PERAMPANEL
Details
- Status
- Prescription
- First Approved
- 2025-05-23
- Routes
- ORAL
- Dosage Forms
- SUSPENSION, TABLET
PERAMPANEL Approval History
What PERAMPANEL Treats
3 indicationsPERAMPANEL is approved for 3 conditions since its original approval in 2025. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Partial-Onset Seizures
- Primary Generalized Tonic-Clonic Seizures
- Epilepsy
PERAMPANEL Boxed Warning
SERIOUS PSYCHIATRIC AND BEHAVIORAL REACTIONS WARNING: SERIOUS PSYCHIATRIC AND BEHAVIORAL REACTIONS Serious or life-threatening psychiatric and behavioral adverse reactions including aggression, hostility, irritability, anger, and homicidal ideation and threats have been reported in patients taking perampanel ( 5.1). These reactions occurred in patients with and without prior psychiatric history, prior aggressive behavior, or concomitant use of medications associated with hostility and aggression...
WARNING: SERIOUS PSYCHIATRIC AND BEHAVIORAL REACTIONS WARNING: SERIOUS PSYCHIATRIC AND BEHAVIORAL REACTIONS Serious or life-threatening psychiatric and behavioral adverse reactions including aggression, hostility, irritability, anger, and homicidal ideation and threats have been reported in patients taking perampanel ( 5.1). These reactions occurred in patients with and without prior psychiatric history, prior aggressive behavior, or concomitant use of medications associated with hostility and aggression ( 5.1). Advise patients and caregivers to contact a healthcare provider immediately if any of these reactions or changes in mood, behavior, or personality that are not typical for the patient are observed while taking perampanel or after discontinuing perampanel ( 5.1). Closely monitor patients particularly during the titration period and at higher doses ( 5.1). Perampanel should be reduced if these symptoms occur and should be discontinued immediately if symptoms are severe or are worsening ( 5.1). WARNING: SERIOUS PSYCHIATRIC AND BEHAVIORAL REACTIONS See full prescribing information for complete boxed warning. Serious or life-threatening psychiatric and behavioral adverse reactions including aggression, hostility, irritability, anger, and homicidal ideation and threats have been reported in patients taking perampanel ( 5.1) Monitor patients for these reactions as well as for changes in mood, behavior, or personality that are not typical for the patient, particularly during the titration period and at higher doses ( 5.1) Perampanel should be reduced if these symptoms occur and should be discontinued immediately if symptoms are severe or are worsening ( 5.1)
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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.
PERAMPANEL FDA Label Details
ProIndications & Usage
Perampanel tablets, a non-competitive AMPA glutamate receptor antagonist, is indicated for: Treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy 4 years of age and older Adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients with epilepsy 12 years of age and older 1.1 Partial-Onset Seizures Perampanel tablets are indicated for the treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy 4 years of age and older. 1.2 Primary Generalized Tonic-Clon...
WARNING: SERIOUS PSYCHIATRIC AND BEHAVIORAL REACTIONS WARNING: SERIOUS PSYCHIATRIC AND BEHAVIORAL REACTIONS Serious or life-threatening psychiatric and behavioral adverse reactions including aggression, hostility, irritability, anger, and homicidal ideation and threats have been reported in patients...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.