Daré Bioscience Initiates Phase 2 Study of DARE-HPV, a Novel Pharmacologic Treatment for Persistent High-Risk HPV Infection with No FDA-Approved Therapies

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Each year, an estimated six million women in the United States acquire a high-risk HPV infection — and there are no FDA-approved treatments DARE-HPV development is backed by a $10 million U.S. government (ARPA-H)-funded contract; topline data readout expected in 2027 SAN DIEGO, May 18, 2026 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ: DARE), a purpose-driven health biotech company solely focused on closing the gap in women’s health between promising science and real-world solutions, today announced the initiation of its Phase 2 clinical study of DARE-HPV, an investigational, proprietary fixed-dose formulation of lopinavir and ritonavir in a soft gel vaginal insert, designed to evaluate DARE-HPV as a potential treatment for persistent high-risk human papillomavirus (HPV) infection. DARE-HPV is being developed as a non-surgical, localized, self-administered therapy designed to clear persistent high-risk HPV infection. HPV infection is the underlying cause of 99% of cervical cancer cases in the United States. There are currently no FDA-approved pharmacologic treatments for HPV infection. The Phase 2 study is a randomized, placebo-controlled, double-blind trial designed to evaluate the safety and antiviral activity of a lower and higher DARE-HPV dose compared with placebo in approximately 100 women with confirmed persistent high-risk HPV infection over an up to 21-day course of daily treatment. The primary endpoint is HPV clearance rate at three months post treatment. Secondary endpoints include safety, tolerability, and reduction in viral load. Daré Bioscience expects to report topline data in 2027. Study initiation follows clearance by the U.S. Food and Drug Administration (FDA) of the Investigational New Drug (IND) application for the study, announced in February 2026, and represents a significant clinical development milestone. By targeting the virus itself rather than waiting for cellular changes to develop, DARE-HPV has the potential to redefine the treatment paradigm in cervical disease prevention. If approved, DARE-HPV could be the first FDA-approved pharmacologic treatment for HPV infection, addressing a substantial unmet need, with more than 6 million women per year in the United States estimated to acquire a high-risk HPV infection. “Initiating this Phase 2 study marks a historic step — for the first time, women with persistent high-risk HPV ...

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