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™.
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
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/06/10 | Phase 1 | Completed | Humanis Saglık Anonim Sirketi | ||
2024/06/10 | Phase 1 | Completed | Humanis Saglık Anonim Sirketi | ||
2024/05/07 | Phase 2 | Recruiting | |||
2023/06/22 | Phase 1 | Recruiting | |||
2023/03/27 | Phase 2 | Recruiting | |||
2023/01/13 | Phase 4 | Not yet recruiting | |||
2022/09/09 | Phase 4 | Completed | |||
2022/08/11 | N/A | UNKNOWN | Yang Xinwei | ||
2022/03/10 | N/A | UNKNOWN | Beijing Children's Hospital | ||
2022/02/25 | N/A | UNKNOWN | Beijing Children's Hospital |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Teva Pharmaceuticals, Inc. | 0480-7068 | ORAL | 12 mg in 1 1 | 9/27/2024 | |
| Eisai Inc. | 62856-280 | ORAL | 10 mg in 1 1 | 11/21/2023 | |
| Teva Pharmaceuticals, Inc. | 0480-7066 | ORAL | 8 mg in 1 1 | 9/27/2024 | |
| Catalyst Pharmaceuticals, Inc. | 69616-276 | ORAL | 6 mg in 1 1 | 1/5/2024 | |
| Catalyst Pharmaceuticals, Inc. | 69616-280 | ORAL | 10 mg in 1 1 | 1/5/2024 | |
| Eisai Inc. | 62856-290 | ORAL | 0.5 mg in 1 mL | 11/21/2023 | |
| Teva Pharmaceuticals, Inc. | 0480-7063 | ORAL | 4 mg in 1 1 | 9/27/2024 | |
| Eisai Inc. | 62856-274 | ORAL | 4 mg in 1 1 | 11/21/2023 | |
| Eisai Inc. | 62856-278 | ORAL | 8 mg in 1 1 | 11/21/2023 | |
| Catalyst Pharmaceuticals, Inc. | 69616-272 | ORAL | 2 mg in 1 1 | 1/5/2024 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 7/23/2012 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| FYCOMPA FILM-COATED TABLET 2 MG | SIN14616P | TABLET, FILM COATED | 2.0 mg | 9/12/2014 | |
| FYCOMPA FILM-COATED TABLET 4MG | SIN14617P | TABLET, FILM COATED | 4.0 mg | 9/12/2014 | |
| FYCOMPA FILM-COATED TABLET 8MG | SIN14619P | TABLET, FILM COATED | 8.0 mg | 9/12/2014 | |
| FYCOMPA ORAL SUSPENSION 0.5MG/ML | SIN16512P | SUSPENSION | 0.50 mg/ml | 6/10/2022 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Perampanel Oral Suspension | 国药准字H20253666 | 化学药品 | 口服混悬剂 | 3/18/2025 | |
| Perampanel Oral Suspension | 国药准字HJ20230052 | 化学药品 | 口服混悬剂 | 5/12/2023 | |
| Perampanel Tablets | 国药准字H20243761 | 化学药品 | 片剂 | 5/21/2024 | |
| Perampanel Tablets | 国药准字H20247284 | 化学药品 | 片剂 | 11/12/2024 | |
| Perampanel Tablets | 国药准字H20244187 | 化学药品 | 片剂 | 6/28/2024 | |
| Perampanel Tablets | 国药准字H20234460 | 化学药品 | 片剂 | 11/7/2023 | |
| Perampanel Tablets | 国药准字H20243012 | 化学药品 | 片剂 | 1/9/2024 | |
| Perampanel Tablets | 国药准字HJ20210063 | 化学药品 | 片剂 | 7/28/2021 | |
| Perampanel Tablets | 国药准字H20243734 | 化学药品 | 片剂 | 5/21/2024 | |
| Perampanel Tablets | H20190053 | 化学药品 | 片剂 | 9/29/2019 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| FYCOMPA ORAL SUSPENSION 0.5MG/ML | N/A | N/A | N/A | 9/9/2022 | |
| FYCOMPA TABLETS 2MG | N/A | N/A | N/A | 4/2/2014 | |
| FYCOMPA TABLETS 12MG | N/A | N/A | N/A | 4/2/2014 | |
| FYCOMPA TABLETS 4MG | N/A | N/A | N/A | 4/2/2014 | |
| FYCOMPA TABLETS 6MG | N/A | N/A | N/A | 4/2/2014 | |
| FYCOMPA TABLETS 8MG | N/A | N/A | N/A | 4/2/2014 | |
| FYCOMPA TABLETS 10MG | N/A | N/A | N/A | 4/2/2014 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| FYCOMPA perampanel (as hemisesquihydrate) 6 mg film coated tablet blister | 207688 | Medicine | A | 5/23/2014 | |
| FYCOMPA perampanel (as hemisesquihydrate) 2 mg film coated tablet blister | 207690 | Medicine | A | 5/23/2014 | |
| FYCOMPA perampanel (as hemisesquihydrate) 10 mg film coated tablet blister | 207692 | Medicine | A | 5/23/2014 | |
| FYCOMPA perampanel (as hemisesquihydrate) 4 mg film coated tablet blister | 207689 | Medicine | A | 5/23/2014 | |
| FYCOMPA perampanel (as hemisesquihydrate) 8 mg film coated tablet blister | 207687 | Medicine | A | 5/23/2014 | |
| FYCOMPA perampanel (as hemisesquihydrate) 12 mg film coated tablet blister | 207691 | Medicine | A | 5/23/2014 | |
| FYCOMPA perampanel (as hemisesquihydrate) 2 mg/4 mL oral suspension | 332505 | Medicine | A | 2/16/2021 |
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