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)

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

Phase 2
Completed
Conditions
Tuberculosis, Multidrug-Resistant
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)

Phase 2
Completed
Conditions
Multidrug Resistant Tuberculosis
Interventions
Drug: Optimized Background Regimen (OBR)
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

Pharmacokinetic and Safety Trial to Determine the Appropriate Dose for Pediatric Patients With Multidrug Resistant Tuberculosis

Phase 1
Completed
Conditions
Pediatric
Multidrug Resistant Tuberculosis
Interventions
First Posted Date
2013-05-17
Last Posted Date
2018-01-30
Lead Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Target Recruit Count
37
Registration Number
NCT01856634
Locations
🇵🇭

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

🇿🇦

Brooklyn Chest Hospital, Ysterplaat, Cape Town, South Africa

Safety and Efficacy Trial of Delamanid for 6 Months in Participants With Multidrug-resistant Tuberculosis

Phase 3
Completed
Conditions
Multidrug-resistant Tuberculosis
Interventions
Drug: Placebo + OBR
First Posted Date
2011-08-29
Last Posted Date
2019-05-15
Lead Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Target Recruit Count
511
Registration Number
NCT01424670

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

Phase 2
Terminated
Conditions
Tuberculosis
Interventions
Drug: Optimized Background Regimen (OBR)
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)

Phase 2
Completed
Conditions
Tuberculosis, Pulmonary
Tuberculosis, Multidrug Resistant
Extensively Drug-Resistant Tuberculosis
Interventions
Drug: Optimized Background Regimen (OBR)
Drug: Placebo
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

Safety, Efficacy and Pharmacokinetics of OPC-67683 in Patients With Pulmonary Tuberculosis

Phase 2
Completed
Conditions
Pulmonary Tuberculosis
First Posted Date
2006-11-20
Last Posted Date
2007-03-07
Lead Sponsor
Otsuka Frankfurt Research Institute GmbH
Target Recruit Count
54
Registration Number
NCT00401271
Locations
🇿🇦

Tiervlei Trial Center, Karl Bremer Hospital, Bellville, W Cape, South Africa

🇿🇦

University of Cape Town Lung Institute, Mowbray, W Cape, South Africa

🇿🇦

Medical Research Council, Durban, South Africa

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

Completed
Conditions
HIV Infections
Interventions
Drug: darunavir/ritonavir dosage #1
Drug: TAF w/cobicistat
Drug: elvitegravir/cobicistat
Drug: darunavir/cobicistat
Drug: atazanavir/cobicistat
Drug: lopinavir/ritonavir dosage #1
Drug: atazanavir/ritonavir/tenofovir dosage #1
Drug: lopinavir/ritonavir dosage #2
Drug: indinavir/ritonavir dosage #1
Drug: atazanavir/ritonavir dosage #1
Drug: tipranavir/ritonavir
Drug: darunavir/ritonavir dosage #4
Drug: indinavir/ritonavir dosage #2
Drug: darunavir/ritonavir dosage #2
Drug: lopinavir/ritonavir dosage #3
Drug: lopinavir/ritonavir dosage #4
Drug: tenofovir/atazanavir/ritonavir dosage #2
Drug: atazanavir/ritonavir dosage #2
Drug: darunavir/ritonavir dosage #3
Drug: levoflaxacin
Drug: ethionamide/prothionamide
Drug: terizidone/cycloserine
Drug: para-aminosalicylic acid (PAS)
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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