News 2025

The phase 3, open-label, randomized controlled and stratified trial compared a 6- to 9-month all-oral regimen containing Bedaquiline, Delamanid, Linezolid, and Clofazimine (BDLC) to the standard WHO-recommended (mostly BDLC + 1 or 2 other medications) 18-month treatment. The trial enrolled 324 participants across six countries with high burdens of drug-resistant TB.

The BDLC regimen reached favourable outcomes in 87% of participants, closely matching the 89% success rate in the control group. However, the study did not demonstrate formal non-inferiority, particularly among participants with extensive disease, who experienced higher relapse rates under the shorter regimen.

“While the BDLC regimen shows promise—especially for patients with limited disease—it’s clear that one size does not fit all,” said Ohanna Kirakosyan, co-author and physician scientist at the Research Center Borstel (FZB) in Germany. “This study is a pivotal step toward personalized medicine for tuberculosis. We now have a clearer understanding of which patients can benefit from shorter treatment and which require longer or reinforced regimens,” says Professor Christoph Lange, Medical Director at FZB and Scientific advisor to MSF for this study.

The study highlights the critical importance of stratifying treatment by disease severity and calls for broader access to rapid diagnostics and continued innovation in TB therapeutics.

This trial represents the first rigorously controlled study specifically designed for patients with pre-XDR TB and underscores the growing potential of individualized approaches in global TB care.

Publication:

Mitnick C., Guglielmetti L., et al. Bedaquiline, delamanid, linezolid, and clofazimine for rifampicin‑resistant tuberculosis: the ENDTB‑Q trial. The Lancet Regional Health – Western Pacific. 2025. doi:10.1016/S2213‑2600(25)00194‑8