Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
DARE-HPV · 1 trial · 2 indications
Proportion of participants with a negative high-risk human papillomavirus (hrHPV) qualitative test at 3 months post end of treatment
| Arm | Type | Description |
|---|---|---|
| DARE-HPV-LD 14 day | ACTIVE_COMPARATOR | 14 day administration of DARE-HPV low dose |
| DARE-HPV-LD 21 day | ACTIVE_COMPARATOR | 21 day administration of DARE-HPV low dose |
| DARE-HPV-HD 14 day | ACTIVE_COMPARATOR | 14 day administration of DARE-HPV high dose |
| DARE-HPV-HD 21 day | ACTIVE_COMPARATOR | 21 day administration of DARE-HPV high dose |
| Placebo 14 day | NO_INTERVENTION | 14 day administration of placebo product |
| Placebo 21 day | NO_INTERVENTION | 21 day administration of placebo product |
| Name | Type | Description |
|---|---|---|
| Lopinavir / ritonavir | DRUG | A fixed-dose ration combination (12:1) of lopinavir and ritonavir in a vaginal capsule. |
Inclusion Criteria: 1. Provision of written informed consent prior to any study-specific procedures. 2. Premenopausal women aged 22-50 years inclusive at the time of screening visit. 3. Positive result for genital hrHPV (types 16, 18, or 'other') on at least 2 tests over the span of at least 12 mon...
DARE-HPV is an investigational small molecule being studied to treat high-risk persistent human papillomavirus (hrHPV) infection. It is in Phase 2 development for HPV, an infectious disease indication. The clinical program enrolls women aged 22 years and older in the United States.
DARE-HPV is being developed by Dare Bioscience, Inc., which trades on the ticker DARE. The company is the sponsor of the Phase 2 study evaluating the candidate in high-risk persistent human papillomavirus infection.
DARE-HPV is in Phase 2 clinical development. It is investigational and has not been approved by the FDA. One Phase 2 trial is currently recruiting, with no completed trials reported for the program.
DARE-HPV is being evaluated in the Phase 2 trial NCT07601074, titled A Study of the Preliminary Efficacy of DARE-HPV to Treat High-risk Persistent Human Papillomavirus (hrHPV). The trial is recruiting 118 participants in the United States and is randomized, double-blind, and active-controlled.
The Phase 2 trial NCT07601074 enrolls female participants aged 22 years and older with high-risk human papillomavirus infection. It does not accept healthy volunteers. The study is active-controlled, randomized, and double-blind, with a planned enrollment of 118 participants across sites in the United States.