Dare Bioscience Secures FDA IND Clearance, $10M ARPA-H Funds for Phase 2 DARE-HPV Trial
FDA has cleared Dare Bioscience’s Investigational New Drug application for DARE-HPV, enabling a Phase 2 clinical study to evaluate its antiviral activity in persistent high-risk HPV infection. The program is supported by a $10 million ARPA-H contract, with $6.5 million received to date, addressing an unmet need with no FDA-approved therapies.
1. FDA Clears IND for Phase 2 Study
The FDA has approved Dare Bioscience’s IND application for DARE-HPV, allowing initiation of a Phase 2 clinical trial to assess safety and antiviral efficacy in women with persistent high-risk HPV infection. This clearance marks the first regulatory milestone for the company’s proprietary lopinavir/ritonavir vaginal insert formulation.
2. DARE-HPV Mechanism and Unmet Need
DARE-HPV is a fixed-dose soft gel vaginal insert designed to target and clear high-risk HPV before precancerous lesions develop. With no FDA-approved pharmacologic treatments, the therapy aims to shift the standard of care from surgical intervention to a self-administered antiviral approach.
3. ARPA-H Funding and Next Steps
The Phase 2 program is backed by a $10 million ARPA-H contract from HHS, of which $6.5 million has been received. Dare Bioscience plans to finalize study design and initiate patient enrollment in 2026, with timelines for interim data announcements to follow.