The Pathway to Potential New TB Treatments

Pretomanid is the result of years of scientific research and development enabled by the essential support of TB Alliance’s donors and other stakeholders.

Over the years, pretomanid has been studied in 20 clinical trials in 14 countries with more than 1,200 clinical trial participants. Learn about the history of pretomanid, and where we stand today.

  • FDA Advisory Committee

    FDA Antimicrobial Drugs Advisory Committee votes 14-4 in favor of safety and efficacy of pretomanid for use in the BPaL regimen

  • Marketing Authorization Application (MAA) submitted

    MAA submitted to European Medicines Agency for pretomanid, in combination with bedaquiline and linezolid

  • New Drug Application (NDA) filed

    NDA accepted for FDA Priority Review for pretomanid, in combination with bedaquiline and linezolid for the treatment of extensively drug-resistant TB (XDR-TB) and treatment-intolerant or non-responsive multidrug-resistant TB (MDR-TB)

  • NDA submitted

    NDA submitted to FDA for pretomanid, in combination with bedaquiline and linezolid for the treatment of XDR-TB and treatment-intolerant or non-responsive MDR-TB

  • Interim Nix-TB data presented

    Data from Nix-TB trial presented at Union Conference, showing among first 75 XDR-TB patients, BPaL regimen cured 89% after six months of treatment and six months of post-treatment follow-up


  • ZeNix continues study of BPaL

    ZeNix Phase 3 clinical trial begins, aiming to optimize BPaL


  • Nix-TB begins enrollment

    Phase 3 Nix-TB clinical trial of BPaL regimen begins, evaluating the most drug-resistant forms of TB, including XDR-TB

  • First Phase 3 begins

    Launch of first Phase 3 trial including Pretomanid

  • Advancing new regimens

    Pretomanid Phase 2B clinical trial begins

  • Non-proprietary name for pretomanid accepted

    In a nod to TB Alliance research center in Pretoria, South Africa, Pretomanid becomes new non-proprietary name for PA-824

  • Salvage study proposed

    Concept for first new study of a novel, all-oral regimen for the most resistant TB cases led to the initiation of the Nix-TB clinical trial

  • Phase 2B begins

    PaMZ Phase 2B clinical trial begins

  • First trial to test new TB regimen

    Pretomanid (PA-824) included in first clinical trial to test combination (PaMZ) of multiple new TB drugs

  • Phase 2 begins

    Phase 2 early bactericidal activity clinical trial begins for pretomanid (PA-824)

  • First-ever "combo study"

    TBA launches preclinical combination study — the first of its kind in TB


  • Phase 1 begins

    Pretomanid (PA-824) Phase 1 clinical trial begins

  • Investigation New Drug application filed

    TB Alliance submits an Investigational New Drug application for pretomanid (PA-824)

  • Preclinical Development

    Pretomanid (PA-824) preclinical studies begin

  • PA-824 in-licensed

    TB Alliance in-licenses pretomanid (PA-824) and analogs from Chiron

  • New compound shows potential

    Nature article mentions the promise of pretomanid (PA-824) to treat TB based on preclinical data