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Lopinavir/ ritonavir

Phase 2

Human Papilloma Virus (HPV) | Small molecule | Infectious Disease |Dare Bioscience, Inc.|Last Updated: Jul 23, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment118

FDA Designations

No designations recorded

Clinical trial landscape

Lopinavir/ ritonavir · 1 trial · 2 indications

Phase 2 1
NCT07601074A Study of the Preliminary Efficacy of DARE-HPV to Treat High-risk Persistent Human Papillomavirus (hrHPV)Human Papilloma Virus (HPV)
NOT YET_RECRUITING118 Analytics
PHASE2NOT YET_RECRUITING
A Study of the Preliminary Efficacy of DARE-HPV to Treat High-risk Persistent Human Papillomavirus (hrHPV)
Human Papilloma Virus (HPV)Unlock trial analytics

Study Endpoints

Primary Endpoints

Efficacy Endpoint
90 days

Proportion of participants with a negative high-risk human papillomavirus (hrHPV) qualitative test at 3 months post end of treatment

Secondary Endpoints

Efficacy Endpoint
60 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
DARE-HPV-LD 14 dayACTIVE_COMPARATOR14 day administration of DARE-HPV low dose
DARE-HPV-LD 21 dayACTIVE_COMPARATOR21 day administration of DARE-HPV low dose
DARE-HPV-HD 14 dayACTIVE_COMPARATOR14 day administration of DARE-HPV high dose
DARE-HPV-HD 21 dayACTIVE_COMPARATOR21 day administration of DARE-HPV high dose
Placebo 14 dayNO_INTERVENTION14 day administration of placebo product
Placebo 21 dayNO_INTERVENTION21 day administration of placebo product

Interventions

NameTypeDescription
Lopinavir / ritonavirDRUGA fixed-dose ration combination (12:1) of lopinavir and ritonavir in a vaginal capsule.
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Eligibility Criteria

Age Range22 Years to 50 Years
SexFEMALE
Healthy VolunteersNo
Study Sites3

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...

Countries:United States
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Recent Changes (Last 90 Days)

LOWJul 24, 2026NCT07601074lastUpdatePostDate: changed
LOWJul 24, 2026NCT07601074lastUpdatePostDate: changed
LOWJul 17, 2026NCT07601074lastUpdatePostDate: changed
LOWJul 17, 2026NCT07601074lastUpdatePostDate: changed
LOWJun 29, 2026NCT07601074lastUpdatePostDate: changed
LOWJun 29, 2026NCT07601074lastUpdatePostDate: changed
LOWJun 2, 2026NCT07601074lastUpdatePostDate: changed
LOWJun 2, 2026NCT07601074lastUpdatePostDate: changed
LOWJun 2, 2026NCT07601074lastUpdatePostDate: changed

Frequently asked questions about Lopinavir/ ritonavir

What is Lopinavir/ritonavir used for?

Lopinavir/ritonavir is being studied for the treatment of high-risk persistent Human Papilloma Virus (HPV) infection. It is an investigational small molecule combination therapy in Phase 2 clinical development for this indication.

What does Lopinavir/ritonavir target?

Lopinavir/ritonavir is a combination of two protease inhibitors that work by inhibiting the viral protease enzyme, which is essential for viral replication. This mechanism is being evaluated for its potential to treat high-risk persistent HPV infection.

Who makes Lopinavir/ritonavir?

Lopinavir/ritonavir is being developed by Dare Bioscience, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol DARE. The company is conducting clinical trials to evaluate the drug for HPV treatment.

What phase is Lopinavir/ritonavir in?

Lopinavir/ritonavir is currently in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities for the treatment of HPV. The ongoing Phase 2 trial is designed to assess its preliminary efficacy.

What clinical trials is Lopinavir/ritonavir in?

Lopinavir/ritonavir is being evaluated in a Phase 2 clinical trial with the identifier NCT07601074. This randomized, double-blind, active-controlled study is investigating the preliminary efficacy of DARE-HPV in treating high-risk persistent HPV infection in women aged 22 years and older in the United States.

Is Lopinavir/ritonavir the same as Lopinavir / ritonavir?

Yes, Lopinavir/ritonavir is the same as Lopinavir / ritonavir. The two names refer to the identical drug combination being developed by Dare Bioscience, Inc. for the treatment of high-risk persistent HPV infection.