Insud Pharma has secured $2.7 million in funding from the Bill & Melinda Gates Foundation to conduct a Phase II clinical trial for a novel sublingual oxytocin treatment aimed at preventing postpartum hemorrhage (PPH), one of the leading causes of maternal mortality worldwide.
The innovative treatment comes in a thermostable tablet form that doesn’t require refrigeration or skilled healthcare personnel for administration, making it particularly valuable for regions with limited access to medical care. According to the World Health Organization (WHO), PPH affects approximately 14 million women annually and causes around 70,000 deaths, primarily in low- and middle-income countries.
The clinical significance of this development is highlighted by current global maternal health statistics: a woman dies every two minutes from pregnancy or childbirth-related causes, with more than 85% of postpartum hemorrhage deaths occurring in Sub-Saharan Africa and South Asia.
Dr. Clara Menéndez, director of the Maternal, Infant and Reproductive Health Program at the Barcelona Institute for Global Health, and advisor to the Mundo Sano Foundation, emphasized the equity implications of this development: “Access to effective drugs with the potential to save the lives of pregnant women is a question of equity, that all women, regardless of where they live, have the same right not to die in childbirth.”
Menéndez added that, “despite its importance, clinical trials on conditions related to maternal health are still scarce. Therefore, this clinical trial is a milestone, especially as it is conducted in low-income countries, although its potential impact will be much broader.”
The clinical trial, scheduled to begin in the first quarter of 2025, will include 180 participants to determine the optimal dose for the sublingual oxytocin treatment. Mundo Sano Foundation, Insud Pharma’s family foundation, will support awareness campaigns and facilitate access to the medication in underserved regions.
