Drugs / Perampanel
Perampanel
Regulatory milestones approvals, filings & regulatory actions · 18 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed epilepsy, early-onset 7 milestones | |||||
| Filed | Japan (PMDA) | Fycompa | epilepsy, early-onset | 2022-08-30 | “it has filed a supplementary new drug application in Japan for its in-house discovered antiepileptic drug (AED) Fycompa ®” eisai.com ↗ |
| Filed | EU (EMA) | Fycompa | epilepsy, early-onset | 2019-02-13 | “it has submitted an application to the European Medicines Agency (EMA) for its in-house discovered antiepileptic drug (AED) Fycompa ® (perampanel)” eisai.com ↗ |
| Filed | China (NMPA) | Fycompa | epilepsy, early-onset | 2018-10-12 | “has accepted for review a New Drug Application for Eisai's antiepileptic drug (AED) perampanel” eisai.com ↗ |
| Filed | US (FDA) | Fycompa | epilepsy, early-onset | 2018-04-02 | “it has submitted to the U.S. Food and Drug Administration (FDA) a supplemental New Drug Application (sNDA) for Eisai’s antiepileptic drug (AED) Fycompa ® (perampanel)” eisai.com ↗ “Eisai has submitted applications for the approval of an additional oral suspension formulation of perampanel in Europe and the United States in June 2015” eisai.com ↗ “Eisai originally submitted the perampanel NDA to the FDA in May 2011, however, resubmitted it in December 2011” eisai.com ↗ “A New Drug Application (NDA) has also been simultaneously submitted in the United States. Perampanel (E2007)” eisai.com ↗ “Eisai originally submitted the perampanel NDA to the FDA in May 2011” eisai.com ↗ |
| Filed | Japan (PMDA) | — | epilepsy, early-onset | 2015-07-27 | “it has submitted a new drug application in Japan for its in-house-discovered antiepileptic drug (AED) perampanel hydrate” eisai.com ↗ |
| Rejected (CRL) | US (FDA) | — | epilepsy, early-onset | 2011-07-29 | “FDA has issued a Refusal to File letter in response to the company's New Drug Application (NDA) for perampanel (E2007)” eisai.com ↗ |
| Filed | EU (EMA) | — | epilepsy, early-onset | 2011-06-24 | “Eisai has submitted applications for the approval of an additional oral suspension formulation of perampanel in Europe and the United States in June 2015” eisai.com ↗ “EMA has accepted for review the company's Marketing Authorization Application (MAA) for the AMPA receptor antagonist perampanel (E2007)” eisai.com ↗ |
| Filed simple partial epilepsy 3 milestones | |||||
| Filed | Japan (PMDA) | Fycompa | simple partial epilepsy | 2019-01-30 | “it has filed a supplementary new drug application in Japan for its in-house discovered antiepileptic drug (AED) Fycompa ® (perampanel)” eisai.com ↗ |
| Filed | EU (EMA) | Fycompa | simple partial epilepsy | — | “Eisai has submitted marketing authorization applications in Europe and the United States seeking approval of its novel AMPA receptor antagonist Fycompa™(perampanel)” eisai.com ↗ |
| Filed | US (FDA) | Fycompa | simple partial epilepsy | — | “Eisai has submitted marketing authorization applications in Europe and the United States seeking approval of its novel AMPA receptor antagonist Fycompa™(perampanel)” eisai.com ↗ |
| Approved Indication not stated 6 milestones | |||||
