Numerous clinical trials, spanning Phase 1 through Phase 4, evaluate the efficacy, safety, and pharmacokinetics of Delamanid for drug-resistant, MDR, XDR, pediatric, and HIV-associated pulmonary tuberculosis. Encompassing completed, active, and terminated protocols, these studies are supported by diverse sponsors, including pharmaceutical companies like Otsuka, academic medical centers, and public institutions such as NIAID. Overall, research focuses on evaluating Delamanid both as a core component and within novel combination regimens to optimize treatment outcomes against resistant mycobacterial infections.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT07675954 | NOT_YET_RECRUITING | Rifampicin-Resistant Tuberculosis |
Seoul National University Hospital |
2026-10-01 | PHASE3 |
| NCT07198685 | NOT_YET_RECRUITING | Treat to Target; Treatment Duration |
Wuhan Pulmonary Hospital |
2025-09-30 | |
| NCT07126639 | NOT_YET_RECRUITING | Efficacy and Safety |
Wuhan Pulmonary Hospital |
2025-09-01 | |
| NCT03828201 | ACTIVE_NOT_RECRUITING | Tuberculosis, Multidrug-Resistant |
Boston University |
2022-06-07 | PHASE2 |
| NCT06649721 | ACTIVE_NOT_RECRUITING | Drug-resistant Tuberculosis; Pulmonary Tuberculosis; Rifampin-resistant Tuberculosis |
Huashan Hospital |
2024-11-27 | PHASE3 |
| NCT06114628 | RECRUITING | Pulmonary Tuberculosis |
University College, London |
2024-01-09 | PHASE2 |
| NCT03568383 | ACTIVE_NOT_RECRUITING | Tuberculosis, MDR |
National Institute of Allergy and Infectious Diseases (NIAID) |
2019-06-03 | PHASE3 |
| NCT07129629 | NOT_YET_RECRUITING | Tuberculosis, Pulmonary; Drug-Susceptible Pulmonary Tuberculosis |
Shanghai Pulmonary Hospital, Shanghai, China |
2025-08-20 | PHASE2 |
| NCT05766267 | ACTIVE_NOT_RECRUITING | Tuberculosis, Pulmonary; Tuberculosis Infection |
Centers for Disease Control and Prevention |
2023-11-21 | PHASE2; PHASE3 |
| NCT06081361 | ACTIVE_NOT_RECRUITING | Pulmonary Tuberculosis; Rifampicin-resistant Tuberculosis |
Beijing Chest Hospital |
2023-12-22 | PHASE3 |
| NCT07170800 | RECRUITING | Tuberculosis; Multidrug Resistant Pulmonary Tuberculosis; Rifampicin-resistant Tuberculosis |
WestVac Biopharma Co., Ltd. |
2025-09-19 | PHASE2 |
| NCT05556746 | ACTIVE_NOT_RECRUITING | Tuberculosis, Pulmonary; HIV |
Brigham and Women's Hospital |
2023-11-24 | PHASE2 |
| NCT06476210 | UNKNOWN | Pulmonary Tuberculosis |
Beijing Chest Hospital |
2024-06 | PHASE4 |
| NCT05382312 | COMPLETED | Tuberculosis |
GlaxoSmithKline |
2022-07-26 | PHASE2 |
| NCT03141060 | COMPLETED | Tuberculosis; HIV Infections |
National Institute of Allergy and Infectious Diseases (NIAID) |
2019-02-18 | PHASE1; PHASE2 |
| NCT05007821 | COMPLETED | Tuberculosis, Multidrug-Resistant; Tuberculosis; Tuberculosis, Pulmonary |
National Institute of Allergy and Infectious Diseases (NIAID) |
2022-09-27 | PHASE2 |
| NCT05971602 | TERMINATED | Pulmonary Tuberculosis |
Gates Medical Research Institute |
2023-07-26 | PHASE2 |
| NCT03896685 | COMPLETED | Tuberculosis, Multidrug-Resistant; Tuberculosis; Pulmonary Tuberculoses; Mycobacterial Infections; Bacterial Infections; Gram-Positive Bacterial Infections |
Médecins Sans Frontières, France |
2020-04-06 | PHASE3 |
| NCT05926466 | UNKNOWN | Tuberculosis, Pulmonary; Other Specified Pulmonary Tuberculosis |
Michael Hoelscher |
2023-09-21 | PHASE2 |
| NCT04062201 | COMPLETED | Tuberculosis; Pre-XDR-TB; Extensively Drug-Resistant Tuberculosis; Multi Drug Resistant Tuberculosis; Rifampicin Resistant Tuberculosis |
Wits Health Consortium (Pty) Ltd |
2019-08-22 | PHASE3 |
| NCT05221502 | COMPLETED | Pulmonary TB |
Otsuka Pharmaceutical Development & Commercialization, Inc. |
2022-04-12 | PHASE2 |
| NCT06224036 | UNKNOWN | Drug-resistant Tuberculosis |
