On August 26, 2026, Daré Bioscience (NASDAQ: DARE) announced that Phase 1 results for its proprietary topical sildenafil cream, 3.6%, have been published in Menopause — The Journal of The Menopause Society, under the title "A phase 1, open-label, within-participant dose-escalation study to evaluate the safety and pharmacokinetics of topical sildenafil cream in healthy postmenopausal women." It is the first peer-reviewed publication of the postmenopausal safety and pharmacokinetic data behind a product Daré is already commercializing in compounded form.

Why It Matters

Female sexual arousal disorder is one of the largest unaddressed indications in sexual medicine — there is no FDA-approved product that directly increases genital blood flow in women, while men have had oral PDE5 inhibitors for nearly three decades. A peer-reviewed safety and PK package in the field's flagship menopause journal is exactly the credibility Daré needs to keep the 505(b)(2) path alive and to give prescribers cover for the compounded version now. The caution for anyone doing diligence: this is a 21-participant Phase 1 safety and pharmacokinetics study, not an efficacy result, and a 503B compounded product occupies a very different position with payers, pharmacies and ad platforms than an approved drug. The publication strengthens the *safety* story; the commercial question is still whether Q3 dispensing volume materializes.

The study design was small and deliberately mechanistic: 21 healthy postmenopausal women, mean age 57, each received a single dose of placebo cream followed by escalating doses of sildenafil cream containing 50mg, 100mg and 200mg of sildenafil citrate, with a 14- to 16-day washout between doses. Nineteen participants completed all four treatment periods. All doses were reported well tolerated, all treatment-emergent adverse events were mild, and there were no serious adverse events, no cardiac TEAEs and no episodes of symptomatic orthostatic hypotension.

The number that matters is the systemic exposure. At the 100mg dose — the one carried into Daré's Phase 2b RESPOND study (NCT04948151) — maximum plasma sildenafil concentration was approximately 3,810 pg/mL, which the company notes is roughly two orders of magnitude below the ~450,000 pg/mL reported in men after a single 100mg oral dose in separate published work. That gap is the entire thesis: deliver the vasodilator to genital tissue, skip the cardiovascular systemic load that makes oral PDE5 inhibitors a poor fit for a female arousal indication.

Commercially, Daré is running a two-track strategy. It continues working toward FDA approval via the 505(b)(2) pathway while simultaneously launching DARE to PLAY Sildenafil Cream — a 503B compounded version of the same formulation — with prescription dispensing and initial product revenue expected to commence in Q3 2026. That mirrors the July 2026 MyMenopauseRx telehealth partnership Afterglow covered, which built the distribution rail this data is meant to support.

Dr. Sheryl Kingsberg, division chief of behavioral medicine at University Hospitals Cleveland Medical Center and a past president of both The Menopause Society and ISSWSH, said in the announcement that the results "show that Daré's proprietary Sildenafil Cream was well tolerated in postmenopausal women with minimal systemic exposure." CEO Sabrina Martucci Johnson noted the underlying market gap plainly: there remains "no FDA-approved pharmacological treatment specifically for female sexual arousal disorder."

Sources

Update — 2026-08-30

{Initial entry — story first created.}