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Daré Bioscience Announces FDA Clearance of IND for Phase 2 Clinical Study of DARE-HPV, a Potential Treatment for Persistent High-Risk HPV Infection, the Most Common Cause of Cervical Cancer
DARE-HPV development supported by $10 million ARPA-H contract; program targets major unmet need with no FDA-approved therapies SAN DIEGO, Feb. 23, 2026 (GLOBE
About this update from Dare Bioscience, Inc.
[{"type":"text","content":"DARE-HPV development supported by $10 million ARPA-H contract; program targets major unmet need with no FDA-approved therapies\nSAN DIEGO, Feb. 23, 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 that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application for DARE-HPV, an investigational, proprietary fixed-dose formulation of lopinavir and ritonavir in a soft gel vaginal insert, allowing initiation of a planned Phase 2 clinical study 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. 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. HPV is one of the most common sexually transmitted viral infections worldwide. An estimated over 11 million women in the U.S. alone acquire a new HPV infection every year. While most HPV infections resolve spontaneously, millions of women experience persistent high-risk HPV infection, the type of HPV infection that can progress to precancerous cervical lesions and, ultimately, cervical cancer if left untreated. According to the Centers for Disease Control and Prevention, high-risk HPV types are responsible for nearly all cases of cervical cancer in the United States. Today, the standard of care does not treat the virus. Instead, women with persistent high-risk HPV infection are monitored through repeated screening. Intervention typically occurs only after precancerous lesions develop, often requiring surgical procedures such as excisional or ablative treatments of cervical tissue. These procedures may increase the risk of preterm birth in future pregnancies and can pose risks to fertility – creating a significant physical and emotional burden for women. “FDA clearance to proceed to Pha...