Drugs / Rufinamide
Rufinamide
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| 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 9 · a red edge is where a trial was stopped
| 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 22 trials | ||||||
| Phase 2 | NCT02095899 | Mar 2014 → May 2015 | peripheral nerve lesion | University of Zurich | Withdrawn | No outcome recorded |
| Phase 2 | NCT00595231 | Mar → Oct 2008 | generalized anxiety disorder | Biotie Therapies Inc. | Completed | No outcome recorded |
| Phase 34 trials | ||||||
| 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 | No outcome recorded |
| 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| Phase 3 | NCT04558580 | Apr 2006 → Dec 2008 | epilepsy | University of South Alabama | Withdrawn | No outcome recorded |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 |
Also used as a comparator or background therapy in 4 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 32 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 42 trials | ||||||
| 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 |
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 15 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 ↗ |
| Known as | SYN111 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00595231 ↗ |
| 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 ↗ |