Fycompa

(Perampanel)

ApprovedSmall molecule

Perampanel is used to treat certain types of seizures in people with epilepsy. It works by reducing abnormal electrical activity in the brain that causes seizures.[2] Fycompa is currently approved and in use across 16 indications[4].[1]

Fycompa is one of 246 small molecule programs targeting Bilateral tonic-clonic seizure. It is currently in Approved.

Indications

Total Trials

Active Trials

245

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Bilateral Tonic-Clonic SeizureCompleted

Epilepsy With Generalized Tonic-Clonic SeizuresApproved

Partial EpilepsyActive, not recruiting

Migraine DisorderApproved

Focal-Onset SeizureApproved

TorticollisApproved

Parkinson DiseaseApproved

Neuropathy, Small FiberApproved

Nervous System DiseaseActive, not recruiting

InsomniaWithdrawn

Bilateral Tonic-Clonic SeizureApproved

Completed

Epilepsy With Generalized Tonic-Clonic SeizuresApproved

Approved

Partial EpilepsyApproved

Active, not recruiting

Migraine DisorderApproved

Approved

Focal-Onset SeizureApproved

Approved

TorticollisApproved

Approved

Parkinson DiseaseApproved

Approved

Neuropathy, Small FiberApproved

Approved

Nervous System DiseasePreclinical

Active, not recruiting

InsomniaApproved

Withdrawn

Showing 10 of 16 indications

Competition

Competitive Landscape

91 competitors in Parkinson Disease

#DrugCompanyPhaseTrials

Fycompa

CCatalyst Biosciences

Approved

72 2

Lopid

Pfizer

Approved

1 3

Neupro

Intropin

Cymbalta

Buspar

Golytely

Dostinex

Epidiolex

Keppra

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2027

Phase 2Recruiting

Heart

NCT06401707

Phase 2Active, not recruiting

Pediatric

NCT04015141

Q4 2028

Phase 1Recruiting

Glioblastoma

NCT07284069

Q4 2032

Phase 1Recruiting

Ketamine

NCT05915013

Q1 2033

Phase 2Recruiting

Ketamine

NCT05786066

Clinical

Trials by Indication[1]

Seizure15 trials

Evaluating Efficacy and Safety of E2007 (Perampanel) Given as Adjunctive Therapy in Subjects With Refractory Partial Seizures

Completed· Eisai logo

Eisai·Phase 3·NCT00700310·712 enrolled

A China RWS to Evaluate the Effectiveness and Safety of Perampanel as an add-on Treatment for Epileptic Seizure

Unknown status·—··NCT05257915·600 enrolled

A Multi-center RWS of Perampanel as an add-on Treatment for Epileptic Seizures in Chinese Children

Unknown status·—··NCT05274035·1,000 enrolled

Show 12 more trials

A Study of Perampanel as Add-on Therapy in Adult and Adolescent Participants With Focal Seizures

Completed· Eisai logo

Eisai··NCT04257604·243 enrolled

Pharmacokinetics, Efficacy, and Safety of Perampanel Oral Suspension on Seizure Frequency in Pediatric Subjects Maintained on One to Three Stable Antiepileptic Drugs

Completed· Eisai logo

Eisai·Phase 2·NCT01527006·63 enrolled

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

Completed· Eisai logo

Eisai·Phase 4·NCT03288129·54 enrolled

A Long-term Extension Study of E2007 in Patients With Refractory Partial Seizures Uncontrolled With Other Anti-Epileptic Drugs (AEDs)

Completed· Eisai logo

Eisai·Phase 2·NCT00903786·21 enrolled

Evaluation of the Efficacy and Safety of E2007 (Perampanel) Given as Adjunctive Therapy in Subjects With Refractory Partial Seizures

Completed· Eisai logo

Eisai·Phase 3·NCT00735397·1,218 enrolled

A Study to Evaluate the Effectiveness of Perampanel as Only Add-on Treatment in Participants With Primary or Secondarily Generalized Tonic-clonic Seizures

Completed· Eisai logo

Eisai··NCT04202159·187 enrolled

Perampanel in Seizure Patients With Primary Glial Brain Tumors

Completed·—·Phase 4·NCT02363933·9 enrolled

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

Completed· Eisai logo

Eisai·Phase 3·NCT01618695·940 enrolled

Perampanel as Adjunctive Therapy in Pediatrics With Partial Onset Seizures or Primary Generalized Tonic Clonic Seizures

Completed· Eisai logo

Eisai·Phase 3·NCT02849626·180 enrolled

4-Year Open-Label Extension Phase of the Parallel-Group Study of E2007 in Patients With Refractory Partial Seizures

