YourChoice Therapeutics has achieved a significant milestone by completing its first-in-human clinical study for YCT-529, the pioneering hormone-free male birth control pill. Announced at the 2024 BIO International Convention, this development marks a breakthrough in contraceptive options, particularly for men.

“We’re one step closer to delivering the world’s first male birth control pill,” said YourChoice Therapeutics Chief Science Officer Nadja Mannowetz. The Phase 1a study showed that YCT-529 is safe and well-tolerated in men, which lays a favorable foundation for further studies. Mannowetz highlighted the promising speed, efficiency, and enthusiasm surrounding YCT-529’s initial trials, underscoring the importance of this advancement in the long journey toward FDA approval.

Innovation in birth control has been stagnant since the female birth control pill was introduced 65 years ago. With the exception of the copper IUD, all new birth control options have relied on dosing women with hormones to prevent pregnancy. “The Pill turns 65 next year, marking more than a half-century of hormonal birth control with no new options for men to reduce the hormonal burden on their partners,” remarked Stewart McCallum, MD FACS, Chief Medical Officer at YourChoice Therapeutics. This milestone reflects a much-needed modernization in contraceptive technology, providing men with an option that could significantly alleviate the hormonal load traditionally shouldered by women.

YCT-529 works by inhibiting the retinoic acid receptor-alpha (RAR-alpha), preventing sperm production by blocking vitamin A in the testes. This mechanism, first discovered in the 1930s, has been extensively validated through decades of research. In preclinical studies, YCT-529 was found to be 99% effective and 100% reversible, with no observed side effects.

“Women’s narrowing reproductive rights offer potent fuel to the fire driving male contraceptive candidates,” noted Gunda Georg, Regents Professor at the University of Minnesota and a key developer of YCT-529. She emphasized the societal readiness for a male contraceptive and praised the swift progress of YCT-529’s first-in-human study, expressing confidence in the success of future trials.

YourChoice Therapeutics, established in 2018 and based in San Francisco, is at the forefront of developing hormone-free family planning products. The company has received substantial support, including a $15 million Series A investment in 2022, and has been backed by the Male Contraceptive Initiative (MCI) in funding early research and clinical trials.

This milestone not only marks a win for men’s health but also represents a significant step towards gender equality in contraceptive responsibility.

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