Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Valaciclovir · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Cohort 1 | EXPERIMENTAL | Subjects in the age group of 2 to less than 6 years will be included |
| Cohort 2 | EXPERIMENTAL | Subjects in the age group of 1 to less than 2 years will be included |
| Cohort 3 | EXPERIMENTAL | Subjects in the age group of 6 months to less than 1 year will be included |
| Cohort 4 | EXPERIMENTAL | Subjects in the age group of 3 months to less than 6 months will be included |
| Cohort 5 | EXPERIMENTAL | Subjects in the age group of 1 month to less than 3 months will be included |
| Name | Type | Description |
|---|---|---|
| Valaciclovir | DRUG | Valaciclovir will be administered as an extemporaneously prepared suspension formulation. Valaciclovir oral suspension will be prepared by crushing marketed Valtrex Caplets 500 milligram (mg) and suspending the resultant powder in Suspension Structured Vehicle USNF with dose strength of 25 milligram per milliliter (mg/mL) or 50 mg/mL. |
Inclusion criteria: * Subjects who have a current herpes virus infection. * Have neonatally acquired herpes at risk of potential recurrence. * Immunocompromised or cancer patients at risk for development of a herpes virus infection. Exclusion criteria: * Hypersensitivity to antiherpetic medicatio...
Valaciclovir is an investigational small molecule being studied for the treatment of Herpes Simplex. It is currently in Phase 1 clinical development, meaning it has not yet been approved for any use. The drug is being evaluated for safety and tolerability in pediatric patients.
Valaciclovir is being developed by GSK plc, a pharmaceutical company listed on the stock exchange under the ticker GSK. The company is conducting clinical trials to evaluate the drug's safety and tolerability in infants and children with Herpes Simplex.
Valaciclovir is in Phase 1 clinical development. This is the earliest stage of testing in humans, focused primarily on assessing the drug's safety and tolerability. The drug is investigational and has not received regulatory approval for any indication.
Valaciclovir has one completed clinical trial, NCT00297206, which was a Phase 1 study of an oral suspension in infants and children with Herpes Simplex. The trial enrolled 36 participants and was conducted in the United States, Chile, and South Africa.
Valaciclovir is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The completed trial, NCT00297206, was a safety and tolerability study, and the drug has not yet progressed to later stages of clinical testing or regulatory review.