11 completed, 4 active not recruiting, 2 unknown, 1 recruiting. 13 Phase 2, 5 Phase 3, 1 Phase 1, 1 Phase 4.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 13 | Completed 9, Active not recruiting 2, Terminated 1, Unknown 1 |
| Phase 3 | 5 | Active not recruiting 3, Completed 1, Withdrawn 1 |
| Phase 1 | 1 | Completed 1 |
| Phase 4 | 1 | Unknown 1 |
Follow delamanid: new trials by email Literature Review of delamanid trials Research Report on delamanid
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 |
|---|---|---|---|---|---|---|
| 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 |
| 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 |
| 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 |
| Safety and Effectiveness of Delamanid-containing Regimen for MDR-TB Patients in China Delamanid - Multidrug Resistant Tuberculosis | Phase 4 | Unknown | Beijing Chest Hospital | 608 | 2020-07-16 | 2022-07-07 |
| 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 |
| Population Pharmacokinetics of Anti-tuberculosis Drugs in Children With Tuberculosis anti-tuberculosis drug - Tuberculosis | Recruiting | Beijing Children's Hospital | 800 | 2018-07-01 | 2018-08-15 | |
| 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 |
| 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 |
| A Trial to Evaluate Safety, Tolerability, and Efficacy of Orally Administered OPC-67683 Delamanid, OBR - Tuberculosis, Multidrug-Resistant | Phase 2 | Completed | Otsuka Pharmaceutical Development & Commercialization, Inc. | 213 | 2009-03-26 | 2021-11-01 |
| A Trial to Evaluate OPC 67683 in Participants With Pulmonary Sputum Culture-positive, Multidrug-resistant Tuberculosis (TB) Delamanid, Optimized Background Regimen (OBR), Placebo - Tuberculosis, Pulmonary, Tuberculosis, Multidrug Resistant | Phase 2 | Completed | Otsuka Pharmaceutical Development & Commercialization, Inc. | 481 | 2008-05-08 | 2021-12-01 |
| Pharmacokinetic Study of Antiretroviral Drugs and Related Drugs During and After Pregnancy atazanavir/cobicistat, darunavir/ritonavir dosage #1, darunavir/ritonavir dosage #2 - HIV Infections | Completed | National Institute of Allergy and Infectious Diseases (NIAID) | 1578 | 2003-06-09 | 2025-12-02 |
Tuberculosis (10) · Tuberculosis, Multidrug-Resistant (10) · Tuberculosis, Pulmonary (8) · HIV Infections (3) · Bacterial Infections (2) · Extensively Drug-Resistant Tuberculosis (1) · Latent Tuberculosis (1) · Mycobacterium Infections (1)
Otsuka Pharmaceutical Development & Commercialization, Inc. (5) · Beijing Chest Hospital (3) · National Institute of Allergy and Infectious Diseases (NIAID) (3) · Boston University (2) · Beijing Children's Hospital (1) · Centers for Disease Control and Prevention (1) · GlaxoSmithKline (1) · Huashan Hospital (1) · Michael Hoelscher (1) · Médecins Sans Frontières, France (1) · Seoul National University Hospital (1)
South Africa (9) · China (7) · Peru (4) · Philippines (4) · Latvia (3) · South Korea (3) · Tanzania (3) · United States (3) · Estonia (2) · India (2) · Vietnam (2) · Argentina (1) · Botswana (1) · Brazil (1) · Canada (1)
A-Dong Shen, Master (1) · Anjanette Reyes-De Leon, MD (1) · Anthony Garcia-Prats, MD (1) · C. Robert Horsburgh, MD (1) · Carole Mitnick, Sc.D (1) · Charles Horsburgh, MD (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) · Liang Li (1) · Lorenzo Guglielmetti, MD (1)
PMID 16470119, PMID 16988514, PMID 18366444, PMID 18795962, PMID 18989231, PMID 20002783, PMID 20632458, PMID 21283017, PMID 22083071, PMID 22129166, PMID 22670901, PMID 23305215, PMID 23392467, PMID 25162818, PMID 25261418, PMID 25407158, PMID 25950206, PMID 25959631, PMID 26202768, PMID 26918544, PMID 27540363, PMID 29369162, PMID 29520730, PMID 29528944, PMID 30134297, PMID 30358179, PMID 30530925, PMID 30651149, PMID 30715324, PMID 31489678, PMID 31676905, PMID 32015036, PMID 32451908, PMID 33252495, PMID 33318014, PMID 33587897, PMID 34076612, PMID 34563240, PMID 34732682, PMID 35028659, PMID 35404075, PMID 35668346, PMID 36522208, PMID 38243296, PMID 39879593, PMID 40064371, PMID 40741959, PMID 40915316, PMID 41090140, PMID 41419836
2008 (1), 2009 (1), U01AI152980 (1)