Cure
Overview
Daré’s drug, the first pharmacologic treatment for HPV infection to reach a clinical trial, came out of three bold bets: repurposing a decades-old drug, skipping venture capital, and negotiating a new regulatory path with the FDA.
Every year, 6 million women in the United States learn they carry a high-risk strain of HPV, the virus behind nearly all cervical cancer. Almost none of them will be treated for it because there is no drug that can. The standard of care is to wait, rescreen, and hope the infection clears before it does damage that requires surgery. For about 13,500 women annually, the infection will progress into invasive cervical cancer, a disease that is largely preventable.
"It's a little surprising that we don't treat that high-risk infection when it happens," says Sabrina Martucci Johnson, Founder and CEO of Daré Bioscience. "And we don't because we don't have a treatment yet. Instead, we wait until there are precancerous lesions that can be surgically removed."
In May, Daré initiated a Phase 2 study of DARE-HPV, the first pharmacologic treatment for persistent high-risk HPV to reach a clinical trial. The randomized, placebo-controlled study will enroll about 100 women at U.S. sites and test a soft-gel vaginal insert taken daily for up to 21 days. The primary endpoint is HPV clearance at three months, and topline data is expected in 2027.
The drug itself is a vaginal formulation of lopinavir and ritonavir, two HIV antivirals. The approach traces to a 2016 proof-of-concept study by University of Manchester researchers and Kenyatta National Hospital in Nairobi, which found the drugs cleared high-risk HPV when delivered vaginally rather than orally. "They had the vision to give women vaginally what was normally an oral antiviral medicine for HIV infection," Johnson says. "In vitro, those drugs are effective against HPV. And by giving them orally, they're just not." Daré licensed the program in 2023 and reformulated it for vaginal delivery, keeping the Manchester team as partners.
The science was just the start.
Charting a Path Where None Existed
No company had developed a treatment for high-risk HPV, and not because the biology was missing. The system had never required one, and the regulatory framework reflected that.
"There's no clear regulatory pathway," Johnson says. "Those of us looking to develop something for this have to negotiate with the Food and Drug Administration (FDA) what that looks like." The central problem was how to define success in a disease where only a fraction of patients will ever develop cancer. "What is a positive outcome? What is success? So that's a lot of work," she says. "And whenever you have that kind of hurdle, it generally stalls innovation a little bit, because the innovators are taking on the risk of their drug, but also having to blaze a new regulatory path."
The FDA cleared Daré's IND in February 2026. Johnson describes the agency as receptive but the process as exacting. "It's been good in terms of the FDA understanding the needs here," she says. "But you still have to work through everything."
Funding followed a similar pattern. Daré has never matched the standard biotech model. Johnson took the company public early, through a 2017 reverse merger with Cerulean Pharma, at a point when private capital for a women's health drug developer was scarce. The HPV trial is funded by a $10 million ARPA-H contract, not venture capital.
"If we were relying solely on investor capital, we might not have been able to get this going," Johnson says. "Being able to apply for and get grant funding made the trial possible, which, if it's successful, can open the door to companies and investors coming in, because then you're at a different risk level." She draws a clear line between the two sources. "The NIH's mandate is to fund innovation. Whereas the mandate of a fund you're meeting with is to make money. That's why it's helpful to consider grant funding. It's a different mandate."
The HPV gap is one piece of a wider pattern, says Kiya Abdisa, MD, a clinical research coordinator at the University of Pennsylvania who works on women's health trials in endometriosis, fibroids, early pregnancy care, and contraception. "Persistent high-risk HPV is not just a test result," she says. "For many women, it means fear, repeat appointments, and waiting with limited options, all while knowing it can raise the risk of cervical cancer." What's shifting, she says, is the response: more research, more funding, and more urgency around conditions women have managed quietly for years.
The Opening Is in Drugs
Johnson is blunt about where new drugs in the field will come from. Early innovation in most therapeutic areas begins at small companies and gets acquired by big pharma. In women's health, she says, that handoff has rarely happened, because there's almost no one to acquire. "We don't know of other drug developers working broadly in women's health on drugs other than ourselves."
That absence is the opportunity. The open space is not in another app or screening tool, but in drug programs and the regulatory paths that go with them, for conditions that affect millions of women and have not been treated as treatable.
It also explains why a 100-woman Phase 2 study matters beyond its own results. "Anytime we have success in women's health, it just validates that we can have clinical successes, that it is possible to innovate," Johnson says. "The further stage of development we get, it's going to make it more and more interesting for pharmaceutical companies to come in. We just need more of them. We need more clinical studies happening in women's health."
For founders working on conditions that have been overlooked, Johnson's advice is less about the science than the path to funding it. "As founders in general, you have to have a lot of tenacity," she says. "But what that means is you just have to be creative and look at a lot of different funding sources." The HPV program is her own example: a licensed academic discovery, a federal grant, and a regulatory path built from scratch, for a condition the field had written off as something women simply manage.
