Drugs / Perampanel
Perampanel
Regulatory milestones approvals, filings & regulatory actions · 5 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (3) | US (FDA) | FYCOMPA | — | 2015-06-19 – 2018-09-27 | fda.gov ↗ |
| Approved | US (FDA) | FYCOMPA | — | 2012-10-22 | fda.gov ↗ |
| Approved | EU (EMA) | Fycompa | — | 2012-07-23 | europa.eu ↗ |
Trials 68 · started per year
today
EU approved 2012
US approved 2012
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT03793868 | Dec 2018 → Aug 2020 | amyotrophic lateral sclerosis | Mayo Clinic | Completed | No outcome recorded |
| Phase 19 trials | ||||||
| Phase 1 | NCT05915013 | Sep 2023 → Dec 2032 expected | major depressive disorder, post-traumatic stress disorder | Yale University | Recruiting | No outcome recorded |
| Phase 1 | NCT03973268 | Jan 2020 → Feb 2027 expected | major depressive disorder | National Institute of Mental Health (NIMH) | Recruiting | No outcome recorded |
| Phase 1 | NCT03367533 | Nov 2018 → Jul 2022 | bipolar disorder, major depressive disorder, post-traumatic stress disorder | Yale University | Completed | No outcome recorded |
| Phase 1 | NCT03424564 | Mar → May 2018 | — | Eisai Inc. | Completed | No outcome recorded |
| Phase 1 | NCT03376997 | Nov 2017 → Feb 2018 | — | Eisai Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02116907 | May → Jul 2014 | — | Eisai Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02020486 | Dec 2013 → Mar 2014 | — | Eisai Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01531920 | May 2010 → Apr 2011 | central nervous system disorder | Eisai Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01209858 | Mar → Oct 2010 | simple partial epilepsy | Eisai Inc. | Completed | No outcome recorded |
| Phase 1/23 trials | ||||||
| Phase 1/2 | NCT04497142 | Nov 2020 → May 2023 | epilepsy, malignant glioma | Dana-Farber Cancer Institute | Completed | No outcome recorded |
| Phase 1/2 | NCT02120365 | Jun 2019 → Feb 2022 | alcohol dependence | Virginia Commonwealth University | Completed | No outcome recorded |
| Phase 1/2 | NCT02131467 | Sep 2017 → Feb 2020 | cervical dystonia | University Health Network, Toronto | Completed | No outcome recorded |
| Phase 224 trials | ||||||
| Phase 2 | NCT05786066 | Apr 2023 → Mar 2033 expected | bipolar disorder, major depressive disorder, post-traumatic stress disorder | Yale University | Recruiting | No outcome recorded |
| Phase 2 | NCT03377309 | Dec 2019 → Jun 2020 | amyotrophic lateral sclerosis | American University of Beirut Medical Center | Terminated | No outcome recorded |
| Phase 2 | NCT04015141 | May 2019 → Apr 2027 expected | childhood-onset epilepsy syndrome, focal epilepsy | Eisai Inc. | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03754582 | Nov 2018 → Dec 2019 | epilepsy | Eisai Inc. | Completed | No outcome recorded |
| Phase 2 | NCT03019419 | Apr 2017 → Dec 2020 | amyotrophic lateral sclerosis | Tokyo Medical University | Completed | No outcome recorded |
| Phase 2 | NCT02914314 | Feb 2017 → Aug 2022 | epilepsy | Eisai Inc. | Completed | No outcome recorded |
| Phase 2 | NCT02511873 | Jan → Dec 2016 | neuropathy, small fiber | PNA Center for Neurological Research | Unknown | No outcome recorded |
| Phase 2 | NCT02668146 | Oct 2015 → Mar 2017 | essential tremor | VA Greater Los Angeles Healthcare System | Unknown | No outcome recorded |
| Phase 2 | NCT01527006 | Jan 2012 → May 2014 | central nervous system disorder | Eisai Inc. | Completed | No outcome recorded |
| Phase 2 | NCT01161524 | Sep 2010 → Jun 2013 | epilepsy | Eisai Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00903786 | Jun 2009 → Aug 2016 | focal epilepsy | Eisai Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00849212 | Apr → Nov 2009 | focal epilepsy | Eisai Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00592774 | Jan → Dec 2008 | neuralgia | Eisai Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00566462 | Oct 2007 → Dec 2008 | Parkinson disease | Eisai Inc. | Terminated | No outcome recorded |
| Phase 2 | NCT00451633 | Mar 2007 → ? | Parkinson disease | Eisai Inc. | Withdrawn | No outcome recorded |
| Phase 2 | NCT00427011 | Feb 2007 → Apr 2008 | Parkinson disease | Eisai Inc. | Terminated | No outcome recorded |
