rufinamide
Trade name: banzel
Approved
Nov 14, 2008
Rufinamide is an anti-epileptic drug that is FDA approved for the treatment of lennox-gastaut syndrome (LGS). The principal mechanism of action of rufinamide is modulation of the activity of sodium channels and, in particular, prolongation of the inactive state of the channel. Hormonal contraceptives may be less effective with rufinamide. Patients on valproate should begin at a rufinamide dose lower than 10 mg/kg per day (pediatric patients) or 400 mg per day (adults). Common adverse reactions include headache, dizziness, fatigue, somnolence, and nausea. — NCATS
Clinical trial activity
12 trials · 10 clinical orgs · 15 marketing orgs
Earliest trial started Feb 1, 2006 (NCT00334958)
Timeline
2000s
2010s
- Jan 1, 2014
Earliest Phase 1 Sponsor(trial)
- May 16, 2016
Glenmark Pharmaceuticals — Marketing Organization
- May 16, 2016
Mylan — Marketing Organization
- May 16, 2016
West-Ward Pharmaceutical — Marketing Organization
- May 16, 2016
PHARMOBEDIENT — Marketing Organization
- Apr 23, 2019
Bionpharma Inc — Marketing Organization
- Apr 23, 2019
Hikma — Marketing Organization
2020s
- Oct 19, 2020
Glasshouse Pharmaceuticals — Marketing Organization
- Dec 18, 2020
Lupin — Marketing Organization
- Feb 23, 2021
Alkem Labs Ltd — Marketing Organization
- May 11, 2021
Hetero Labs Ltd — Marketing Organization
- Oct 26, 2022
Aurobindo Pharma — Marketing Organization
- Nov 7, 2022
Chartwell Pharmaceuticals — Marketing Organization
- May 15, 2023
Micro Labs Ltd India — Marketing Organization
- Apr 15, 2025
MSN Laboratories — Marketing Organization
Indications
Approved for
Mechanism of action
- Sodium channel alpha subunitBLOCKER
Sodium channel alpha subunit blocker
- Sodium channel protein type 1 subunit alpha (SCN1A) ↗
- Sodium channel protein type 5 subunit alpha (SCN5A) ↗
- Sodium channel protein type 4 subunit alpha (SCN4A) ↗
- Sodium channel protein type 7 subunit alpha (SCN7A) ↗
- Sodium channel protein type 2 subunit alpha (SCN2A) ↗
- Sodium channel protein type 9 subunit alpha (SCN9A) ↗
- Sodium channel protein type 3 subunit alpha (SCN3A) ↗
- Sodium channel protein type 11 subunit alpha (SCN11A) ↗
- Sodium channel protein type 8 subunit alpha (SCN8A) ↗
- Sodium channel protein type 10 subunit alpha (SCN10A) ↗
- Sodium channel protein type I alpha subunit
- Sodium channel protein type V alpha subunit
- Sodium channel protein type IV alpha subunit
- Sodium channel protein type VII alpha subunit
- Sodium channel protein type IX alpha subunit
- Sodium channel protein type II alpha subunit
- Sodium channel protein type III alpha subunit
- Sodium channel protein type XI alpha subunit
- Sodium channel protein type VIII alpha subunit
- Sodium channel protein type X alpha subunit
- Sodium channel alpha subunits; brain (Types I, II, III)
Approval history
- approvedNov 14, 2008
Chemistry & pharmacology
SMILES
NC(=O)C1=CN(CC2=C(F)C=CC=C2F)N=N1- Mol. weight
- 238.1935 g/mol
- Lipinski Ro5
- Pass
- Rule of 3
- No
- Chirality
- Achiral Molecule
- Inorganic
- No
- Polymer
- No
- Delivery
- Oral
- Availability
- Prescription Only
Oral
Yes
Parenteral
No
Topical
No
Sources
- WikipediaRufinamide ↗
- NCATSWFW942PR79 ↗
