Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Zonisamide · 2 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Zonisamide Capsules 100 mg |
| 2 | ACTIVE_COMPARATOR | Zonegran® Capsules 100 mg |
| Name | Type | Description |
|---|---|---|
| Zonisamide Capsules 100 mg | DRUG | 100mg, single dose fed |
| Zonegran® Capsules 100 mg | DRUG | 100mg, single dose fed |
Inclusion Criteria: 1. Age: 18 years and older. 2. Sex: Male. 3. Weight: At least 60 kg (132 lbs) and within 15% of Ideal Body Weight (IBW), as referenced by the Table of ""Desirable Weights of Adults"" Metropolitan Life Insurance Company, 1999 (See Part II ADMINISTRATIVE ASPECTS OF BIOEQUIVALENCE ...
Zonisamide is a small molecule drug developed by Viatris Inc. (ticker VTRS). It is being studied in Phase 1 clinical development, with two completed trials in healthy volunteers. The specific medical conditions it is intended to treat have not been disclosed.
Zonisamide targets several sodium channel proteins: SCN1A, SCN2A, SCN4A, SCN5A, SCN7A, and SCN9A. It acts as a blocker of these targets, which are part of the voltage-gated sodium channel family involved in electrical signaling in cells.
Zonisamide is developed by Viatris Inc., which trades under the ticker symbol VTRS. Viatris is the company responsible for the clinical development of this drug candidate.
Zonisamide is in Phase 1 clinical development. Two Phase 1 trials have been completed, and there are currently no active trials. The drug is investigational and has not been approved by the FDA for any indication.
Zonisamide has been studied in two completed Phase 1 trials: NCT00650052, a fasting study, and NCT00649714, a fed study. Both compared Zonisamide Capsules 100 mg with Zonegran Capsules 100 mg in healthy male volunteers in the United States.