A report from GHTC and Policy Cures Research examines how US federal funding for global health R&D is delivering impact both abroad and at home.

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R&D across health areas | Tuberculosis

R&D for Tuberculosis

How new tools can transform the fight

Tuberculosis (TB) has burdened humanity for thousands of years. Today, it is the world’s leading infectious disease killer: 10.8 million people fell ill with TB and 1.25 million died in 2023 alone. Additionally, growing resistance to available drugs is making the disease more deadly and difficult to treat.

To end the epidemic, new technologies to prevent, treat, and diagnose TB are urgently needed, including a new vaccine with better protective efficacy, shorter and safer treatment regimens, and improved diagnostics designed specifically for underserved populations and low-resource settings.

  • 1.25 million
    people die annually from TB
  • 400,000 people
    develop MDR-TB each year
  • $16.7 trillion
    cost of MDR-TB to global economy by 2050

Research successes

Technologies have transformed the fight against TB:

  • Bedaquiline, a drug for multidrug-resistant TB (MDR-TB) developed with NIH and USAID support, was approved by the FDA in 2012. A pediatric version was later approved in 2020.
  • The first child-friendly TB medicines, developed with USAID support, were introduced in 2016. They are appropriately dosed, dissolvable, and fruit-flavored.
  • Pretomanid, a drug for highly drug-resistant TB (DR-TB), developed with USAID and NIH support, was approved by the FDA in 2019. Pretomanid-based regimens have dramatically improved DR-TB treatment outcomes and reduced treatment time from up to two years to six months.
  • A shorter, four-month treatment regimen for drug-susceptible TB, developed with CDC and NIH support, was endorsed by the World Health Organization in 2022, marking the first major advancement in drug-susceptible treatment in nearly 50 years.
  • 3HP and 1HP, short-course preventative regimens to stop latent TB from becoming active, developed with CDC and NIH support, were introduced in 2011 and 2018, respectively, making treatment more tolerable and shorter (one to three months versus six).
  • New diagnostic innovations, including the Xpert and Truenat rapid, automated molecular tests, which are suitable for lower-level health facilities.

Continued progress is possible, not inevitable Continued progress is possible, not inevitable

Continued progress is possible, not inevitable

Key missing tools Key missing tools

To end TB, we need new tools to detect, prevent, and treat infection, including:

  • Shorter, safer, and simpler treatment regimens for active TB that include both novel drugs and next-generation versions of existing drugs to improve tolerability, acceptability, adherence, and treatment outcomes and address rising drug resistance.
  • Specifically dosed and formulated treatment regimens for pregnant people and children.
  • New vaccines for prevention and treatment that are cost-effective, safe for pregnant people, and protect across ages. The current vaccine, developed in 1921, is effective at preventing some types of TB in infants, but it offers inconsistent protection in adults against pulmonary TB.
  • Rapid, non-sputum-based, point-of-care diagnostics that are accurate, affordable, and suitable for use in low-resource settings and primary health care facilities, as well as rapid DR-TB tests that enable treatment to be tailored to individuals and help safeguard against drug resistance.

Breakthroughs on the brink Breakthroughs on the brink

  • Twenty-two new or repurposed drugs for TB are in clinical development, including 11 from a new class or with a new mechanism of action. Ongoing research will determine how to optimally combine this next generation of new drugs to further shorten the duration and improve the efficacy and safety of TB treatment regimens and preserve the longevity of new agents and drug classes against the development of drug resistance.
  • There are 17 potential preventative and therapeutic TB vaccines in development, including a vaccine candidate, M72/AS01E, currently in a Phase 3 trial, that shows promise in preventing pulmonary TB in adolescents and adults and, if proven successful, could become the first new TB vaccine in more than 100 years.
  • New approaches and strategies for TB vaccine research are invigorating the field, including research on new routes of administration, such as using inhaled, aerosolized TB vaccines and mRNA technology, and new models for vaccine testing, including preclinical animal and in vitro models that can mirror humans.
  • New, innovative methods to administer treatment, such as long-acting injectable agents, microarray patches, and implants, may lower the cost and burden of treatment by reducing the frequency and number of treatments that patients need. Nanomedicine is another area that could have the potential to reduce drug doses and side effects, improving treatment compliance.
  • More portable and affordable chest X-ray screening devices, point-of-care ultrasound devices, digital stethoscopes, and cough apps that use artificial intelligence are in the research pipeline, along with less-expensive, next-generation urine- and swab-based molecular tests, all of which could contribute to bringing care closer to patients and improving diagnostics access for underserved populations.

