KEPPRA
Keppra (levetiracetam) is an antiepileptic medication indicated for the treatment of partial-onset seizures in patients 1 month of age and older. It is also indicated as adjunctive therapy for the treatment of myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy, and primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy.
How KEPPRA Works
The precise mechanism by which levetiracetam exerts its antiepileptic effect is unknown. The drug binds to the synaptic vesicle protein SV2A, which is thought to be involved in the regulation of vesicle exocytosis. Evidence indicates that levetiracetam’s affinity for SV2A correlates with its antiseizure potency in animal models, suggesting that this interaction significantly contributes to its therapeutic mechanism of action.
Details
- Status
- Prescription
- First Approved
- 1999-11-30
- Routes
- INTRAVENOUS, ORAL
- Dosage Forms
- INJECTABLE, SOLUTION, TABLET
KEPPRA Approval History
What KEPPRA Treats
3 indicationsKEPPRA is approved for 3 conditions since its original approval in 1999. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Partial-Onset Seizures
- Myoclonic Seizures
- Primary Generalized Tonic-Clonic Seizures
Drugs Similar to KEPPRA
FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
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.
KEPPRA FDA Label Details
ProIndications & Usage
FDA Label (PDF)KEPPRA is indicated for the treatment of partial-onset seizures in patients 1 month of age and older KEPPRA is indicated for adjunctive therapy for the treatment of: Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy 1.1 Partial-Onset Seizures KEPPRA is indicated for the treatment of partial-onset seizures in patients 1 month of age and older. 1.2 Myoclonic Seizures in Patients with Juvenile Myoclonic Epilepsy KEPPRA is indicated as adjuncti...
Want competitive intelligence?
See who's developing similar drugs and track their progress
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.