ZONISADE
ZONISADE (zonisamide) is an anti-epileptic agent indicated for use as an adjunctive therapy. It is approved for the treatment of partial-onset seizures in both adults and pediatric patients 16 years of age and older. As an adjunctive treatment, it is used in combination with other therapies to manage seizure activity in these patient populations.
How ZONISADE Works
The exact mechanism of zonisamide's anticonvulsant effects is unknown, but it is thought to act on sodium and calcium channels. By blocking sodium channels and reducing voltage-dependent, transient inward calcium currents, the drug helps stabilize neuronal membranes. It also suppresses synaptically-driven electrical activity and acts as a carbonic anhydrase inhibitor, though the therapeutic contribution of the latter is not established.
Details
- Status
- Prescription
- First Approved
- 2022-07-15
- Routes
- ORAL
- Dosage Forms
- SUSPENSION
ZONISADE Approval History
What ZONISADE Treats
1 indicationsZONISADE is approved for 1 conditions since its original approval in 2022. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Partial-Onset Seizures
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Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
ZONISADE FDA Label Details
ProIndications & Usage
FDA Label (PDF)ZONISADE is indicated as adjunctive therapy for the treatment of partial-onset seizures in adults and pediatric patients 16 years and older. ZONISADE is indicated as adjunctive therapy for the treatment of partial-onset seizures in adults and pediatric patients 16 years of age and older .
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.