Beijing Chest Hospital |
2023-10-31 | PHASE2 |
| NCT02754765 | COMPLETED | Tuberculosis, Multidrug-Resistant; Infection, Bacterial; Pulmonary Tuberculoses |
Médecins Sans Frontières, France |
2016-12 | PHASE3 |
| NCT04550832 | COMPLETED | Infections and Infestations; Pulmonary Tuberculosis |
LigaChem Biosciences, Inc. |
2021-10-28 | PHASE2 |
| NCT03959566 | COMPLETED | Pulmonary Tuberculosis; Other Specified Pulmonary Tuberculosis |
Michael Hoelscher |
2021-05-06 | PHASE2 |
| NCT04421495 | UNKNOWN | Multidrug Resistant Tuberculosis |
Beijing Chest Hospital |
2020-07-16 | PHASE4 |
| NCT03678688 | COMPLETED | Pulmonary TB |
Otsuka Pharmaceutical Development & Commercialization, Inc. |
2018-10-18 | PHASE1; PHASE2 |
| NCT02975570 | WITHDRAWN | Tuberculosis Multi Drug Resistant Active |
Boston University |
2017-08 | PHASE3 |
| NCT02619994 | COMPLETED | Tuberculosis, Multidrug-Resistant |
Seoul National University Hospital |
2016-01 | PHASE2 |
| NCT01859923 | COMPLETED | Multidrug Resistant Tuberculosis |
Otsuka Pharmaceutical Development & Commercialization, Inc. |
2013-07-20 | PHASE2 |
| NCT02583048 | COMPLETED | Tuberculosis; HIV Infections |
National Institute of Allergy and Infectious Diseases (NIAID) |
2016-08-15 | PHASE2 |
| NCT01856634 | COMPLETED | Multidrug Resistant Tuberculosis; Pediatric |
Otsuka Pharmaceutical Development & Commercialization, Inc. |
2013-06-14 | PHASE1 |
| NCT01424670 | COMPLETED | Multidrug-resistant Tuberculosis |
Otsuka Pharmaceutical Development & Commercialization, Inc. |
2011-09-02 | PHASE3 |
| NCT02573350 | COMPLETED | Tuberculosis, Multidrug-Resistant |
Otsuka Pharmaceutical Development & Commercialization, Inc. |
2009-03-26 | PHASE2 |
| NCT01424670 | Completed | Multidrug-resistant Tuberculosis |
Otsuka Pharmaceutical Development & Commercialization Inc. |
2011-09-02 | Phase 3 |
| NCT01131351 | TERMINATED | Tuberculosis |
Otsuka Pharmaceutical Development & Commercialization, Inc. |
2010-02-19 | PHASE2 |
| NCT00685360 | COMPLETED | Tuberculosis, Pulmonary; Tuberculosis, Multidrug Resistant; Extensively Drug-Resistant Tuberculosis |
Otsuka Pharmaceutical Development & Commercialization, Inc. |
2008-05-08 | PHASE2 |
| NCT01131351 | Terminated | Tuberculosis |
Otsuka Pharmaceutical Development & Commercialization Inc. |
2010-02-19 | Phase 2 |
(data from https://clinicaltrials.gov, updated on 2026-06-30)
Check the
Delamanid
product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.
Mechanism and Biochemical Profile
Appendix RUO and cGMP Quality Standards
| Quality Dimension | RUO (Research Use Only) | cGMP (Current Good Manufacturing Practice) |
|---|---|---|
| Clinical Applicability | Prohibited in human clinical trials or medical diagnostics. | Mandatory for human clinical trials (Phase I–III) and therapies. |
| Regulatory Status | Non-regulated grade; exempt from drug manufacturing laws. | Legally enforced by health authorities (e.g., FDA, EMA, NMPA). |
| Facility Environment | Unclassified analytical or research laboratories. | Validated Cleanrooms (ISO Class 5–8) with continuous monitoring. |
| Quality Control | Basic purity and activity testing. | Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma). |
| Process Validation | Basic equipment calibration; no process validation required. | Full qualification (IQ/OQ/PQ) and complete batch records. |
| Quality Assurance | Vendor self-declared without required formal QMS. | Mandatory QA/QC unit, Change Control, CAPA, and vendor audits. |
| Regulatory Impact | High risk of IND rejection if used as a critical raw material. | Required for IND/NDA filings, supported by Drug Master Files (DMF). |
Footnotes
Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).
Note: Technical data last updated: Sep 1, 2026.