While the FDA has approved over 20 different categories of contraceptives, only two are available for men to prevent pregnancy in their partners - condoms and vasectomies. 25% of women who use contraception use an oral birth control pill, but there are no equivalent methods currently available for men.
Research from the University of Minnesota College of Pharmacy, published in Nature Communications, laid the groundwork for the first hormone-free male birth control pill to enter clinical trials.
The new drug, called YCT-529, is a first-in-class, hormone-free and orally administered male contraceptive. Developed in collaboration with Columbia University in New York and YourChoice Therapeutics, YCT-529 works as a contraceptive by stopping the production of sperm.
The research found:
- In male mice, the drug caused infertility and was 99% effective in preventing pregnancies within four weeks of use.
- In male non-human primates, the drug lowered sperm counts within two weeks of starting the drug.
- Both mice and non-human primates fully regained fertility after stopping the drug. Mice regained fertility within six weeks, and non-human primates fully recovered their sperm count in 10-15 weeks.
- No side effects from the drug were detected in either group.
"A safe and effective male pill will provide more options to couples for birth control," said Gunda Georg, the corresponding author of the study and a professor in the College of Pharmacy where the drug molecule was developed. "It will allow a more equitable sharing of responsibility for family planning and provide reproductive autonomy for men."
Next steps are already underway: the research established that YCT-529 was suitable for human studies, and a phase 1 clinical trial for the drug was completed successfully in 2024 by YourChoice Therapeutics. The drug is currently undergoing safety and efficacy testing in a second clinical trial.
"This study laid the groundwork for human clinical trials of YCT-529, which are progressing efficiently," said Nadja Mannowetz, lead author, chief science officer and co-founder of YourChoice Therapeutics. "With the unintentional pregnancy rate at nearly 50% in the U.S. and globally, we need more contraceptive options, particularly for men."
The research was supported by the National Institutes of Health, the National Institute of Child Health and Human Development, YourChoice Therapeutics and the Male Contraceptive Initiative.