| Label expansions (3) | US (FDA) | FYCOMPA | — | 2015-06-19 – 2018-09-27 | fda.gov ↗ |
| Filed | Other | Fycompa | — | 2016-07-04 | “Eisai Mexico has also received approval for the antiepileptic agent Inovelon® and submitted the antiepileptic agent Fycompa® as well as the antiobesity agent lorcaserin for...” eisai.com ↗ “Regarding antiepileptic agents, Eisai Mexico has received approval for Inovelon® and has submitted Fycompa® for regulatory review.” eisai.com ↗ |
| Filed | Other | Fycompa | — | 2013-09-12 | “Eisai has also filed for regulatory approval in Russia for Fycompa® (perampanel), an AMPA receptor antagonist” eisai.com ↗ |
| Filed | Other | Fycompa | — | 2013-04-05 | “In addition, Eisai has also filed for regulatory approval in Russia for AMPA receptor antagonist Fycompa® (perampanel).” eisai.com ↗ |
| Approved | US (FDA) | FYCOMPA | — | 2012-10-22 | fda.gov ↗ |
| Approved | EU (EMA) | Fycompa | — | 2012-07-23 | europa.eu ↗ |
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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 · 1 missed | ||||||
| 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 | Missed primary |
| Phase 1/2 | NCT02131467 | Sep 2017 → Feb 2020 | cervical dystonia | University Health Network, Toronto | Completed | No outcome recorded |
| Phase 224 trials · 1 missed | ||||||
| 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 | Missed primary |
| 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 · 3 met primary · 1 missed | ||||||
| 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 | Missed primary |
| 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 | Met primary |
| Phase 3 | NCT01393743 | Sep 2011 → May 2014 | epilepsy with generalized tonic-clonic seizures | Eisai Inc. | Completed | Met primary |
| 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 | Met primary |
| Phase 3 | NCT00699972 | Apr 2008 → Oct 2010 | focal epilepsy | Eisai Inc. | Completed | Mixed |
| 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 Stop: Enrollment |
| Phase 4 | NCT04417907 | Oct 2021 → May 2023 | epilepsy | Kimford Jay Meador | Terminated | No outcome recorded Stop: Business |
| Phase 4 | NCT04650204 | Dec 2020 → Apr 2023 | epilepsy, grade II glioma, grade III glioma | Mayo Clinic | Terminated | No outcome recorded Stop: Business |
| 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 |
| Comparator or background therapy9 trials | ||||||
| Phase 0 | NCT07284069 Comparator | Mar 2026 → Nov 2028 expected | glioblastoma | Aarhus University Hospital | Recruiting | No outcome recorded |
| Phase 1/2 | NCT04502589 Comparator | Oct 2020 → Aug 2021 | alcohol-related disorders | Virginia Commonwealth University | Completed | No outcome recorded |
| Phase 2 | NCT06401707 Comparator | May 2024 → May 2026 overdue | cardiac arrest, epilepsy | University of California, San Francisco | Recruiting | No outcome recorded |
| Phase 2/3 | NCT00505284 Comparator | Jun 2007 → Jul 2008 | diabetic neuropathy | Eisai Inc. | Completed | No outcome recorded |
| 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 4 | NCT02727101 Comparator | Nov 2015 → Jul 2017 | epilepsy | Mid-Atlantic Epilepsy and Sleep Center, LLC | Terminated | No outcome recorded Stop: Enrollment |
