Research and development for tuberculosis

Status of the pipeline for new TB products

WHO continues to promote and monitor progress in the development of new TB vaccines, diagnostics and medicines. In June 2023, WHO launched a new online platform to track progress in the development of new TB drugs and vaccines, as well as operational research projects. A high-level summary of the status of the pipelines for new TB diagnostics, drugs and vaccines in active development, as of September 2023 is further summarized here.

• The diagnostic pipeline has expanded considerably in terms of the number of tests, products or methods in development. These include molecular tests for the detection of TB disease and drug resistance, interferon-gamma release assays for the detection of TB infection, biomarker-based assays for detection of TB infection and disease, computer-aided detection for TB screening using digital chest radiography, and a new class of aerosol-capture technologies for detection of TB disease.
• There are 28 drugs for the treatment of TB disease in Phase I, Phase II or Phase III trials. These drugs comprise 18 new chemical entities, two drugs that have received accelerated regulatory approval, one drug that was recently approved by the United States Food and Drug Administration under the limited population pathway for antibacterial and antifungal drugs, and seven repurposed drugs. Various combination regimens with new or repurposed drugs, as well as host-directed therapies, are in Phase II or Phase III trials.
• There are at least 29 clinical trials and implementation research studies to evaluate drug regimens and models of delivery for TB preventive treatment. Examples included a trial for the prevention of multidrug resistant TB using delamanid, studies to assess how to optimize treatment administration in very young children and people with HIV, and trials of rifamycin monotherapies for durations of 6 or 8 weeks.
• There are 16 vaccine candidates in clinical trials: four in Phase I, eight in Phase II and four in Phase III. They included candidates to prevent TB infection and TB disease, and to help improve the outcomes of treatment for TB disease. 

Effective vaccines are critical to achieve annual global and national reductions in TB incidence and mortality that are much faster than those achieved historically. Recognizing the critical role of TB vaccines in achieving rapid reductions in TB incidence and mortality, WHO has given considerable attention to high- level actions aimed at accelerating vaccine development and use.

In September 2023, in association with the second UN high-level meeting on TB, the WHO Director-General launched the “TB vaccine accelerator council”. The council aims to boost the TB vaccine pipeline and facilitate the licensing and use of safe TB vaccines that will have a substantial impact on the TB epidemic, by catalysing high-level alignment among national governments, funding agencies, global agencies and communities on both the important challenges in TB vaccine development and the actions required to address them.