Delamanid
- Generic Name
- Delamanid
- Brand Names
- Deltyba
- Drug Type
- Small Molecule
- Chemical Formula
- C25H25F3N4O6
- CAS Number
- 681492-22-8
- Unique Ingredient Identifier
- 8OOT6M1PC7
- Background
Delamanid is an anti-tuberculosis agent derived from the nitro-dihydro-imidazooxazole class of compounds that inhibits mycolic acid synthesis of bacterial cell wall . It is used in the treatment of multidrug-resistant and extensively drug-resistant tuberculosis (TB) in a combination regimen. Emergence of multidrug-resistant and extensively drug-resistant tuberculosis creates clinical challenges for patients, as the disease is associated with a higher mortality rate and insufficient therapeutic response to standardized antituberculosis treatments as Isoniazid and Rifampicin. Multidrug-resistant tuberculosis may also require more than 2 years of chemotherapy and second-line therapies with narrow therapeutic index . In a clinical study involving patients with pulmonary multidrug-resistant tuberculosis or extensively drug-resistant tuberculosis, treatment of delamanid in combination with WHO-recommended optimised background treatment regimen was associated with improved treatment outcomes and reduced mortality rate . Spontaneous resistance to delamanid was observed during treatment, where mutation in one of the 5 F420 coenzymes responsible for bioactivation of delamanid contributes to this effect . Delamanid is approved by the EMA and is marketed under the trade name Deltyba as oral tablets. It is marketed by Otsuka Pharmaceutical Co., Ltd (Tokyo, Japan).
- Indication
Indicated for use as part of an appropriate combination regimen for pulmonary multi-drug resistant tuberculosis (MDR-TB) in adult patients when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability .
- Associated Conditions
- Pulmonary Multi-Drug Resistant Tuberculosis (MDR-TB)
Innovating Shorter, All- Oral, Precised Treatment Regimen for Rifampicin Resistant Tuberculosis：BDLL Chinese Cohort
- Conditions
- Drug-resistant TuberculosisPulmonary TuberculosisRifampin-resistant Tuberculosis
- Interventions
- First Posted Date
- 2024-10-21
- Last Posted Date
- 2025-04-01
- Lead Sponsor
- Huashan Hospital
- Target Recruit Count
- 120
- Registration Number
- NCT06649721
- Locations
- 🇨🇳
The Fifth Hospital of Shijiazhuang, Shijiazhuang, Hebei, China
🇨🇳Wenzhou Central Hospital, Wenzhou, Zhejiang, China
🇨🇳Beijing Chest Hospital, Beijing, China
Clinical Study of JDB0131 Benzenesulfonate Tablets in Patients With Drug-sensitive Pulmonary Tuberculosis
- Conditions
- Drug-resistant Tuberculosis
- Interventions
- First Posted Date
- 2024-01-25
- Last Posted Date
- 2024-01-25
- Lead Sponsor
- Beijing Chest Hospital
- Target Recruit Count
- 52
- Registration Number
- NCT06224036
- Locations
- 🇨🇳
Wuhan Chest Hospital (Wuhan Institute For Tuberculosis Control), Wuhan, Hubei, China
🇨🇳West China Hospital, Sichuan University, Chendu, Sichuan, China
Platform Assessing Regimens and Durations In a Global Multisite Consortium for TB
- Conditions
- Pulmonary Tuberculosis
- Interventions
- First Posted Date
- 2023-11-02
- Last Posted Date
- 2024-10-16
- Lead Sponsor
- University College, London
- Target Recruit Count
- 2500
- Registration Number
- NCT06114628
- Locations
- 🇿🇦
TASK Eden, George, South Africa
🇹🇿NIMR Mbeya, Mbeya, Tanzania
🇿🇦TASK Brooklyn, Cape Town, South Africa
Innovating Shorter, All- Oral, Precised, Individualized Treatment Regimen for Rifampicin Resistant Tuberculosis：Contezolid, Delamanid and Bedaquiline Cohort
- Conditions
- Pulmonary TuberculosisRifampicin-resistant Tuberculosis