| Phase 2 | NCT00416195 | Dec 2006 → Feb 2008 | epilepsy | Eisai Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00368472 | Oct 2006 → Jun 2014 | epilepsy | Eisai Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00165789 | Sep 2005 → Feb 2006 | Parkinson disease | Eisai Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00144690 | Mar 2005 → Feb 2007 | epilepsy | Eisai Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00154063 | Jan 2005 → Jun 2006 | — | Eisai Inc. | Completed | No outcome recorded |
| Phase 2 | NCT01634360 | Nov 2004 → Jun 2008 | Parkinson disease | Eisai Inc. | Terminated | No outcome recorded |
| Phase 2 | NCT01172379 | May 2004 → Feb 2005 | Parkinson disease | Eisai Inc. | Completed | No outcome recorded |
| Phase 2 | NCT03780907 | Feb → Aug 2003 | epilepsy | Eisai Inc. | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT00592904 | Jan 2008 → Nov 2009 | neuralgia | Eisai Inc. | Completed | No outcome recorded |
| Phase 314 trials | ||||||
| Phase 3 | NCT04309721 | Nov 2022 | partial motor epilepsy | Assistance Publique - Hôpitaux de Paris | Terminated | No outcome recorded |
| Phase 3 | NCT03201900 | Jun 2017 → Feb 2019 | focal epilepsy | Eisai Inc. | Completed | No outcome recorded |
| Phase 3 | NCT02834793 | Dec 2016 → May 2021 | Lennox-Gastaut syndrome | Eisai Inc. | Terminated | No outcome recorded |
| Phase 3 | NCT02849626 | Nov 2016 → Feb 2019 | combined generalized and focal epilepsy | Eisai Inc. | Completed | No outcome recorded |
| Phase 3 | NCT02427607 | May 2015 → Sep 2016 | epilepsy | Eisai Inc. | Completed | No outcome recorded |
| Phase 3 | NCT01618695 | May 2012 → Sep 2014 | focal epilepsy | Eisai Inc. | Completed | No outcome recorded |
| Phase 3 | NCT01393743 | Sep 2011 → May 2014 | epilepsy with generalized tonic-clonic seizures | Eisai Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00735397 | Oct 2008 → Sep 2014 | epilepsy | Eisai Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00699582 | May 2008 → Dec 2010 | focal epilepsy | Eisai Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00699972 | Apr 2008 → Oct 2010 | focal epilepsy | Eisai Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00505622 | Jul 2007 → Apr 2008 | Parkinson disease | Eisai Inc. | Terminated | No outcome recorded |
| Phase 3 | NCT00360412 | Oct 2006 → Apr 2008 | Parkinson disease | Eisai Inc. | Terminated | No outcome recorded |
| Phase 3 | NCT00368108 | Aug 2006 → Jan 2008 | Parkinson disease | Eisai Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00286897 | Feb 2006 → Jun 2007 | Parkinson disease | Eisai Inc. | Completed | No outcome recorded |
| Phase 413 trials | ||||||
| Phase 4 | NCT05684978 | Oct 2025 | new-onset refractory status epilepticus | Wayne State University | Terminated | No outcome recorded |
| Phase 4 | NCT05533814 | Oct 2022 → Jan 2025 | epilepsy | Eisai Co., Ltd. | Completed | No outcome recorded |
| Phase 4 | NCT05201703 | Mar 2022 → Dec 2023 | epilepsy | University of Florida | Terminated | No outcome recorded |
| Phase 4 | NCT04417907 | Oct 2021 → May 2023 | epilepsy | Kimford Jay Meador | Terminated | No outcome recorded |
| Phase 4 | NCT04650204 | Dec 2020 → Apr 2023 | epilepsy, grade II glioma, grade III glioma | Mayo Clinic | Terminated | No outcome recorded |
| Phase 4 | NCT04118829 | Nov 2019 → Sep 2022 | epilepsy | Carilion Clinic | Unknown | No outcome recorded |
| Phase 4 | NCT03653741 | Oct 2018 → Nov 2021 | — | Weill Medical College of Cornell University | Completed | No outcome recorded |
| Phase 4 | NCT03457129 | Apr 2018 → Feb 2021 | epilepsy | University of Arizona | Completed | No outcome recorded |
| Phase 4 | NCT03288129 | Aug 2017 → Apr 2021 | epilepsy with generalized tonic-clonic seizures, focal epilepsy | Eisai Inc. | Completed | No outcome recorded |
| Phase 4 | NCT02900755 | Dec 2016 → Apr 2019 | — | Seoul National University Hospital | Completed | No outcome recorded |
| Phase 4 | NCT02726074 | May 2016 → Apr 2018 | epilepsy | Eisai Co., Ltd. | Completed | No outcome recorded |
| Phase 4 | NCT02363933 | Apr 2015 → Mar 2017 | primary brain neoplasm | Duke University | Completed | No outcome recorded |
| Phase 4 | NCT02220972 | Mar 2015 → Aug 2016 | focal epilepsy | Eisai Inc. | Withdrawn | No outcome recorded |
| Phase not applicable3 trials | ||||||
| — | NCT03636958 | Feb 2021 → Jul 2025 | epilepsy | Assistance Publique Hopitaux De Marseille | Withdrawn | No outcome recorded |