| — | NCT02307578 Background | — | Lennox-Gastaut syndrome | Eisai Inc. | No longer available | No outcome recorded |
| — | NCT01871233 Background | — | focal epilepsy | Eisai Inc. | No longer available | No outcome recorded |
News releases announcing trial results or a regulatory action · 50
| Date | Issuer | Release |
|---|---|---|
| 2024-05-13 | Eisai Inc. | Regulatory ANTIEPILEPTIC DRUG FYCOMPA® APPROVED IN CHINA FOR ADJUNCTIVE TREATMENT OF PRIMARY GENERALIZED TONIC-CLONIC SEIZURES eisai.com ↗
Through this indication expansion, Fycompa can now be used in China as an adjunctive treatment for primary generalized tonic-clonic seizures. |
| 2024-02-22 | Ligand Pharmaceuticals | Regulatory Ligand Partner Eisai Receives Approval in Japan for Injection Formulation of Antiepileptic Drug Fycompa® ligand.com ↗
Ligand Pharmaceuticals Incorporated (Nasdaq: LGND) today announced that its partner Eisai Co., Ltd. obtained marketing authorization approval in January 2024 from the Japanese Ministry of Health, Labour and Welfare for the injection formulation of its in-house discovered antiepileptic drug (AED) Fycompa® (perampanel) in Japan as an alternative therapy when oral administration is temporarily not possible. |
| 2024-01-18 | Eisai Inc. | Regulatory ANTIEPILEPTIC DRUG FYCOMPA® INJECTION FORMULATION APPROVED IN JAPAN ADDRESSING MEDICAL NEEDS FOR TREATMENT THROUGH A NON-ORAL ADMINISTRATION ROUTE eisai.com ↗
announced today that it has obtained marketing authorization approval from the Japanese Ministry of Health, Labour and Welfare for the injection formulation of its in-house discovered antiepileptic drug (AED) Fycompa ® (perampanel) in Japan |
| 2023-03-08 | Catalyst Pharmaceuticals, Inc. | Results Catalyst Pharmaceuticals Announces a Recent Third-Party Publication in Peer-Reviewed Journal Epilepsia Showing Perampanel (FYCOMPA®) Demonstrated High Efficacy in Patients with Rare Genetic Epilepsies globenewswire.com ↗
Out of 137 patients treated with perampanel, 60 patients (43.5%) sustained over 75% reduction in seizure frequency, including 38 (27.5%) with greater than 90% reduction in seizure frequency. |
| 2022-08-30 | Eisai Inc. | Regulatory SUPPLEMENTARY NEW DRUG APPLICATION SUBMITTED IN JAPAN FOR ANTIEPILEPTIC DRUG FYCOMPA® INJECTION FORMULATION AS A NEW ROUTE OF ADMINISTRATION eisai.com ↗ |
| 2021-08-02 | Eisai Inc. | Regulatory ANTI-EPILEPTIC DRUG FYCOMPA® APPROVED IN CHINA AS MONOTHERAPY FOR PARTIAL-ONSET SEIZURES AND PEDIATRIC INDICATION FOR PARTIAL-ONSET SEIZURES eisai.com ↗
Through this approval, Fycompa is now available in China as a monotherapy and an adjunctive treatment for partial-onset seizures (with or without secondarily generalized seizures) in patients with epilepsy 4 years of age and older. |
| 2020-11-16 | Eisai Inc. | Regulatory EISAI RECEIVES APPROVAL FOR INDICATION EXPANSION OF ANTI-EPILEPTIC AGENT FYCOMPA® FOR USE IN PEDIATRIC PATIENTS eisai.com ↗
announced that it has been received approval from the European Commission for the use of its in-house discovered and developed anti-epileptic agent (AED) Fycompa ® (generic name: perampanel) in the treatment of pediatric patients. |
