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Drug

Perampanel

Established medicine
ClassGlutamate receptor ionotropic AMPA antagonistResearchOngoing clinical research

Also known as FYCOMPA, 3-(2-Cyanophenyl)-5-(2-pyridyl)-1-phenyl-1,2-dihydropyridin-2-one, Perampanelum.

RxNorm1356552ChEMBLCHEMBL1214124ATCN03AX22UNIIH821664NPK
5
Active clinical trials
4
Protein targets
3
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

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

Clinical trial2026-07-10Results expected Q2 2027 · ClinicalTrials.gov

Recall (Class II): PERAMPANEL

Regulatory2026-06-17FDA

Approval: PERAMPANEL (ANDA219052)

Regulatory2026-06-15FDA

PeRampanel fOr Status ePilEpticus pRophylaxis Post-cardiac Arrest

Clinical trial2026-05-20Primary completion · ClinicalTrials.gov

Phase 0/1 Randomized Clinical Trial of SENIcapoc and PERAmpanel Mono- and Combination Therapy of Newly Diagnosed Glioblastoma

Clinical trial2026-05-07Results expected Q4 2028 · ClinicalTrials.gov

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

Clinical trial2026-05-06Results expected Q4 2032 · ClinicalTrials.gov

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

Clinical trial2026-05-06Results expected Q1 2033 · ClinicalTrials.gov

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

Clinical trial2025-10-10Terminated · ClinicalTrials.gov

A Multicenter, Open-Label, Prospective Study With an Extension Phase to Evaluate the Efficacy and Safety of Perampanel Monotherapy in Untreated Subjects With Focal Onset Seizures With or Without Focal to Bilateral Tonic-Clonic Seizures

Clinical trial2025-01-23Completed · ClinicalTrials.gov

Pilot Study of Perampanel on Peritumoral Hyperexcitability and Seizure Control in Newly Diagnosed High Grade Glioma

Clinical trial2024-08-05Results posted · ClinicalTrials.gov

An Open-Label Study With an Extension Phase to Evaluate the Pharmacokinetics of Perampanel (E2007) Oral Suspension When Given as an Adjunctive Therapy in Subjects From 1 Month to Less Than 4 Years of Age With Epilepsy

Clinical trial2024-03-15Results posted · ClinicalTrials.gov

Approval: Fycompa (EMA)

Regulatory2012-07-23EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Perampanel
Aliases & brands
FYCOMPA3-(2-Cyanophenyl)-5-(2-pyridyl)-1-phenyl-1,2-dihydropyridin-2-onePerampanelum
RxNorm CUI
1356552
ChEMBL ID
CHEMBL1214124
ATC codes
N03AX22
UNII
H821664NPK
Primary mechanism
Glutamate receptor ionotropic AMPA antagonist
Regulatory jurisdictions
emafda

Pharmacology & targets

4 targets

Known molecular targets and mechanisms supported by curated pharmacology databases.

Glutamate receptor 4
GRIA4 · P48058
ANTAGONISTGlutamate receptor ionotropic AMPA antagonist
Glutamate receptor 3
GRIA3 · P42263
ANTAGONISTGlutamate receptor ionotropic AMPA antagonist
Glutamate receptor 2
GRIA2 · P42262
ANTAGONISTGlutamate receptor ionotropic AMPA antagonist
Glutamate receptor 1
GRIA1 · P42261
ANTAGONISTGlutamate receptor ionotropic AMPA antagonist

Regulatory timeline

3 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2012-07-23
Latest approval
2026-06-15
Authorities
FDA · EMA
Total events
3
fdaU.S. Food and Drug Administration· 2 events
2026-06-17RecallSafety
Recall (Class II): PERAMPANEL
Evidence ↗
2026-06-15Approval
Approval: PERAMPANEL (ANDA219052)
Evidence ↗
emaEuropean Medicines Agency· 1 event
2012-07-23Approval
Approval: Fycompa (EMA)
Indication: Fycompa is indicated for the adjunctive treatment of partial-onset seizures with or without secondarily generalised seizures in adult and adolescent patients from 12 years of age… Show full indication

Fycompa is indicated for the adjunctive treatment of partial-onset seizures with or without secondarily generalised seizures in adult and adolescent patients from 12 years of age with epilepsy. Fycompa is indicated for the adjunctive treatment of primary generalised tonic-clonic seizures in adult and adolescent patients from 12 years of age with idiopathic generalised epilepsy.

