ZeNix

Partners: Mylan

ZeNix is a clinical trial testing the BPaL regimen, which consists of pretomanid, bedaquiline, and linezolid. Zenix will evaluate whether the efficacy of the BPaL drug regimen can be maintained, while reducing toxicity, through a lower dose and shorter duration of linezolid.

Background:

Overview

ZeNix is a successor to Nix-TB, a pivotal trial of the BPaL regimen, which was recently approved by US FDA  for treatment of adults with extensively drug resistant, treatment-intolerant or nonresponsive multidrug resistant pulmonary TB. Zenix tests a version of BPaL with a lower dose and shorter duration of linezolid, to determine whether the efficacy of BPaL can be maintained while reducing toxicity. Zenix enrolls participants with XDR-TB at sites in Africa and Eastern Europe.

About the New Treatment(s)

BPaL consists of bedaquiline, pretomanid, and linezolid. More information about pretomanid and BPaL can be found here.

Timeline

ZeNix began in Q4 2017. ZeNix is scheduled to report findings on an ongoing basis at predetermined milestones.

Additional Resources 

 

Phase 3

Trial Components

Regimens