Sildenafil Cream for Women Clears a Major Safety Hurdle

The same drug in Viagra is being reinvented as a cream for women. Daré Bioscience, a San Diego biotech company focused on women's health, announced this month that peer-reviewed results published in Sexual Medicine show its experimental sildenafil cream for women puts far less of the drug into the bloodstream than the oral pill, a safety finding the company says supports a potential treatment with no FDA-approved alternative. The company's announcement is available in full from GlobeNewswire.

The condition at the center of this work is female sexual arousal disorder, or FSAD, which Daré describes as the clinical counterpart of erectile dysfunction in men. It involves a persistent inability to maintain sufficient genital arousal during sex, often tied to insufficient blood flow to the genitalia, and it frequently causes genuine distress or strain in relationships. Company market research estimates that roughly ten million women in the United States are actively looking for help with its symptoms. There are currently no FDA-approved pharmacological treatments for the condition, a gap the sildenafil cream for women is being developed to fill.

The newly published paper reports a Phase 1 trial that tested the sildenafil cream for women formulation in 62 healthy men who received a single dose of the cream at 36 or 71 milligrams, with or without condom use, or a standard 50-milligram sildenafil tablet. At the 71-milligram topical dose, the peak concentration of sildenafil in the blood was about 187 times lower than after the 50-milligram pill, and total exposure to the drug in the body was roughly thirty-three times lower, according to the company. All 14 reported side effects were mild, with no serious adverse events and no discontinuations. The researchers did not try to measure whether the cream improved sexual function; the study only looked at safety and how much drug enters the bloodstream.

What it could mean for women

The 71-milligram dose is the same one Daré tested in a Phase 2b trial in premenopausal women with FSAD, with efficacy results published in Obstetrics & Gynecology and safety results in the Journal of Sexual Medicine. In that trial of 200 women, the sildenafil cream for women significantly increased reported arousal sensation and reduced sexual distress in a central subgroup of participants, and it was well tolerated, with no difference in side effects compared with the placebo cream.

The safety data matter because oral sildenafil can lower blood pressure and cause headache, flushing, nausea, and dizziness; in the women's trial those effects did not show up, most likely because so little of the drug reached the bloodstream, lead author Dr. Annie Thurman said, as reported by Urology Times.

The product is a sildenafil cream for women being developed as an on-demand treatment, the company has said. Daré has said it plans to pursue Phase 3 trials following feedback from the FDA, which could make the cream the first FDA-approved treatment for FSAD. The company's December 2024 filing with the SEC said two confirmatory studies would be needed to support an eventual new drug application, describing the planned Phase 3 program as an adequate and well-controlled study reflecting earlier FDA recommendations. If the trials succeed, the sildenafil cream for women would create an entirely new category of approved medicine for women's sexual health.

Why researchers say it matters

Women's sexual health has long received a fraction of the research attention given to men's. Viagra was approved for men in 1998, and nearly three decades later, women with an analogous condition still have no approved drug option of their own. The gap is not just symbolic: arousal disorder is one of the most common sexual complaints among women, and patients are routinely told their options are limited to therapy, lubricants, or waiting for the problem to pass.

The new peer-reviewed data give Daré something the program did not have before, which is published evidence that a targeted cream can deliver sildenafil where it is needed without sending most of it through the body. The cream remains investigational, and Phase 3 trials will decide whether the benefit is strong and consistent enough for regulators. But for the women living with FSAD, the results are a concrete sign that a sildenafil cream for women is moving through the pipeline. For related reading, see our coverage of what a Kinsey survey found about Gen Z and sex and the conversation doctors skip on sexual recovery after breast cancer.