Evidence ↗

Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

59 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
59
registered trials across all phases
LATEST COMPLETION 2025
5
Active studies
4
Recruiting
26
Late-stage (III+)
37
Completed
17
Discontinued
PHASE DISTRIBUTIONn = 59
Early Phase 12Phase 112Phase 1 / 24Phase 215Phase 310Phase 414Phase N / A2

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

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

TerminatedPH IVWayne State Universityn=12025

A Multicenter, Open-Label, Prospective Study With an Extension Phase to Evaluate the Efficacy and Safety of Perampanel Monotherapy in Untreated Subjects With Focal Onset Seizures With or Without Focal to Bilateral Tonic-Clonic Seizures

CompletedPH IVEisai Korea Inc.n=1252025

Pilot Study of Add-On Fycompa (Perampanel)Treatment for Catamenial Epilepsy

TerminatedPH IVUniversity of Floridan=72023

Effects of Titration Rate on Cognitive and Behavioral Side Effects of Perampanel

TerminatedPH IVKimford Jay Meadorn=292023

A Phase IV, Prospective, Open-Label, Parallel Study Evaluating the Effect of an Adjunctive Anti-Seizure Medication Using a Glutamatergic Modulator in Patients With Focal Epilepsy and High-Grade Glioma

TerminatedPH IVMayo Clinicn=42023

Recent completions

Trials that read out recently, adding to the completed evidence base.

A Multicenter, Open-Label, Prospective Study With an Extension Phase to Evaluate the Efficacy and Safety of Perampanel Monotherapy in Untreated Subjects With Focal Onset Seizures With or Without Focal to Bilateral Tonic-Clonic Seizures

CompletedPH IVEisai Korea Inc.n=1252025

An Open-label, Balanced, Randomized, Two Treatment, Two Sequence, Two Period, Two Way Cross-over, Single Dose Bioequivalence Study of Perampanel Tablets 10 mg of Humanis Sağlık A.Ş., Turkey and Fycompa 10 mg Film-coated Tablets of Eisai GmbH Edmund-Rumpler-Straße 3 60549 Frankfurt am Main Deutschland in Normal, Healthy, Adult, Human Subjects Under Fasting Condition

CompletedPH IHumanis Saglık Anonim Sirketin=302024

An Open-label, Balanced, Randomized, Two Treatment, Two Sequence, Two Period, Two Way Cross-over, Single Dose Bioequivalence Study of Perampanel Tablets 12 mg of Humanis Sağlık A.Ş., Turkey and Fycompa 12 mg Film-coated Tablets of Eisai GmbH Edmund-Rumpler-Straße 3 60549 Frankfurt am Main Germany in Normal, Healthy, Adult, Human Subjects Under Fasting Condition

CompletedPH IHumanis Saglık Anonim Sirketin=302023

Pilot Study of Perampanel on Peritumoral Hyperexcitability and Seizure Control in Newly Diagnosed High Grade Glioma

CompletedPH I/IIDana-Farber Cancer Instituten=122023

An Open-Label Study With an Extension Phase to Evaluate the Pharmacokinetics of Perampanel (E2007) Oral Suspension When Given as an Adjunctive Therapy in Subjects From 1 Month to Less Than 4 Years of Age With Epilepsy

CompletedPH IIEisai Inc.n=262023

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

CompletedPH IYale Universityn=132022
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.