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.

Cambodia

Cambodia

Pathway: GDF, NPAP, Regulatory Approval
Region: South-East Asia

Chad

Chad

Pathway: GDF, NPAP
Region: Africa

China

China

Pathway: NPAP
Region: Western Pacific

Cuba

Cuba

Pathway: GDF, NPAP
Region: Americas

Fiji

Fiji

Pathway: GDF, NPAP
Region: Western Pacific

Gibraltar

Gibraltar
Pathway: GDF
Region: Europe

Guam

Guam

Pathway: GDF, Regulatory Approval
Region: Western Pacific

India

India

Pathway: GDF, Regulatory Approval
Region: South-East Asia

Indonesia

Indonesia

Pathway: GDF, NPAP, Operational Research, Regulatory Approval
Region: South-East Asia

Iraq

Iraq

Pathway: GDF, NPAP
Region: Eastern Mediterranean

Italy

Italy

Pathway: Regulatory Approval
Region: Europe

Japan

Japan

Pathway: NPAP
Region: Western Pacific

Jordan

Jordan

Pathway: GDF, NPAP
Region: Eastern Mediterranean

Kenya

Kenya

Pathway: GDF, NPAP, Regulatory Submission Underway
Region: Africa

Kosovo

Kosovo
Pathway: GDF, Regulatory Approval
Region: Europe

Latvia

Latvia

Pathway: GDF, Regulatory Approval
Region: Europe

Libya

Libya

Pathway: GDF
Region: Eastern Mediterranean

Mali

Mali

Pathway: GDF, NPAP
Region: Africa

Malta

Malta

Pathway: Regulatory Approval
Region: Europe

Myanmar

Myanmar

Pathway: GDF, NPAP, Operational Research, Regulatory Approval
Region: South-East Asia

Namibia

Namibia

Pathway: GDF, NPAP, Regulatory Submission Underway
Region: Africa

Nauru

Nauru

Pathway: GDF, NPAP
Region: Western Pacific

Nepal

Nepal

Pathway: GDF, NPAP
Region: South-East Asia

Nigeria

Nigeria

Pathway: GDF, NPAP, Operational Research, Regulatory Submission Underway
Region: Africa

Oman

Oman

Pathway: GDF, NPAP
Region: Eastern Mediterranean

Pakistan

Pakistan

Pathway: GDF, NPAP, Regulatory Submission Underway
Region: Eastern Mediterranean

Palau

Palau

Pathway: GDF, NPAP
Region: Western Pacific

Peru

Peru

Pathway: GDF, NPAP, Regulatory Approval
Region: Americas

Qatar

Qatar

Pathway: NPAP
Region: Eastern Mediterranean

Samoa

Samoa

Pathway: GDF, NPAP
Region: Western Pacific

Spain

Spain

Pathway: Regulatory Approval
Region: Europe

Togo

Togo

Pathway: GDF, NPAP
Region: Africa

Tonga

Tonga

Pathway: GDF, NPAP
Region: Western Pacific

Uganda

Uganda

Pathway: GDF, NPAP, Regulatory Submission Underway
Region: Africa

Ukraine

Ukraine

Pathway: GDF, Operational Research, Regulatory Approval
Region: Europe

Vietnam

Vietnam

Pathway: GDF, NPAP, Operational Research, Regulatory Approval
Region: South-East Asia

Zambia

Zambia

Pathway: GDF, NPAP, Regulatory Submission Underway
Region: Africa