The National Institutes of Health is awarding $21 million to launch a research program that will build computer-based models of human hormone regulation. Announced on Monday, the Computational Modeling of Hormone Homeostasis Initiative aims to simulate how biological differences between men and women alter drug dosing, treatment response, and toxicity.
Existing animal and mathematical tools fail to capture variations between male and female biology, according to Nicole Kleinstreuer, NIH deputy director for program coordination, planning, and strategic initiatives. Kleinstreuer stated that using human biological data across a lifespan will help researchers evaluate therapies more accurately and support informed clinical decisions.
Biological sex hormones influence tissues throughout the human body, including the lungs, bones, and immune system. Hormonal shifts during puberty, menstrual cycles, pregnancy, and menopause trigger systemic physical changes and long-term organ responses that standard pharmacological testing often overlooks.
Awarded research teams will apply computational approaches to test therapeutic efficacy and drug safety. The selected techniques include interactive machine learning, AI-enhanced multi-scale models, physics-informed models of mechanical stress and tissue remodeling, and digital twins designed as virtual biological replicas.
Janine Clayton, NIH associate director for research on women’s health, said incorporating sex as a biological variable will help streamline testing for drugs and biologics while accelerating translation from laboratory research to patient care.
Grants for the initiative are distributed across awards OD042764, OD042817, OD042825, OD042813, OD042820, and OD042823. The agency, which comprises 27 institutes and centers, operates under the U.S. Department of Health and Human Services.