Completed· Eisai logo

Eisai·Phase 2·NCT00368472·138 enrolled

A Efficacy and Safety Study of Adjunctive Perampanel in Primary Generalized Tonic Clonic Seizures

Completed· Eisai logo

Eisai·Phase 3·NCT01393743·163 enrolled

Trial Evaluating the Efficacy and Safety of Perampanel Added to Monotherapy in Participants With Partial Onset Seizures With or Without Secondary Generalization

Completed· Eisai logo

Eisai·Phase 4·NCT02726074·106 enrolled

Epilepsy14 trials

Post-market Study of AMPA Receptor Antagonists for Epilepsy Patients in Hong Kong

Unknown status·—··NCT03457961·80 enrolled

Clinical Efficacy and Safety of Perampanel Monotherapy in the Treatment of Children With Focal Epilepsy

Unknown status·YYang Xinwei··NCT05497193·280 enrolled

A Study to Evaluate the Safety and Efficacy of Fycompa® (Perampanel) as Add-on Therapy in Participants With Epilepsy

Completed· Eisai logo

Eisai··NCT04230044·117 enrolled

Show 11 more trials

A Global, Postmarketing Observational Safety Study to Evaluate the Safety and Tolerability of Fycompa (Perampanel) as Add-on Therapy in Epilepsy Patients Aged Greater Than or Equal to 12 Years

Completed· Eisai logo

Eisai··NCT02033902·500 enrolled

An Open-label Extension Study to Evaluate the Safety and Tolerability of Perampanel (E2007) Administered as an Adjunctive Therapy in Epilepsy Subjects

Completed· Eisai logo

Eisai·Phase 3·NCT02427607·7 enrolled

Perampanel for Treatment of Adults With Refractory Focal Epilepsy : a Pilot Study.

Terminated·MMid-Atlantic Epilepsy and Sleep Center, LLC·Phase 4·NCT02727101·8 enrolled

A Study to Assess Safety and Efficacy of Perampanel in Indian Participants as an Adjunctive Treatment in Partial Onset Seizures With or Without Secondary Generalized Seizures in Participants With Epilepsy Aged 12 Years or Older

Completed· Eisai logo

Eisai··NCT03836924·200 enrolled

Efficacy and Safety of Perampanel in Combination in Glioma-refractory Epilepsy

Withdrawn·AAssistance Publique Hopitaux De Marseille·N/A·NCT03636958

A Study to Investigate Dosage, Effectiveness, and Safety of Perampanel When Used as First Add-on Therapy in Participants >=12 Years With Partial Onset Seizures With or Without Secondary Generalization or With Primary Generalized Tonic-Clonic Seizures Associated With Idiopathic Generalized Epilepsy

Completed· Eisai logo

Eisai··NCT04252846·191 enrolled

Post-stroke Epilepsy: Primary Prophylaxis Study

Unknown status·NNational Cheng Kung University·N/A·NCT04858841·180 enrolled

A Study of Intravenous Perampanel in Japanese Participants With Epilepsy

Completed· Eisai logo

Eisai·Phase 2·NCT03754582·21 enrolled

The Efficacy of Fycompa (Perampanel) in Children With Epilepsy

Completed·NNational Taiwan University Hospital··NCT04608799·38 enrolled

Perampanel for the Reduction of Seizure Frequency in Patients With High-grade Glioma and Focal Epilepsy

Terminated·MMayo Clinic·Phase 4·NCT04650204·4 enrolled

Pharmacokinetic Study With an Oral Suspension of Perampanel as Adjunctive Therapy in Pediatric Subjects With Epilepsy

Completed· Eisai logo

Eisai·Phase 2·NCT02914314·26 enrolled

MPA10 trials

Demonstrate Bioequivalence Between 6 ? 2-mg Tablets of Perampanel and a Single 12-mg Tablet of Perampanel in Healthy Subjects

Completed· Eisai logo

Eisai·Phase 1·NCT01396590·54 enrolled

Pharmacokinetic Study of Perampanel in Chinese Healthy Subjects

Completed· Eisai logo

Eisai·Phase 1·NCT03424564·44 enrolled

A Study to Demonstrate Bioequivalence Between 6 x 2 mg Tablets of Perampanel and a Single 12 mg Tablet of Perampanel in Healthy Subjects

Completed· Eisai logo

Eisai·Phase 1·NCT01240187·22 enrolled

Show 7 more trials

Demonstrate Bioequivalence Between 3 x 2-mg Tablets of Perampanel and a Single 6-mg Tablet of Perampanel in Healthy Subjects

