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 tub...

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)
Associated Therapies
-

Evaluating Newly Approved Drugs for Multidrug-resistant TB

First Posted Date
2016-04-28
Last Posted Date
2024-07-24
Lead Sponsor
Médecins Sans Frontières, France
Target Recruit Count
754
Registration Number
NCT02754765
Locations
🇵🇪

Hospital Nacional Dos de Mayo Parque Historia de la Medicina, Lima, Peru

🇰🇿

National Center for Tuberculosis Problems, Almaty, Kazakhstan

🇬🇪

National Center for Tuberculosis and Lung Diseases, Tbilisi, Georgia

and more 9 locations

Treatment Shortening of MDR-TB Using Existing and New Drugs

First Posted Date
2015-12-02
Last Posted Date
2019-02-04
Lead Sponsor
Seoul National University Hospital
Target Recruit Count
238
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

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

A Trial to Evaluate Safety, Tolerability, and Efficacy of Orally Administered OPC-67683

Phase 2
Completed
Conditions
Interventions
First Posted Date
2015-10-09
Last Posted Date
2021-11-01
Lead Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Target Recruit Count
213
Registration Number
NCT02573350
Locations
🇪🇪

Tartu University Lung Hospital, Tartu, Estonia

🇰🇷

Asan Medical Center, Seoul, Korea, Republic of

🇰🇷

Younsei University Medical Center, Seoul, Korea, Republic of

and more 5 locations

A 6-Month Safety, Efficacy, and Pharmacokinetic (PK) Trial of Delamanid in Pediatric Participants With Multidrug Resistant Tuberculosis (MDR-TB)

First Posted Date
2013-05-22
Last Posted Date
2020-11-23
Lead Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Target Recruit Count
37
Registration Number
NCT01859923
Locations
🇵🇭

Lung Center of the Philippines, Quezon City, Metro Manila, Philippines

🇵🇭

De La Salle Health Sciences Institute, Dasmariñas, Cavite, Philippines

🇿🇦

Brooklyn Chest Hospital, Ysterplaat, Cape Town, South Africa

Safety and Pharmacokinetics (PK) in Multidrug-Resistant (MDR) Refractive Tuberculosis

First Posted Date
2010-05-26
Last Posted Date
2021-11-11
Lead Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Target Recruit Count
10
Registration Number
NCT01131351
Locations
🇱🇹

Hospital for Tuberculosis and Lung Diseases, Siauliai, Lithuania

🇱🇻

Infectology Center of Latvia - Clinic of Tuberculosis and Lung Diseases, Ogre, Latvia

🇱🇹

National Tuberculosis and Infectious Diseases University Hospital, Vilnius, Lithuania

A Trial to Evaluate OPC 67683 in Participants With Pulmonary Sputum Culture-positive, Multidrug-resistant Tuberculosis (TB)

First Posted Date
2008-05-28
Last Posted Date
2021-12-01
Lead Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Target Recruit Count
481
Registration Number
NCT00685360
Locations
🇵🇪

Hospital Nacional Sergio E. Bernales, Lima, Peru

🇵🇪

Hospital Nacional Hipolito Unanue, Unanue, Peru

🇵🇪

Hospital Nacional Daniel Alcides Carrión, Carrion, Peru

and more 14 locations

Pharmacokinetic Study of Antiretroviral Drugs and Related Drugs During and After Pregnancy

First Posted Date
2002-08-01
Last Posted Date
2022-07-22
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Target Recruit Count
1578
Registration Number
NCT00042289
Locations
🇺🇸

Usc La Nichd Crs, Los Angeles, California, United States

🇿🇦

Wits RHI Shandukani Research Centre CRS, Johannesburg, Gauteng, South Africa

🇺🇸

Boston Medical Center Ped. HIV Program NICHD CRS, Boston, Massachusetts, United States

and more 59 locations
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