Delamanid (OPC-67683) for treatment of multi-drug-resistant tuberculosis

Abstract

The research and development of delamanid was carried out by Otsuka Pharmaceutical Development and Commercialization (Osaka, Tokyo, Japan). It belongs to the group of nitroimidazoles. It inhibits the synthesis of mycolic acids, crucial component of the cell wall of the Mycobacterium tuberculosis complex. It is insoluble in water and its activity was proven in several in vitro and in vivo studies. Its market approval was obtained in April 2014 in Europe. Its bactericidal activity was demonstrated in individuals with drug-susceptible and drug-resistant tuberculosis (MDR- and XDR-TB). The safety and tolerability profile was good; the notified increased QT interval was not clinically relevant. It was approved for adults but ongoing clinical trials and clinical experiences have been proving its efficacy in the pediatric population.

Keywords:

• delamanid
• MDR-TB prevention
• mycolic acid inhibition
• nitro-dihydro-imidazooxazole
• tuberculosis

Financial &competing interests disclosure

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Key issues

• Delamanid is a new innovative drug for the treatment of MDR- and XDR-TB.

• Delamanid is well tolerated and safe; only QT prolongation without clinical relevance had been described.

• The recommended dose for adults is 100 mg b.i.d for 24 weeks.

• Delamanid has limited drug–drug interactions.

• Delamanid can prospectively be prescribed within innovative shorter treatment regimens for the treatment of both drug-susceptible and MDR/XDR-TB.

• Delamanid is likely to have a role in the treatment of LTBI.

• Authorization in several countries. In some settings, compassionate use based on experts’ opinion.