MedPath

Delamanid

Generic Name
Delamanid
Brand Names
Deltyba
Drug Type
Small Molecule
Chemical Formula
C25H25F3N4O6
CAS Number
681492-22-8
Unique Ingredient Identifier
8OOT6M1PC7

Overview

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)

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2025/08/19
Not Applicable
Not yet recruiting
Shanghai Pulmonary Hospital, Shanghai, China
2025/08/17
Not Applicable
Not yet recruiting
Wuhan Pulmonary Hospital
2024/10/21
Phase 3
Recruiting
2024/01/25
Phase 2
Recruiting
Beijing Chest Hospital
2023/11/02
Phase 2
Recruiting
2023/10/13
Phase 3
Active, not recruiting
Beijing Chest Hospital
2023/07/03
Phase 2
Recruiting
Michael Hoelscher
2023/03/13
Phase 2
Recruiting
2022/09/27
Phase 2
Recruiting
2022/05/19
Phase 2
Recruiting

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product
ARTG ID
Sponsor
Registration Type
Status
Registration Date
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
No Health Canada approvals found for this drug.

CIMA AEMPS Drug Approvals

Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
DELTYBA 50 MG COMPRIMIDOS RECUBIERTOS CON PELICULA
113875004
COMPRIMIDO RECUBIERTO CON PELÍCULA
Uso Hospitalario
Commercialized

Philippines FDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product
Company
Registration Number
Dosage Form
Strength
Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name
MA Holder
MA Number
Pharmaceutical Form
Active Ingredient
Authorization Date
No UK EMC drug information found for this drug.

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