US-Backed Group Reports Success with New Tuberculosis Treatment in Phase 2 Study

The US-backed non-profit TB Alliance announced results from a Phase 2 clinical trial, presented at the Union World Conference on Lung Health on November 19, 2025, showing that the novel antibiotic candidate sorfequiline (TBAJ-876), used in the 'SPaL' regimen with pretomanid and linezolid, may significantly improve and further shorten tuberculosis (TB) treatment1.

This Phase 2 study suggests the potential to reduce TB treatment duration even beyond the 6-month regimen established by the earlier BPaL combination for drug-resistant TB1.

The BPaL regimen (bedaquiline, pretomanid, and linezolid), also developed by TB Alliance, previously demonstrated efficacy in drug-resistant TB and was notable as the first TB drug regimen developed by a non-profit to receive regulatory approval1.

Pretomanid, one of the drugs in both BPaL and the new SPaL regimens, has already reached more than 210,000 courses ordered globally, with an estimated 11,000 lives and $100 million saved1.

TB Alliance’s Phase 2 success with sorfequiline sets the stage for a planned Phase 3 clinical trial in 2026, aiming for an ultra-short regimen effective for both drug-sensitive and drug-resistant TB forms1.

US agencies involved in supporting the research include the Department of Defense, Department of State, and the National Institutes of Health1.

Sources:

1. https://www.prnewswire.com/news-releases/phase-2-clinical-trial-results-show-potential-to-shorten-tb-treatment-time-302619952.html