On September 14, 2026, Daré Bioscience (NASDAQ: DARE) announced the peer-reviewed publication of a Phase 1 study of its proprietary topical Sildenafil Cream, 3.6% in healthy adult men, appearing in Sexual Medicine, an official journal of the International Society for Sexual Medicine. The paper — "An open-label, single-dose, randomized, parallel-group study of the safety and relative bioavailability of topical sildenafil cream vs oral sildenafil in healthy male adults" — is the second Phase 1 publication for the program in under three weeks, following the postmenopausal-women data published in Menopause on August 26.

Why It Matters

Systemic exposure is the entire argument for topical sexual-wellness pharmacology. Oral sildenafil's side-effect profile — headache, flushing, visual disturbance, and the hard contraindication against nitrates — flows directly from drug circulating body-wide. A formulation that delivers roughly 3% relative bioavailability while placing drug where it is meant to act is the mechanistic case for a product that could plausibly reach patients for whom oral PDE5 inhibitors are unsuitable, including women with female sexual arousal disorder, the indication Daré is actually chasing. For the broader sexual wellness market, this is a useful marker of where the category's scientific frontier sits. Female arousal has no FDA-approved topical pharmacologic treatment, and the space is crowded with compounded and supplement-grade products making claims on far thinner evidence. Two peer-reviewed Phase 1 publications in three weeks — in *Menopause* and in *Sexual Medicine* — is the kind of paper trail that separates a drug-development program from a wellness brand. Whether it converts into an approvable product depends entirely on the Phase 2b efficacy readout in women, which is where the commercial question actually gets answered.

The headline finding is a pharmacokinetic gap large enough to change the risk conversation around a very familiar molecule. The open-label, randomized study enrolled 62 healthy men who received a single dose of either 36 mg or 71 mg of sildenafil in topical cream form, applied to the penis with or without condom use, or a 50 mg oral sildenafil tablet. Mean maximum plasma concentrations in the topical groups ranged from 969 to 1,274 pg/mL, against roughly 238,000 pg/mL for the oral dose. Relative bioavailability for the topical arms landed between 2.55% and 3.20%. At the 71 mg topical dose, mean peak plasma concentration ran approximately 187-fold lower than the 50 mg oral dose, with total exposure (AUClast and AUCinf) about 33- to 34-fold lower.

Safety data were unremarkable in the way early-phase sponsors hope for. Across all 62 subjects there were 14 treatment-emergent adverse events, all mild, with no serious events, no severe events, no deaths and no discontinuations. Notably, 7 of those 14 events — half the total — occurred in 5 participants who received oral sildenafil rather than the cream. The 71 mg topical dose has been carried forward into a Phase 2b study in women.

Daré was careful to frame why a women's health company ran a study in men. "We are a women's health company, and that remains at the center of everything we do," said president and CEO Sabrina Martucci Johnson, describing the company's core strength as applying "sophisticated formulation and drug-delivery science to well-understood active ingredients." The men's cohort provided a clean comparison against the oral reference product — the 50 mg tablet is indicated in men, not women — letting Daré characterize its delivery profile against the established standard.

The limitations are real and worth stating plainly: this is Phase 1 pharmacokinetics and safety, not efficacy. The study did not measure erectile response or arousal outcomes, and the 62 participants were healthy men without erectile dysfunction. It strengthens the evidence base for the formulation without establishing a treatment benefit. Investors have been reading these disclosures unsentimentally — shares fell 8.54% the day after the August 26 postmenopausal publication.

Sources

Update — 2026-09-15

{Initial entry — story first created.}