4 active not recruiting, 4 completed, 1 not yet recruiting, 1 withdrawn. 10 Phase 3, 1 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 10 | Active not recruiting 4, Completed 4, Not yet recruiting 1, Withdrawn 1 |
| Phase 2 | 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 6-Month MDR-END Plus Regimen for Rifampicin-Resistant Tuberculosis MDR-END Plus regimen, Standard-of-care (SoC) treatment - Rifampicin-Resistant Tuberculosis | Phase 3 | Not yet recruiting | Seoul National University Hospital | 294 | 2026-10-01 | 2026-06-30 |
| Innovating Shorter, All- Oral, Precised Treatment Regimen for Rifampicin Resistant Tuberculosis：BDLL Chinese Cohort bedaquiline, delamanid, linezolid - Drug-resistant Tuberculosis, Pulmonary Tuberculosis | Phase 3 | Active not recruiting | Huashan Hospital | 120 | 2024-11-27 | 2025-09-02 |
| Innovating Shorter, All- Oral, Precised, Individualized Treatment Regimen for Rifampicin Resistant Tuberculosis：Contezolid, Delamanid and Bedaquiline Cohort Bedaquiline, Delamanid, Contezolid - Pulmonary Tuberculosis, Rifampicin-resistant Tuberculosis | Phase 3 | Active not recruiting | Beijing Chest Hospital | 186 | 2023-12-22 | 2025-04-01 |
| 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 |
| Evaluating Newly Approved Drugs in Combination Regimens for Multidrug-Resistant TB With Fluoroquinolone Resistance (endTB-Q) Bedaquiline 100 MG, Delamanid 50 MG Oral Tablet, Clofazimine 100 MG Oral Capsule - Tuberculosis, Multidrug-Resistant, Tuberculosis | Phase 3 | Completed | Médecins Sans Frontières, France | 323 | 2020-04-06 | 2025-02-10 |
| Building Evidence for Advancing New Treatment for Rifampicin Resistant Tuberculosis (RR-TB) Comparing a Short Course of Treatment (Containing Bedaquiline, Delamanid and Linezolid) With the Current South African Standard of Care Bedaquiline Oral Tablet, Linezolid Oral Tablet, Delamanid in Oral Dosage Form - Tuberculosis, Pre-XDR-TB | Phase 3 | Completed | Wits Health Consortium (Pty) Ltd | 402 | 2019-08-22 | 2024-08-28 |
| Protecting Households On Exposure to Newly Diagnosed Index Multidrug-Resistant Tuberculosis Patients Delamanid (DLM), Isoniazid (INH), Pyridoxine (vitamin B6) - Tuberculosis, MDR | Phase 3 | Active not recruiting | National Institute of Allergy and Infectious Diseases (NIAID) | 5832 | 2019-06-03 | 2025-06-15 |
| Efficacy and Tolerability of Delamanid, Linezolid, Pyrazinamide and Levofloxacin Delamanid, Linezolid, Levofloxacin - Tuberculosis Multi Drug Resistant Active | Phase 3 | Withdrawn | Boston University | 2017-08-01 | 2017-09-11 | |
| Evaluating Newly Approved Drugs for Multidrug-resistant TB Bedaquiline, Delamanid, Clofazimine - Tuberculosis, Multidrug-Resistant, Infection, Bacterial | Phase 3 | Completed | Médecins Sans Frontières, France | 754 | 2016-12-01 | 2025-02-10 |
| Safety and Efficacy Trial of Delamanid for 6 Months in Participants With Multidrug-resistant Tuberculosis Delamanid + OBR, Placebo + OBR - Multidrug-resistant Tuberculosis | Phase 3 | Completed | Otsuka Pharmaceutical Development & Commercialization, Inc. | 511 | 2011-09-02 | 2019-05-15 |
Tuberculosis, Multidrug-Resistant (7) · Tuberculosis (5) · Tuberculosis, Pulmonary (5) · Bacterial Infections (2) · Extensively Drug-Resistant Tuberculosis (2) · Gram-Positive Bacterial Infections (1) · Latent Tuberculosis (1) · Mycobacterium Infections (1)
Médecins Sans Frontières, France (2) · Beijing Chest Hospital (1) · Boston University (1) · Centers for Disease Control and Prevention (1) · Huashan Hospital (1) · National Institute of Allergy and Infectious Diseases (NIAID) (1) · Otsuka Pharmaceutical Development & Commercialization, Inc. (1) · Seoul National University Hospital (1) · Wits Health Consortium (Pty) Ltd (1)
South Africa (6) · Peru (4) · India (3) · Vietnam (3) · China (2) · Haiti (2) · Kazakhstan (2) · Lesotho (2) · Pakistan (2) · Philippines (2) · Uganda (2) · Botswana (1) · Brazil (1) · Canada (1) · Estonia (1)
Carole Mitnick, Sc.D (2) · Lorenzo Guglielmetti, MD (2) · Amita Gupta, MD, MHS (1) · Anneke Hesseling, MD, PhD (1) · C. Robert Horsburgh, MD (1) · Daniel W Fitzgerald, MD (1) · Ekaterina V Kurbatova, MD, PhD, MPH (1) · Francesca M Conradie (1) · Gavin Churchyard, MBBCh MMed FRCP FCP(SA) PhD (1) · Jae-Joon Yim, MD, PhD (1) · Jennifer Hughes, MBBCh (1) · Jeongha Mok, MD, PhD (1) · Kelly Dooley, MD (1) · Susan Swindells, MBBS (1)
PMID 30630778, PMID 31676905, PMID 34563240, PMID 35028659, PMID 38037119, PMID 39879593, PMID 40683298, PMID 40915316, PMID 42341301