US government investment in tuberculosis R&D (in 2018) US$ millions

Breakthroughs on the brink
US Government R&D efforts US Government R&D efforts

The US government is leading efforts to advance research and development (R&D) to end the TB epidemic through a whole-of-government approach:

  • National Institutes of Health (NIH) conducts basic, translational, and clinical research to accelerate the development of new tools to diagnose, prevent, and treat TB.
  • US Agency for International Development (USAID) supports R&D for new TB diagnostics and drugs. The agency also works with CDC and NIH to support basic and applied R&D for MDR-TB as part of the National Action Plan for Combating Multidrug-Resistant Tuberculosis.
  • Centers for Disease Control and Prevention (CDC) supports clinical and epidemiological research for TB through national and international partnerships, such as the TB Trials Consortium, which has supported the development and implementation of new TB technologies and significantly improved global TB treatment and prevention guidelines.
  • Department of Defense has funded research on TB vaccines, drugs, and diagnostics through the Congressionally Directed Medical Research Programs (CDMRP) and other contracts, but, to enable the former, TB must be added each year to the CDMRP list of eligible diseases.
  • Food and Drug Administration (FDA) administers the Tropical Disease Priority Review Voucher Program to incentivize investment in products for neglected diseases, including TB, and implements an expedited approval pathway for antibiotics that can apply to DR-TB products.
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Introduction

10.8 million people fell ill, 1.25 million died, TB leading infectious killer: World Health Organization. Tuberculosis. Accessed October 31, 2024. https://www.who.int/news-room/fact-sheets/detail/tuberculosis

400,000 people develop MDR-TB:  World Health Organization. Global Tuberculosis Report 2024. World Health Organization; 2024. https://www.who.int/teams/global-tuberculosis-programme/tb-reports/global-tuberculosis-report-2024

$16.7 trillion cost of MDR-TB: Zweynert A. Drug-resistant TB threatens to kill 75 million people by 2050, cost $16.7 trillion. Reuters. March 23, 2015. Accessed July 17, 2024. https://www.reuters.com/article/us-health-tuberculosis-economy/drug-resistant-tb-threatens-to-kill-75-million-people-by-2050-cost-16-7-trillion-idUSKBN0MK00520150324/

Research successes

Bedaquiline: Thomas K. F.D.A. Approves Drug for Resistant Tuberculosis. New York Times. December 31, 2012. Accessed July 17, 2024. https://www.nytimes.com/2013/01/01/business/fda-approves-new-tuberculosis-drug.html

Bedaquiline, pediatric version: U.S. FDA Approves New Pediatric Formulation of SIRTURO® (bedaquiline) as Part of Combination Therapy to Treat Children with Pulmonary Multidrug-Resistant Tuberculosis. Press release. Johnson & Johnson; May 27, 2020. https://www.jnj.com/media-center/press-releases/u-s-fda-approves-new-pediatric-formulation-of-sirturoo-bedaquiline-as-part-of-combination-therapy-to-treat-children-with-pulmonary-multidrug-resistant-tuberculosis

Child-friendly TB medicines: TB Alliance. Child-friendly medicines. Accessed July 17, 2023. https://www.tballiance.org/child-friendly-medicines

Pretomanid, new drug for highly drug-resistant TB: FDA Approves New Treatment for Highly Drug-Resistant Forms of Tuberculosis. Press release. TB Alliance; August 14, 2019. https://www.tballiance.org/news/fda-approves-new-treatment-highly-drug-resistant-forms-tuberculosis

Shorter, four-month treatment regimen: Mckenna L. Pipeline Report 2023: Tuberculosis Treatment. Treatment Action Group; 2023. https://www.treatmentactiongroup.org/wp-content/uploads/2024/03/pipeline_TB_Treatment_2023_final.pdf

3HP and 1 HP, short-course preventative regimens: Mckenna L. Pipeline Report 2023: Tuberculosis Treatment. Treatment Action Group; 2023. https://www.treatmentactiongroup.org/wp-content/uploads/2024/03/pipeline_TB_Treatment_2023_final.pdf

Diagnostic innovations, general: Branigan D. Pipeline Report 2023: Tuberculosis Diagnostics. Treatment Action Group; 2023. https://www.treatmentactiongroup.org/wp-content/uploads/2023/11/2023_pipeline_TB_diagnostics_final.pdf

Diagnostic innovations, Xpert: Stop TB Partnership Global Drug Facility. Xpert MTB/RIF and Ultra Technical Information Note. Stop TB Partnership Global Drug Facility; 2019. https://stoptb.org/assets/documents/gdf/drugsupply/Xpert_info_note.pdf

Diagnostic innovations, Truenat: Foundation for Innovative New Diagnostics. WHO endorses Truenat molecular diagnostic tests for TB. News Medical Life Sciences. July 3, 2020. Accessed July 17, 2024. https://www.news-medical.net/news/20200703/WHO-endorses-Truenat-molecular-diagnostic-tests-for-TB.aspx

Continued progress is possible, not inevitable

Bill & Melinda Gates Foundation. Goalkeepers 2024 Report. The Race to Nourish a Warming World. Bill & Melinda Gates Foundation; 2024. https://www.gatesfoundation.org/goalkeepers/report/2024-report/

