Daré Bioscience said it has started a Phase 2 clinical study of DARE-HPV, its investigational vaginal insert containing lopinavir and ritonavir for persistent high-risk HPV infection. The program follows earlier FDA clearance of the IND and is supported by ARPA-H funding.
Daré Bioscience said it has initiated a Phase 2 clinical study of DARE-HPV, an investigational soft-gel vaginal insert containing lopinavir and ritonavir, for persistent high-risk HPV infection.
The company said the program is supported by ARPA-H funding. It also previously announced FDA clearance of the IND for the Phase 2 study in February 2026.
Persistent high-risk HPV infection remains a clinical challenge, and Daré said there are no FDA-approved therapies for the condition. The new study marks the next step in the company’s development program.
Daré first signaled in its May 14 business update that it was preparing to advance DARE-HPV into Phase 2. The May 18 announcement confirmed that the study had begun.
The company has not yet disclosed the number of participants, sites, dosing details, or timing for topline Phase 2 data.
What comes next
Investors and clinicians will be watching for details on enrollment, endpoints, and whether the study can provide early evidence of benefit in clearing persistent infection.
Revision note
Initial automated publication.