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ZeNix

Partners: Macleods, Hongqi Pharmaceutical, KNCV Tuberculosefonds, International Tuberculosis Research Center (ITRC), Viatris, Lupin

Background:

Overview
ZeNix is a successor to Nix-TB, a pivotal trial of the BPaL regimen, which was approved by the U.S. FDA in 2019 for the treatment of adults with highly drug-resistant pulmonary tuberculosis (TB). ZeNix tested 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 enrolled participants across 11 sites across Georgia, Moldova, Russia, and South Africa.

ZeNix Participant Graphic


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

Results
Results of the ZeNix trial were published in the September 2022 issue of the New England Journal of Medicine, which reported that the treatment regimen remained effective against highly drug-resistant strains of TB with reduced dosage and/or duration of the linezolid component of the regimen. Along with the maintenance of efficacy, there was a decrease in linezolid-associated side effects that accompanied the reduced dosage or duration of linezolid.



Publications

Phase 3

Trial Components

Regimens