Drugs / Rufinamide
Rufinamide
Regulatory milestones approvals, filings & regulatory actions · 6 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed Lennox-Gastaut syndrome 2 milestones | |||||
| Filed | Other | Inovelon | Lennox-Gastaut syndrome | 2013-09-12 | “Eisai has also filed for regulatory approval in Russia for Fycompa® (perampanel), an AMPA receptor antagonist, and Inovelon® (rufinamide), a treatment for seizures associated...” eisai.com ↗ |
| Filed | Japan (PMDA) | — | Lennox-Gastaut syndrome | 2012-08-30 | “it has submitted a marketing authorization application to Japan’s Ministry of Health, Labour and Welfare (MHLW) for rufinamide” eisai.com ↗ |
| Rejected simple partial epilepsy 1 milestone | |||||
| Rejected (CRL) | US (FDA) | BANZEL | simple partial epilepsy | — | “Eisai received a complete response letter for BANZEL™ as an adjunctive treatment for partial-onset seizures” eisai.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| Label expansion | US (FDA) | BANZEL | — | 2015-02-12 | fda.gov ↗ |
| Approved | US (FDA) | BANZEL | — | 2008-11-14 | fda.gov ↗ |
| Approved | EU (EMA) | Inovelon | — | 2007-01-16 | europa.eu ↗ |
Trials 8
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT06740825 | Oct → Dec 2024 | — | Daiichi Sankyo | Completed | No outcome recorded |
| Phase 1 | NCT02332174 | Mar → Jun 2014 | epilepsy | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT02095899 | Mar 2014 → May 2015 | peripheral nerve lesion | University of Zurich | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 34 trials · 1 met primary | ||||||
| Phase 3 | NCT01151540 | Nov 2010 → Aug 2013 | Lennox-Gastaut syndrome | Eisai Inc. | Completed | No outcome recorded |
| Phase 3 | NCT01146951 | Jun 2010 → Aug 2011 | Lennox-Gastaut syndrome | Eisai Inc. | Completed | Met primary |
| Phase 3 | NCT00448539 | Mar 2007 → May 2010 | focal epilepsy | Eisai Inc. | Terminated | No outcome recorded |
| Phase 3 | NCT04558580 | Apr 2006 → Dec 2008 | epilepsy | University of South Alabama | Withdrawn | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT03778424 | — | Lennox-Gastaut syndrome | Eisai Inc. | Available | No outcome recorded |
| Comparator or background therapy4 trials | ||||||
| Phase 3 | NCT01405053 Comparator | Jun 2011 → Nov 2015 | Lennox-Gastaut syndrome | Eisai Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00334958 Comparator | Feb 2006 → May 2009 | epilepsy | Eisai Inc. | Completed | No outcome recorded |
| Phase 4 | NCT02205931 Comparator | Jan 2015 → Jun 2018 | epilepsy | University College, London | Unknown | No outcome recorded |
| Phase 4 | NCT00552526 Comparator | Nov 2007 → Jan 2011 | epilepsy | Oslo University Hospital | Unknown | No outcome recorded |
News releases announcing trial results or a regulatory action · 11
| Date | Issuer | Release |
|---|---|---|
| 2022-11-02 | Eisai Inc. | Regulatory EISAI SATISFIES ALL-CASE STUDY REQUIREMENT FOR ANTIEPILEPTIC AGENT INOVELON® eisai.com ↗
the MHLW has concluded that the all-case study was conducted properly and the necessary measures to ensure proper use of the product were sufficient to lift the condition. |
| 2015-02-16 | Eisai Inc. | Regulatory EISAI RECEIVES APPROVAL OF ANTIEPILEPTIC DRUG BANZEL® (RUFINAMIDE) AS ADJUNCTIVE TREATMENT FOR PEDIATRIC PATIENTS IN THE UNITED STATES U.S. PATENT EXCLUSIVITY EXTENDED BY SIX MONTHS eisai.com ↗
Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today that its U.S. subsidiary Eisai Inc. has received approval of an additional pediatric indication for Eisai's antiepileptic drug (AED) BANZEL®(rufinamide) from the U.S. Food and Drug Administration (FDA). |
| 2014-10-15 | Eisai Inc. | Regulatory U.S. FDA ACCEPTS EISAI'S sNDA FOR BANZEL® (RUFINAMIDE) AS ADJUNCTIVE TREATMENT IN PEDIATRIC PATIENTS WITH LENNOX-GASTAUT SYNDROME eisai.com ↗
Acceptance of the sNDA indicates that the FDA has found the company's submission to be sufficiently complete to review. |
| 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. |
