YourChoice Therapeutics announced that YCT-529, a hormone free male contraceptive pill, completed its first in human safety trial with positive results. The clinical study marked a significant step toward expanding birth control options beyond condoms and vasectomies for men.
Safety Trial Meets Primary Endpoints
Researchers conducted the Phase 1a trial with sixteen healthy male volunteers between the ages of thirty two and fifty nine. All participants had previously undergone vasectomies as a precautionary measure to prevent any permanent impact on fertility during the safety assessment. The study evaluated single ascending doses of ten, thirty, ninety, and one hundred eighty milligrams of YCT-529 against placebo controls.
Nadja Mannowetz, co-founder and chief scientific officer of YourChoice Therapeutics, stated that “we saw good and quick bioavailability” across all dosages tested. The drug reached maximum concentration in plasma within thirty minutes and maintained levels exceeding the therapeutic threshold for twenty four hours. Participants also received thirty milligram doses with food to assess dietary effects on absorption.
No Adverse Effects Detected
Furthermore, The trial results showed that YCT-529 was well tolerated with no adverse effects noted. Investigators observed no changes in heart rate, hormone levels including testosterone and follicle stimulating hormone, or inflammatory biomarkers. Furthermore, the study detected no impact on sexual desire or mood among participants. As reported by ALO360, the safety profile met the high standards required for contraceptive medications.
Akash Bakshi, co-founder and chief executive officer of YourChoice Therapeutics, emphasized the historical significance of the development. “One hundred sixty nine years is a long time to wait for innovation,” he said. He added that “we need more male methods, and we need them quickly.”
Mechanism Blocks Vitamin A Pathway
YCT-529 functions as a retinoic acid receptor alpha antagonist. The compound blocks access to a vitamin A metabolite in the testes, which prevents the gene expression changes necessary for sperm production. This mechanism differs from hormonal approaches that suppress testosterone, which often cause side effects such as mood changes, weight gain, and altered libido.
Moreover, Preclinical studies in mice and non-human primates preceded the human trials. Researchers found that YCT-529 achieved ninety nine percent effectiveness in preventing pregnancies in mice within four weeks. Male non-human primates showed reduced sperm counts within two weeks of treatment. Both species fully regained fertility after discontinuing the drug, with mice recovering within six weeks and primates requiring ten to fifteen weeks.
Development Enters Next Phase
YourChoice Therapeutics initiated a Phase 1b/2a trial in September 2024 to evaluate the drug’s impact on sperm production over twenty eight and ninety day periods. This ongoing study will enroll up to sixty six men to assess tolerability and efficacy. The company anticipates results from this expanded trial in 2025.
Additionally, Gunda Georg, a professor at the University of Minnesota College of Pharmacy and collaborator on the project, noted that “a safe and effective male pill will provide more options to couples for birth control.” She stated that the development “will allow a more equitable sharing of responsibility for family planning.”
