Sildenafil Cream, 3.6% - (RESPOND)

October 8, 2026: Daré Bioscience (NASDAQ: DARE) said Phase 1 data for its investigational Sildenafil Cream, 3.6% will be presented at the Sexual Medicine Society of North America annual fall meeting in Orlando on October 9, 2026, in an abstract session on sexual medicine innovations.

The open-label, single-dose, randomized, parallel-cohort Phase 1 study compared topical Sildenafil Cream with oral sildenafil in healthy adult men, assessing adverse events and relative bioavailability. At the 71 mg topical dose, mean maximum plasma concentration was about 187-fold lower than with a 50 mg oral dose, and systemic exposure (AUC) was about 33- to 34-fold lower. All treatment-emergent adverse events were mild; there were no serious or severe adverse events, deaths, or discontinuations due to treatment-emergent adverse events.

Daré said the findings support further clinical development of the topical formulation and its potential for local sildenafil delivery with substantially lower systemic exposure than oral dosing. The program is being developed for female sexual arousal disorder (FSAD); the company said the cream has already been studied in Phase 1, Phase 2a, and Phase 2b trials in women. Daré also said it is continuing activities to advance the product toward the FDA’s 505(b)(2) pathway.