Mpox Countermeasures Lag Behind Global Needs
DESPITE two public health emergency declarations, development of mpox therapeutics and diagnostics remains critically behind the needs of affected populations. Researchers analyzing data from late 2022 to early 2025 found that although the number of diagnostic tests for mpox has grown, independent validation and therapeutic innovation continue to fall short. The findings reveal systemic weaknesses in outbreak preparedness and response.
Diagnostic Expansion Without Real-World Readiness
Between December 2022 and January 2025, the number of mpox diagnostics registered globally increased, suggesting growing attention to testing capacity. However, validation has not kept pace. Only two molecular point-of-care assays have received emergency use authorization, and none of the available antigen rapid diagnostic tests have undergone independent verification. This gap limits decentralized, real-time detection in community and low-resource settings, key to containing outbreaks before wider spread.
Therapeutic Pipeline Shows Minimal Progress
The analysis identified 17 clinical trials investigating mpox therapeutics, with 14 focused on direct-acting antivirals. Of these, 86% examined tecovirimat, the only drug with consistent safety data but no proven efficacy and increasing evidence of viral resistance. The lack of diversification in therapeutic candidates underscores the fragility of the pipeline and its overreliance on a single antiviral agent.
Vulnerable Populations Excluded
Alarmingly, vulnerable populations, including children, pregnant women, and individuals living with HIV, remain largely excluded from therapeutic studies despite experiencing higher mortality rates. The authors highlight a fundamental mismatch between the available medical countermeasures and real-world clinical needs, particularly in low-income regions disproportionately affected by mpox.
Without stronger investment in research, validation, and equitable access, the mpox response risks repeating past failures seen in other emerging infections.
Strengthening investment in mpox research, diagnostic innovation, and equitable access will be vital to prevent future outbreaks and improve patient outcomes worldwide.
Reference: Perez Casas C et al. In Critical Condition: The Urgent Need to Support Mpox Therapeutic and Diagnostic Pipelines. Clin Infect Dis. 2025;ciaf529.