| 2020-10-16 | Eisai Inc. | Regulatory SUPPLEMENTARY NEW DRUG APPLICATIONS FOR ANTI-EPILEPTIC DRUG FYCOMPA® AS MONOTHERAPY FOR PARTIAL-ONSET SEIZURES, PEDIATRIC INDICATION FOR PARTIAL-ONSET SEIZURES ACCEPTED IN CHINA eisai.com ↗
Fycompa ® (product name in China: 卫克泰 ® , generic name: perampanel) as monotherapy for partial-onset seizures and pediatric indication for partial onset seizures in patients with epilepsy 4 years or older have been accepted in China by the National Medical Products Administration. |
| 2020-09-23 | Eisai Inc. | Regulatory EISAI RECEIVES POSITIVE OPINION FROM EMA’S CHMP ON USE OF ANTIEPILEPTIC AGENT FYCOMPA® IN PEDIATRIC PATIENTS eisai.com ↗ |
| 2020-01-23 | Eisai Inc. | Regulatory APPROVAL OF ANTIEPILEPTIC DRUG FYCOMPA® IN JAPAN FOR MONOTHERAPY AND PEDIATRIC INDICATIONS FOR PARTIAL-ONSET SEIZURES, AS WELL AS A NEW FORMULATION eisai.com ↗ |
| 2019-10-15 | Eisai Inc. | Regulatory NEW DRUG APPROVAL FOR FYCOMPA® FOR ADJUNCTIVE TREATMENT OF PARTIAL ONSET SEIZURES IN CHINA eisai.com ↗
Fycompa was designated for Priority Review by the NMPA due to its significant clinical benefits compared to existing treatments, and was approved in about 12 months since the submission in September 2018. |
| 2019-02-13 | Eisai Inc. | Regulatory EISAI SUBMITS APPLICATION IN EUROPE SEEKING APPROVAL FOR FYCOMPA® AS TREATMENT FOR PEDIATRIC PATIENTS WITH EPILEPSY eisai.com ↗
it has submitted an application to the European Medicines Agency (EMA) for its in-house discovered antiepileptic drug (AED) Fycompa ® (perampanel) seeking approval for use in pediatric patients with epilepsy. |
| 2019-01-30 | Eisai Inc. | Regulatory SUPPLEMENTARY NEW DRUG APPLICATION SUBMITTED IN JAPAN FOR FYCOMPA® AS MONOTHERAPY FOR PARTIAL-ONSET SEIZURES, PEDIATRIC INDICATION FOR PARTIAL-ONSET SEIZURES, AS WELL AS NEW FORMULATION eisai.com ↗ |
| 2019-01-04 | Eisai Inc. | Regulatory NEW DRUG APPLICATION FOR PERAMPANEL DESIGNATED FOR PRIORITY REVIEW BY CHINA NATIONAL MEDICAL PRODUCTS ADMINISTRATION FOR ADJUNCTIVE TREATMENT OF PARTIAL ONSET SEIZURES eisai.com ↗
has been designated for Priority Review by the National Medical Products Administration (NMPA) due to perampanel’s significant clinical benefit compared to existing treatments. |
| 2018-11-28 | Eisai Inc. | Results PRIMARY ENDPOINT MET IN PHASE III CLINICAL STUDY OF FYCOMPA® AS MONOTHERAPY FOR PARTIAL-ONSET SEIZURES AIMING FOR SUBMISSION IN JAPAN eisai.com ↗
From the results of this study, the percentage of patients who achieved seizure-free exceeded the criteria for efficacy, and the primary endpoint was met. |
| 2018-10-12 | Eisai Inc. | Regulatory NEW DRUG APPLICATION FOR PERAMPANEL FOR ADJUNCTIVE TREATMENT OF PARTIAL ONSET SEIZURES ACCEPTED IN CHINA eisai.com ↗
Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) has announced that the National Medical Products Administration of China has accepted for review a New Drug Application for Eisai's antiepileptic drug (AED) perampanel (generic name, product name: Fycompa ® ) as an adjunctive treatment for partial onset seizures in epilepsy patients 12 years of age and older. |
| 2018-10-01 | Eisai Inc. | Regulatory FYCOMPA® NEWLY APPROVED BY U.S. FDA AS TREATMENT FOR PARTIAL-ONSET SEIZURES IN PEDIATRIC PATIENTS WITH EPILEPSY eisai.com ↗
Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today that its U.S. subsidiary Eisai Inc. received approval from the U.S. Food and Drug Administration (FDA) for an indication expansion for Eisai's antiepileptic drug (AED) Fycompa (perampanel) to cover partial-onset seizures in pediatric patients with epilepsy 4 years of age and older. |
| 2018-05-31 | Eisai Inc. | Regulatory U.S. FDA DESIGNATES FOR PRIORITY REVIEW EISAI’S SUPPLEMENTAL NEW DRUG APPLICATION FOR ANTIEPILEPTIC DRUG FYCOMPA® AS TREATMENT FOR PEDIATRIC PATIENTS WITH EPILEPSY eisai.com ↗
Furthermore, Eisai has included a study in this sNDA requested by the FDA in a Pediatric Written Request, and therefore FDA has designated this application for Priority Review, which means the review period will be six months. |
| 2018-04-02 | Eisai Inc. | Regulatory EISAI SUBMITS SUPPLEMENTAL NEW DRUG APPLICATION TO U.S. FDA FOR FYCOMPA® AS TREATMENT FOR PEDIATRIC PATIENTS WITH EPILEPSY eisai.com ↗ |
| 2017-07-27 | Eisai Inc. | Regulatory U.S. FDA APPROVES ADDITIONAL USE OF ANTIEPILEPTIC DRUG FYCOMPA® AS MONOTHERAPY FOR PARTIAL-ONSET SEIZURES eisai.com ↗
Fycompa is the first AED to be approved as monotherapy for partial-onset seizures in accordance with this regulatory pathway. |
| 2016-09-27 | Eisai Inc. | Regulatory EISAI SUBMITS SUPPLEMENTAL APPLICATION FOR PARTIAL LABEL CHANGE FOR ANTIEPILEPTIC DRUG FYCOMPA® AS MONOTHERAPY FOR TREATMENT OF PARTIAL-ONSET SEIZURES BASED ON NEW U.S. FDA POLICY eisai.com ↗
Based on the policy, Eisai Inc. has submitted a supplemental application for monotherapy labelling for Fycompa which includes pharmacokinetic information supporting proposed doses to be used in monotherapy. |
| 2016-03-28 | Eisai Inc. | Regulatory EISAI'S IN-HOUSE DEVELOPED ANTIEPILEPTIC DRUG FYCOMPA® (PERAMPANEL HYDRATE) APPROVED IN JAPAN AS ADJUNCTIVE THERAPY FOR PARTIAL-ONSET AND GENERALIZED TONIC-CLONIC SEIZURES eisai.com ↗
Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today that its in-house-discovered antiepileptic drug (AED) Fycompa® (perampanel hydrate) has been approved in Japan as an adjunctive therapy for partial-onset seizures (including secondarily generalized seizures) or primary generalized tonic-clonic seizures in patients with epilepsy showing inadequate response to other AEDs. |
| 2015-11-02 | Eisai Inc. | Results EISAI PRESENTS RESULTS FROM PHASE Ⅲ TRIAL OF ANTIEPILEPTIC DRUG PERAMPANEL AS ADJUNCTIVE THERAPY FOR REFRACTORY PARTIAL-ONSET SEIZURES CONDUCTED IN ASIA INCLUDING JAPAN ORAL PRESENTATION GIVEN AT 49TH CONGRESS OF THE JAPAN EPILEPSY SOCIETY eisai.com ↗
In the study, perampanel demonstrated a significantly higher reduction in seizure frequency compared to placebo. |
| 2015-07-27 | Eisai Inc. | Regulatory EISAI SUBMITS NEW DRUG APPLICATION IN JAPAN FOR IN-HOUSE-DISCOVERED ANTIEPILEPTIC DRUG PERAMPANEL AS ADJUNCTIVE THERAPY FOR PARTIAL-ONSET AND GENERALIZED TONIC-CLONIC SEIZURES eisai.com ↗
Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today it has submitted a new drug application in Japan for its in-house-discovered antiepileptic drug (AED) perampanel hydrate (generic name, U.S. and Europe brand name: Fycompa®, “perampanel”) as an adjunctive therapy for partial-onset and primary generalized tonic-clonic seizures. |
