Riluzole

Overview

A glutamate antagonist (receptors, glutamate) used as an anticonvulsant (anticonvulsants) and to prolong the survival of patients with amyotrophic lateral sclerosis. Riluzole is marketed as Rilutek by Sanofi.

Indication

For the treatment of amyotrophic lateral sclerosis (ALS, Lou Gehrig's Disease)

Associated Conditions

Amyotrophic Lateral Sclerosis (ALS)

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Phase IIB Study of PHENOGENE-1A (Cromolyn) as an Adjuvant Therapy in Mild to Moderate ALS	2025/08/26	NCT07142291	Not Applicable	Not yet recruiting	PhenoNet, Inc.
Pharmacokinetics of Y-4 Tablets With Pregabalin Capsules and Riluzole Tablets in Chinese Healthy Subject	2025/04/20	NCT06935721	Phase 1	Recruiting	Beijing Tiantan Hospital
Evaluate the Safety of Neuronata-R® Inj. Suspended With HypoTHermosol® FRS (HTS-FRS) in Patients With ALS	2024/11/06	NCT06676423	Phase 1	Completed	Corestemchemon, Inc.
Repurposing Riluzole for Cancer-Related Cognitive Impairment: A Pilot Trial	2024/08/30	NCT06580002	Phase 2	Recruiting	University of California, Irvine
The Role of Glutamatergic Function in the Pathophysiology of Treatment-resistant Schizophrenia	2024/02/21	NCT06270108	Early Phase 1	Recruiting	King's College London
Treatment Combining Riluzole and IFB-088 in Bulbar Amyotrophic Lateral Sclerosis (TRIALS Protocol)	2022/08/19	NCT05508074	Phase 2	Completed	InFlectis BioScience
RiLuzole to Reduce Atrial FIb Study Using Holter Monitoring	2022/03/23	NCT05292209	Phase 2	Recruiting	University of Utah
The Treatment of Amyotrophic Lateral Sclerosis With Huollingshengji Granules	2021/07/06	NCT04950933	Phase 2	UNKNOWN	Peking University Third Hospital
Riluzole in Combination With mFOLFOX6 and Bevacizumab in Treating Patients With Metastatic Colorectal Cancer	2021/02/21	NCT04761614	Phase 1	Completed	Ning Jin
Evaluation the Efficacy and Safety of Mutiple Lenzumestrocel (Neuronata-R® Inj.) Treatment in Patients with ALS	2021/02/09	NCT04745299	Phase 3	Active, not recruiting	Corestemchemon, Inc.

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Riluzole	AvKARE	42291-775	ORAL	50 mg in 1 1	1/10/2024
TIGLUTIK	EDW PHARMA, INC	70726-0303	ORAL	50 mg in 10 mL	2/8/2024
Riluzole	Quinn Pharmaceuticals	69076-200	ORAL	50 mg in 1 1	10/3/2023
Teglutik	EDW PHARMA	70726-0305	ORAL	5 mg in 1 mL	2/27/2024
Rilutek	Covis Pharma US, Inc	70515-700	ORAL	50 mg in 1 1	3/31/2020
riluzole	Glenmark Pharmaceuticals Inc., USA	68462-381	ORAL	50 mg in 1 1	7/10/2020
Riluzole	Mylan Pharmaceuticals Inc.	0378-4145	ORAL	50 mg in 1 1	5/11/2016
Riluzole	Ascend Laboratories, LLC	67877-286	ORAL	50 mg in 1 1	11/10/2021
Riluzole	Sun Pharmaceutical Industries, Inc.	62756-538	ORAL	50 mg in 1 1	8/19/2020
Exservan	Mitsubishi Tanabe Pharma America, Inc.	70510-2201	ORAL	50 mg in 1 1	4/21/2021

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
Rilutek	Sanofi Winthrop Industrie,82 Avenue Raspail,94250 Gentilly,FRANCE	Authorised	6/10/1996
Riluzole Zentiva	Zentiva k.s.,U Kabelovny 130,Dolni Mecholupy,102 00 Prague 10,Czechia	Authorised	5/7/2012

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
RILUTEK TABLET 50 mg	Opella Healthcare International SAS	SIN09426P	TABLET, FILM COATED	50 mg	7/31/1997

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
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
RILUKEM riluzole 50mg film-coated tablet blister pack	207453	Pharmacor Pty Ltd	Medicine	A	6/4/2014
TEGLUTIK riluzole 50 mg/10 mL oral liquid suspension bottle	292987	Seqirus Pty Ltd	Medicine	A	8/21/2018
RILUKEM riluzole 50mg film-coated tablet bottle	343970	Pharmacor Pty Ltd	Medicine	A	3/25/2022
RILUZOLE SANDOZ riluzole 50mg film-coated tablet blister pack	167717	Sandoz Pty Ltd	Medicine	A	3/8/2012
PHARMACOR RILUZOLE riluzole 50mg film-coated tablet bottle	343972	Pharmacor Pty Ltd	Medicine	A	3/25/2022
APOTEX-RILUZOLE Riluzole 50mg tablet blister pack	168092	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	6/8/2011
RILUCOR riluzole 50mg film-coated tablet bottle	343971	Pharmacor Pty Ltd	Medicine	A	3/25/2022
RILUTEK riluzole 50mg tablet blister pack	79744	Sanofi-Aventis Australia Pty Ltd	Medicine	A	5/13/2002
PHARMACOR RILUZOLE riluzole 50mg film-coated tablet blister pack	207455	Pharmacor Pty Ltd	Medicine	A	6/4/2014
APO-RILUZOLE Riluzole 50mg tablet bottle	168094	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	6/8/2011

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
APO-RILUZOLE	Apotex Inc	02352583	Tablet - Oral	50 MG	9/25/2012
RILUTEK	sanofi-aventis canada inc	02242763	Tablet - Oral	50 MG	10/26/2000
MYLAN-RILUZOLE	Mylan Pharmaceuticals ULC	02390299	Tablet - Oral	50 MG	10/23/2012

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
RILUZOL PMCS 50 MG COMPRIMIDO RECUBIERTO CON PELICULA EFG	Pro.Med.Cs Praha A.S.	75131	COMPRIMIDO RECUBIERTO CON PELÍCULA	Uso Hospitalario	Not Commercialized
RILUTEK 50 mg COMPRIMIDOS RECUBIERTOS CON PELICULA	Sanofi Winthrop Industrie	96010001	COMPRIMIDO RECUBIERTO	Uso Hospitalario	Not Commercialized
RILUZOL AUROVITAS 50 mg COMPRIMIDOS RECUBIERTOS CON PELÍCULA EFG	Aurovitas Spain, S.A.U.	75160	COMPRIMIDO RECUBIERTO CON PELÍCULA	Uso Hospitalario	Commercialized
TEGLUTIK 5MG/ML SUSPENSION ORAL	Italfarmaco S.A.	78243	SUSPENSIÓN ORAL	Uso Hospitalario	Commercialized
RILUZOL SUN 50 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG	Sun Pharmaceutical Industries (Europe) B.V.	75015	COMPRIMIDO RECUBIERTO CON PELÍCULA	Uso 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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