- Interventions
- First Posted Date
- 2023-10-13
- Last Posted Date
- 2025-04-01
- Lead Sponsor
- Beijing Chest Hospital
- Target Recruit Count
- 186
- Registration Number
- NCT06081361
- Locations
- 🇨🇳
Fuzhou Pulmonary Hospital of Fujian, Fuzhou, China
🇨🇳People's Hospital of Linyi, Linyi, China
🇨🇳Fourth People's Hospital of Nanning, Nanning, China
BTZ-043 Dose Evaluation in Combination and Selection
- Conditions
- Tuberculosis, PulmonaryOther Specified Pulmonary Tuberculosis
- Interventions
- First Posted Date
- 2023-07-03
- Last Posted Date
- 2023-12-22
- Lead Sponsor
- Michael Hoelscher
- Target Recruit Count
- 90
- Registration Number
- NCT05926466
- Locations
- 🇹🇿
National Institute for Medical Research (NIMR-Mwanza),, Mwanza, Tanzania
🇿🇦TASK Applied Sciences Clinical Research Centre, Cape Town, South Africa
🇹🇿National Institute for Medical Research (NIMR-MMRC), Mbeya, Tanzania
Short-course Regimens for the Treatment of Pulmonary Tuberculosis
- Conditions
- Tuberculosis, PulmonaryTuberculosis Infection
- Interventions
- First Posted Date
- 2023-03-13
- Last Posted Date
- 2025-02-11
- Lead Sponsor
- Centers for Disease Control and Prevention
- Target Recruit Count
- 288
- Registration Number
- NCT05766267
- Locations
- 🇺🇸
TBTC Site 26 Seattle & King County TB Control Program, Seattle, Washington, United States
🇺🇸TBTC Site 64A New York City Department of Health and Mental Hygiene- Corona Chest Center, Jackson Heights, New York, United States
🇺🇸TBTC Site 63 San Antonio VA Medical Center (South Texas Group), San Antonio, Texas, United States
Ultra-Short Course Bedaquiline, Clofazimine, Pyrazinamide and Delamanid Versus Standard Therapy for Drug-Susceptible TB
- Conditions
- Tuberculosis, PulmonaryHIV
- Interventions
- First Posted Date
- 2022-09-27
- Last Posted Date
- 2025-02-13
- Lead Sponsor
- Brigham and Women's Hospital
- Target Recruit Count
- 156
- Registration Number
- NCT05556746
- Locations
- 🇭🇹
GHESKIO, Port-au-Prince, Haiti
🇿🇦University of Cape Town, Cape Town, South Africa
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
- Conditions
- Tuberculosis
- Interventions
- First Posted Date
- 2022-05-19
- Last Posted Date
- 2024-02-22
- Lead Sponsor
- GlaxoSmithKline
- Target Recruit Count
- 128
- Registration Number
- NCT05382312
- Locations
- 🇿🇦
GSK Investigational Site, Cape Town, South Africa
Safety and Efficacy Evaluation of 4-month Regimen of OPC-167832, Delamanid and Bedaquiline in Participants With Drug-Susceptible Pulmonary TB
- Conditions
- Pulmonary TB
- Interventions
- First Posted Date
- 2022-02-03
- Last Posted Date
- 2025-04-10
- Target Recruit Count
- 122
- Registration Number
- NCT05221502
- Locations
- 🇿🇦
Aurum Institute - Tembisa Clinical Research Centre, Tembisa, Gauteng, South Africa
🇿🇦TASK Applied Science, Brooklyn Chest Hospital Premises, Cape Town, South Africa
🇿🇦University of CapeTown Lung Center Institute, Cape Town, South Africa
Linezolid Dosing Strategies in Drug-Resistant TB
- Conditions
- Tuberculosis, Multidrug-ResistantTuberculosisTuberculosis, Pulmonary
- Interventions
- First Posted Date
- 2021-08-16
- Last Posted Date
- 2025-03-24
- Target Recruit Count
- 132
- Registration Number
- NCT05007821
- Locations
- 🇧🇼
Gaborone CRS (Site ID: 12701), Gaborone, South-East District, Botswana
🇧🇷Instituto de Pesquisa Clinica Evandro Chagas (IPEC) CRS (Site ID: 12101), Rio De Janeiro, Brazil
🇭🇹GHESKIO Institute of Infectious Diseases and Reproductive Health (GHESKIO - IMIS) CRS (Site ID: 31730), Port-au-Prince, Haiti
Drug Development Updates
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