In Critical Condition: The Urgent Need to Support Mpox Therapeutic and Diagnostic Pipelines

Despite 2 public health emergency declarations, limited progress has been made in the development of essential medical countermeasures for mpox, including therapeutics and point-of-care (POC) diagnostics. We analyzed mpox diagnostics registered in a public database in December 2022 and January 2025. The number of tests increased; however, independent validation lagged behind. While the World Health Organization has granted emergency use listing to 2 POC molecular tests, there are no independently validated antigen rapid diagnostic tests (AgRDTs) essential for decentralized detection. The therapeutics pipeline has shown minimal progress since 2022. Of 17 clinical trials, 14 evaluated direct-acting antivirals; 86% focused solely on tecovirimat, a drug that shows safety but not efficacy with documented resistance concerns. Key vulnerable populations, including children, pregnant women, and people with human immunodeficiency virus, remain absent from studies despite higher mortality rates. Our pipeline analysis revealed a fundamental mismatch between available countermeasures and actual needs, particularly in low-resource settings.