Daré Bioscience Study Shows Topical Sildenafil Cream Has 187-Fold Lower Systemic Exposure Than Oral Form — Daré Bioscience, Inc.

Event summary

Daré Bioscience published Phase 1 study results in Sexual Medicine showing its topical Sildenafil Cream has 187-fold lower systemic exposure than oral sildenafil.
The study enrolled 62 healthy men, comparing 36 mg and 71 mg topical doses with a 50 mg oral dose.
Topical administration resulted in mean maximum plasma concentrations ranging from 969 to 1,274 pg/mL vs. 238,000 pg/mL for oral sildenafil.
The 71 mg topical dose was used in a subsequent Phase 2b study for female sexual arousal disorder.

The big picture

Daré Bioscience's study results strengthen the scientific foundation for its proprietary topical Sildenafil Cream, demonstrating significantly lower systemic exposure compared to oral administration. This positions the company to address unmet needs in women's sexual health while potentially expanding the clinical evidence base for localized drug delivery approaches. The findings come as the biotech sector increasingly focuses on targeted therapies and personalized medicine solutions.

What we're watching

Clinical Translation: How the lower systemic exposure profile will impact regulatory approval and market positioning for Daré's topical sildenafil formulation.
Women's Health Focus: Whether Daré can sustain its women's health focus while leveraging broader clinical evidence from male studies.
Competitive Differentiation: The pace at which Daré can establish its formulation as a differentiated approach in sexual health treatments.