| 2013-03-25 | Eisai Inc. | Regulatory EISAI RECEIVES MANUFACTURING AND MARKETING AUTHORIZATION FOR ANTIEPILEPTIC AGENT INOVELON® IN JAPAN eisai.com ↗
Eisai Co., Ltd. (Headquarters: Tokyo, President & CEO: Haruo Naito, “Eisai”) announced today that it has received manufacturing and marketing authorization in Japan from the Japanese Ministry of Health, Labour and Welfare (MHLW) for antiepileptic agent Inovelon® (rufinamide), approving the drug as an adjunctive therapy to other antiepileptic drugs (AEDs) in the treatment of Lennox-Gastaut syndrome (LGS), a rare disorder. |
| 2012-08-30 | Eisai Inc. | Regulatory EISAI SUBMITS APPLICATION IN JAPAN FOR ANTIEPILEPTIC AGENT RUFINAMIDE FOR LENNOX-GASTAUT SYNDROME eisai.com ↗
Eisai Co., Ltd. (Headquarters: Tokyo, President & CEO: Haruo Naito, “Eisai”) announced today that it has submitted a marketing authorization application to Japan’s Ministry of Health, Labour and Welfare (MHLW) for rufinamide (generic name), an antiepileptic agent developed by the company in Japan. |
| 2011-06-28 | Eisai Inc. | Regulatory EISAI'S ANTIEPILEPTIC AGENT BANZEL™ RECEIVES APPROVAL IN CANADA eisai.com ↗
Eisai Co., Ltd. (Headquarters: Tokyo, President & CEO: Haruo Naito, “Eisai”) announced today that its Canadian pharmaceutical subsidiary Eisai Limited ( “Eisai Canada”) has received approval to market the company's antiepileptic agent Banzel™ (rufinamide) for adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome (LGS) in children 4 years and older and adults. |
| 2011-03-04 | Eisai Inc. | Regulatory U.S. FDA APPROVES ANTI-EPILEPTIC AGENT BANZEL® (RUFINAMIDE) ORAL SUSPENSION, 40MG/ML Indicated for Adjunctive Treatment of Seizures Associated With Lennox-Gastaut Syndrome in Children 4 Years and Older and Adults eisai.com ↗ |
| 2010-07-20 | Eisai Inc. | Regulatory FDA ACCEPTS BANZEL® (RUFINAMIDE) ORAL SUSPENSION NDA FOR REVIEW eisai.com ↗
Eisai Co., Ltd. (Headquarters: Tokyo, President & CEO: Haruo Naito) announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) submitted by its U.S. subsidiary Eisai Inc. for a new oral suspension (40 mg/mL) formulation of the Eisai's antiepileptic agent BANZEL® (generic name: rufinamide). |
| 2008-11-17 | Eisai Inc. | Regulatory FDA Approves BANZEL™ (rufinamide) as Adjunctive Treatment for Lennox-Gastaut Syndrome eisai.com ↗
the U.S. Food and Drug Administration (FDA) approved BANZEL™ (rufinamide) for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in children 4 years and older and adults. |
| 2007-01-22 | Eisai Inc. | Regulatory Inovelon® recieves Marketing Authorization Approval from European Commission eisai.com ↗
In November, 2006, the company received a positive opinion by the Committee for Medicinal Products for Human Use, which was ratified by EC at this time. |
All press releases naming this drug 22 releases
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 14 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | rufinamide | “Drugs from ACT groups N03A, N05BA, N05CD, H02A or S01EC will be used including prednisolon,levetiracetam, valproate, carbamazepine, oxcarbazepine, topiramate, felbamate,...” NCT00552526 ↗ |
| Known as | 60231/4 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201754 ↗ |
| Known as | Banzel | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201754 ↗ |
| Known as | CGP 33101 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201754 ↗ |
| Known as | E-2080 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201754 ↗ |
| Known as | Inovelon | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201754 ↗ |
| Known as | RUF 331 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201754 ↗ |
| Known as | Rufinamida | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201754 ↗ |
| Modality | Small molecule | “rufinamide, a novel anticonvulsant medication, which, as a triazole derivative, is structurally unrelated to any other currently used anticonvulsant medication” PMID 33179247 ↗ Nov 2020 |
| Route | Oral | “Rufinamide will be administered orally” NCT00334958 ↗ |