Completed· Eisai logo

Eisai·Phase 1·NCT01396577·54 enrolled

Bioequivalence Study of Perampanel Tablets 12 mg

Completed·HHumanis Saglık Anonim Sirketi·Phase 1·NCT06450223·30 enrolled

Perampanel Titration and Cognitive Effects

Terminated·KKimford Jay Meador·Phase 4·NCT04417907·29 enrolled

Bioequivalence Study of Perampanel Tablets 10 mg

Completed·HHumanis Saglık Anonim Sirketi·Phase 1·NCT06450236·30 enrolled

Bioequivalence Study Between a 4-mg Dose of Fine Granules of Perampanel and a 4-mg Tablet of Perampanel in Healthy Japanese Subjects

Completed· Eisai logo

Eisai·Phase 1·NCT03399734·24 enrolled

Correlation of Serum Level of Perampanel (PER) Level to Cerebrospinal Fluid (CSF) Levels of PER

Unknown status·CCarilion Clinic·Phase 4·NCT04118829·25 enrolled

A Multiple Dose Pharmacokinetic Study of Perampanel in Korean Healthy Subjects

Completed· Eisai logo

Eisai·Phase 1·NCT02020486·20 enrolled

Parkinson's Disease3 trials

Long-Term Safety, Tolerability and Efficacy in Perampanel Treated Parkinson's Disease Patients With Motor Fluctuations

Terminated· Eisai logo

Eisai·Phase 2·NCT01634360·185 enrolled

Efficacy, Safety, and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients With Motor Fluctuations

Completed· Eisai logo

Eisai·Phase 3·NCT00368108·752 enrolled

Evaluation of the Long-term Safety, Tolerability, and Efficacy of Perampanel (E2007) as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Subjects With Motor Fluctuations

Terminated· Eisai logo

Eisai·Phase 3·NCT00505622·328 enrolled

Ketamine3 trials

The Impact of AMPA Receptor Blockade on Ketamine's Anti-Suicidal Effects

Recruiting·YYale University·Phase 2·NCT05786066·30 enrolled

Alpha-Amino-3-Hydroxy-5-Methyl-4- Isoxazole Propionic Acid Receptor Components of the Anti-Depressant Ketamine Response, Pilot Trial

Completed·YYale University·Phase 1·NCT03367533·13 enrolled

Alpha-Amino-3-Hydroxy-5-Methyl-4- Isoxazole Propionic Acid Receptor Components of the Anti-Depressant Ketamine Response

Recruiting·YYale University·Phase 1·NCT05915013·50 enrolled

23 more indications

Cognition2 trials

A Study With an Open-label Extension Phase to Evaluate the Effect of Perampanel (E2007) on Cognition, Growth, Safety, Tolerability, and Pharmacokinetics in Adolescents

Completed· Eisai logo

Eisai·Phase 2·NCT01161524·133 enrolled

Effects of Perampanel on Cognition and Electroencephalography in Patients With Epilepsy

Completed·SSeoul National University Hospital·Phase 4·NCT02900755·30 enrolled

Amyotrophic Lateral Sclerosis2 trials

Perampanel Single Ascending Dose Transcranial Magnetic Stimulation Biomarker Study in Amyotrophic Lateral Sclerosis

Completed·MMayo Clinic·Phase 1·NCT03793868·22 enrolled

A Clinical Trial to Evaluate the Safety and Efficacy of Fycompa in Subjects With Amyotrophic Lateral Sclerosis (ALS)

Terminated·SStony Brook University·N/A·NCT03020797·12 enrolled

ESS2 trials

An Extended Access Program (EAP) for Perampanel

No longer available· Eisai logo

Eisai··NCT02307578

An Extended Access Program for Perampanel

No longer available· Eisai logo

Eisai··NCT01871233

Status Epilepticus2 trials

Perampanel in Focal Status Epilepticus

Terminated·AAssistance Publique - Hôpitaux de Paris·Phase 3·NCT04309721·1 enrolled

Efficacy and Safety of Perampanel in the Treatment of Refractory Status Epilepticus

Terminated·WWayne State University·Phase 4·NCT05684978·1 enrolled

Tumor1 trial

Effect of Perampanel on Peritumoral Hyperexcitability in HGG

Completed·—·Phase 1/2·NCT04497142·12 enrolled

Bilateral tonic-clonic seizure1 trial

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

Completed· Eisai logo

Eisai·Phase 4·NCT05533814·125 enrolled

Oral1 trial

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

Completed· Eisai logo

Eisai·Phase 1·NCT02279485·100 enrolled

Intravenous1 trial

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

Completed· Eisai logo

Eisai·Phase 1·NCT03376997·48 enrolled

Cervical Dystonia1 trial

Safety and Tolerability of Perampanel in Cervical Dystonia

Completed·UUniversity Health Network, Toronto·Phase 1/2·NCT02131467·25 enrolled

Pediatrics1 trial

Population Pharmacokinetics of Antiepileptic in Pediatrics

Completed·AAssistance Publique - Hôpitaux de Paris··NCT03196466·753 enrolled

Essential Tremor1 trial

An Efficacy/Safety Study of Perampanel for Reducing Essential Tremor

Unknown status·VVA Greater Los Angeles Healthcare System·Phase 2·NCT02668146·16 enrolled

