MedPath

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)

Safety and Effectiveness of Delamanid-containing Regimen for MDR-TB Patients in China

Phase 4
Conditions
Multidrug Resistant Tuberculosis
Interventions
First Posted Date
2020-06-09
Last Posted Date
2022-07-07
Lead Sponsor
Beijing Chest Hospital
Target Recruit Count
608
Registration Number
NCT04421495
Locations
🇨🇳

Public Health Clinical Center of Chengdu, Chengdu, China

🇨🇳

Heilongjiang Province center for tuberculosis Control and Prevention, Haerbin, China

🇨🇳

Tuberculosis Hospital in Jilin Province, Jilin, China

and more 22 locations

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

Phase 3
Completed
Conditions
Tuberculosis
Pre-XDR-TB
Extensively Drug-Resistant Tuberculosis
Multi Drug Resistant Tuberculosis
Rifampicin Resistant Tuberculosis
Interventions
First Posted Date
2019-08-20
Last Posted Date
2024-08-28
Lead Sponsor
Wits Health Consortium (Pty) Ltd
Target Recruit Count
402
Registration Number
NCT04062201
Locations
🇿🇦

Jose Pearson TB Hospital, Port Elizabeth, Eastern Cape, South Africa

🇿🇦

King DinuZulu Hospital Complex, Durban, KwaZulu Natal, South Africa

Evaluating Newly Approved Drugs in Combination Regimens for Multidrug-Resistant TB With Fluoroquinolone Resistance (endTB-Q)

Phase 3
Completed
Conditions
Gram-Positive Bacterial Infections
Mycobacterial Infections
Bacterial Infections
Tuberculosis, Multidrug-Resistant
Tuberculosis
Pulmonary Tuberculoses
Interventions
First Posted Date
2019-04-01
Last Posted Date
2025-02-10
Lead Sponsor
Médecins Sans Frontières, France
Target Recruit Count
323
Registration Number
NCT03896685
Locations
🇱🇸

Partners In Health Lesostho, Maseru, Lesotho

🇵🇰

Institute of Chest Disease,, Kotri, Pakistan

🇻🇳

Hanoi Lung Hospital, Hanoi, Vietnam

and more 7 locations

Efficacy and Tolerability of Bedaquiline, Delamanid, Levofloxacin, Linezolid, and Clofazimine to Treat MDR-TB

Phase 2
Recruiting
Conditions
Tuberculosis, Multidrug-Resistant
Interventions
First Posted Date
2019-02-04
Last Posted Date
2025-04-27
Lead Sponsor
Boston University
Target Recruit Count
220
Registration Number
NCT03828201
Locations
🇵🇭

De La Salle Health Sciences Institute, Dasmariñas, Philippines

🇻🇳

National Lung Hospital, Hanoi, Vietnam

Protecting Households On Exposure to Newly Diagnosed Index Multidrug-Resistant Tuberculosis Patients

Phase 3
Active, not recruiting
Conditions
Tuberculosis, MDR
Interventions
Dietary Supplement: Pyridoxine (vitamin B6)
First Posted Date
2018-06-26
Last Posted Date
2025-04-23
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Target Recruit Count
5834
Registration Number
NCT03568383
Locations
🇧🇼

Gaborone CRS, Gaborone, South-East District, Botswana

🇧🇷

Instituto de Pesquisa Clinica Evandro Chagas (IPEC) CRS, Rio de Janeiro, Brazil

🇭🇹

GHESKIO Institute of Infectious Diseases and Reproductive Health (GHESKIO - IMIS) CRS, Port-au-Prince, Haiti

and more 28 locations

Evaluating the Pharmacokinetics, Safety, and Tolerability of Delamanid in Combination With Optimized Multidrug Background Regimen (OBR) for Multidrug-Resistant Tuberculosis (MDR-TB) in HIV-Infected and HIV-Uninfected Children With MDR-TB

Phase 1
Active, not recruiting
Conditions
Tuberculosis
HIV Infections
Interventions
Drug: Optimized multidrug background regimen (OBR) for children with MDR-TB
First Posted Date
2017-05-04
Last Posted Date
2025-01-17
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Target Recruit Count
37
Registration Number
NCT03141060
Locations
🇮🇳

Byramjee Jeejeebhoy Medical College (BJMC) CRS, Pune, Maharashtra, India

🇿🇦

Sizwe CRS, Johannesburg, Gauteng, South Africa

🇿🇦

PHRU Matlosana CRS, Klerksdorp, North West Province, South Africa

and more 2 locations

Efficacy and Tolerability of Delamanid, Linezolid, Pyrazinamide and Levofloxacin

Phase 3
Withdrawn
Conditions
Tuberculosis Multi Drug Resistant Active
Interventions
First Posted Date
2016-11-29
Last Posted Date
2017-09-11
Lead Sponsor
Boston University
Registration Number
NCT02975570

Evaluating Newly Approved Drugs for Multidrug-resistant TB

Phase 3
Completed
Conditions
Tuberculosis, Multidrug-Resistant
Infection, Bacterial
Pulmonary Tuberculoses
Interventions
First Posted Date
2016-04-28
Last Posted Date
2025-02-10
Lead Sponsor
Médecins Sans Frontières, France
Target Recruit Count
754
Registration Number
NCT02754765
Locations
🇰🇿

City Centre of Phthisiopulmonology, Almaty, Kazakhstan

🇵🇰

The Indus Hospital, Karachi, Pakistan

🇰🇿

Center of Phthisiopulmonology of Almaty Health Department, Almaty, Kazakhstan

and more 9 locations

Treatment Shortening of MDR-TB Using Existing and New Drugs

Phase 2
Completed
Conditions
Tuberculosis, Multidrug-Resistant
Interventions
Drug: Locally-used WHO-approved MDR-TB regimen in Korea
First Posted Date
2015-12-02
Last Posted Date
2025-01-03
Lead Sponsor
Seoul National University Hospital
Target Recruit Count
214
Registration Number
NCT02619994
Locations
🇰🇷

Division of Pulmonology and Critical Care Medicine, Department of Internal Medicine and Lung Institute of Medical Research Center, Seoul National University College of Medicine, Seoul, Korea, Republic of

Evaluating the Safety, Tolerability, and Pharmacokinetics of Bedaquiline and Delamanid, Alone and in Combination, For Drug-Resistant Pulmonary Tuberculosis

Phase 2
Completed
Conditions
HIV Infections
Tuberculosis
Interventions
Drug: Multidrug Background Treatment (MBT) for TB
First Posted Date
2015-10-21
Last Posted Date
2022-01-27
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Target Recruit Count
84
Registration Number
NCT02583048
Locations
🇵🇪

Barranco CRS, Lima, Peru

🇿🇦

Task Applied Science (TASK) CRS, Cape Town, Western Cape Province, South Africa

🇿🇦

South African Tuberculosis Vaccine Initiative (SATVI) CRS, Cape Town, Western Cape Province, South Africa

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