, Volume 74, Issue 9, pp 1041–1045 | Cite as

Delamanid: First Global Approval

  • Nicola J. Ryan
  • Jin Han LoEmail author
R&D Insight Report


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.


European Union Marketing Approval CHMP Orphan Drug Status Optimise Background Therapy 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.



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.


  1. 1.
    van den Boogaard J, Kibiki GS, Kisanga ER, Boeree MJ, Aarnoutse RE. New drugs against tuberculosis: problems, progress, and evaluation of agents in clinical development. Antimicrob Agents Chemother. 2009;53(3):849–62.PubMedCentralPubMedCrossRefGoogle Scholar
  2. 2.
    Ginsberg AM. Drugs in development for tuberculosis. Drugs. 2010;70:2201–14.PubMedCrossRefGoogle Scholar
  3. 3.
    Field SK, Fisher D, Jarand JM, Cowie RL. New treatment options for multidrug-resistant tuberculosis. Ther Adv Respir Dis. 2012;6(5):255–68.PubMedCrossRefGoogle Scholar
  4. 4.
    Villemagne B, Crauste C, Flipo M, Baulard AR, Deprez B, Willand N. Tuberculosis: the drug development pipeline at a glance. Eur J Med Chem. 2012;51:1–16.PubMedCrossRefGoogle Scholar
  5. 5.
    Otsuka Pharmaceutical. Otsuka Wins European Marketing Authorization for Deltyba(TM) (delamanid). Media Release. 20 Apr 2014. Available at Accessed 14 May 2014.
  6. 6.
    Otsuka Pharmaceutical Co L. Otsuka’s Novel Treatment for Multidrug-Resistant Tuberculosis, Delamanid, Submitted For Regulatory Approval in Japan—Half Century Since Last Drug Was Approved in Japan for Tuberculosis. Media Release. 27 Mar 2013. Available at Accessed 14 May 2014.
  7. 7.
    European Medicines Agency. Public summary of opinion on orphan designation. Media Release. 15 Nov 2011. Available at Accessed 14 May 2014.
  8. 8.
    Gler MT, Skripconoka V, Sanchez-Garavito E, Xiao H, Cabrera-Rivero JL, Vargas-Vasquez DE, et al. Delamanid for multidrug-resistant pulmonary tuberculosis. N Engl J Med. 2012;366(23):2151–60.PubMedCrossRefGoogle Scholar
  9. 9.
    Skripconoka V, Danilovits M, Pehme L, Tomson T, Skenders G, Kummik T, et al. Delamanid improves outcomes and reduces mortality in multidrug-resistant tuberculosis. Eur Respir J. 2013;41(6):1393–400.PubMedCentralPubMedCrossRefGoogle Scholar
  10. 10.
    Otsuka Pharmaceutical. Summary of Product Characteristics. Available at http://eceuropaeu/health/documents/community-register/2014/20140428126881/anx_126881_enpdf. Accessed 14 May 2014.Google Scholar
  11. 11.
    European Medicines Agency. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 18-21 November 2013. Media Release. 22 Nov 2013. Available at
  12. 12.
    Diacon AH, Dawson R, Hanekom M, Narunsky K, Venter A, Hittel N, et al. Early bactericidal activity of delamanid (OPC-67683) in smear-positive pulmonary tuberculosis patients. Int J Tuberc Lung Dis. 2011;15(7):949–54.PubMedCrossRefGoogle Scholar
  13. 13.
    Matsumoto M, Hashizume H, Tomishige T, Kawasaki M, Tsubouchi H, Sasaki H, et al. OPC-67683, a nitro-dihydro-imidazooxazole derivative with promising action against tuberculosis in vitro and in mice. PLoS Med. 2006;3(11):e466.PubMedCentralPubMedCrossRefGoogle Scholar
  14. 14.
    Saliu OY, Crismale C, Schwander SK, Wallis RS. Bactericidal activity of OPC-67683 against drug-tolerant Mycobacterium tuberculosis. J Antimicrob Chemother. 2007;60(5):994–8.PubMedCrossRefGoogle Scholar
  15. 15.
    Zhang Q, Liu Y, Tang S, Sha W, Xiao H. Clinical benefit of delamanid (OPC-67683) in the treatment of multidrug-resistant tuberculosis patients in China. Cell Biochem Biophys. 2013;67(3):957–63.PubMedCrossRefGoogle Scholar
  16. 16.
    Otsuka Pharmaceutical. Safety and efficacy of delamanid for 6 months in patients with multidrug resistant tuberculosis [NCT01424670]. Available at Accessed 14 May 2014.
  17. 17.
    Otsuka Pharmaceutical. Pharmacokinetic and safety trial to determine the appropriate dose for pediatric patients with multidrug resistant tuberculosis [NCT01856634]. Available at Accessed 14 May 2014.
  18. 18.
    Otsuka Pharmaceutical. A 6-month safety, efficacy and pharmacokinetic trial of delamanid in pediatric patients with multidrug resistant tuberculosis [NCT01859923]. Available at Accessed 14 May 2014.

Copyright information

© Springer International Publishing Switzerland 2014

Authors and Affiliations

  1. 1.AdisAucklandNew Zealand
  2. 2.AdisAucklandNew Zealand

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