Key missing tools

Madlen N, Branigan D. Getting Better Faster: Delivering on the Promise of New TB Treatments. 1/4/6X24 Campaign; 2024. https://www.treatmentactiongroup.org/wp-content/uploads/2024/03/146_report_final.pdf

World Health Organization. Global Tuberculosis Report 2023: Research & innovation. World Health Organization; 2023. https://www.who.int/teams/global-tuberculosis-programme/tb-reports/global-tuberculosis-report-2023/tb-research-and-innovation

Breakthroughs on the Brink

Twenty-two new or repurposed drugs: Mckenna L. Pipeline Report 2023: Tuberculosis Treatment. Treatment Action Group; 2023. https://www.treatmentactiongroup.org/wp-content/uploads/2024/03/pipeline_TB_Treatment_2023_final.pdf

17 potential preventative and therapeutic TB vaccines: Frick M. Pipeline Report 2023: Tuberculosis Vaccines. Treatment Action Group; 2023. https://www.treatmentactiongroup.org/wp-content/uploads/2023/10/2023_pipeline_TB_vaccines_final.pdf

17 potential preventative and therapeutic TB vaccines, M72/AS01E: Adepoju P. New TB vaccine on trial. Nature Africa. March 24, 2024. Accessed July 17, 2024. https://www.nature.com/articles/d44148-024-00101-1

New approaches and strategies for TB vaccine research, aerosolized TB vaccine: University of Oxford. Breakthrough aerosol human infection model gives hope for future tuberculosis vaccine development. University of Oxford. April 15, 2024. Accessed July 27, 2024. https://www.ox.ac.uk/news/2024-04-15-breakthrough-aerosol-human-infection-model-gives-hope-future-tuberculosis-vaccine

New approaches and strategies for TB vaccine research, mRNA technology: Aizenman N. Frozen cells reveal a clue for a vaccine to block the deadly TB bug. NPR Goats and Soda. March 6, 2023. Accessed July 17, 2024. https://www.npr.org/sections/goatsandsoda/2023/03/06/1161248152/it-appears-scientists-are-closer-to-making-a-vaccine-that-blocks-tuberculosis

New approaches and strategies for TB vaccine research, preclinical animal and in vitro models:  Chugh S, Kar Bahal R, Dhiman R, Singh R. Antigen identification strategies and preclinical evaluation models for advancing tuberculosis vaccine development. NPJ Vaccines. 9, 57 (2024). https://doi.org/10.1038/s41541-024-00834-y

New innovative methods to administer treatment:  Branigan D. Injectables Redux: Developing Acceptable Long-Acting Formulations for TB Prevention Amidst a Push for All-Oral Treatment. Treatment Action Group TAGline newsletter. October 2021. Accessed July 17, 2024. https://www.treatmentactiongroup.org/resources/tagline/tagline-october-2021/injectables-redux-developing-acceptable-long-acting-formulations-for-tb-prevention-amidst-a-push-for-all-oral-treatment/

New innovative methods to administer treatment, nanomedicine: Slater K B, Kim D, Chand P, et al. A Current Perspective on the Potential of Nanomedicine for Anti-Tuberculosis Therapy. Tropical Medicine and Infectious Disease. 2023; 8(2): 100. https://doi.org/10.3390%2Ftropicalmed8020100

Devices/diagnostics:  Branigan D. Pipeline Report 2023: Tuberculosis Diagnostics. Treatment Action Group; 2023. https://www.treatmentactiongroup.org/wp-content/uploads/2023/11/2023_pipeline_TB_diagnostics_final.pdf

US government investment in tuberculosis R&D

G-FINDER data portal. Policy Cures Research; 2023. Accessed May 14, 2024. https://gfinderdata.policycuresresearch.org/

US government investment in tuberculosis R&D

All: Kaiser Family Foundation. The U.S. Government and Global Tuberculosis Efforts. Accessed July 17, 2024. https://www.kff.org/global-health-policy/fact-sheet/the-u-s-government-and-global-tuberculosis-efforts/

Department of Defense: Search Awards. Department of Defense Congressionally Directed Medical Research Programs; 2023. Accessed July 27, 2024. https://cdmrp.health.mil/search.aspx

Food and Drug Administration, Tropical Disease Priority Review Voucher:  US Food and Drug Administration. Tropical Disease Priority Review Voucher Program. Accessed July 17, 2024. https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/tropical-disease-priority-review-voucher-program  

Food and Drug Administration, expedited approval pathway:  US Food and Drug Administration. Limited Population Pathway for Antibacterial and Antifungal Drugs – the LPAD Pathway. Accessed July 17, 2024. https://www.fda.gov/drugs/development-resources/limited-population-pathway-antibacterial-and-antifungal-drugs-lpad-pathway

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