Daré Bioscience Presents Phase 1 Data for Sildenafil Cream, Showing…

Event summary

Daré Bioscience will present Phase 1 data for its Sildenafil Cream at the SMSNA Annual Fall Scientific Meeting on October 9, 2026.
The study showed that the 71 mg topical dose had a mean maximum plasma concentration of sildenafil approximately 187-fold lower compared to the 50 mg oral dose.
Systemic exposure (AUC) was approximately 33- to 34-fold lower with the topical formulation, and all adverse events were mild.
The data supports the potential for lower systemic exposure compared to oral administration, advancing the cream as a treatment for female sexual arousal disorder (FSAD).
Daré Bioscience is pursuing the FDA’s 505(b)(2) regulatory pathway for Sildenafil Cream and offers it as a compounded product under the name DARE to PLAY™.

The big picture

Daré Bioscience’s presentation of Phase 1 data for its Sildenafil Cream highlights the potential for a topical formulation to deliver sildenafil with substantially lower systemic exposure compared to oral administration. This aligns with broader industry trends toward targeted drug delivery and the growing focus on women’s health, particularly in areas like female sexual arousal disorder (FSAD), where there are currently no FDA-approved pharmacological treatments. The company’s strategic approach of pursuing the 505(b)(2) regulatory pathway while offering the product as a compounded drug underscores the challenges and opportunities in bringing innovative solutions to market in a highly regulated environment.

What we're watching

Regulatory Pathway: Whether Daré Bioscience can successfully navigate the FDA’s 505(b)(2) pathway for Sildenafil Cream, given the need to rely on prior safety and efficacy data.
Market Adoption: The pace at which DARE to PLAY™ Sildenafil Cream gains market acceptance as a compounded product, given the lack of FDA approval for such products.
Clinical Development: How the Phase 1 data in men translates to the ongoing clinical development program in women with FSAD, where no FDA-approved treatments currently exist.