Charlottesville, VA, and New York, NY -- Contraline Inc., a clinical-stage biotechnology company, and the Population Council, an international non-profit research organization, announced today they have executed a global, exclusive license agreement for the Nestorone®/Testosterone (NES/T) male contraceptive gel.
With the license now in full effect, the NES/T program will transition from the Population Council to Contraline. Contraline will lead late-stage development, regulatory engagement, and advancement toward U.S. and global approvals as the first reversible contraceptive drug for men.
NES/T is a once-daily topical gel combining Nestorone®, a synthetic progestin, and testosterone that suppresses sperm production while maintaining normal testosterone levels.
The product was co-developed by the Population Council and the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), part of the US National Institutes of Health. Having successfully completed a global Phase 2b trial in 462 couples, NES/T is the most advanced investigational male contraceptive to date, demonstrating strong potential for safety, efficacy, reversibility, and patient acceptability.
Contraline has begun actively planning a pivotal Phase 3 clinical program, which is expected to be the first Phase 3 trial of a hormonal male contraceptive in history.
“This is a transformative milestone for Contraline and for reproductive health more broadly. We believe NES/T has the potential to become the first new contraceptive introduced for men since the vasectomy more than 120 years ago,” said Kevin Eisenfrats, Co-Founder & CEO of Contraline. “NES/T could fundamentally change how contraception is approached – enabling more men to take on contraception directly and reducing the burden that has historically fallen on women.”
“Our team at Contraline is uniquely positioned to carry forward the groundbreaking work of the Population Council and NICHD. Together with our ADAM™ program, we are advancing both short-acting and long-acting male contraceptive options toward late-stage clinical development and approval. Global demand for novel, reversible male contraceptive methods has never been greater, and Contraline is at the forefront of this movement.”
“We look forward to Contraline advancing the NES/T program through Phase 3 and beyond, building on their demonstrated expertise in male contraceptive development,” said Anita Garg, Senior Director for Strategy and Commercial Relations at the Population Council. “This collaboration builds on decades of Population Council and NICHD research aimed at delivering a safe, effective, and reversible contraceptive option that expands choice for men and couples worldwide.”
Important Safety Information: The NES/T gel is an investigational drug and has not been approved by the U.S. Food and Drug Administration or any other regulatory authority.
About Contraline: Contraline, Inc. is a clinical-stage, biotechnology company focused on innovation in reproductive health. The company’s mission is to develop novel male contraceptives that are safe, effective, and reversible. Visit www.contraline.com.
About the Population Council: The Population Council is a leading research organization dedicated to building an equitable and sustainable world that enhances the health and well-being of current and future generations. We generate ideas, produce evidence, and design solutions to improve the lives of people around the world. Learn more at www.popcouncil.org.
Media Contacts:
Martin Sandgren Klover Communications press@klovercommunications.com (949) 438-0425
Francesca Heintz Director of Communications, Population Council fheintz@popcouncil.org