Access to the BPaL Regimen

TB Alliance is committed to ensuring access to pretomanid as part of a TB treatment regimen.

Pretomanid is a tuberculosis (TB) drug developed by TB Alliance for the treatment of highly drug-resistant TB for use in combination with bedaquiline and linezolid – collectively known as the BPaL regimen. The regimen received its first regulatory approval in August 2019 and availability and accessibility has continued to spread around the world.

Use the tool below to find details on accessibility in any country, either in terms of regulatory approval, or access through the Named Patient Access Program (NPAP) through partnership with Viatris, through the The Stop TB Partnership’s Global Drug Facility (GDF) catalog of TB medicines, or through ongoing operational research or similar projects in specific countries. Clicking on a country's name will open the World Health Organization's TB profile for that country.

PATHWAYS TO ACCESS:

  • Regulatory approval of BPaL is indicated in countries where the regimen was reviewed and approved by a regulatory authority, for example the United States Food and Drug Administration (FDA), the European Medicines Agency (EMA) or the Drug Controller General of India (DCGI).
  • The NPAP is designed for patients in countries where regulatory approval or other access mechanisms for BPaL are not yet available. TB Alliance’s commercialization partner Viatris launched the program in May 2020. More information is available here.
  • Listing in the GDF catalogue of TB medicines ensures that the treatment course will be available to 150 countries representing the vast majority of the global TB burden. More information is available here.
  • In specific countries, TB Alliance is working with clinicians to implement the BPaL regimen under operational research settings. These efforts are underway in various parts of the world to help increase access to TB treatment options.


