Product Description
Rufinamide is a triazole derivative structurally unrelated to currently marketed antiepileptic drugs. Rufinamide was profiled for anticonvulsant activity at the National Institutes of Health and showed broad-spectrum anticonvulsant properties at nontoxic doses in animal models. (Sourced from: https://pubmed.ncbi.nlm.nih.gov/17199032/)
Mechanisms of Action: Sodium Channel Blocker
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: *
Approval Status: Approved
Approved Countries: Argentina | Australia | Austria | Belgium | Brazil | Canada | Chile | Colombia | Croatia | Cyprus | Czech | Denmark | Ecuador | Egypt | Estonia | European Medicines Agency | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | Indonesia | Ireland | Israel | Italy | Japan | Korea | Latvia | Lithuania | Luxembourg | Malaysia | Netherlands | New Zealand | Norway | Peru | Philippines | Poland | Portugal | Romania | Russia | Singapore | Slovakia | Slovenia | Spain | Sweden | Switzerland | Taiwan | United Kingdom | United States | Uruguay
Approved Indications: None
Known Adverse Events: None
Company: Eisai
Company Location:
Company CEO: Haruo Naito
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: United States
Active Clinical Trial Count: 4
Recent & Upcoming Milestones
Highest Development Phases
Phase 3: Lennox Gastaut Syndrome|Seizures
Phase 1: Healthy Volunteers
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
2016-004952-30 |
2016-004952-30 | P3 |
Active, not recruiting |
Lennox Gastaut Syndrome |
2020-03-16 |
2025-05-06 |
Primary Completion Date|Start Date|Study Completion Date|Treatments|Trial Status |
|
2016-004950-14 |
2016-004950-14 | P3 |
Active, not recruiting |
Seizures |
2023-06-19 |
2025-06-28 |
Primary Completion Date|Start Date|Study Completion Date|Treatments |
|
NCT06740825 |
AC220-164 | P1 |
Completed |
Healthy Volunteers |
2024-12-09 |
2024-12-19 |
Primary Endpoints|Treatments |
|
2016-004953-34 |
2016-004953-34 | P3 |
Active, not recruiting |
Lennox Gastaut Syndrome |
2019-11-17 |
2025-06-25 |
Primary Completion Date|Start Date|Study Completion Date|Treatments|Trial Status |