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Delamanid: First Global Approval

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Abstract

Delamanid, a nitro-dihydro-imidazooxazole derivative, has been developed by Otsuka Pharmaceutical for the treatment of multidrug-resistant tuberculosis (MDR-TB). Delamanid received its first global approval for the treatment of MDR-TB in the European Union (EU), for use in combination with optimised background therapy. It is also under review for marketing in Japan for MDR-TB, the first drug application filed in Japan for this indication. Delamanid has been granted orphan drug status in both the EU and Japan. This article summarizes the milestones in the development of delamanid leading to this first approval for MDR-TB.

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Disclosure

The preparation of this report was not supported by any external funding. During the peer review process the manufacturer of the agent under review was offered an opportunity to comment on the article. Changes resulting from any comments received were made by the authors on the basis of scientific completeness and accuracy. N.J. Ryan is a contracted employee of Adis, Springer SBM. J.H. Lo is a salaried employee of Adis, Springer SBM.

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Authors and Affiliations

  1. Adis, Level 1, 5 The Warehouse Way, Northcote 0627; Private Bag 65901, Mairangi Bay 0754, Auckland, New Zealand

    Jin Han Lo

  2. Adis, Auckland, New Zealand

    Nicola J. Ryan

Authors
  1. Nicola J. Ryan
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  2. Jin Han Lo
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Corresponding author

Correspondence to Jin Han Lo.

Additional information

This profile has been extracted and modified from the Adis R&D Insight drug pipeline database. Adis R&D Insight tracks drug development worldwide through the entire development process, from discovery, through pre-clinical and clinical studies to market launch.

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Ryan, N.J., Lo, J.H. Delamanid: First Global Approval. Drugs 74, 1041–1045 (2014). https://doi.org/10.1007/s40265-014-0241-5

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