Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
FV-100 · 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...
FV-100 is an investigational small molecule being developed for the treatment of herpes zoster, also known as shingles. It is being studied in adults aged 50 years and older with the condition. Bristol-Myers Squibb Company is developing the drug, which has been evaluated in a Phase 2 clinical trial.
FV-100 is being developed by Bristol-Myers Squibb Company, which trades on the New York Stock Exchange under the ticker BMY. The company sponsored a Phase 2 study of the drug in patients with herpes zoster. No partnership or licensing details for FV-100 have been disclosed.
FV-100 is in Phase 2 development for herpes zoster. One Phase 2 trial has been completed, and no active trials are currently listed. The drug is investigational and has not been approved by the FDA for any indication.
FV-100 has been studied in one completed Phase 2 trial, NCT00900783, titled A Study of FV-100 Versus Valacyclovir in Patients With Herpes Zoster. The trial enrolled 350 patients aged 50 years and older, was randomized, double blind, and used an active control comparing FV-100 against valacyclovir.
The Phase 2 trial NCT00900783 compared FV-100 directly against valacyclovir in 350 patients with herpes zoster. It was a randomized, double-blind, active-controlled study in adults aged 50 years and older. The trial has been completed, and no active studies of FV-100 are currently listed.