Daré Bioscience Adds U.S. Patent Protection for DARE-HPV as Phase 2 Trial Advances

Key Points

• Daré Bioscience announced a new U.S. patent covering topical lopinavir-and-ritonavir formulations for HPV-related cervical conditions.
• Daré holds an exclusive U.S. license to the patent, which the company expects to provide protection into at least 2039.
• Its investigational DARE-HPV vaginal insert is being tested in a Phase 2 trial of approximately 100 women with persistent high-risk HPV infection.
• The trial’s primary endpoint is HPV clearance three months after treatment, with topline results expected in 2027.
• The program is supported by approximately $10 million in ARPA-H funding and a $2 million NIAID award.

Daré Bioscience (NASDAQ: DARE) said a newly issued U.S. patent strengthens the intellectual property supporting DARE-HPV, its investigational treatment for persistent high-risk human papillomavirus infection. The announcement comes as a placebo-controlled Phase 2 trial evaluates whether the self-administered vaginal insert can clear the infection.

New Patent Covers Topical HPV-Related Cervical Treatments

U.S. Patent No. 12,678,439, titled “Lopinavir and Ritonavir for the Treatment of Cervix Disorders,” was issued on July 14, 2026, to Douglas Pharmaceuticals Limited, Daré’s licensor. It covers certain topical pharmaceutical compositions containing lopinavir and ritonavir, including specified ratios and formulations for HPV-related cervical conditions.

Daré said the patent includes claims involving the treatment or prevention of HPV-related cervical neoplasias and is expected to provide protection into at least 2039. The company holds an exclusive U.S. license to this patent and a broader DARE-HPV patent family under a 2023 agreement with Douglas Pharmaceuticals.

Phase 2 Trial Will Test HPV Clearance

DARE-HPV is a fixed-dose lopinavir-and-ritonavir formulation delivered as a soft-gel vaginal insert. Daré is developing it as a localized, non-surgical treatment that patients could administer themselves.

The ongoing randomized, double-blind Phase 2 trial plans to enroll approximately 100 women with confirmed persistent high-risk HPV infection. It will compare lower and higher DARE-HPV doses with placebo over up to 21 days of daily treatment, measuring HPV clearance three months after treatment as its primary endpoint. Daré expects topline results in 2027.

Funding Supports DARE-HPV Development

Daré said the program has approximately $10 million in non-dilutive support from the Advanced Research Projects Agency for Health and a $2 million award from the National Institute of Allergy and Infectious Diseases.

The company sees an unmet need because there is currently no FDA-approved pharmacologic treatment to clear HPV infection. DARE-HPV remains investigational: the new patent protects specified inventions, but it does not establish that the treatment works or that it will receive FDA approval.