Rufinamide

Overview

Rufinamide is a triazole derivative and an anticonvulsant medication to treat seizure disorders like Lennox-Gastuat syndrome, a form of childhood epilepsy. Clinical trials suggest its efficacy in the treatment of partial seizures.

Indication

治疗4岁以上及成人Lennox-Gastaut症候群的癫痫症。

Associated Conditions

Lennox-Gastaut Syndrome

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Study to Assess the Effect of a CYP3A Weak Inducer Rufinamide on Quizartinib Pharmacokinetics in Healthy Subjects	2024/12/18	NCT06740825	Phase 1	Completed	Daiichi Sankyo
Safety Study of Rufinamide Given as an add-on Therapy to Treat Patients With Seizures	2020/09/22	NCT04558580	Phase 3	Withdrawn	University of South Alabama
An Extended Access Program (EAP) for Participants Who Have Completed Rufinamide Study E2080-G000-303	2018/12/19	NCT03778424	N/A	AVAILABLE	Eisai Inc.
Population Pharmacokinetics of Antiepileptic in Pediatrics	2017/06/22	NCT03196466	N/A	Recruiting	Assistance Publique - Hôpitaux de Paris
Pharmacokinetics and Tolerability of Rufinamide in Healthy Chinese Subjects	2015/01/06	NCT02332174	Phase 1	Completed	Wuhan Union Hospital, China
Post-marketing Surveillance of Long-term Administration of Inovelon Tablets in Patients With Lennox-Gastaut Syndrome	2014/06/26	NCT02175173	N/A	Completed	Eisai Co., Ltd.
Effect of Rufinamide on Chronic Postthoracotomy Pain Syndrome	2014/03/26	NCT02095899	Phase 2	Withdrawn	University of Zurich
Study of Rufinamide in Pediatric Subjects 1 to Less Than 4 Years of Age With Lennox-Gastaut Syndrome Inadequately Controlled With Other Anti-epileptic Drugs	2011/07/29	NCT01405053	Phase 3	Completed	Eisai Inc.
A Long Term Extension Study of E2080 in Lennox-Gastaut Patients	2010/06/28	NCT01151540	Phase 3	Completed	Eisai Co., Ltd.
A Placebo-Controlled, Double-Blind Comparative Study of E2080 in Lennox-Gastaut Syndrome Patients (Study E2080-J081-304)	2010/06/22	NCT01146951	Phase 3	Completed	Eisai Limited

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Rufinamide	Camber Pharmaceuticals, Inc.	31722-688	ORAL	40 mg in 1 mL	12/28/2023
Rufinamide	Hikma Pharmaceuticals USA Inc.	0054-0528	ORAL	40 mg in 1 mL	9/3/2020
rufinamide	Glenmark Pharmaceuticals Inc., USA	68462-714	ORAL	400 mg in 1 1	1/31/2021
Rufinamide	Mylan Pharmaceuticals Inc.	0378-2331	ORAL	400 mg in 1 1	6/15/2021
RUFINAMIDE	Micro Labs Limited	42571-392	ORAL	400 mg in 1 1	5/17/2023
RUFINAMIDE	Lupin Pharmaceuticals, Inc.	68180-802	ORAL	100 mg in 1 1	8/1/2025
Rufinamide	Camber Pharmaceuticals, Inc.	31722-599	ORAL	400 mg in 1 1	6/2/2021
Rufinamide	Mylan Pharmaceuticals Inc.	0378-2330	ORAL	200 mg in 1 1	6/15/2021
Rufinamide	Camber Pharmaceuticals, Inc.	31722-598	ORAL	200 mg in 1 1	6/2/2021
Banzel	Eisai Inc.	62856-583	ORAL	400 mg in 1 1	11/17/2023

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
Inovelon	Eisai GmbH,Eisai GmbH,Edmund-Rumpler-Strasse 3,60549 Frankfurt am Main,Germany	Authorised	1/16/2007

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
INOVELON FILM-COATED TABLET 200 MG	Bushu Pharmaceutical Ltd. Misato Factory, Eisai Manufacturing Limited (Primary and Secondary Packager)	SIN15146P	TABLET, FILM COATED	200 mg	1/5/2017

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
INOVELON TABLETS 200MG	N/A	EISAI (HONG KONG) COMPANY LIMITED	N/A	N/A	10/28/2015
INOVELON TABLETS 400MG	N/A	EISAI (HONG KONG) COMPANY LIMITED	N/A	N/A	10/28/2015
INOVELON TABLETS 100MG	N/A	EISAI (HONG KONG) COMPANY LIMITED	N/A	N/A	10/28/2015

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
INOVELON rufinamide 200 mg film-coated tablet blister pack	287524	Eisai Australia Pty Ltd	Medicine	A	6/27/2018
INOVELON rufinamide 400 mg film-coated tablet blister pack	287537	Eisai Australia Pty Ltd	Medicine	A	6/27/2018
INOVELON rufinamide 100 mg film-coated tablet blister pack	287523	Eisai Australia Pty Ltd	Medicine	A	6/27/2018

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
BANZEL	EISAI LIMITED	02369648	Tablet - Oral	400 MG	9/1/2011
AURO-RUFINAMIDE	auro pharma inc	02545985	Tablet - Oral	200 MG	7/4/2024
BANZEL	EISAI LIMITED	02369613	Tablet - Oral	100 MG	10/20/2011
BANZEL	EISAI LIMITED	02369621	Tablet - Oral	200 MG	8/29/2011
AURO-RUFINAMIDE	auro pharma inc	02545993	Tablet - Oral	400 MG	7/4/2024
BANZEL	EISAI LIMITED	02388685	Suspension - Oral	40 MG / ML	N/A

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
INOVELON 100 mg COMPRIMIDOS RECUBIERTOS CON PELICULA	Eisai Gmbh	06378001	COMPRIMIDO RECUBIERTO CON PELÍCULA	Diagnóstico Hospitalario	Commercialized
INOVELON 200 mg COMPRIMIDOS RECUBIERTOS CON PELICULA	Eisai Gmbh	06378009	COMPRIMIDO RECUBIERTO CON PELÍCULA	Diagnóstico Hospitalario	Commercialized
INOVELON 400 mg COMPRIMIDOS RECUBIERTOS CON PELICULA	Eisai Gmbh	06378015	COMPRIMIDO RECUBIERTO CON PELÍCULA	Diagnóstico Hospitalario	Commercialized
INOVELON 40 mg/ml SUSPENSION ORAL	Eisai Gmbh	06378017	SUSPENSIÓN ORAL	Diagnóstico Hospitalario	Commercialized

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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