Six decades after the first oral contraceptive for women was approved in the United States, University of Minnesota researchers are one step closer to developing a non-hormonal birth control pill for men. 

A recent study published in Communications Medicine found that the drug, YCT-529, was safe, effective and, importantly, reversible in mice and non-human primates. 

YCT-529 targets the process by which Vitamin A, an essential nutrient, enables sperm production, while leaving Vitamin A levels intact.

Once YCT-529 is removed, “the factory starts working again,” lead author and co-founder of YourChoice Therapeutics, Nadja Mannowetz said.

YCT-529 is not the only non-hormonal male contraceptive in development, Gunda Georg, the corresponding author and head of the Department of Medicinal Chemistry at the University, said. However, this drug is the furthest ahead in successfully completing a Phase 1 clinical human trial. 

Georg said that the high pharmaceutical standards for contraceptives can make it difficult to attract investors. 

“The whole field of contraception is an orphan area,” Georg said. “So there’s not much research ongoing, if any, in the pharmaceutical industry.” 

Contraceptive drugs must have exceptionally high efficacy rates and low side-effect profiles to be approved, Georg said. 

“One has to make sure that there’s no negative effect on the future offspring of the people who have been taking the birth control pill,” Georg said. 

The small start-up supporting the development of the drug, YourChoice Therapeutics, has seen immense potential in the contraceptive arena since its inception. Originally, Mannowetz said the company entered the field with an interest in developing non-hormonal birth control options for women. 

“I went out running around on campus to ask women, ‘Hey, are you using contraception? If so, are you happy with it?’ And it was crazy. Nearly every woman was complaining,” Mannowetz said.

Co-founder and CEO of YourChoice Therapeutics, Akash Bakshi, said the company’s mission was to improve the health and well-being of women by offering non-hormonal birth control options, “because that’s what we heard women were displeased with.” 

The company shifted its focus after seeing greater interest from investors in non-hormonal birth control for men.

“The idea of moving to a male method actually fits within the scope of that original mission, because we still believe that we may be able to decrease the hormonal burden on women,” Bakshi said. 

Looking forward, the team is cautiously optimistic. As the first drug of its kind to complete a controlled clinical trial, YCT-529 may face regulatory challenges while it continues blazing the path for other non-hormonal male contraceptives, Georg said. 

There is also evidence that drug development in the U. S. has slowed down after the recent mass layoffs at the Food and Drug Administration. 

“We will continue to do research … and continue moving it forward,” Bakshi said.