YourChoice Therapeutics, a pioneer in the field of male contraception, has announced the initiation of a phase one clinical trial for YCT-529, a groundbreaking male birth control pill. This development marks a significant advancement in contraceptive technology, offering a promising alternative to the limited options currently available to men.

The trial commenced in San Francisco, with the first group of male volunteers being dosed with YCT-529. The drug, noted for its hormone-free formulation, promises to be 99% effective and completely reversible, without any side effects. This innovative approach to contraception has generated considerable excitement in the medical community, as it addresses the long-standing need for more male contraceptive options.

Contraception has traditionally been viewed as a woman’s responsibility, with male options restricted to methods like withdrawal, condoms, and vasectomy. Each of these methods comes with its own set of limitations and does not fully address the shared responsibility of pregnancy prevention. Furthermore, hormonal male contraceptives in development pose various side effects, including cardiovascular risks and mood changes, due to their suppression of testosterone.

YCT-529 operates through a unique mechanism as a retinoic acid receptor-alpha (RAR-alpha) inhibitor. It prevents sperm production by obstructing access to vitamin A, a method rooted in research dating back to the 1930s. This hormone-free approach was chosen based on extensive research and is seen as a viable alternative to the hormonal methods that are currently in development.

The pill’s development is led by Gunda Georg, regents professor at the University of Minnesota’s College of Pharmacy. Georg shares: “The last innovation in contraception was the birth control pill for women, and that’s more than 60 years ago. The world is ready for a male contraceptive agent and delivering one that’s hormone-free is simply the right thing to do given what we know about the side effects women have endured for decades from The Pill. We consciously chose to inhibit the vitamin A signaling pathway in the testis because nearly 100 years of research has validated this pathway and shows that infertility can be reversed easily. Our preclinical data is strong, showing that YCT-529 was 99% effective in preventing mouse pregnancies and decreasing monkey sperm counts after two weeks of dosing. YCT-529 has also demonstrated a strong safety profile, and full reversibility in mice and monkeys once treatment ended. I commend the YourChoice Therapeutics team for taking this candidate into the clinic and feel confident in its safety profile, which the phase one study will affirm.”

“Contraceptives work only if they’re used,” said Akash Bakshi, co-founder and CEO of YourChoice Therapeutics. “YCT-529 blocks a protein—not hormones—to prevent sperm production. We believe this will be more attractive to men, most of whom view pregnancy prevention as a shared responsibility even despite today’s limited contraceptive options, which are permanent or only moderately effective. The dearth of options reinforces the centuries-old view that pregnancy prevention is ‘a woman’s responsibility.’ It’s not, and we’re committed to advancing the first hormone-free birth control pill for men that’s effective, convenient, and temporary. We thank our investors and the male volunteers who have stepped forward to be a part of this mission.”

The Male Contraceptive Initiative has contributed funding to the development of YCT-529 since its inception. Executive Director Heather Vahdat commented: “While most men view pregnancy prevention as a shared responsibility, they have few options to participate. The first human study for a hormone-free male birth control pill is a long-awaited milestone and a landmark achievement in the quest for reproductive autonomy. While significant work lies ahead, we believe YCT-529’s first human study is a significant step toward a future where both men and women have the power to decide and control contraceptive use, pregnancy, and childbearing, a kind of health equity we believe is long overdue.”

“A male birth control pill has been the holy grail of contraceptive research and development for decades, and YourChoice Therapeutics is positioned to be a pioneer in this field,” said Maryanna Saenko, Co-founder and Partner at Future Ventures. “YCT-529 represents the first hormone-free therapy, finally enabling men to have an effective birth control option without interfering with their hormones. YourChoice Therapeutics has a world-class team and strong preclinical results guiding this next phase one study, which we believe brings us one step closer to a paradigm shift in how men and women view and participate in contraception planning.”

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