A groundbreaking male birth control pill is advancing through clinical trials, marking a major step toward expanding contraceptive options. Researchers from the University of Minnesota College of Pharmacy, in collaboration with Columbia University and YourChoice Therapeutics, have developed YCT-529a hormone-free oral contraceptive designed for men.Unlike traditional contraceptives that rely on hormonal changes, YCT-529 works by inhibiting sperm production. The drug has already completed its first phase of human clinical trials and is now undergoing further safety and efficacy testing. If approved, it could provide an alternative to the limited birth control options like condoms and vasectomies currently available to men. Breakthrough findings from preclinical trialsPreclinical testing has shown highly promising results for YCT-529. In male mice, the drug prevented pregnancy with 99% effectiveness within just four weeks of use. In male non-human primates, it significantly reduced sperm counts within two weeks of administration.Crucially, the research demonstrated that YCT-529s effects are reversible. Male mice regained fertility within six weeks of stopping the drug, while non-human primates fully recovered sperm production within 10 to 15 weeks. Additionally, no side effects were observed in either group, reinforcing its potential as a safe contraceptive option.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.Progressing towards human clinical trialsFollowing the success of preclinical studies, YCT-529 has entered human clinical trials. The first phase, conducted by YourChoice Therapeutics in 2024, was completed successfully. The drug is now in a second clinical trial, focusing on further evaluating its safety and effectiveness in humans.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.Expanding contraceptive options for menDespite the FDA approving over 20 types of birth control, men currently have only two primary choicescondoms or vasectomies. The introduction of a male contraceptive pill could revolutionize family planning. By giving men an effective, hormone-free option, couples would have more balanced choices when it comes to pregnancy prevention. This could reduce the burden placed on women, who often bear the primary responsibility for contraception.Additionally, a male birth control pill would be particularly beneficial for those who cannot use female hormonal contraceptives due to health conditions or side effects.However, YCT-529 could change that by providing men with a reliable, reversible, and hormone-free alternative.RECOMMENDED ARTICLESWith clinical trials moving forward, researchers are optimistic that YCT-529 could soon enter the market. If successful, it will not only expand birth control options but also promote greater shared responsibility in family planning.