| — | NCT04858841 | Aug 2020 → Jul 2023 | middle cerebral artery infarction | National Cheng Kung University | Unknown | No outcome recorded |
| — | NCT03020797 | Jan 2017 → Jan 2023 | amyotrophic lateral sclerosis | Stony Brook University | Terminated | No outcome recorded |
Also used as a comparator or background therapy in 9 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT07284069 Comparator | Mar 2026 → Nov 2028 expected | glioblastoma | Aarhus University Hospital | Recruiting | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT04502589 Comparator | Oct 2020 → Aug 2021 | alcohol-related disorders | Virginia Commonwealth University | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT06401707 Comparator | May 2024 → May 2026 overdue | cardiac arrest, epilepsy | University of California, San Francisco | Recruiting | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT00505284 Comparator | Jun 2007 → Jul 2008 | diabetic neuropathy | Eisai Inc. | Completed | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT00700310 Comparator | Aug 2008 → Aug 2009 | focal epilepsy | Eisai Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00360308 Comparator | Nov 2006 → Apr 2008 | Parkinson disease | Eisai Inc. | Terminated | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT02727101 Comparator | Nov 2015 → Jul 2017 | epilepsy | Mid-Atlantic Epilepsy and Sleep Center, LLC | Terminated | No outcome recorded |
| Phase not stated2 trials | ||||||
| — | NCT01871233 Background | — | focal epilepsy | Eisai Inc. | No longer available | No outcome recorded |
| — | NCT02307578 Background | — | Lennox-Gastaut syndrome | Eisai Inc. | No longer available | No outcome recorded |
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 80 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Perampanel | “In the present study, we propose to evaluate whether pre-treatment with perampanel, an AMPAR antagonist, blocks or reduces the acute antidepressant effects of ketamine in...” NCT03973268 ↗58“14C-labeled perampanel dissolved in ethanol and administered using a capsule formulation in a single dose, one day” NCT02116907 ↗ “E2007 (perampanel)” NCT00144690 ↗ “Perampanel” NCT00699972 ↗ |
| Known as | 2007 | “effects of 2007/Fycompa (perampanel) on sleep” NCT02220972 ↗ |
| Known as | E2007 | “A Randomized, Double-blind, Placebo-controlled, Parallel-group Study With an Open-label Extension Phase to Evaluate the Effect of Perampanel (E2007) on Cognition, Growth,...” NCT01161524 ↗24“An Open-label Pilot Study With an Extension Phase to Evaluate the Pharmacokinetics, and to Generate Preliminary Safety, Tolerability, and Efficacy of Perampanel (E2007) Oral...” NCT01527006 ↗ “An Open-Label Extension Phase of the Double-Blind, Placebo-Controlled, Dose-Escalation, Parallel-Group Studies to Evaluate the Efficacy and Safety of E2007 (Perampanel) Given...” NCT00735397 ↗ “Evaluation of the Long-term Safety, Tolerability, and Efficacy of Perampanel (E2007) as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Subjects With Motor Fluctuations” NCT00505622 ↗ “Assessment of Perampanel (E2007) on Synaptic Dopamine” NCT00566462 ↗ “Perampanel (E2007) in Subjects With Cervical Dystonia” NCT02131467 ↗ “Perampanel (E2007) Oral Suspension” NCT02914314 ↗ “E2007 (perampanel)” NCT00699972 ↗ |
| Known as | ER-155055-90 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1214124 ↗ |
| Known as | Fycompa | “Perampanel (Fycompa®) is a non-competitive AMPA-receptor antagonist approved for the treatment of focal and generalized tonic-clonic seizures.” NCT07284069 ↗4“effects of 2007/Fycompa (perampanel) on sleep” NCT02220972 ↗ |
| Known as | PER | “early, preventive introduction of low-dose antiepileptic drug therapy (levetiracetam [LEV] or perampanel [PER]) in patients who have experienced middle cerebral artery (MCA) infarction” PMID 37999939 ↗ Nov 20232“Perampanel (PER) is a new drug available for add-on therapy in patients with a focal epilepsy.” NCT04309721 ↗ “perampanel (PER)” NCT04417907 ↗ |
| Action | Inhibit | “oral perampanel, a novel, selective, non-competitive AMPA antagonist” PMID 21883097 ↗ Aug 2011 |
| Modality | Small molecule | — CHEMBL1214124 ↗ |
| Route | Oral | “escalating doses of oral perampanel” PMID 21883097 ↗ Aug 2011 |