PERAMPANEL
PERAMPANEL is indicated for the treatment of Partial-Onset Seizures; Primary Generalized Tonic-Clonic Seizures; Epilepsy.
How PERAMPANEL Works
Perampanel acts as a non-competitive antagonist of the ionotropic AMPA glutamate receptor located on post-synaptic neurons. By targeting these receptors, the drug inhibits the activity of glutamate, which is the primary excitatory neurotransmitter in the central nervous system. While the precise mechanism for its antiepileptic effects in humans is unknown, the drug is designed to reduce the neuronal over-excitation associated with neurological disorders.
Development Insights
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)
PERAMPANEL Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to PERAMPANEL
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
37 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05915013 | 2000021345_a 1R01MH129371-01A1 | Ph 1 | recruiting | Alpha-Amino-3-Hydroxy-5-Methyl-4- Isoxazole Propionic Acid Receptor Components of the Anti-Depressant Ketamine Response |
| NCT05684978 | IRB-22-05-4691 | Ph 4 | terminated | Efficacy and Safety of Perampanel in the Treatment of Refractory Status Epilepticus |
| NCT06401707 PROSPER | 23-39712 | Ph 2 | recruiting | PeRampanel fOr Status ePilEpticus pRophylaxis Post-cardiac Arrest |
| NCT05533814 | E2007-M082-606 | Ph 4 | completed | A Study to Evaluate the Efficacy and Safety of Perampanel Monotherapy in Untreated Participants With Focal Onset Seizures With or Without Focal to Bilateral Tonic-clonic Seizures |
| NCT03367533 | 2000021345 No NIH funding per PI | Ph 1 | completed | Alpha-Amino-3-Hydroxy-5-Methyl-4- Isoxazole Propionic Acid Receptor Components of the Anti-Depressant Ketamine Response, Pilot Trial |
| NCT04497142 results posted | 20-059 2P50CA165962-06A1 | Ph 1, Ph 2 | completed | Effect of Perampanel on Peritumoral Hyperexcitability in HGG |
| NCT02914314 results posted | E2007-G000-238 | Ph 2 | completed | Pharmacokinetic Study With an Oral Suspension of Perampanel as Adjunctive Therapy in Pediatric Subjects With Epilepsy |
| NCT04309721 PEPSI | P160949J 2019-000882-19 | Ph 3 | terminated | Perampanel in Focal Status Epilepticus |
| NCT02120365 results posted | HM20014446 1407014397, R21AA026681 | Ph 1, Ph 2 | completed | Rapid Determination Of The Clinical Utility Of Perampanel For The Treatment Of Alcohol Dependence |
| NCT04650204 results posted | 19-006286 NCI-2020-01290, MC2072 | Ph 4 | terminated | Perampanel for the Reduction of Seizure Frequency in Patients With High-grade Glioma and Focal Epilepsy |
| NCT02849626 results posted | E2007-G000-311 2014-002167-16 | Ph 3 | completed | Perampanel as Adjunctive Therapy in Pediatrics With Partial Onset Seizures or Primary Generalized Tonic Clonic Seizures |
| NCT03288129 results posted | E2007-G000-410 2017-001180-20 | Ph 4 | completed | Study to Evaluate the Efficacy and Safety of Perampanel as Monotherapy or First Adjunctive Therapy in Subjects With Partial Onset Seizures With or Without Secondarily Generalized Seizures or With Primary Generalized Tonic-Clonic Seizures |
| NCT02834793 results posted | E2007-G000-338 2014-002321-35 | Ph 3 | terminated | Study of Perampanel as Adjunctive Treatment for Inadequately Controlled Seizures Associated With Lennox-Gastaut Syndrome |
| NCT02900755 | 1602-107-742 | Ph 4 | completed | Effects of Perampanel on Cognition and Electroencephalography in Patients With Epilepsy |
| NCT01618695 results posted | E2007-J000-335 | Ph 3 | completed | A Study With an Open-label Extension Phase to Evaluate the Efficacy and Safety of Perampanel (E2007) Administered as an Adjunctive Therapy in Subjects With Refractory Partial-onset Seizures |
| NCT03019419 | A2016-J000-001 | Ph 2 | completed | Perampanel for Sporadic Amyotrophic Lateral Sclerosis (ALS) |
| NCT03754582 results posted | E2007-J081-240 | Ph 2 | completed | A Study of Intravenous Perampanel in Japanese Participants With Epilepsy |
| NCT02131467 SAFE-PER-CD | 17-5864.4 | Ph 1, Ph 2 | completed | Safety and Tolerability of Perampanel in Cervical Dystonia |
