Daré Bioscience announced that the U.S. Food and Drug Administration has cleared its Investigational New Drug application for DARE‑HPV, a fixed‑dose lopinavir/ritonavir vaginal insert designed to treat persistent high‑risk human papillomavirus (HPV) infection. The clearance allows the company to begin a planned Phase 2 clinical study that will evaluate the safety and antiviral activity of the product in women with persistent high‑risk HPV.
DARE‑HPV is a soft‑gel vaginal insert that delivers a fixed dose of the antiretroviral drugs lopinavir and ritonavir. The Phase 2 study will enroll women who have not cleared high‑risk HPV after standard monitoring, and will assess whether the insert can eliminate the virus before precancerous lesions develop. The study is expected to start in 2026 and will provide the first clinical data on a pharmacologic approach to HPV management.
The program is supported by a $10 million contract from the Advanced Research Projects Agency for Health (ARPA‑H), of which $6.5 million has already been received. The ARPA‑H award was announced in October 2024, and the company has also secured grant funding from the Gates Foundation for a non‑hormonal contraceptive and from the National Institute of Allergy and Infectious Diseases (NIAID) for DARE‑HPV development.
President and CEO Sabrina Johnson said, "FDA clearance to proceed to Phase 2 represents an important regulatory milestone for DARE‑HPV and for women who currently have no treatment options for persistent high‑risk HPV infection." She added, "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. DARE‑HPV 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." Johnson also noted, "With ARPA‑H support and FDA clearance in hand, we are positioned to advance DARE‑HPV efficiently into Phase 2 and generate clinical data that could meaningfully change how persistent high‑risk HPV infection is managed."
Daré Bioscience is a women’s health company focused on contraception, menopause, pelvic pain, fertility, vaginal health, and infectious disease. In addition to DARE‑HPV, the company is developing Ovaprene®, a contraceptive, Sildenafil Cream for female sexual arousal disorder, and DARE‑HRT1 for menopause. In February 2026, Bayer terminated its license agreement for Ovaprene, returning all rights to Daré. The company’s current ratio is 1.18 and it is burning cash at a typical pace for a clinical‑stage biotech, underscoring the importance of securing non‑dilutive funding such as the ARPA‑H award.
The FDA clearance positions Daré Bioscience as a potential pioneer in providing the first pharmacologic treatment for high‑risk HPV, a disease that currently relies on watch‑and‑wait monitoring and surgical intervention. If the Phase 2 study demonstrates safety and antiviral efficacy, the company could shift the standard of care and address a significant unmet medical need, potentially opening a new therapeutic market for women worldwide.
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