Afghanistan Eastern Mediterranean
  • GDF
  • NPAP
Albania Europe
  • GDF
  • NPAP
Algeria Africa
  • GDF
  • NPAP
American Samoa Western Pacific
  • GDF
Andorra Europe
  • Regulatory Approval
Angola Africa
  • GDF
  • NPAP
Antigua and Barbuda Americas
  • NPAP
Argentina Americas
  • GDF
  • NPAP
Armenia Europe
  • GDF
  • NPAP
Australia Western Pacific
  • NPAP
Azerbaijan Europe
  • GDF
  • NPAP
  • Regulatory Submission Underway
Bahamas Americas
  • NPAP
Bahrain Eastern Mediterranean
  • NPAP
Bangladesh South-East Asia
  • GDF
  • NPAP
  • Regulatory Submission Underway
Barbados Americas
  • NPAP
Belarus Europe
  • GDF
  • NPAP
  • Regulatory Submission Underway
Belize Americas
  • GDF
  • NPAP
Benin Africa
  • GDF
  • NPAP
Bhutan South-East Asia
  • GDF
  • NPAP
Bolivia Americas
  • GDF
  • NPAP
Bosnia and Herzegovina Europe
  • GDF
  • NPAP
Botswana Africa
  • GDF
  • NPAP
Brazil Americas
  • GDF
  • NPAP
Brunei Darussalam Western Pacific
  • NPAP
Bulgaria Europe
  • GDF
  • Regulatory Approval
Burkina Faso Africa
  • GDF
  • NPAP
Burundi Africa
  • GDF
  • NPAP
Cabo Verde Africa
  • GDF
Cambodia South-East Asia
  • GDF
  • NPAP
Cameroon Africa
  • GDF
  • NPAP
Canada Americas
  • NPAP
Central African Republic Africa
  • GDF
  • NPAP
Chad Africa
  • GDF
  • NPAP
Chile Americas
  • GDF
  • NPAP
China Western Pacific
  • NPAP
Colombia Americas
  • GDF
  • NPAP
Comoros Africa
  • GDF
  • NPAP
Congo (Democratic Republic of) Africa
  • GDF
  • Regulatory Approval
Congo (Republic of) Africa
  • GDF
  • NPAP
Costa Rica Americas
  • GDF
  • NPAP
Cuba Americas
  • GDF
  • NPAP
Democratic People's Republic of Korea South-East Asia
  • GDF
  • NPAP
Djibouti Africa
  • GDF
  • NPAP
Dominica Americas
  • GDF
  • NPAP
Dominican Republic Americas
  • GDF
  • NPAP
Ecuador Americas
  • GDF
  • NPAP
Egypt (Arab Republic of) Eastern Mediterranean
  • GDF
  • NPAP
El Salvador Americas
  • GDF
  • NPAP
Equitorial Guinea Africa
  • GDF
  • NPAP
Eritrea Africa
  • GDF
  • NPAP
Estonia Europe
  • GDF
  • Regulatory Approval
Ethiopia Africa
  • GDF
  • NPAP
  • Regulatory Submission Underway
Fiji Western Pacific
  • GDF
  • NPAP
Gabon Africa
  • GDF
  • NPAP
Gambia (The) Africa
  • GDF
  • NPAP
Georgia Europe
  • GDF
  • Regulatory Approval
Ghana Africa
  • GDF
  • NPAP
Gibraltar Europe
  • GDF
Grenada Americas
  • GDF
  • NPAP
Guam Western Pacific
  • GDF
  • Regulatory Approval
Guatemala Americas
  • GDF
  • NPAP
Guinea Africa
  • GDF
  • NPAP
Guinea-Bissau Africa
  • GDF
  • NPAP
Guyana Americas
  • GDF
  • NPAP
Haiti Americas
  • GDF
  • NPAP
Honduras Americas
  • GDF
  • NPAP
Hungary Europe
  • GDF
  • Regulatory Approval
India South-East Asia
  • GDF
  • Regulatory Approval
Indonesia South-East Asia
  • GDF
  • NPAP
  • Operational Research
  • Regulatory Submission Underway
Iran (Islamic Republic of) Eastern Mediterranean
  • GDF
  • NPAP
Iraq Eastern Mediterranean
  • GDF
  • NPAP
Israel Europe
  • NPAP
Jamaica Americas
  • GDF
  • NPAP
Japan Western Pacific
  • NPAP
Jordan Eastern Mediterranean
  • GDF
  • NPAP
Kazakhstan Europe
  • GDF
  • NPAP
  • Regulatory Submission Underway
Kenya Africa
  • GDF
  • NPAP
  • Regulatory Submission Underway
Kiribati Western Pacific
  • GDF
  • NPAP
Korea (Republic of) Western Pacific
  • Regulatory Approval
Kosovo Europe
  • GDF
  • Regulatory Approval
Kyrgyzstan (Kyrgyz Republic) Europe
  • NPAP
  • Operational Research
  • Regulatory Submission Underway
Latvia Europe
  • GDF
  • Regulatory Approval
Lebanon Eastern Mediterranean
  • GDF
  • NPAP
Lesotho Africa
  • GDF
  • NPAP
Liberia Africa
  • GDF
  • NPAP
Libya Eastern Mediterranean
  • GDF
Lithuania Europe
  • GDF
  • Regulatory Approval
Madagascar Africa
  • GDF
  • NPAP
Malawi Africa
