Pulmonary Tuberculosis: Developing Drugs for Treatment May 2026

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/pulmonary-tuberculosis-developing-drugs-treatment?utm_medium=email&utm_source=govdelivery The U.S. Food and Drug Administration (FDA) published a final guidance for industry, “Pulmonary Tuberculosis: Developing Drugs for Treatment,” last month. The guidance aims to assist sponsors in the clinical development of investigational drugs to treat pulmonary tuberculosis (TB), an airborne bacterial infection caused by Mycobacterium tuberculosis (M. tuberculosis) that primarily attacks the lungs. This guidance addresses FDA’s current thinking regarding the overall development program for a new investigational drug or drugs to be used in combination with approved drugs, or as a new regimen that includes one or more investigational drugs to support a pulmonary TB treatment indication. This guidance finalizes the FDA draft guidance issued on December 15, 2022. The final guidance includes edits and updated information in the following areas: nonclinical and safety considerations, study populations, efficacy endpoints, and trial design considerations. Infections caused by M. tuberculosis occur in the United States and are endemic in many parts of the world. Resistance to multiple drugs and coinfection with human immunodeficiency virus (HIV) pose challenges in TB management. Drugs with new mechanisms of action, improved safety profiles, fewer drug-drug interactions, and treatment-shortening combination regimens are needed to manage this infection.