Perampanel
- Generic Name
- Perampanel
- Brand Names
- Fycompa
- Drug Type
- Small Molecule
- Chemical Formula
- C23H15N3O
- CAS Number
- 380917-97-5
- Unique Ingredient Identifier
- H821664NPK
Overview
Perampanel is a noncompetitive AMPA glutamate receptor antagonist. It is marketed under the name Fycompa™ and is indicated as an adjunct in patients over 12 years old for the treatment of partial-onset seizures that may or may not occur with generalized seizures. The FDA label includes an important black-boxed warning of serious or life-threatening behavioral and psychiatric reactions in patients taking Fycompa™.
Background
Perampanel is a noncompetitive AMPA glutamate receptor antagonist. It is marketed under the name Fycompa™ and is indicated as an adjunct in patients over 12 years old for the treatment of partial-onset seizures that may or may not occur with generalized seizures. The FDA label includes an important black-boxed warning of serious or life-threatening behavioral and psychiatric reactions in patients taking Fycompa™.
Indication
Perampanel is indicated for the treatment of partial-onset seizures with or without secondarily generalized seizures in epileptic patients four years of age and older. It is also indicated as an adjunct in the treatment of primary generalized tonic-clonic seizures in epileptic patients aged 12 years and older.
Associated Conditions
- Epilepsy, Primary Generalized Tonic-Clonic Seizures
- Partial-Onset Seizures
Clinical Trials
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Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2014/04/22 | Phase 1 | Completed | |||
2014/04/17 | Phase 1 | Completed | |||
2014/01/13 | N/A | Completed | |||
2013/12/25 | Phase 1 | Completed | |||
2013/06/06 | N/A | NO_LONGER_AVAILABLE | |||
2012/07/06 | Phase 2 | Terminated | |||
2012/06/13 | Phase 3 | Completed | |||
2012/02/13 | Phase 1 | Completed | |||
2012/02/06 | Phase 2 | Completed | |||
2011/07/19 | Phase 1 | Completed |
FDA Approved Products
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Product Name | Manufacturer | Route | Strength | Approved | NDC Code |
|---|
No FDA products found
No FDA products found for this drug
EMA Approved Products
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Medicine Name | EMA Number | Auth. Holder | Country | Drug Type | Status | Issued | Opinion | Revision |
|---|
No EMA products found
No EMA products found for this drug
HSA Approved Products
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Product Name | Manufacturer | Dosage Form | Strength | Approved | Approval No. |
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No HSA products found for this drug
NMPA Approved Products
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Product Name | Approval No. | Manufacturer | Dosage Form | Trade Name | Strength | Type | Status | Date | Import |
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No NMPA products found for this drug
PPB Approved Products
Product Name | Registration Code | Company | Category | Sale Type | Reg. Date |
|---|---|---|---|---|---|
HK-67556 | Part 1, Schedule 1 & Schedule 3 Poison | POM | 2022/09/09 | ||
HK-62763 | Part 1, Schedule 1 & Schedule 3 Poison | POM | 2014/04/02 | ||
HK-62759 | Part 1, Schedule 1 & Schedule 3 Poison | POM | 2014/04/02 | ||
HK-62762 | Part 1, Schedule 1 & Schedule 3 Poison | POM | 2014/04/02 | ||
HK-62764 | Part 1, Schedule 1 & Schedule 3 Poison | POM | 2014/04/02 | ||
HK-62761 | Part 1, Schedule 1 & Schedule 3 Poison | POM | 2014/04/02 | ||
HK-62760 | Part 1, Schedule 1 & Schedule 3 Poison | POM | 2014/04/02 |
TGA Approved Products
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Product Name | ARTG ID | Sponsor | Status | Reg. Date | Ingredient |
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