Current Trials

TB Alliance and its partners conduct clinical trials in high TB burden countries around the world. A clinical trial may test one or more regimens simultaneously.

  • The purpose of this study is to evaluate the mycobactericidal activity, safety, tolerability, and pharmacokinetics of 5 doses of linezolid
  • NC-005 is a Phase 2B trial of the BPaZ and BPaMZ regimens to further explore its potential to be an improved TB treatment. This trial includes people with drug-sensitive as well as people with some forms of multidrug-resistant TB.
  • Nix-TB is the first clinical trial to test a novel regimen that holds the potential to be a shorter, all-oral, and affordable treatment for XDR-TB. The Nix-TB regimen consists of drugs with minimal resistance, pretomanid, bedaquiline, and linezolid. Participants will be treated with the intent to cure for 6-9 months. Nix-TB is an open label trial that enables patients to be assessed at regular intervals. The trial has an adaptive design, which can accommodate the addition of new treatments or treatment protocols over the course of study, based on new information generated.
  • TB Alliance is working to develop appropriate child-friendly formulations of the current standard TB treatment. The first wave of these new products has already reached market.
  • ZeNix is a clinical trial to testing a novel regimen that holds the potential to be a shorter, all-oral, and affordable treatment for XDR-TB. ZeNix is testing a regimen consisting of three drugs with minimal resistance, pretomanid, bedaquiline, and linezolid (BPaL). It will evaluate whether the efficacy of the BPaL drug regimen can be maintained, while reducing toxicity by testing a lower dose and shorter duration of the drug linezolid.

Completed Trials

  • NC-001 was Phase II clinical trial that tested the PaMZ regimen (PA-824 + moxifloxacin + pyrazinamide). The regimen was administered for two weeks. Results found PaMZ could kill more than 99 percent of patients’ TB bacteria within two weeks and could be more effective than existing treatments.
  • The New Combination 2 (NC-002) Phase 2 SSCC trial continued to develop the PaMZ TB treatment regimen, comprised of PA-824, moxifloxacin, and pyrazinamide. It was an 8-week trial, which recruits both DS-TB and MDR-TB patients.
  • The New Combination 3 (NC-003) clinical trial tested the BPaZ regimen, consisting of bedaquiline, PA-824, and pyrazinamide. The two-week study found that the BPaZ regimen killed more than 99% of TB bacteria over the course of 14 days, and that the treatment was safe.
  • REMoxTB was a global Phase 3 clinical trial conducted at nearly 50 sites. The trial tested whether substituting moxifloxacin for a single drug in the standard TB therapy could reduce treatment of drug-sensitive disease from six months to four.
  • The STAND trial tested the novel three-drug regimen PaMZ in both DS-TB and MDR-TB patients.