Advancing Maternal Health with Long-Acting Therapeutics: Priorities, Efficacy and Safety Considerations, and Emerging...

Maternal health remains a critical global concern, particularly in underserved populations and in low- and middle-income countries where access to safe and effective therapeutics is limited. Despite the use of medications by most women during pregnancy, the exclusion of pregnant and lactating women from clinical trials has resulted in significant data gaps, hindering informed treatment decisions. As long-acting therapeutics transition into mainstream treatment and prevention strategies, it is critical to ensure these disparities are neither perpetuated nor widened. This review synthesizes insights from the maternal health session of the July 2025 workshop of the Community of Practice for Long-Acting Therapeutics in Maternal and Pediatric Health. It was convened and hosted by the University of Liverpool Centre of Excellence for Long-Acting Therapeutics with funding from Unitaid. Key themes explored during the session include (1) regulatory initiatives, research networks, and data infrastructures that are driving systemic change in maternal health research over the past two decades; (2) important efficacy and safety considerations during pregnancy and lactation using insights from long-acting antiretrovirals currently in clinical use; and (3) selected long-acting drug delivery systems with potential applications in maternal health. Starting with maternal health priorities, here we included further insights regarding long-acting injectable antipsychotics, long-acting reversible contraceptives, and the role of in silico modeling in bridging existing gaps. Several immediately actionable recommendations are presented on advancing long-acting therapeutics for maternal health priorities during pregnancy and lactation.