| 2015-06-25 | Eisai Inc. | Regulatory EUROPEAN COMMISSION APPROVES INDICATION EXPANSION OF EISAI’S ANTIEPILEPTIC AGENT FYCOMPA® FOR ADJUNCTIVE TREATMENT OF PRIMARY GENERALIZED TONIC-CLONIC SEIZURES eisai.com ↗
Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today that its U.K. subsidiary Eisai Europe Ltd. has received approval from the European Commission (EC) for an indication expansion regarding the use of its in-house developed antiepileptic agent Fycompa® (perampanel hydrate) for the adjunctive treatment of primary generalized tonic-clonic (PGTC) seizures in adult and adolescent patients from 12 years of age with idiopathic generalized epilepsy. |
| 2015-06-22 | Eisai Inc. | Regulatory U.S. FDA APPROVES EISAI’S ANTIEPILEPTIC AGENT FYCOMPA® AS ADJUNCTIVE TREATMENT FOR PRIMARY GENERALIZED TONIC-CLONIC SEIZURES eisai.com ↗
The FDA's decision to approve the indication expansion was based on a placebo-controlled clinical phase Ⅲ study (Study 332) of Fycompa in 164 patients aged 12 years and older with PGTC seizures. |
| 2015-05-27 | Eisai Inc. | Regulatory EISAI RECEIVES POSITIVE CHMP OPINION ON INDICATION EXPANSION FOR ANTIEPILEPTIC AGENT FYCOMPA® (PERAMPANEL) AS ADJUNCTIVE TREATMENT OF PRIMARY GENERALIZED TONIC-CLONIC SEIZURES eisai.com ↗ |
| 2015-04-24 | Eisai Inc. | Regulatory EISAI COMMENCES BUSINESS IN MEXICO, AIMS TO EXPAND CONTRIBUTION TO PATIENTS IN LATIN AMERICA ANTICANCER AGENTS HALAVEN® AND GLIADEL® NEWLY LAUNCHED eisai.com ↗
In addition to these newly launched anticancer products, Eisai Mexico has submitted the antiepileptic agents Inovelon® and Fycompa®, the anticancer agent Targretin® as well as the antiobesity agent BELVIQ® for regulatory review. |
| 2015-01-05 | Eisai Inc. | Results PHASE Ⅲ TRIAL OF ANTIEPILEPTIC DRUG PERAMPANEL AS ADJUNCTIVE THERAPY IN PATIENTS WITH REFRACTORY PARTIAL-ONSET SEIZURES CONDUCTED IN ASIA INCLUDING JAPAN AND CHINA MEETS PRIMARY ENDPOINT eisai.com ↗
Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today that a Phase Ⅲ clinical trial (Study 335) of its in-house-discovered antiepileptic drug (AED) perampanel (generic name, U.S. and Europe brand name: Fycompa®) in patients with refractory partial-onset seizures conducted in Asia (including Japan and China) has met its primary endpoint. |
| 2014-12-08 | Eisai Inc. | Results EISAI PRESENTS RESULTS FROM PHASE Ⅲ TRIAL OF ANTIEPILEPTIC DRUG FYCOMPA® AS ADJUNCTIVE THERAPY FOR PRIMARY GENERALIZED TONIC-CLONIC SEIZURES AT 68TH AMERICAN EPILEPSY SOCIETY ANNUAL MEETING eisai.com ↗
A reduction in PGTC seizure frequency of 76.5% was observed in the Fycompa group, which was statistically significant when compared to a reduction of 38.4% for placebo (p<0.0001). |
| 2014-11-07 | Eisai Inc. | Regulatory STATEMENT REGARDING THE GERMAN FEDERAL JOINT COMMITTEE'S DECISION ON ANTIEPILEPTIC DRUG FYCOMPA® eisai.com ↗
It is deeply regrettable that the G-BA's conclusion did not appropriately assess the clinical value brought about by the innovative properties of Fycompa or the needs of patients. |
