Bryan, Texas — January 7, 2026 — Sano Women’s Health announced today that a recently completed Embryofetal Development (EFD) study showed no evidence of pregnancy-related or fetal harm from its investigational vaginal gel product containing Occidiofungin, supporting continued development of the therapy for women’s health indications.
The study evaluated Occidiofungin gel in pregnant rabbits using the same vaginal route planned for human use. Researchers tested three dose levels, including a high dose approximately ten times greater than the intended clinical dose. Even at the highest exposure, the study found no adverse effects on mothers, pregnancies, or developing fetuses.
Key findings from the study include:
No treatment-related side effects in pregnant animals
No impact on pregnancy outcomes, including implantation or litter size
No effects on fetal growth, development, or survival
No increase in fetal abnormalities compared with control animals
The study was conducted in accordance with international regulatory guidelines (ICH S5(R3) and followed recognized animal welfare standards.
“These results are an important step forward for our program,” said James Leif Smith, Co-CEO of Sano Women’s Health. “Demonstrating a strong reproductive safety profile—especially at doses well above what we expect to use clinically—gives us confidence as we move ahead with development.”
Sano has completed Phase 1 SAD and MAD clinical studies and is targeting to initiate Phase 2 clinical studies in March of 2026.
About Occidiofungin
Occidiofungin is a novel antifungal compound being developed as a locally administered vaginal gel for the treatment of Recurrent Vulvovaginal Candidiasis (RVVC). Local delivery is intended to maximize efficacy at the site of infection while minimizing systemic exposure. Occidiofungin is a first-in-class peptide drug with a strong IP position. The drug has FDA Fast Track and QIDP designations with the FDA.
About Sano Women’s Health
Sano Women’s Health is a clinical-stage company focused on developing innovative therapies for underserved conditions in women’s health, with an emphasis on safety, efficacy, and patient-centered delivery. Sano is developing Occidiofungin to treat RVVC. A treatment for recurrent vulvovaginal candidiasis is an unmet medical need for 9 million women in the US, and 160 million women worldwide.
For more information, please visit www.sanowomenshealth.com
Contact
James Smith, Co-CEO: jsmith@sanochemicals.com
Janice Miles, Co-CEO: jmiles@sanochemicals.com