Alcohol Dependence1 trial

Rapid Determination Of The Clinical Utility Of Perampanel For The Treatment Of Alcohol Dependence

Completed·VVirginia Commonwealth University·Phase 1/2·NCT02120365·22 enrolled

Insomnia1 trial

To Evaluate the Effect of Perampanel on Objective and Subjective Sleep in Subjects With Insomnia and Partial Onset Seizures

Withdrawn· Eisai logo

Eisai·Phase 4·NCT02220972

Pilot Study1 trial

Assessment of Perampanel (E2007) on Synaptic Dopamine in Mild-moderate PD Patients: A Pilot Study With [^123I]-IBZM SPECT

Terminated· Eisai logo

Eisai·Phase 2·NCT00566462·1 enrolled

ART1 trial

Retrospective Evaluation of Perampanel in a French Neurology and Epileptology Department (Hospices Civil de Lyon)

Completed·HHospices Civils de Lyon··NCT02876289·110 enrolled

Glioblastoma1 trial

Senicapoc and Perampanel for Newly Diagnosed Glioblastoma

Recruiting·—·Phase 1·NCT07284069·36 enrolled

Lennox-Gastaut syndrome1 trial

Study of Perampanel as Adjunctive Treatment for Inadequately Controlled Seizures Associated With Lennox-Gastaut Syndrome

Terminated· Eisai logo

Eisai·Phase 3·NCT02834793·101 enrolled

Neurophysiology1 trial

Effects of Perampanel on Neurophysiology Test Perimeters

Completed·WWeill Medical College of Cornell University·Phase 4·NCT03653741·12 enrolled

ALS1 trial

Fycompa Titration Intervals and Effects on Retention Rate

Completed·UUniversity of Arizona·Phase 4·NCT03457129·20 enrolled

Alcohol Use Disorder1 trial

Open Label Pilot Study of Perampanel for the Treatment of Alcohol Use Disorder

Completed·VVirginia Commonwealth University·Phase 1/2·NCT04502589·4 enrolled

Sporadic Amyotrophic Lateral Sclerosis1 trial

Perampanel for Sporadic Amyotrophic Lateral Sclerosis (ALS)

Completed·TTokyo Medical University·Phase 2·NCT03019419·66 enrolled

Heart1 trial

PeRampanel fOr Status ePilEpticus pRophylaxis Post-cardiac Arrest

Recruiting·UUniversity of California, San Francisco·Phase 2·NCT06401707·52 enrolled

Pediatric1 trial

An Open-Label Study With Extension Phase to Evaluate the Efficacy and Safety of Perampanel Administered as an Adjunctive Therapy in Pediatric Subjects (Age 1 Month to Less Than 18 Years) With Childhood Epilepsy

Active, not recruiting· Eisai logo

Eisai·Phase 2·NCT04015141·100 enrolled

Regulatory

FDA Approval Timeline[5]

Oct 22, 2012

FYCOMPA

NDA NDA202834

Apr 29, 2016

FYCOMPA

NDA NDA208277

Sources

References

[1]
ClinicalTrials.gov — 72 trial records for Perampanel. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Fycompa drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Perampanel compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Perampanel. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA208277). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Fycompa. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Catalyst Biosciences company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Glutamate Receptor Ionotropic AMPA Antagonist[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: CCatalyst Biosciences

Patent Landscape[6]

Patent #Expires

8772497Jul 1, 2026

Fycompa

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2027

Q4 2028

Q4 2032

Q1 2033

Trials by Indication[1]

Seizure15 trials

Epilepsy14 trials

MPA10 trials

Parkinson's Disease3 trials

Ketamine3 trials

Cognition2 trials

Amyotrophic Lateral Sclerosis2 trials

ESS2 trials

Status Epilepticus2 trials

Tumor1 trial

Bilateral tonic-clonic seizure1 trial

Oral1 trial

Intravenous1 trial

Cervical Dystonia1 trial

Pediatrics1 trial

Essential Tremor1 trial

Alcohol Dependence1 trial

Insomnia1 trial

Pilot Study1 trial

ART1 trial

Glioblastoma1 trial

Lennox-Gastaut syndrome1 trial

Neurophysiology1 trial

ALS1 trial

Alcohol Use Disorder1 trial

Sporadic Amyotrophic Lateral Sclerosis1 trial

Heart1 trial

Pediatric1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Patent Landscape[6]

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