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 19 clinical trials in 14 countries with more than 1,100 clinical trial participants. Learn about the history of pretomanid, and where we stand today.
ZeNix Results Published
ZeNix results published in the New England Journal of Medicine demonstrated maintained efficacy of the BPaL regimen with reduced dosage of linezolid
WHO TB Treatment Guidelines
WHO updated its TB treatment guidelines to allow for programmatic implementation of treating almost all forms of drug-resistant TB with pretomanid-containing regimens
TB PRACTECAL Results Presented
Data from MSF’s TB-PRACTECAL demonstrating the safety and effectiveness of several pretomanid-containing regimens for treatment of drug-resistant TB presented The Union Conference 2021
ZeNix Results Presented
Data from ZeNix trial demonstrating effectiveness of BPaL can be maintained with reduced dosing of linezolid presented at International AIDS Society Conference
Nix-TB Results Published
Nix-TB data demonstrating a successful outcome in 95 of 107 patients after six months of treatment with BPaL and six months of post-treatment follow-up published in the New England Journal of Medicine
WHO Prequalification
Pretomanid was listed by the World Health Organization (WHO) as a Prequalified Medicinal Product
European Authorisation
Pretomanid received received EU marketing authorisation in combination regimen with bedaquiline and linezolid to treat highly drug-resistant TB
India Approval
Pretomanid received approval from the Drug Controller General of India (DCGI) for conditional access under the National Tuberculosis Elimination Program (NTEP) program
FDA Approval
Pretomanid received approval from the U.S. Food and Drug Administraion (FDA) for the use of pretomanid for the treatment of highly drug-resistant TB in a combination regimen
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
DESData 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-upC
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
ZeNix continues study of BPaL
ZeNix Phase 3 clinical trial begins, aiming to optimize BPaL
First Phase 3 begins
Launch of first Phase 3 trial including Pretomanid
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 beginsDESC
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
Investigational 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