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GS-1179

Phase 2

HSV-2 Infection | Small Molecules | Other |Gilead Sciences, Inc.|Trials Updated: Nov 3, 2026

GS-1179 development status

Highest phase Phase 2
Registered trials 1 across 1 sponsor since Nov 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment300

FDA Designations

No designations recorded

GS-1179 clinical trials

GS-1179 · 1 trial · 1 indication

Phase 2 1
NCT07912996Study to Compare GS-1179 Versus Valacyclovir in HSV-2 Seropositive Participants With Recurrent Genital HerpesHSV-2 Infection
NOT YET_RECRUITING300 Analytics
PHASE2NOT YET_RECRUITING
Study to Compare GS-1179 Versus Valacyclovir in HSV-2 Seropositive Participants With Recurrent Genital Herpes
HSV-2 InfectionUnlock trial analytics

Study Endpoints

Primary Endpoints

Percentage of Participants Experiencing Adverse Events (AEs)
Enrollment up to 92 days
Percentage of Participants Experiencing Premature Study-Dug Discontinuation due to AEs
Enrollment up to 92 days
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities
First dose date up to 92 days
Herpes Simplex Virus Type 2 (HSV-2) Shedding Rate During the Swabbing Period
Day 8 to Day 38

Secondary Endpoints

Proportion of Participants Free of Genital Herpes Recurrences at Day 92
Day 92
Proportion of Participants Free of Genital Herpes Recurrences at Day 120
Day 120
Genital Herpes Lesion Rate During the Treatment Period
Up to 92 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
GS-1179 High Dose + VACV Placebo to Match (PTM)EXPERIMENTALParticipants will be randomized to receive a high-dose of GS-1179 once weekly up to 85 days and VACV PTM once daily up to 92 days.
GS-1179 Low Dose + VACV Placebo to Match (PTM)EXPERIMENTALParticipants will be randomized to receive a low-dose of GS-1179 once weekly up to 85 days and VACV PTM once daily up to 92 days.
VACV + GS-1179 PTMACTIVE_COMPARATORParticipants will be randomized to receive VACV once daily up to 92 days and GS-1179 PTM once weekly up to 85 days.

Interventions

NameTypeDescription
GS-1179DRUGAdministered orally
GS-1179 PTMDRUGAdministered orally
ValacyclovirDRUGAdministered orally
Valacyclovir PTMDRUGAdministered orally
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo

Key Inclusion Criteria: * Individuals assigned male or female at birth, 18 years of age or older at screening, able to understand and give written informed consent and comply with treatment and follow up. Individuals assigned male or female at birth who are of childbearing potential and engage in h...

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Recent Changes (Last 90 Days)

LOWNov 3, 2026NCT07912996NEW_TRIAL: changed
LOWNov 3, 2026NCT07912996NEW_TRIAL: changed