- ChEMBLCHEMBL1201754 ↗
Also known as
- 1-(2,6-difluorobenzyl)-1h-1,2,3-triazole-4-carboxamide
- 1h-1,2,3-triazole-4-carboxamide, 1-((2,6-difluorophenyl)methyl)-
- 60231/4
- banzel
- banzel
- banzel
- banzel
- cgp 33101
- cgp 33101
- cgp-33101
- cgp-33101
- cgp-33101
- cgp-33101
- e2080
- e2080
- e2080
- inovelon
- inovelon
- inovelon
- inovelon
- ruf-331
- ruf-331
- rufinamide
- rufinamide
- rufinamide
- rufinamide
- rufinamide
- rufinamide
- rufinamide
- rufinamide
- rufinamide
- rufinamide
- rufinamide
- rufinamide
- syn111
- syn111
- xilep
- xilep
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT06740825 | Phase 1 | Oct 29, 2024 | Daiichi Sankyo |
| NCT04650204 | Phase 4 | Dec 15, 2020 | Mayo Clinic, National Cancer Institute (NCI) |
| NCT02095899 | Phase 2 | Mar 1, 2014 | University of Zurich |
| NCT02332174 | Phase 1 | Mar 1, 2014 | Huazhong University of Science and Technology |
| NCT01405053 | Phase 3 | Jun 1, 2011 | Eisai, Hopital Femme Mere Enfant |
| NCT01151540 | Phase 3 | Nov 1, 2010 | Eisai |
| NCT01146951 | Phase 3 | Jun 1, 2010 | Eisai |
| NCT00595231 | Phase 2 | Mar 1, 2008 | Biotie Therapies, INC Research |
| NCT00448539 | Phase 3 | Mar 1, 2007 | Eisai |
| NCT04558580 | Phase 3 | Apr 30, 2006 | University of South Alabama |
| NCT00334958 | Phase 3 | Feb 1, 2006 | Eisai |
| NCT03778424 | N/A | — | Eisai |
Organizations
Research & Development (10)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Eisai | For profit | 6 | 6 | 2 | 2006 |
| Biotie Therapies | For profit | 1 | 1 | 1 | 2008 |
| Daiichi Sankyo | For profit | 1 | 1 | 1 | 2024 |
| Hopital Femme Mere Enfant | Academic/Hospital | 1 | 0 | 1 | 2011 |
| Huazhong University of Science and Technology | Academic/Hospital | 1 | 1 | 1 | 2014 |
| INC Research | For profit | 1 | 0 | 1 | 2008 |
| Mayo Clinic | Academic/Hospital | 1 | 1 | 1 | 2020 |
| National Cancer Institute (NCI) | Government | 1 | 0 | 1 | 2020 |
| University of South Alabama | Academic/Hospital | 1 | 1 | 1 | 2006 |
| University of Zurich | Academic/Hospital | 1 | 1 | 1 | 2014 |
Marketing (20)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Alkem Labs Ltd | For profit | MKTG | Feb 23, 2021 |
| Aurobindo Pharma | For profit | MKTG | Oct 26, 2022 |
| Bionpharma Inc | For profit | MKTG | Apr 23, 2019 |
| Bionpharma Inc | For profit | SYN | Apr 23, 2019 |
| Chartwell Pharmaceuticals | For profit | MKTG | Nov 7, 2022 |
| Eisai | For profit | NDA | Nov 14, 2008 |
| Glasshouse Pharmaceuticals | For profit | SYN | Nov 7, 2022 |
| Glasshouse Pharmaceuticals | For profit | MKTG | Oct 19, 2020 |
| Glenmark Pharmaceuticals | For profit | MKTG | May 16, 2016 |
| Hetero Labs Ltd | For profit | MKTG | May 11, 2021 |
| Hikma | For profit | MKTG | Apr 23, 2019 |
| Hikma | For profit | SYN | May 16, 2016 |
| Lupin | For profit | MKTG | Dec 18, 2020 |
| Lupin | For profit | SYN | Dec 18, 2020 |
| MSN Laboratories | For profit | MKTG | Apr 15, 2025 |
| Micro Labs Ltd India | For profit | MKTG | May 15, 2023 |
| Mylan | For profit | MKTG | May 16, 2016 |
| Mylan | For profit | SYN | May 16, 2016 |
| PHARMOBEDIENT | For profit | MKTG | May 16, 2016 |
| West-Ward Pharmaceutical | For profit | MKTG | May 16, 2016 |