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Drug ReportsPerampanel
Fycompa(perampanel)
Fycompa (perampanel) is a small molecule pharmaceutical. Perampanel was first approved as Fycompa on 2012-07-23. It is used to treat partial epilepsies, seizures, and tonic-clonic epilepsy in the USA. It has been approved in Europe to treat partial epilepsies.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
nervous system diseasesD009422
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
Fycompa
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Perampanel
Tradename
Company
Number
Date
Products
FYCOMPACatalyst PharmaceuticalsN-202834 RX2012-10-22
6 products, RLD, RS
FYCOMPACatalyst PharmaceuticalsN-208277 RX2016-04-29
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
fycompaNew Drug Application2024-01-05
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Perampanel, Fycompa, Catalyst Pharms
87724972026-07-01DP
69495712024-06-08DS, DPU-106, U-2088, U-2089, U-2428, U-2429
ATC Codes
N: Nervous system drugs
— N03: Antiepileptics
— N03A: Antiepileptics
— N03AX: Other antiepileptics in atc
— N03AX22: Perampanel
HCPCS
No data
Clinical
Clinical Trials
104 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
EpilepsyD004827EFO_0000474G40.9483101742
SeizuresD012640HP_0002069G40.4110971541
Healthy volunteers/patients———8——1—9
Complex partial epilepsyD017029EFO_1000877—2—1137
Partial epilepsiesD004828EFO_0004263————325
Tonic-clonic epilepsyD004830EFO_0007262————145
Status epilepticusD013226EFO_0008526G41—11114
Drug resistant epilepsyD000069279—————123
GliomaD005910EFO_0000520—11—1—2
Brain neoplasmsD001932EFO_0003833C71———1—1
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Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Parkinson diseaseD010300EFO_0002508G20—65——11
Peripheral nervous system diseasesD010523HP_0009830G64—21——2
Diabetic neuropathiesD003929EFO_1000783——22——2
Lennox gastaut syndromeD065768—G40.81——1—12
NeuralgiaD009437EFO_0009430——21——2
Postherpetic neuralgiaD051474———21——2
SyndromeD013577————1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Amyotrophic lateral sclerosisD000690HP_0007354G12.2112——14
Motor neuron diseaseD016472EFO_0003782G12.212——14
Major depressive disorderD003865EFO_0003761F2231———4
Depressive disorderD003866EFO_1002014F32.A31———4
SclerosisD012598——11——13
Bipolar disorderD001714EFO_0000289F30.921———3
Post-traumatic stress disordersD013313EFO_0001358F43.121———3
Traumatic stress disordersD040921——21———3
DyskinesiasD020820HP_0002310G24—2———2
AlcoholismD000437EFO_0003829F10.122———2
Show 12 more
Indications Phases 1
No data
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Neoplasm metastasisD009362EFO_0009708—————22
Generalized epilepsyD004829——————22
StrokeD020521EFO_0000712I63.9————11
Middle cerebral artery infarctionD020244EFO_1001045G46.0————11
Nervous system diseasesD009422—G00-G99————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common namePerampanel
INNperampanel
Description
Perampanel is a member of the class of bipyridines that is 2,3'-bipyridin-6'-one substituted at positions 1' and 5' by phenyl and 2-cyanophenyl groups respectively. Used as an adjunctive therapy for the treatment of partial-onset seizures in patients with epilepsy. It has a role as an AMPA receptor antagonist and an anticonvulsant. It is a pyridone, a nitrile and a member of bipyridines. It is functionally related to a benzonitrile.
Classification
Small molecule
Drug classionotropic non-NMDA (N-methyl D-aspartate) glutamate receptors [AMPA (alpha-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid receptor) and/or KA (kainite antagonist) receptors]: antagonists
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Structure (InChI/SMILES or Protein Sequence)
N#Cc1ccccc1-c1cc(-c2ccccn2)cn(-c2ccccc2)c1=O
Identifiers
PDB—
CAS-ID380917-97-5
RxCUI—
ChEMBL IDCHEMBL1214124
ChEBI ID71013
PubChem CID9924495
DrugBankDB08883
UNII IDH821664NPK (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
Fycompa – Catalyst Pharmaceuticals
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Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 2,632 documents
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Safety
Black-box Warning
Black-box warning for: Fycompa
Adverse Events
Top Adverse Reactions
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3,870 adverse events reported
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