Daré Bioscience to Present Phase 1 Sildenafil Cream Data at Scientific Meeting
Daré Bioscience, Inc. (NASDAQ:DARE) announced that clinical data from a Phase 1 study evaluating its topical Sildenafil Cream, 3.6% will be presented at the Sexual Medicine Society of North America annual meeting in Orlando, Florida. The presentation, scheduled for October 9, 2026, compares the safety and absorption of the topical cream against oral sildenafil in healthy male adults.
The clinical trial showed that a 71 mg topical dose of the cream resulted in a mean maximum blood concentration approximately 187-fold lower than a 50 mg oral dose of sildenafil. Systemic exposure was also about 33 to 34 times lower. All reported side effects in the study were mild, with no severe adverse events or treatment discontinuations. These results support the delivery of the drug locally to reduce overall bodily exposure.
Daré Bioscience is developing the cream as a potential treatment for female sexual arousal disorder, a condition that currently lacks any approved drug therapies. While the company prepares for the FDA regulatory pathway for approval, it is also offering the formulation as a compounded product through a specialized outsourcing facility, though this version is not federally approved.
Key points
- Daré Bioscience will present Phase 1 trial data for its topical Sildenafil Cream at a scientific meeting on October 9, 2026.
- The study found that the topical cream resulted in 187-fold lower maximum blood concentration compared to oral sildenafil.
- All reported adverse events in the trial were mild, with no serious side effects or patient discontinuations.
- The company is developing the cream as a potential treatment for female sexual arousal disorder, which currently has no approved drugs.
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What is Sildenafil Cream used for?
Daré Bioscience is developing Sildenafil Cream as a potential treatment for female sexual arousal disorder, a condition that currently has no FDA-approved pharmacological treatments.
How did Sildenafil Cream perform in the Phase 1 trial?
The topical cream showed a 187-fold lower maximum plasma concentration and 33- to 34-fold lower systemic exposure compared to oral sildenafil, with only mild side effects reported.
Is Sildenafil Cream currently available?
It is available in the U.S. as a compounded product called DARE to PLAY Sildenafil Cream, which is manufactured under quality standards but is not approved by the FDA.