| 2014-10-21 | Eisai Inc. | Regulatory U.S. FDA ACCEPTS sNDA FOR ANTIEPILEPTIC AGENT FYCOMPA® AS ADJUNCTIVE TREATMENT OF PRIMARY GENERALIZED TONIC-CLONIC SEIZURES eisai.com ↗ |
| 2014-08-20 | Eisai Inc. | Regulatory EISAI SUBMITS APPLICATIONS FOR ANTIEPILEPSY AGENT FYCOMPA® SIMULTANEOUSLY IN EUROPE AND U.S. SEEKING INDICATION EXPANSION AS ADJUNCTIVE TREATMENT OF PRIMARY GENERALIZED TONIC-CLONIC SEIZURES eisai.com ↗ |
| 2014-06-17 | Eisai Inc. | Results PHASE Ⅲ TRIAL OF ANTIEPILEPTIC DRUG FYCOMPA® (PERAMPANEL) MEETS PRIMARY ENDPOINTS AS ADJUNCTIVE THERAPY IN PATIENTS WITH UNCONTROLLED PRIMARY GENERALIZED TONIC-CLONIC SEIZURES eisai.com ↗
Fycompa significantly reduced PGTC seizure frequency |
| 2014-05-12 | Eisai Inc. | Regulatory EISAI RESUBMITS ANTIEPILEPTIC DRUG FYCOMPA® TO GERMAN FEDERAL JOINT COMMITTEE FOR ADDITIONAL BENEFIT ASSESSMENT eisai.com ↗ |
| 2013-09-12 | Eisai Inc. | Regulatory EISAI ANNOUNCES LAUNCH OF ANTICANCER AGENT HALAVEN® AS COMPANY'S FIRST PRODUCT IN RUSSIA eisai.com ↗
Moreover, Eisai has also filed for regulatory approval in Russia for Fycompa® (perampanel), an AMPA receptor antagonist, and Inovelon® (rufinamide), a treatment for seizures associated with Lennox-Gastaut syndrome. |
| 2013-04-05 | Eisai Inc. | Regulatory EISAI ESTABLISHES PHARMA SALES SUBSIDIARY IN MOSCOW AHEAD OF PLANNED DIRECT SALES LAUNCH IN RUSSIA eisai.com ↗
In addition, Eisai has also filed for regulatory approval in Russia for AMPA receptor antagonist Fycompa® (perampanel). |
| 2012-12-11 | Eisai Inc. | Regulatory SCOTTISH MEDICINES CONSORTIUM APPROVES AMPA RECEPTOR ANTAGONIST FYCOMPA® AS ANTIEPILEPTIC TREATMENT UNDER NATIONAL HEALTH SERVICE SCOTLAND eisai.com ↗
The SMC approval of perampanel is the drug’s first HTA worldwide. |
| 2012-10-23 | Eisai Inc. | Regulatory U.S. FDA APPROVES EISAI’S AMPA RECEPTOR ANTAGONIST FYCOMPA™ (PERAMPANEL) AS ADJUNCTIVE TREATMENT FOR PARTIAL-ONSET SEIZURES IN PATIENTS WITH EPILEPSY AGE 12 AND OLDER eisai.com ↗ |
| 2012-09-25 | Eisai Inc. | Regulatory EISAI OPENS NEW SOLID DOSE GLOBAL MANUFACTURING LINE FOR ANTIEPILEPTIC AGENT FYCOMPA® AT ITS PRODUCTION PLANT IN HATFIELD, U.K. Ceremony attended by Rt Hon. David Willetts, Minister of State for Universities and Science eisai.com ↗
has received a license (marketing authorization type II variation: addition of manufacturing site) from the European regulatory authorities for solid dose manufacturing of the antiepileptic agent Fycompa® (perampanel) |
| 2012-07-27 | Eisai Inc. | Regulatory EUROPEAN COMMISSION APPROVES EISAI'S AMPA RECEPTOR ANTAGONIST FYCOMPA® (PERAMPANEL) First Approval for the New Class of Partial Epilepsy Treatment in the World eisai.com ↗ |
| 2012-05-28 | Eisai Inc. | Regulatory EISAI GAINS POSITIVE CHMP OPINION FOR AMPA RECEPTOR ANTAGONIST FYCOMPA™ (PERAMPANEL) eisai.com ↗
its U.K. subsidiary Eisai Europe Ltd. has received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for the use of Fycompa TM (perampanel) |
| 2012-03-06 | Eisai Inc. | Regulatory U.S. FDA ACCEPTS RESUBMISSION OF AMPA RECEPTOR ANTAGONIST PERAMPANEL (E2007) NEW DRUG APPLICATION eisai.com ↗
Acceptance of the NDA indicates that the FDA has found the company's resubmission to be sufficiently complete to review. |
| 2011-12-26 | Eisai Inc. | Regulatory EISAI RESUBMITS AMPA RECEPTOR ANTAGONIST PERAMPANEL (E2007) NDA TO U.S. FDA eisai.com ↗
Eisai Co., Ltd. (Headquarters: Tokyo, President & CEO: Haruo Naito, “Eisai”) announced today that it resubmitted the New Drug Application (NDA) for the investigational AMPA receptor antagonist perampanel for partial-onset seizures associated with epilepsy to the U.S. Food and Drug Administration (FDA) on December 22, 2011 (U.S. eastern standard time). |
| 2011-09-01 | Eisai Inc. | Results EISAI PRESENTS NEW RESEARCH ON EPILEPSY PIPELINE, PORTFOLIO AT THE 29TH INTERNATIONAL EPILEPSY CONGRESS Looks to Expand Global Epilepsy Product Portfolio eisai.com ↗
perampanel 12 mg once-daily reduced median-frequency by 17.6 percent (p=0.0011) versus placebo (9.7 percent) among patients receiving treatment with one to three other epilepsy drugs. |
| 2011-07-29 | Eisai Inc. | Regulatory U.S. FDA PROVIDES RESPONSE TO PERAMPANEL NEW DRUG APPLICATION eisai.com ↗
Eisai Co., Ltd. (Headquarters: Tokyo, President & CEO: Haruo Naito, “Eisai”) announced today that the U.S. Food and Drug Administration (FDA) has issued a Refusal to File letter in response to the company's New Drug Application (NDA) for perampanel (E2007), an investigational drug, for the treatment of partial-onset seizures associated with epilepsy which was submitted in May 2011. |
| 2011-06-24 | Eisai Inc. | Regulatory EUROPEAN MEDICINES AGENCY ACCEPTS FOR REVIEW EISAI'S MAA FOR AMPA RECEPTOR ANTAGONIST PERAMPANEL (E2007) eisai.com ↗
Eisai Co., Ltd. (Headquarters: Tokyo, President & CEO: Haruo Naito, “Eisai”) announced today that the European Medicines Agency (EMA) has accepted for review the company's Marketing Authorization Application (MAA) for the AMPA receptor antagonist perampanel (E2007) for the treatment of partial-onset seizures associated with epilepsy. |
| 2010-08-24 | Eisai Inc. | Results EISAI ANNOUNCES POSITIVE RESULTS OF PHASE Ⅲ TRIAL FOR PERAMPANEL IN EPILEPSY eisai.com ↗
Eisai Co., Ltd. (Headquarters: Tokyo, President & CEO: Haruo Naito, “Eisai”) announced today that results of a Phase III study in epilepsy patients with refractory partial seizures demonstrate the clinical benefits of the novel investigational compound E2007 (generic name: perampanel). |
| 2008-04-11 | Eisai Inc. | Results Status of the E2007 (perampanel) Development Program Termination of Parkinson's Disease Clinical Development and Focus on Neuropathic Pain and Epilepsy Indications eisai.com ↗
The results, compared with placebo, did not show a significant difference in the primary endpoint of reduction of "off" time (time when signs and symptoms of Parkinson's disease return as the effect of levodopa wears off). |
| 2007-10-30 | Eisai Inc. | Results Eisai Announces Change in Regulatory Submission Strategy of E2007 for Parkinson's Disease eisai.com ↗
According to the currently available analysis results, E2007, compared with placebo, did not show a significant difference in the primary endpoint of reduction in “off” time (time when Parkinson's symptoms return as the effect of levodopa wears off). |
All press releases naming this drug 81 releases
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 |