Pretomanid is a tuberculosis (TB) drug developed by TB Alliance that is was approved by the U.S. Food and Drug Administration in August 2019 for the treatment of highly drug-resistant forms of TB for use in a combination regimen with bedaquiline and linezolid (known as the BPaL regimen). A Marketing Authorization Application is also under review by the European Medicines Agency for pretomanid and the BPaL regimen.
Please find some materials about pretomanid and the BPaL regimen below, as well as the FDA press release and the pretomanid Full Prescribing Information.
BPaL dosing package for a patient participating in the Nix-TB clinical trial, representing one week of the six-month treatment.
Downloadable Factsheets
Videos
Password: BPaL2019
Password: BPaL2019
Additional Resources
About TB Alliance
TB Alliance is a not-for-profit organization dedicated to finding faster-acting and affordable drug regimens to fight TB. Through innovative science and with partners around the globe, we aim to ensure equitable access to faster, better TB cures that will advance global health and prosperity. TB Alliance operates with support from Australia’s Department of Foreign Affairs and Trade, Bill & Melinda Gates Foundation, Cystic Fibrosis Foundation, European & Developing Countries Clinical Trials Partnership, Germany’s Federal Ministry of Education and Research through KfW, Global Health Innovative Technology Fund, Indonesia Health Fund, Irish Aid, Medical Research Council (United Kingdom), National Institute of Allergy and Infectious Disease, Netherlands Ministry of Foreign Affairs, Rockefeller Foundation, United Kingdom Department for International Development, and the United States Agency for International Development.
- Find the FDA Advisory Committee Meeting Materials.
- Read more from the TB Alliance presentation from the FDA Advisory Committee Meeting.
- Learn more about pretomanid and the BPaL regimen.
- Learn about pretomanid’s development and review the latest updates.
Download a photo of pretomanid here:
Mel Spigelman
President and CEO
Dr. Spigelman is the President and Chief Executive Officer of TB Alliance, and a Member of its Board of Directors. Prior to being appointed President and CEO in 2009, Dr. Spigelman served for five and a half years as the Director of Research & Development at TB Alliance. He was instrumental in forging key organizational partnerships and building the pipeline of TB drug candidates. Notably, Dr. Spigelman was a leader in developing a regimen-based paradigm of TB drug development – a faster and more efficient approach, which is emerging as the gold standard within the TB drug research field.
Presently, Dr. Spigelman is Co-Chair of the Working Group on New Drugs of the WHO Stop TB Partnership, and is a member of the Governing Board of the Tres Cantos Open Lab, GlaxoSmithKline.
Francesca Conradie
Principal Investigator, Nix-TB Clinical Trial
Dr. Conradie is the principal investigator of Nix-TB, TB Alliance’s first Phase 3 trial evaluating the BPaL regimen. Throughout her career, Dr. Conradie has been a part of the research agenda that brought effective antiretroviral therapy to millions of South Africans living with HIV. Now, she is focused on TB research, especially new treatment strategies for drug-resistant TB.
Dr. Conradie obtained her MBBCh at the University of the Witwatersrand, Johannesburg, South Africa.