Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Valacyclovir · 3 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Valacyclovir Hydrochloride Tablets 1000mg |
| 2 | ACTIVE_COMPARATOR | Valtrex® Tablets 1000 mg |
| Name | Type | Description |
|---|---|---|
| Valacyclovir Hydrochloride Tablets 1000mg | DRUG | 1000mg, single dose fed |
| Valtrex® 1000 mg | DRUG | 1000mg, single dose fed |
| Valacyclovir Hydrochloride Tablets 1000 mg | DRUG | 1000mg, single dose fed |
| Valtrex® Tablets 1000 mg | DRUG | 1000mg, single dose fed |
Inclusion Criteria: 1. Age: 18 years and older. 2. Sex: Male and/or non-pregnant, non-lactating female. 1. Women of childbearing potential must have negative serum beta human chorionic gonadotropin (beta-HCG) pregnancy tests performed within 21 days prior to the start of the study and on the ev...
Valacyclovir is an investigational small molecule being studied in healthy volunteers. It is in Phase 1 clinical development, with completed trials evaluating the drug in healthy adult participants. The drug is being developed by Viatris Inc. (VTRS).
Valacyclovir is being developed by Viatris Inc., a biopharmaceutical company traded on the NASDAQ under the ticker VTRS. The company is conducting Phase 1 clinical trials of the drug in the United States.
Valacyclovir is in Phase 1 clinical development. Three Phase 1 trials have been completed, all enrolling healthy volunteers. The drug is investigational and has not been approved by the FDA.
Valacyclovir has been studied in three completed Phase 1 trials: NCT00649870, NCT00649974, and NCT00650494. These trials evaluated the drug in healthy volunteers in the United States, with enrollments of 26, 28, and 66 participants respectively.
Valacyclovir is being studied in trials that compare it to Valtrex tablets. The trials are designed to evaluate the pharmacokinetics of Valacyclovir hydrochloride tablets 1000 mg relative to Valtrex tablets 1000 mg under fasting and fed conditions.