ArticleNature communications2026
Sex representation in trials relative to indication-specific disease burden in FDA-approved drugs (2015-2023).
Article in Nature communications, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Authors and funding
2 authors.
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Abstract
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 indications. Additionally, among trials leading to approval, female participation aligns with or exceeds disease prevalence in 67% of cases. Alignment is strongest in oncology, whereas cardiovascular and autoimmune diseases most often under-enroll women, with no improvement over time. We discuss that gains in female enrollment have plateaued and that further progress will require advances in diagnostics, greater use of objective endpoints, and improved tools to assess risks for women of reproductive potential.
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