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valaciclovir granules

Phase 3

Varicella | Small molecule | Other |GSK plc|Last Updated: Apr 15, 2015

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLED
Total Trials1
Total Enrollment43
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00169416Evaluation Of Valaciclovir In Patients With ChickenpoxPHASE3 COMPLETED 43Mar 1, 2005Aug 1, 2005Apr 15, 2015 -
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Study Endpoints
Primary Endpoints
Plasma aciclovir concentrations approximately 1 - 2 hours post-dose, and/or 1, 2, 4 and 6 hours following administration of the valaciclovir HCl granules 25mg/kg -dose.
Secondary Endpoints
Plasma valaciclovir concentrations approximately 1 - 2 hours post-dose, and/or 1, 2, 4 and 6 hours following administration of the valaciclovir HCl granules 25mg/kg -dose.
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Interventions
NameTypeDescription
valaciclovir HCl granulesDRUG -
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Eligibility Criteria
Age Range1 Year — 11 Years
SexALL
Healthy VolunteersNo

Inclusion criteria: * Subjects aged 1 year to less than 12 years with a clinical diagnosis of chickenpox within 48 hours of the onset of the rash. Exclusion criteria: * History of hypersensitivity reactions. * Impaired hepatic or renal function. * Gastrointestinal dysfunction. * Serious underlyin...

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