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Delamanid

Alternative Names: delamanid, opc-67683
Latest Update: 2025-01-17
Latest Update Note: Clinical Trial Update

Product Description

Mechanisms of Action: Cell Wall Synthesis Inhibitor

Novel Mechanism: No

Modality: Small Molecule

Route of Administration: Oral

FDA Designation: None *

Approval Status: Not Approved

Approved Countries: Austria | Belgium | Croatia | Czech | Estonia | European Medicines Agency | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | Indonesia | Ireland | Italy | Japan | Korea | Latvia | Lithuania | Netherlands | Peru | Philippines | Poland | Portugal | Romania | Russia | Slovakia | South Africa | Spain | Sweden | Turkey | Ukraine | United Kingdom | Uruguay

Approved Indications: None

Known Adverse Events: None

Company: Otsuka
Company Location: NEW YORK NY 10271
Company CEO:
Additonal Commercial Interests: None

Clinical Description

Map of Global Clinical Trials for Delamanid

Countries in Clinic: Botswana, Brazil, Georgia, Haiti, India, Kazakhstan, Kenya, Pakistan, Peru, Philippines, South Africa, Tanzania, Thailand, Uganda, Unknown Location, Vietnam, Zimbabwe

Active Clinical Trial Count: 11

Highest Development Phases

Phase 3: Communicable Diseases|Gram-Positive Bacterial Infections|Mycobacterium Infections|Tuberculosis, Multidrug-Resistant|Tuberculosis, Pulmonary

Phase 2: HIV Infections

Trial

Phase

Trial Status

Disease

Primary Completion Date

Probability of Success
PHOENIx MDR-TB

P3

Recruiting

Tuberculosis, Multidrug-Resistant

2027-07-30

DRAMATIC

P2

Recruiting

Tuberculosis, Multidrug-Resistant

2027-05-01

PARADIGM4TB

P2

Recruiting

Tuberculosis, Pulmonary

2027-02-24

IMPAACT 2005

P2

Active, not recruiting

Tuberculosis, Multidrug-Resistant|HIV Infections

2025-05-05

Recent News Events

Date

Type

Title

11/14/2024

News Article

 ACTG Presents Two Studies Providing Insights Into TB Treatment at Union Conference on Lung Health

05/09/2024

PubMed

 Sputum culture reversion in longer treatments with bedaquiline, delamanid, and repurposed drugs for drug-resistant tuberculosis.

05/03/2024

PubMed

 Comparison of QTc interval changes in drug-resistant tuberculosis patients on delamanid-containing regimens versus shorter treatment regimens.

04/26/2024

PubMed

 Mitigating treatment failure of pulmonary pre-extensively drug-resistant tuberculosis: The role of new and repurposed drugs.

03/21/2024

News Article

 Otsuka Announces Interim Data from Phase 2b/c Trial Indicating New Investigational Compound May Shorten Tuberculosis Treatment

09/19/2023

News Article

 Healthcare Contract Research Organization Market 2023 Share, Upcoming Trends, Key Segments, Growth Status and Forecast 2031

08/09/2023

News Article

 PAN-TB Collaboration Announces the Start of a Phase 2 Clinical Trial to Evaluate Two Novel Tuberculosis Treatment Regimens

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