Nonclinical and Clinical Studies of the New Anti-Tuberculosis Drug «Perchlozone®»

Abstract

This article describes clinical development stages for the novel anti-TB drug «Perchlozone®», which has been approved in Russian Federation in 2012. Based on the phase I–III clinical studies results, efficacy and safety of the drug were assessed, and its adverse effects in the treatment of pulmonary TB were described. Perchlozone as a part of combination therapy in patients with drugresistant pulmonary TB significantly reduced the mean time to culture conversion as compared with standard chemotherapy regimens. Increasing MDR/XDR TB incidence makes perchlozone an important anti-TB drug which has a high anti-TB activity, primarily, against drugresistant Mycobacteria strains.

Keywords

• tuberculosis
• chemotherapy
• perchlozone®
• nonclinical assessment
• clinical efficacy
• adverse effects
• indications