The trial will assess the tolerability and impact on sperm count of the hormone-free male birth-control pill. Credit: Ground Picture/Shutterstock.

YourChoice Therapeutics has dosed the first cohort of male subjects in a Phase Ia/IIb clinical trial of YCT-529, a hormone-free male birth control pill.

The trial will assess the drug’s tolerability and its impact on sperm count in up to 50 male volunteers aged between 28 and 70 years.

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Conducted by New Zealand-based NZCR, this trial will explore multiple ascending doses of the drug candidate.

The trial commencement comes after the company confirmed the safety of YCT-529 in men in a Phase Ia study.

YourChoice Therapeutics chief science officer Nadja Mannowetz said: “A new birth control option for men would not only offer a shot of innovation to a very deserving healthcare segment, but also improve women’s health as reproductive rights and even access to contraceptives are at risk.

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“Women have shouldered the burden of pregnancy prevention for too long. Data continue to show that men want to help, and they’re willing to try new birth control options. Data also shows women trust them to do so. After nearly two centuries of no innovation in male birth control, it’s time for change, and we’re pleased to be a part of it.”

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A retinoic acid receptor-alpha (RAR-alpha) inhibitor, YCT-529 works by blocking access to vitamin A in the testes, thus preventing sperm production.

This mechanism of action was discovered by scientists in the 1930s, with decades of research validating this approach, including several studies on various animals demonstrating induced infertility through vitamin A deprivation.

Findings from the preclinical studies have indicated that YCT-529 is as effective, if not more so, than traditional female birth control pills.

Launched in 2018, YourChoice focuses on developing innovative contraceptive solutions.

The company’s efforts were supported by a $15m Series A investment received in 2022.

YourChoice Therapeutics CEO Akash Bakshi said: “169 years is a long time to wait for innovation. I can’t think of another area of medicine where innovation has stalled for nearly two centuries.

“We need more male methods, and we need them quickly. We anticipate another efficient trial and hope to announce results in 2025.”