The BPaL regimen (comprised of bedaquiline, pretomanid and linezolid) was first studied clinically in the Phase 3 Nix-TB trial. Nix-TB participants with XDR-TB and treatment intolerant or nonresponsive MDR-TB were enrolled for treatment with the BPaL regimen for six months, extendable to nine months, with the intent to cure. Nix-TB is an open-label, single-arm trial that enrolled 107 patients in South Africa. 

BPaL (bee-pal) was first studied in the Nix-TB Phase 3 clinical trial, which enrolled people with highly drug-resistant TB in South Africa. Nix-TB data, published in the New England Journal of Medicine, have demonstrated a successful outcome in 95 of the first 107 patients (90 percent) after six months of treatment with BPaL and six months of post-treatment follow-up. For two patients, treatment was extended to nine months. BPaL has been tested in DR-TB patients co-infected with HIV, including those receiving antiretrovirals (ARVs), and similar outcomes were reported in participants based on HIV status.