Pretomanid and the BPaL Regimen

Pretomanid is an investigational tuberculosis (TB) drug developed by TB Alliance for use in combination with bedaquiline and linezolid that is the subject of a New Drug Application currently under Priority Review by the U.S. Food and Drug Administration, as well as a Marketing Authorization Application under review by the European Medicines Agency.

Learn about pretomanid’s development and review the latest updates here.

About Pretomanid

Pretomanid is a new chemical entity and a member of a class of compounds known as nitroimidazooxazines. Novel compounds are important in pursuing new TB treatments because resistance to drugs and drug classes currently used to treat TB is widespread. During early development, pretomanid was referred to as PA-824. Pretomanid was developed by TB Alliance as an oral tablet formulation for the treatment of tuberculosis in combination with other anti-tuberculosis agents.

One such combination is BPaL, which consists of bedaquiline + pretomanid + linezolid.

Learn more about pretomanid here.

About the BPaL Regimen

BPaL is currently under Priority Review by the U.S. Food and Drug Administration (FDA) for the treatment of adults with pulmonary extensively drug-resistant tuberculosis (XDR-TB) or multidrug-resistant TB (MDR-TB) who are treatment-intolerant or non-responsive.

BPaL was first studied in the Nix-TB trial, which enrolled people with XDR-TB as well as treatment-intolerant or non-responsive MDR-TB. A modified intent-to-treat analysis of Nix-TB data included in the regulatory submission indicated that treatment with the BPaL regimen resulted in a favorable outcome in 90 percent of patients after six months of treatment and six months of post-treatment follow-up.

Current therapy for drug-resistant TB often requires people to take drugs for 6 months to 2 years or longer—or risk developing more difficult to treat drug-resistant TB. The WHO reports historical treatment success for XDR-TB at about 34 percent. BPaL has been tested in drug-resistant TB patients co-infected with HIV, including those receiving antiretrovirals (ARVs).

Pretomanid by the Numbers

Scientific Publications

A full list of peer-reviewed research studying pretomanid and pretomanid-containing regimens is available.

View the publications