  • GDF
  • NPAP
Malaysia South-East Asia
  • GDF
  • NPAP
Maldives South-East Asia
  • GDF
  • NPAP
Mali Africa
  • GDF
  • NPAP
Marshall Islands Western Pacific
  • GDF
  • NPAP
Mauritania Africa
  • GDF
  • NPAP
Mauritius Africa
  • GDF
  • NPAP
Mexico Americas
  • GDF
  • NPAP
Micronesia (Federated States of) Western Pacific
  • GDF
  • NPAP
Moldova (Republic of) Europe
  • GDF
  • NPAP
  • Regulatory Submission Underway
Monaco Europe
  • Regulatory Approval
Mongolia Western Pacific
  • GDF
  • NPAP
Montenegro Europe
  • GDF
  • NPAP
Morocco Eastern Mediterranean
  • GDF
  • NPAP
Mozambique Africa
  • GDF
  • Regulatory Approval
Myanmar South-East Asia
  • GDF
  • NPAP
  • Regulatory Submission Underway
Namibia Africa
  • GDF
  • NPAP
Nauru Western Pacific
  • GDF
  • NPAP
Nepal South-East Asia
  • GDF
  • NPAP
New Zealand Western Pacific
  • NPAP
Nicaragua Americas
  • GDF
  • NPAP
Niger Africa
  • GDF
  • NPAP
Nigeria Africa
  • GDF
  • NPAP
  • Operational Research
  • Regulatory Submission Underway
Northern Mariana Islands Western Pacific
  • GDF
  • Regulatory Approval
Oman Eastern Mediterranean
  • GDF
  • NPAP
Pakistan Eastern Mediterranean
  • GDF
  • NPAP
  • Regulatory Submission Underway
Palau Western Pacific
  • GDF
  • NPAP
Panama Americas
  • GDF
  • NPAP
Papua New Guinea Western Pacific
  • GDF
  • NPAP
Paraguay Americas
  • GDF
  • NPAP
Peru Americas
  • GDF
  • NPAP
  • Regulatory Submission Underway
Philippines (Republic of the) South-East Asia
  • GDF
  • NPAP
  • Operational Research
  • Regulatory Submission Underway
Qatar Eastern Mediterranean
  • NPAP
Romania Europe
  • GDF
  • Regulatory Approval
Russian Federation Europe
  • NPAP
Rwanda Africa
  • GDF
  • NPAP
Saint Kitts and Nevis Americas
  • NPAP
Saint Lucia Americas
  • GDF
  • NPAP
Samoa Western Pacific
  • GDF
  • NPAP
San Marino Europe
  • Regulatory Approval
São Tomé and Principe Africa
  • GDF
  • NPAP
Saudi Arabia Eastern Mediterranean
  • GDF
  • NPAP
Senegal Africa
  • GDF
  • NPAP
Serbia Europe
  • GDF
  • NPAP
Seychelles Africa
  • GDF
  • NPAP
Sierra Leone Africa
  • GDF
  • NPAP
Singapore Western Pacific
  • NPAP
Solomon Islands Western Pacific
  • GDF
  • NPAP
Somalia Africa
  • GDF
  • NPAP
South Africa Africa
  • GDF
  • Operational Research
  • Regulatory Submission Underway
South Sudan Africa
  • GDF
  • NPAP
Sri Lanka South-East Asia
  • GDF
  • NPAP
Sudan Africa
  • GDF
  • NPAP
Suriname Americas
  • GDF
  • NPAP
Switzerland Europe
  • Regulatory Approval
Syrian Arab Republic Eastern Mediterranean
  • GDF
  • NPAP
Tajikistan Europe
  • GDF
  • Operational Research
  • Regulatory Approval
Thailand South-East Asia
  • GDF
  • NPAP
  • Regulatory Submission Underway
Timor-Leste South-East Asia
  • GDF
  • NPAP
Togo Africa
  • GDF
  • NPAP
Tonga Western Pacific
  • GDF
  • NPAP
Trinidad and Tobago Americas
  • NPAP
Tunisia Eastern Mediterranean
  • GDF
  • NPAP
Turkey Europe
  • GDF
  • NPAP
Turkmenistan Europe
  • GDF
  • Regulatory Approval
Tuvalu Western Pacific
  • GDF
  • NPAP
Uganda Africa
  • GDF
  • NPAP
Ukraine Europe
  • GDF
  • NPAP
  • Operational Research
  • Regulatory Submission Underway
United Arab Emirates Eastern Mediterranean
  • GDF
  • NPAP
United Kingdom Europe
  • Regulatory Approval
United States Americas
  • Regulatory Approval
Uruguay Americas
  • NPAP
Uzbekistan Europe
  • GDF
  • Regulatory Approval
Vanuatu Western Pacific
  • GDF
  • NPAP
Vatican City
  • NPAP
Vietnam South-East Asia
  • GDF
  • NPAP
  • Operational Research
  • Regulatory Submission Underway
West Bank and Gaza Eastern Mediterranean
  • GDF
Yemen (Republic of) Eastern Mediterranean
  • GDF
  • NPAP
Zambia Africa
  • GDF
  • NPAP
Zimbabwe Africa
  • GDF
  • Regulatory Approval