| NCT02726074 results posted | E2007-M065-412 | Ph 4 | completed | Trial Evaluating the Efficacy and Safety of Perampanel Added to Monotherapy in Participants With Partial Onset Seizures With or Without Secondary Generalization |
| NCT01161524 results posted | E2007-G000-235 | Ph 2 | completed | A Study With an Open-label Extension Phase to Evaluate the Effect of Perampanel (E2007) on Cognition, Growth, Safety, Tolerability, and Pharmacokinetics in Adolescents |
| NCT03399734 | E2007-J081-053 | Ph 1 | completed | Bioequivalence Study Between a 4-mg Dose of Fine Granules of Perampanel and a 4-mg Tablet of Perampanel in Healthy Japanese Subjects |
| NCT03376997 | E2007-A001-050 | Ph 1 | completed | Study to Evaluate Bioavailability of a Single 12 mg Dose of Perampanel for Three Intravenous Infusion Durations Relative to a Single 12 mg Perampanel Oral Tablet in Healthy Subjects |
| NCT00903786 results posted | E2007-J081-233 | Ph 2 | completed | A Long-term Extension Study of E2007 in Patients With Refractory Partial Seizures Uncontrolled With Other Anti-Epileptic Drugs (AEDs) |
| NCT03424564 | E2007-C086-052 | Ph 1 | completed | Pharmacokinetic Study of Perampanel in Chinese Healthy Subjects |
| NCT02427607 results posted | E2007-J000-341 | Ph 3 | completed | An Open-label Extension Study to Evaluate the Safety and Tolerability of Perampanel (E2007) Administered as an Adjunctive Therapy in Epilepsy Subjects |
| NCT02363933 results posted | Pro00055609 | Ph 4 | completed | Perampanel in Seizure Patients With Primary Glial Brain Tumors |
| NCT02727101 | maes 008 | Ph 4 | terminated | Perampanel for Treatment of Adults With Refractory Focal Epilepsy : a Pilot Study. |
| NCT01393743 results posted | E2007-G000-332 | Ph 3 | completed | A Efficacy and Safety Study of Adjunctive Perampanel in Primary Generalized Tonic Clonic Seizures |
| NCT01527006 results posted | E2007-G000-232 | Ph 2 | completed | Pharmacokinetics, Efficacy, and Safety of Perampanel Oral Suspension on Seizure Frequency in Pediatric Subjects Maintained on One to Three Stable Antiepileptic Drugs |
| NCT00735397 results posted | E2007-G000-307 | Ph 3 | completed | Evaluation of the Efficacy and Safety of E2007 (Perampanel) Given as Adjunctive Therapy in Subjects With Refractory Partial Seizures |
| NCT00700310 results posted | E2007-G000-306 2007-006169-33 | Ph 3 | completed | Evaluating Efficacy and Safety of E2007 (Perampanel) Given as Adjunctive Therapy in Subjects With Refractory Partial Seizures |
| NCT02279485 | E2007-A001-048 | Ph 1 | completed | A Study to Demonstrate Bioequivalence Between a 12-mg Dose of an Oral Suspension Formulation of Perampanel and a 12-mg Tablet Formulation of Perampanel Under Fasted and Fed Conditions in Healthy Subjects |
| NCT02020486 | E2007-K082-047 | Ph 1 | completed | A Multiple Dose Pharmacokinetic Study of Perampanel in Korean Healthy Subjects |
| NCT02220972 | E2007-A001-408 | Ph 4 | withdrawn | To Evaluate the Effect of Perampanel on Objective and Subjective Sleep in Subjects With Insomnia and Partial Onset Seizures |
| NCT01240187 | E2007-E044-037 | Ph 1 | completed | A Study to Demonstrate Bioequivalence Between 6 x 2 mg Tablets of Perampanel and a Single 12 mg Tablet of Perampanel in Healthy Subjects |
| NCT01396590 | E2007-A001-040 | Ph 1 | completed | Demonstrate Bioequivalence Between 6 ? 2-mg Tablets of Perampanel and a Single 12-mg Tablet of Perampanel in Healthy Subjects |
| NCT01396577 | E2007-A001-039 | Ph 1 | completed | Demonstrate Bioequivalence Between 3 x 2-mg Tablets of Perampanel and a Single 6-mg Tablet of Perampanel in Healthy Subjects |
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
Indications & Usage
PERAMPANEL is indicated for the treatment of Partial-Onset Seizures; Primary Generalized Tonic-Clonic Seizures; Epilepsy.
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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Full clinical data, patents, trials, and competitive landscape for perampanel.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment