Perampanel

Treats partial-onset seizures with or without secondarily generalized seizures. Sold as Fycompa. Every FDA application for this active ingredient: 2 branded and 7 generic.

As of Nov 14, 2026, FDA lists 9 applications for Perampanel (sold as Fycompa), first approved Oct 22, 2012, with 5 new uses approved and 0 published complete response letters.

First approved: Oct 22, 2012
Applications: 9
New uses approved: 5
Complete response letters: 0
Medicare spending, 2025: $73.9M
First approved in the EU: Jul 23, 2012
First approved in Japan: Mar 28, 2016

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name


Fycompa	Part D	$64.8M	-14%	6,377
Perampanel	Part D	$9.1M	New	2,846

What Pharmacies Pay

Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change

PERAMPANEL 0.5 MG/ML ORAL SUSP: $3.88 per MLGeneric · new this year
PERAMPANEL 10 MG TABLET: $14.40 per unitGeneric · new this year
PERAMPANEL 12 MG TABLET: $14.03 per unitGeneric · new this year
PERAMPANEL 2 MG TABLET: $6.56 per unitGeneric · new this year
PERAMPANEL 4 MG TABLET: $15.08 per unitGeneric · -52% in a year
PERAMPANEL 6 MG TABLET: $18.60 per unitGeneric · new this year
PERAMPANEL 8 MG TABLET: $17.68 per unitGeneric · new this year
FYCOMPA 0.5 MG/ML ORAL SUSP: $4.45 per MLBrand · 0% in a year
FYCOMPA 10 MG TABLET: $39.10 per unitBrand · 0% in a year
FYCOMPA 12 MG TABLET: $39.08 per unitBrand · 0% in a year
FYCOMPA 2 MG TABLET: $19.72 per unitBrand · 0% in a year
FYCOMPA 4 MG TABLET: $39.11 per unitBrand · 0% in a year

Orphan Designations (FDA)

One designation, 0 approved for the designated use; see all orphan designations

Treatment of Lennox-Gastaut SyndromeEisai Inc. · designated Dec 7, 2012 · withdrawn

Approvals in the EU (EMA)

First approved in the EU 3 months before the US. Centrally authorised medicines, matched by ingredient; see all EU approvals

Fycompa, new substanceEisai GmbH · Jul 23, 2012

Approvals in Japan (PMDA)

First approved in Japan 41 months after the US. PMDA's English list since 2008, matched by ingredient; see all Japanese approvals

Fycompa, new approvalA drug with a new route of administration indicated for the following treatment: partial seizures (including secondary generalized seizures) in patients… · Eisai Co., Ltd. · Jan 18, 2024
Fycompa Fine, new approvalA drug in an additional dosage form and drugs with a revised indication and a new additional pediatric dosage for the treatment of partial seizures… · Eisai Co., Ltd. · Jan 23, 2020
Fycompa, new ingredientDrugs with a new active ingredient indicated for use as an adjunctive therapy with other antiepileptic drugs to treat partial seizures (including secondary… · Eisai Co., Ltd. · Mar 28, 2016

Clinical Trials

9 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


Senicapoc and Perampanel for Newly Diagnosed GlioblastomaGlioblastoma · Aarhus University Hospital	Early phase 1	Recruiting	Dec 16, 2025
A Study to Evaluate the Safety of Fycompa Injection in Participants With Partial-Onset Seizures or Primary Generalized Tonic- Clonic SeizuresPartial-Onset Seizures, Primary Generalized Tonic-clonic Seizures · Eisai Co., Ltd.	—	Recruiting	Oct 24, 2024
PeRampanel fOr Status ePilEpticus pRophylaxis Post-cardiac ArrestHeart Arrest, Seizures · University of California, San Francisco	Phase 2	Recruiting	May 7, 2024
Alpha-Amino-3-Hydroxy-5-Methyl-4- Isoxazole Propionic Acid Receptor Components of the Anti-Depressant Ketamine ResponseDepressive Disorder, Major, Post Traumatic Stress Disorder · Yale University	Phase 1	Recruiting	Jun 22, 2023
The Impact of AMPA Receptor Blockade on Ketamine's Anti-Suicidal EffectsDepressive Disorder, Major Depressive Disorder · Yale University	Phase 2	Recruiting	Mar 27, 2023
Antiepileptic Drugs in Elderly PatientsSeizure, Epileptic · Wei Zhao	—	Recruiting	Jul 15, 2022
Implantable Microdevice In Primary Brain TumorsGrade II Glioma, Grade III Glioma · Oliver Jonas	Early phase 1	Recruiting	Oct 23, 2019
A Study to Evaluate Efficacy and Safety of Perampanel Administered as an Adjunctive Therapy in Pediatric Participants With Childhood EpilepsyPediatric Epileptic Syndrome, Partial-onset Seizures · Eisai Inc.	Phase 2	Active, not recruiting	Jul 10, 2019

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Oct 22, 2012	FycompaNDA 202834 · New molecular entity	Catalyst Pharms	16	Marketed
Apr 29, 2016	FycompaNDA 208277 · New dosage form	Catalyst Pharms	5	Marketed
May 23, 2025	PerampanelANDA 209801	Teva Pharms USA Inc	0	Marketed
Jul 11, 2025	PerampanelANDA 218152	Msn	0	Marketed
Nov 25, 2025	PerampanelANDA 209538	Taro	0	Marketed
Nov 25, 2025	PerampanelANDA 218178	Msn	0	Marketed
Jun 15, 2026	PerampanelANDA 219052	Taro	0	Marketed
Oct 2, 2026	PerampanelANDA 220492	Aurobindo Pharma Ltd	0	Marketed
—	PerampanelANDA 209877	Accord Hlthcare	0	Discontinued

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA