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A revolutionary hormone-free male birth control pill, YCT-529, successfully completed its initial human safety trial, marking a significant step toward equitable contraception options. The pill, developed by YourChoice Therapeutics in collaboration with the University of Minnesota and Columbia University, offers a safe, reversible, and non-hormonal alternative to condoms and vasectomies.
The phase 1 clinical trial, conducted in the UK and published on July 22, 2025, in Communications Medicine, tested YCT-529 on 16 healthy men aged 32 to 59, all of whom had undergone vasectomies to eliminate pregnancy risks.
The trial evaluated the drug’s safety, absorption, and tolerability at various doses, up to 180 mg, taken with or without food. The drug reached desired bloodstream levels, with 180 mg identified as the likely optimal daily dose, and showed no serious side effects, hormonal imbalances, or impacts on heart rate, mood, or sexual function.
"The positive results from this first clinical trial laid the groundwork for a second trial, where men receive YCT-529 for 28 days and 90 days, to study safety and changes in sperm parameters," the study authors wrote in their paper.
YCT-529 targets the retinoic acid receptor alpha (RAR-α), a protein critical for sperm production. By blocking a vitamin A metabolite from binding to this receptor, the pill halts sperm production without affecting testosterone levels, avoiding side effects like mood swings, libido loss, or weight gain associated with hormonal contraceptives.
Preclinical trials demonstrated YCT-529’s effectiveness. In mice, the pill achieved 99% efficacy in preventing pregnancy, with fertility restored within 4–6 weeks after discontinuation. Non-human primates showed significant sperm count reductions within two weeks, with full recovery within 10–15 weeks.
Currently, men rely on condoms or vasectomies, the latter of which may not always be successfully reversed. YCT-529 offers a non-invasive, reversible option, promoting shared responsibility in family planning. Dr. Stephanie Page, an endocrinologist at the University of Washington, called the safety results a “critical first step” toward expanding reversible contraceptive options for men.
YourChoice Therapeutics has launched phase 1b/2a trials with about 50 participants to assess YCT-529’s efficacy in suppressing sperm counts over 28 and 90 days. These trials, ongoing in 2025, continue to prioritize men with vasectomies or those not planning to father children.
The upcoming trial will not only monitor safety but also evaluate changes in sperm parameters, building directly on the foundation laid by the successful first phase. If successful, phase 3 trials and regulatory approval could make YCT-529 available by 2027–2030.
Backed by the National Institutes of Health and the Male Contraceptive Initiative, YCT-529 could transform reproductive health by balancing contraceptive responsibilities between genders.
Professor Gunda Georg of the University of Minnesota emphasized its potential, stating, “A safe and effective male pill will provide more options to couples and provide reproductive autonomy for men.”
Reference:
1. Mannowetz, Nadja, Stewart W McCallum, Sharan Sidhu, Karen H Mena, Eric P Ruby, Ramiro Castro-Santamaria, Emily Dodds, et al. “Safety and Pharmacokinetics of the Non-hormonal Male Contraceptive YCT-529.” Communications Medicine 5, no. 1 (July 22, 2025). https://doi.org/10.1038/s43856-025-01004-4.
(Rh/Eth/Pooja Bansal/MSM/SE)
