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Pritelivir

Phase 3

HSV Infection | Small molecule | Other |Medpace Holdings, Inc. Common Stock|Last Updated: Jun 12, 2026

Development status

Highest phase Phase 3
Registered trials 1 across 1 sponsor since Mar 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment158

FDA Designations

No designations recorded

Clinical trial landscape

Pritelivir · 1 trial · 1 indication

Phase 3 1
NCT03073967Trial on Efficacy and Safety of Pritelivir Tablets for Treatment of Acyclovir-resistant Mucocutaneous HSV (Herpes Simplex Virus) Infections in Immunocompromised SubjectsHSV Infection
COMPLETED158 Analytics
PHASE3COMPLETED
Trial on Efficacy and Safety of Pritelivir Tablets for Treatment of Acyclovir-resistant Mucocutaneous HSV (Herpes Simplex Virus) Infections in Immunocompromised Subjects
HSV InfectionUnlock trial analytics

Study Endpoints

Primary Endpoints

Efficacy measured by cure rate
Up to a maximum of 28 days

Number of subjects cured (all lesions healed as assessed by the Investigator) during the treatment period of up to 28 days relative to the total number of subjects treated with trial medication in the respective treatment group.

Secondary Endpoints

Efficacy measured by cure rate
Up to a maximum of 42 days
Efficacy measured by time to lesion healing
Up to a maximum of 42 days
Efficacy measured by recurrence rate
At 2 months following post treatment visit, from randomization up to a maximum of 108 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Part C, PritelivirEXPERIMENTALOral tablets, 100mg/day (400mg loading dose on day 1) for up to 28 days and potential prolongation for up to additional 14 days
Part C,ACTIVE_COMPARATORInvestigator's Choice: Foscarnet iv, 40 mg/kg tid or 60mg/kg bid or Cidofovir iv, 5 mg/kg body weight given once weekly or Cidofovir 1% or 3%, topically applied 2 to 4 times daily or Imiquimod 5%, topically applied 3 times per week, for up to 28 days and potential prolongation for up to additional 14 days.
Part D+F, PritelivirEXPERIMENTALOral tablets, 100mg/day (400mg loading dose on day 1) for up to 28 days and potential prolongation for up to additional 14 days
Part E, PritelivirEXPERIMENTALOral tablets, 100mg/day (400mg loading dose on day 1) for up to 28 days and potential prolongation for up to additional 14 days

Interventions

NameTypeDescription
PritelivirDRUG100 mg oral tablets
Investigator's choiceDRUGFoscarnet iv, 40 mg/kg BW tid or 60mg/kg bid or Cidofovir iv, 5 mg/kg BW given once weekly or Cidofovir 1% or 3%, topically applied 2 to 4 times daily or Imiquimod 5%, Solution for iv infusion or topical application
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Eligibility Criteria

Age Range16 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites70

Part C inclusion criteria 1. Immunocompromised men and women of any ethnic group aged ≥16 years. In Canada, Germany, Belgium: Immunocompromised (due to conditions including but not limited to HIV infection, hematopoietic cell or solid organ transplantation, and chronic use of immunosuppress...

Countries:United StatesArgentinaAustraliaBelgiumCanadaFranceGeorgiaGermanyGreeceIsraelItalyMexicoSwitzerlandUkraineUnited Kingdom
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