Peer-reviewed paper summarizes safety profile for hormone-free male birth control pill
SAN FRANCISCO--(BUSINESS WIRE)--YourChoice Therapeutics, Inc., pioneering hormone-free family planning products, today announced that Communications Medicine, a Nature Portfolio Journal, published the results of YCT-529’s first-in-human study, which showed that single doses of the hormone-free birth control pill for men were well tolerated. YCT-529 is a retinoic acid receptor-alpha (RAR-α) antagonist designed to be a first-in-class, hormone-free, orally administered male contraceptive. Positive results from the phase 1a study supported the candidate’s current trial, which reinforces YCT-529 as the only non-hormonal birth control pill for men being evaluated in human studies. 
The manuscript, “Safety and Pharmacokinetics of the Non-Hormonal Male Contraceptive YCT-529,” showed that a single dose (up to 180 mg) of YCT-529 was well-tolerated in 16 male volunteers. Further, it had no effect on participants’ heart rate, blood parameters, testosterone levels, sexual desire or mood. The publication follows a March 2025 publication describing YCT-529’s preclinical studies, which showed it was 99 percent effective, 100 percent reversible within six weeks after cessation, and had no side effects in mice and non-human primates. The current clinical study is investigating multiple ascending doses (MAD) of the once-daily pill in up to 50 male volunteers to evaluate safety, tolerability and effect on sperm count.
Lead author and YourChoice Therapeutics’ Chief Science Officer Nadja Mannowetz, PhD, commented: “A peer-reviewed publication for our first-in-human study reinforces YCT-529’s strong safety profile. It also shows ‘the Pill for men’ had no effect on sexual desire or mood. Two back-to-back publications demonstrate our commitment to conducting rigorous studies, which strengthens our ability to develop the first hormone-free birth control pill for men efficiently and as expeditiously as possible to meet the growing demand.”
Nearly half of all pregnancies globally are unintended, suggesting an urgent need for more male contraceptive options. There is also high demand for new methods. A recent study showed men are very interested in using new male contraceptive options and women are confident they’ll take them correctly. YCT-529 is on track to be a novel option. It blocks sperm production by disrupting vitamin A metabolism in the testes. It specifically inhibits retinoic acid from binding to its receptor, RAR-α, a pathway essential for sperm development and supported by nearly a century of research.
“Studies and surveys continue to show that men want to share the burden of pregnancy prevention with their partners,” said Akash Bakshi, CEO of YourChoice Therapeutics. “But they have just one non-permanent contraceptive option—condoms—and it’s 170 years old. Innovation is long overdue. Data show men favor an oral contraceptive and one that’s hormone-free, positioning YCT-529 as potentially transformative for a healthcare segment that’s been stagnant for more than a century and a half.”
UK-based Quotient Sciences conducted the phase 1a study, which began in December 2023 and was completed in June 2024. New Zealand-based NZCR is conducting the current study.
About YCT-529
YCT-529, a first-in-class new chemical entity, is a retinoic acid receptor-alpha (RAR-α) inhibitor that is designed to prevent production of sperm cells in the testes as well as their release. YourChoice Therapeutics is currently assessing safety and efficacy of YCT-529 in a phase 1b/2a clinical trial in New Zealand as the first non-hormonal, oral male contraceptive. YourChoice Therapeutics developed YCT-529 in collaboration with Dr. Gunda Georg, a globally recognized medicinal chemist and awardee of one of the largest NIH-funded Contraceptive Centers. The Male Contraceptive Initiative (MCI) has been committed to funding the early research and YCT-529’s phase one clinical trial in men.
About YourChoice Therapeutics
YourChoice Therapeutics is a clinical-stage biopharmaceutical company developing the first hormone-free birth control pill for men. Based in San Francisco, the company is advancing the only male pill in human studies. Preclinical studies showed YCT-529 performed as effectively or better than the female birth control pill, and a phase 1a study demonstrated that YCT-529 was well tolerated by men. Future programs will apply the company’s patented therapeutic platform to develop hormone-free family planning products for women. Established in 2018, the company received a $15M Series A investment in 2022. For more information, visit www.yourchoicetx.com and follow the company on LinkedIn.
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