Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Valacyclovir · 2 trials · 1 indication
Bioequivalence based on Cmax
Bioequivalence based on AUC0-t
Bioequivalence based on AUC0-inf
Bioequivalence based on Cmax
Bioequivalence based on AUC0-t
Bioequivalence based on AUC0-inf
| Arm | Type | Description |
|---|---|---|
| Valacyclovir | EXPERIMENTAL | Test 1000 mg Valacyclovir Tablet |
| Valtrex | ACTIVE_COMPARATOR | Reference Listed 1000 mg Valtrex Tablet |
| Name | Type | Description |
|---|---|---|
| Valacyclovir | DRUG | 1000 mg Tablet |
Inclusion Criteria * Male or female, non-smokers, 18 years of age and older. * Capable of consent * BMI greater than or equal to 19.0 and less than or equal to 30.0 kg/m2 Exclusion Criteria Subjects to whom any of the following applies will be excluded from the study: * Clinically significant il...
Valacyclovir is an investigational small molecule being studied in healthy volunteers. It is currently in Phase 1 clinical development, with two completed trials evaluating its pharmacokinetics under fed and fasting conditions. The drug is not approved for any indication and remains in early-stage clinical testing.
Valacyclovir is being developed by Teva Pharmaceutical Industries Limited, a company traded on the New York Stock Exchange under the ticker TEVA. The company is conducting Phase 1 clinical trials to evaluate the drug's behavior in healthy subjects.
Valacyclovir is in Phase 1 clinical development. It has completed two Phase 1 trials, both involving healthy volunteers, with a total enrollment of 96 participants. The drug is investigational and has not received regulatory approval.
Valacyclovir has two completed Phase 1 trials: NCT01149460, a study of a 1000 mg tablet under fed conditions in Canada with 36 participants, and NCT01149499, a study of the same tablet under fasting conditions in the United States with 60 participants. Both trials enrolled healthy adults aged 18 years and older.
Valacyclovir is not FDA approved. It is an investigational drug currently in Phase 1 clinical development, with all completed trials conducted in healthy volunteers. No approval status has been established, and the drug remains under clinical investigation.