Daré Bioscience Receives FDA Clearance for Phase 2 Trial of DARE-HPV, First Potential Treatment for Persistent High-Risk HPV Infection
Key Insights
Daré Bioscience received FDA clearance for its IND application to initiate a Phase 2 clinical study of DARE-HPV (search), a novel vaginal insert formulation targeting persistent high-risk HPV (search) infection.
DARE-HPV (search) represents a potential breakthrough as the first FDA-approved pharmacologic treatment for HPV (search) infection, which causes 99% of cervical cancer cases in the United States.
The development program is supported by a $10 million ARPA-H (search) contract, with the Phase 2 study expected to evaluate safety and antiviral activity in women with persistent high-risk HPV (search) infection.
Daré Bioscience announced that the U.S. Food and Drug Administration has cleared the company's Investigational New Drug application for DARE-HPV (search), enabling initiation of a Phase 2 clinical study to evaluate this investigational therapy as a potential treatment for persistent high-risk human papillomavirus infection. The proprietary fixed-dose formulation combines lopinavir and ritonavir in a soft gel vaginal insert designed as a non-surgical, localized, self-administered therapy.
The regulatory milestone addresses a significant unmet medical need, as there are currently no FDA-approved pharmacologic treatments for HPV (search) infection, which underlies 99% of cervical cancer cases in the United States. DARE-HPV (search) represents a paradigm shift by targeting the virus itself rather than waiting for cellular changes to develop.
Addressing a Major Public Health Challenge
HPV (search) ranks among the most common sexually transmitted viral infections worldwide, with an estimated over 11 million women in the U.S. acquiring new HPV infections annually. While most HPV infections resolve spontaneously, millions of women experience persistent high-risk 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.
Current standard of care does not treat the virus directly. Instead, women with persistent high-risk HPV (search) infection undergo repeated screening and monitoring. 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 significant physical and emotional burden for women.
Clinical Development and Funding Support
The planned Phase 2 study will evaluate the safety and antiviral activity of DARE-HPV (search) in women with persistent high-risk HPV (search) infection. The development program is supported by a $10 million contract funded by the Advanced Research Projects Agency for Health (ARPA-H (search)), part of the U.S. Department of Health and Human Services, with $6.5 million received to date.
"FDA clearance to proceed to Phase 2 represents an important regulatory milestone for DARE-HPV (search) and for women who currently have no treatment options for persistent high-risk HPV (search) infection," said Sabrina Johnson, President and CEO of Daré Bioscience. "For decades, women have been told to 'watch and wait' to see if the virus clears on its own. If it does not, the only option has been surgery once precancerous changes appear."
Potential to Transform Treatment Paradigm
DARE-HPV (search) is designed to intervene earlier in the disease process by targeting the virus itself before progression to cervical disease. This approach aims to eliminate the frequent "watchful waiting" visits to healthcare providers that are costly, burdensome, and contribute to socioeconomic and racial disparities in cervical cancer care.
Johnson emphasized the therapy's potential impact: "DARE-HPV (search) is designed to intervene earlier – targeting the virus itself before progression to cervical disease – aiming to eliminate the frequent 'watchful waiting' visits to a health care provider that are costly, burdensome, and contribute to socioeconomic and racial disparities in cervical cancer."
The company plans to provide additional details regarding the Phase 2 study design and anticipated timelines for study initiation in the coming months, with preparations underway for 2026 launch. Johnson added that with ARPA-H (search) support and FDA clearance secured, the company is positioned to advance DARE-HPV (search) efficiently into Phase 2 and generate clinical data that could meaningfully change how persistent high-risk HPV (search) infection is managed.