Sex representation in trials relative to indication-specific disease burden in FDA-approved drugs (2015–2023) (opens in new tab)

Sex-based disparities in disease burden and therapeutic response motivate efforts to prioritize women’s health in drug development. We analyzed 195 drugs across 98 indications approved by the United States Food and Drug Administration (FDA) between 2015 and 2023 to assess whether industry focus and clinical trial enrollment reflect disease prevalence among males and females. Here, we show that therapies for female-predominant indications receive 1.5 times more approvals than male-predominant ...