines (6) · Tanzania (5) · China (4) · Peru (4) · Haiti (3) · Latvia (3) · South Korea (3) · Vietnam (3) · Estonia (2) · Uganda (2) · United States (2) · Botswana (1) · Brazil (1) · Canada (1)
Andreas H Diacon, Dr. (1) · Anjanette Reyes-De Leon, MD (1) · Anthony Garcia-Prats, MD (1) · Charles Horsburgh, MD (1) · Constance A. Benson (1) · Daniel W Fitzgerald, MD (1) · Ekaterina V Kurbatova, MD, PhD, MPH (1) · Ethel Weld, MD (1) · Gary Maartens, MBChB, MMed (1) · Kelly Dooley, MD (1) · Kelly Dooley, MD, PhD (1) · Louvina van der Laan, MD (1) · Melchor VG Frias, IV, MD (1)
PMID 22670901, PMID 30651149, PMID 33587897, PMID 35315690, PMID 35404075, PMID 35668346, PMID 36522208, PMID 36808186, PMID 37280643, PMID 38243296, PMID 38768617, PMID 39612928, PMID 40064371, PMID 40645196, PMID 40645198, PMID 40915316, PMID 41121745, PMID 41461639, PMID 42214407
2008 (1), 2009 (1), U01AI152980 (1), U01AI170426 (1)