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Drug

Rufinamide

Established medicine
ClassSodium channel alpha subunit blockerResearchOngoing clinical research

Also known as Banzel, Rufinamida.

RxNorm69036ChEMBLCHEMBL1201754ATCN03AF03UNIIWFW942PR79
10
Protein targets
1
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

A Phase 1, Open Label, Randomized, Parallel Drug Interaction Study to Evaluate the Effect of a CYP3A Weak Inducer Rufinamide on the Pharmacokinetics of Quizartinib in Healthy Subjects

Clinical trial2024-12-09Completed · ClinicalTrials.gov

A Double-Blind, Placebo-Controlled, Parallel-Group Study of Rufinamide Given as Adjunctive Therapy in Patients With Refractory Partial Seizures

Clinical trial2021-06-14Results posted · ClinicalTrials.gov

A Multicenter, Randomized, Controlled, Open-label Study to Evaluate the Cognitive Development Effects and Safety, and Pharmacokinetics of Adjunctive Rufinamide Treatment in Pediatric Subjects 1 to Less Than 4 Years of Age With Inadequately Controlled Lennox-Gastaut Syndrome

Clinical trial2019-08-06Results posted · ClinicalTrials.gov

A Long Term Extension Study of E2080 in Lennox-Gastaut Patients

Clinical trial2019-03-11Results posted · ClinicalTrials.gov

A Placebo-Controlled, Double-Blind Comparative Study of E2080 in Lennox-Gastaut Syndrome Patients

Clinical trial2018-01-24Results posted · ClinicalTrials.gov

Effect of Rufinamide on Chronic Postthoracotomy Pain Syndrome. A Prospective, Randomized, Double-blind, Placebo Controlled, Monocenter Study.

Clinical trial2015-05-01Withdrawn · ClinicalTrials.gov

Pharmacokinetics and Tolerability of Rufinamide Following Single and Multiple Oral Doses and Effect of Food on Pharmacokinetics in Healthy Chinese Subjects

Clinical trial2014-06-01Completed · ClinicalTrials.gov

An Open-Label Extension Study of Rufinamide Given as Adjunctive Therapy in Patients With Refractory Partial Seizures

Clinical trial2010-05-14Terminated · ClinicalTrials.gov

A Double-Blind, Placebo-Controlled, Parallel-Group Study of Rufinamide Given as Adjunctive Therapy in Patients With Refractory Partial Seizures

Clinical trial2008-12-01Withdrawn · ClinicalTrials.gov

Approval: Inovelon (EMA)

Regulatory2007-01-16EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Rufinamide
Aliases & brands
BanzelRufinamida
RxNorm CUI
69036
ChEMBL ID
CHEMBL1201754
ATC codes
N03AF03
UNII
WFW942PR79
Primary mechanism
Sodium channel alpha subunit blocker
Regulatory jurisdictions
ema

Pharmacology & targets

10 targets

Known molecular targets and mechanisms supported by curated pharmacology databases.

Sodium channel protein type 1 subunit alpha
SCN1A · P35498
BLOCKERSodium channel alpha subunit blocker
Sodium channel protein type 5 subunit alpha
SCN5A · Q14524
BLOCKERSodium channel alpha subunit blocker
Sodium channel protein type 4 subunit alpha
SCN4A · P35499
BLOCKERSodium channel alpha subunit blocker
Sodium channel protein type 7 subunit alpha
SCN7A · Q01118
BLOCKERSodium channel alpha subunit blocker
Sodium channel protein type 2 subunit alpha
SCN2A · Q99250
BLOCKERSodium channel alpha subunit blocker
Sodium channel protein type 9 subunit alpha
SCN9A · Q15858
BLOCKERSodium channel alpha subunit blocker
Sodium channel protein type 3 subunit alpha
SCN3A · Q9NY46
BLOCKERSodium channel alpha subunit blocker
Sodium channel protein type 11 subunit alpha
SCN11A · Q9UI33
BLOCKERSodium channel alpha subunit blocker
Sodium channel protein type 8 subunit alpha
SCN8A · Q9UQD0
BLOCKERSodium channel alpha subunit blocker
Sodium channel protein type 10 subunit alpha
SCN10A · Q9Y5Y9
BLOCKERSodium channel alpha subunit blocker

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2007-01-16
Latest approval
2007-01-16
Authorities
EMA
Total events
1
emaEuropean Medicines Agency· 1 event
2007-01-16Approval
Approval: Inovelon (EMA)

Indication: Inovelon is indicated as adjunctive therapy in the treatment of seizures associated with Lennox Gastaut syndrome in patients 4 years of age and older.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

9 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
9
registered trials across all phases
LATEST COMPLETION 2024
6
Late-stage (III+)
6
Completed
3
Discontinued
PHASE DISTRIBUTIONn = 9
Phase 12Phase 21Phase 36

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

A Multicenter, Randomized, Controlled, Open-label Study to Evaluate the Cognitive Development Effects and Safety, and Pharmacokinetics of Adjunctive Rufinamide Treatment in Pediatric Subjects 1 to Less Than 4 Years of Age With Inadequately Controlled Lennox-Gastaut Syndrome

CompletedPH IIIEisai Inc.n=372015

A Long Term Extension Study of E2080 in Lennox-Gastaut Patients

CompletedPH IIIEisai Co., Ltd.n=542013

A Placebo-Controlled, Double-Blind Comparative Study of E2080 in Lennox-Gastaut Syndrome Patients

CompletedPH IIIEisai Limitedn=662011

An Open-Label Extension Study of Rufinamide Given as Adjunctive Therapy in Patients With Refractory Partial Seizures

TerminatedPH IIIEisai Inc.n=2862010

A Double-Blind, Placebo-Controlled, Parallel-Group Study of Rufinamide Given as Adjunctive Therapy in Patients With Refractory Partial Seizures

CompletedPH IIIEisai Inc.n=3562009

Recent completions

Trials that read out recently, adding to the completed evidence base.

A Phase 1, Open Label, Randomized, Parallel Drug Interaction Study to Evaluate the Effect of a CYP3A Weak Inducer Rufinamide on the Pharmacokinetics of Quizartinib in Healthy Subjects

CompletedPH IDaiichi Sankyon=322024

A Multicenter, Randomized, Controlled, Open-label Study to Evaluate the Cognitive Development Effects and Safety, and Pharmacokinetics of Adjunctive Rufinamide Treatment in Pediatric Subjects 1 to Less Than 4 Years of Age With Inadequately Controlled Lennox-Gastaut Syndrome

CompletedPH IIIEisai Inc.n=372015

Pharmacokinetics and Tolerability of Rufinamide Following Single and Multiple Oral Doses and Effect of Food on Pharmacokinetics in Healthy Chinese Subjects

CompletedPH IUnion Hospital, Tongji Medical College, Huazhong University of Science and Technologyn=402014

A Long Term Extension Study of E2080 in Lennox-Gastaut Patients

CompletedPH IIIEisai Co., Ltd.n=542013

A Placebo-Controlled, Double-Blind Comparative Study of E2080 in Lennox-Gastaut Syndrome Patients

CompletedPH IIIEisai Limitedn=662011

A Double-Blind, Placebo-Controlled, Parallel-Group Study of Rufinamide Given as Adjunctive Therapy in Patients With Refractory Partial Seizures

CompletedPH IIIEisai Inc.n=3562009
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.