linical data from a Phase 1 study that evaluated the Company’s proprietary Sildenafil Cream, 3.6% investigational product (Sildenafil Cream) will be presented at the Annual Fall Scientific Meeting of the Sexual Medicine Society of North America (SMSNA), taking place October 8-11, 2026, in Orlando, Florida.
Annie Thurman, MD, FACOG, Medical Director of Daré Bioscience, will present "An Open-Label, Single-Dose, Randomized, Parallel-Cohort Study of the Safety and Relative Bioavailability of Topical Sildenafil Cream, Versus Oral Sildenafil in Healthy Male Adults" during the Innovations in Sexual Medicine Abstracts session on Friday, October 9, 2026. A copy of the presentation will be made available through the Presentations, Events & Webcasts page of the Investors section of the Company’s website (darebioscience.com). The poster will be accessible for approximately 30 days after Dr. Thurman’s live presentation.
The Phase 1 study evaluated the adverse events and relative bioavailability of Daré Bioscience’s proprietary topical Sildenafil Cream compared with oral sildenafil in healthy adult men. The study provides additional clinical evidence supporting further clinical development of the Company’s topical formulation and its potential to deliver sildenafil locally while resulting in substantially lower systemic exposure compared with oral administration.
In the study, at the 71 mg topical dose, mean maximum plasma concentration of sildenafil was approximately 187-fold lower compared to the 50 mg oral dose, while systemic exposure measured by area under the curve (AUC) was approximately 33- to 34-fold lower. All treatment-emergent adverse events reported in the study were mild, with no serious adverse events, severe adverse events, deaths or discontinuations due to treatment-emergent adverse events. Findings from the study were recently published in Sexual Medicine, an official journal of the International Society for Sexual Medicine. The journal article may be accessed here.
"These findings provide additional clinical evidence supporting the rationale for topical delivery of sildenafil and the potential for substantially lower systemic exposure compared with oral administration," said Annie Thurman, MD, FACOG, Medical Director of Daré Bioscience. "As a physician and clinical researcher focused on women’s health, I believe understanding this data on the pharmacokinetic and potential safety profile of our proprietary formulation in men is an important component of advancing Sildenafil Cream as a potential treatment for women with female sexual arousal disorder."
The Phase 1 study in men complements Daré Bioscience’s clinical development program evaluating Sildenafil Cream in women with female sexual arousal disorder (FSAD). Daré Bioscience’s Sildenafil Cream has been studied in Phase 1, Phase 2a and Phase 2b clinical trials in women. Daré Bioscience is developing Sildenafil Cream as a potential treatment for FSAD, a condition for which there are currently no FDA-approved pharmacological treatments.
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