Contraline has exercised its option to exclusively license the Nestorone/Testosterone gel from the Population Council, advancing development of what could become the first FDA-approved hormonal contraceptive for men. The NES/T gel recently completed a global Phase 2b clinical trial involving 462 couples.
NES/T is a once-daily topical gel that delivers Nestorone and testosterone to suppress sperm production while maintaining normal hormone levels. The contraceptive was developed by the Population Council’s Center for Biomedical Research and the Eunice Kennedy Shriver National Institute of Child Health and Human Development.
The Phase 2b trial results position NES/T as the most advanced investigational male contraceptive studied to date, with data showing potential for high efficacy, safety, reversibility, and patient acceptability.
Contraline will transition the NES/T program in-house upon execution of the license agreement and plans to advance the contraceptive through Phase 3 trials toward commercialization. The company is also developing ADAM, giving it two male contraceptive programs in late-stage development.
“This marks a pivotal moment not just for Contraline, but for the future of contraception,” said Kevin Eisenfrats, Co-Founder and CEO of Contraline. “With NES/T and ADAM, we will be advancing two male contraceptive programs towards late-stage trials and approvals, positioning us at the forefront of a category that will reshape global reproductive health.”
The licensing agreement represents progress in developing male contraceptive options, which have remained limited compared to female contraceptive choices. Current male contraceptive methods are primarily limited to condoms and vasectomy.
“We are delighted that Contraline, a leader in male contraceptive development, has exercised their option to license the NES/T contraceptive gel,” said Anita Garg, Senior Director of Strategy and Commercial Relations at the Population Council’s Center for Biomedical Research.
The NES/T gel remains an investigational drug product not yet authorized by the FDA or other regulatory authorities worldwide. It is currently available only for investigational use in approved clinical trials.
