Daré Bioscience presents sildenafil cream Phase 1 data at SMSNA 2026

Daré Bioscience has presented Phase 1 clinical data for its proprietary Sildenafil Cream 3.6% at the Sexual Medicine Society of North America annual meeting in Orlando, offering the clearest pharmacokinetic picture yet for its topical formulation ahead of a planned FDA 505(b)(2) submission.

The study, conducted in healthy adult men, compared the topical cream against oral sildenafil in a randomised, parallel-cohort, open-label design. At the 71 mg topical dose, mean maximum plasma concentration was approximately 187-fold lower than that seen with a 50 mg oral tablet, while systemic exposure measured by area under the curve was 33- to 34-fold lower. All treatment-emergent adverse events were rated mild; no serious adverse events, deaths or treatment discontinuations were recorded. The findings have been published in Sexual Medicine, the journal of the International Society for Sexual Medicine.

Relevance to the FSAD programme

Annie Thurman, Medical Director of Daré Bioscience, framed the male pharmacokinetics study as a building block for the company's female sexual arousal disorder pipeline. "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," she said.

Daré has already run Phase 1, Phase 2a and Phase 2b trials of the cream in women with FSAD, a condition the company highlights currently has no FDA-approved pharmacological treatment. The male bioavailability data provides the regulatory and scientific grounding to argue that meaningful local efficacy may be achievable without the systemic side-effect burden associated with oral PDE5 inhibitors.

While pursuing full approval via the 505(b)(2) pathway, Daré is also distributing a compounded version, branded DARE to PLAY, through a Section 503B outsourcing facility under current Good Manufacturing Practices. The compounded product is not FDA-approved, and the FDA does not evaluate it for safety or efficacy, a distinction the company discloses prominently.

Market and regulatory context

FSAD sits within a broader women's sexual health segment that has attracted renewed commercial and regulatory attention since the FDA approved flibanserin for hypoactive sexual desire disorder in 2015 and bremelanotide in 2019, both indicated for premenopausal women. Neither targets arousal physiology directly, leaving a genuine unmet-need gap that Daré is seeking to occupy with a mechanism more targeted to genital blood flow.

The 505(b)(2) pathway, which allows applicants to rely in part on existing safety and efficacy data for previously approved drugs, is a logical route for a novel formulation of an established active ingredient. Sildenafil's long regulatory history with the FDA should reduce some of the pharmacological uncertainty, though the agency will require evidence that the topical route achieves meaningful clinical outcomes in women. The company has not disclosed a timeline for an NDA filing, and investors will be watching for a Phase 3 design announcement as the next substantive milestone.

The SMSNA presentation will be followed by a poster period of approximately 30 days, and slides are available on Daré's investor relations website.