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 diseases | D009422 |
| signs and symptoms pathological conditions | D013568 |
Trade Name
FDA
EMA
Fycompa, Perampanel
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 |
|---|---|---|---|---|
| FYCOMPA | Catalyst Pharmaceuticals | N-202834 RX | 2012-10-22 | 6 products, RLD, RS |
| FYCOMPA | Catalyst Pharmaceuticals | N-208277 RX | 2016-04-29 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| fycompa | New Drug Application | 2024-01-05 |
| perampanel | ANDA | 2024-09-27 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| seizures | — | D012640 | G40.4 |
| partial epilepsies | EFO_0004263 | D004828 | — |
| tonic-clonic epilepsy | EFO_0007262 | D004830 | — |
Agency Specific
FDA
EMA
No data
HCPCS
No data
Clinical
Clinical Trials
105 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Seizures | D012640 | — | G40.4 | 1 | 9 | 9 | 4 | 9 | 31 |
| Epilepsy | D004827 | EFO_0000474 | G40.9 | 2 | 8 | 3 | 7 | 8 | 28 |
| Healthy volunteers/patients | — | — | — | 8 | — | — | 1 | — | 9 |
| Complex partial epilepsy | D017029 | EFO_1000877 | — | 2 | — | 1 | 1 | 2 | 6 |
| Tonic-clonic epilepsy | D004830 | EFO_0007262 | — | — | — | — | 1 | 4 | 5 |
| Partial epilepsies | D004828 | EFO_0004263 | — | — | — | — | 2 | — | 2 |
| Sleep initiation and maintenance disorders | D007319 | — | F51.01 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Parkinson disease | D010300 | EFO_0002508 | G20 | — | 6 | 5 | — | — | 11 |
| Peripheral nervous system diseases | D010523 | — | G64 | — | 2 | 1 | — | — | 2 |
| Diabetic neuropathies | D003929 | EFO_1000783 | — | — | 2 | 2 | — | — | 2 |
| Lennox gastaut syndrome | D065768 | — | G40.81 | — | — | 1 | — | 1 | 2 |
| Neuralgia | D009437 | EFO_0009430 | — | — | 2 | 1 | — | — | 2 |
| Postherpetic neuralgia | D051474 | — | — | — | 2 | 1 | — | — | 2 |
| Syndrome | D013577 | — | — | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Dyskinesias | D020820 | — | G24 | — | 2 | — | — | — | 2 |
| Glioma | D005910 | EFO_0000520 | — | 1 | 1 | — | — | — | 1 |
| Small fiber neuropathy | D000071075 | — | — | — | 1 | — | — | — | 1 |
| Migraine disorders | D008881 | EFO_0003821 | G43 | — | 1 | — | — | — | 1 |
Indications Phases 1
No data
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neoplasm metastasis | D009362 | EFO_0009708 | — | — | — | — | — | 2 | 2 |
| Generalized epilepsy | D004829 | — | — | — | — | — | — | 1 | 1 |
| Amyotrophic lateral sclerosis | D000690 | EFO_0000253 | G12.21 | — | — | — | — | 1 | 1 |
| Motor neuron disease | D016472 | EFO_0003782 | G12.2 | — | — | — | — | 1 | 1 |
| Sclerosis | D012598 | — | — | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Perampanel |
| INN | perampanel |
| 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 class | ionotropic 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 |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | N#Cc1ccccc1-c1cc(-c2ccccn2)cn(-c2ccccc2)c1=O |
Identifiers
| PDB | — |
| CAS-ID | 380917-97-5 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1214124 |
| ChEBI ID | 71013 |
| PubChem CID | 9924495 |
| DrugBank | DB08883 |
| UNII ID | H821664NPK (ChemIDplus, GSRS) |
Target
No data
Variants
No data
Financial
Revenue by drug
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Fycompa – Catalyst Pharmaceuticals
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Tabular view
Estimated US medical usage
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 3,249 documents
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Safety
Black-box Warning
Black-box warning for: Fycompa, Perampanel
Adverse Events
Top Adverse Reactions
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4,678 adverse events reported
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