Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
valacyclovir · 1 trial · 2 indications
| Arm | Type | Description |
|---|---|---|
| 2 | EXPERIMENTAL | FV-100, 400 mg once daily AND valacyclovir placebo, three times a day, for seven days |
| 3 | ACTIVE_COMPARATOR | Valacyclovir, 1 gram, three times a day AND FV-100 placebo, once daily, for seven days |
| 1 | EXPERIMENTAL | FV-100, 200 mg once daily AND valacyclovir placebo, three times a day, for seven days |
| Name | Type | Description |
|---|---|---|
| valacyclovir | DRUG | 1 gram, three times a day for seven days |
| FV-100 | DRUG | 400 mg, once daily, for seven days |
| Valacyclovir placebo | DRUG | three times a day, for seven days |
| FV-100 placebo | DRUG | once daily, for seven days |
Inclusion Criteria: * Men and women ≥ 50 years of age * Patients with a clinical diagnosis of HZ as evidenced by a unilateral dermatomal rash * Patients with zoster-related pain (ZBPI worst pain score \> 0) * Patients able to be enrolled into the study ≤ 72 hours from appearance of rash (i.e., lesi...
Valacyclovir is an investigational small molecule being studied for the treatment of Herpes Zoster, also known as shingles. It is being evaluated in patients aged 50 years and older. The drug is currently in Phase 2 clinical development and is not yet approved for this indication.
Valacyclovir is being developed by Bristol-Myers Squibb Company, which trades under the ticker BMY. The company is conducting clinical trials to evaluate the drug's safety and efficacy for the treatment of Herpes Zoster.
Valacyclovir is in Phase 2 clinical development for the treatment of Herpes Zoster. It is an investigational drug and has not been approved by regulatory authorities. One Phase 2 trial has been completed, with a total enrollment of 350 participants.
Valacyclovir has been studied in one completed Phase 2 clinical trial with the identifier NCT00900783. The trial, titled "A Study of FV-100 Versus Valacyclovir in Patients With Herpes Zoster," enrolled 350 participants and was a randomized, double-blind, active-controlled study.
Valacyclovir is not the same as FV-100. In the clinical trial NCT00900783, valacyclovir was used as the active comparator against the investigational drug FV-100. The trial was designed to compare the two treatments in patients with Herpes Zoster.