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Rilutek

(Riluzole)

ApprovedSmall molecule

AAzurity Pharmaceuticals

Riluzole is used to slow the progression of amyotrophic lateral sclerosis (ALS), a disease that causes progressive weakness and loss of muscle control. It helps extend survival time and delay the need for breathing assistance in ALS patients.[2] Rilutek is currently approved and in use across 22 indications[4].[1]

Rilutek is one of 471 small molecule programs targeting Spinocerebellar Ataxia 7. It is currently in Approved.

22

Indications

70

Total Trials

13

Active Trials

470

Competitors

3

FDA Applications

NDA/BLA/ANDA regulatory filings

1

Patents

Pipeline

Status by Indication[4][1]

Indication

Spinocerebellar Ataxia 7Approved

Depressive DisorderApproved

Cutaneous MelanomaApproved

Huntington DiseaseApproved

Cerebellar AtaxiaCompleted

Alzheimer DiseaseApproved

Fragile X SyndromeCompleted

Progressive Supranuclear PalsyApproved

Tourette SyndromeCompleted

Amyotrophic Lateral SclerosisUnknown status

Spinocerebellar Ataxia 7Approved

Approved

Depressive DisorderApproved

Approved

Cutaneous MelanomaApproved

Approved

Huntington DiseaseApproved

Approved

Cerebellar AtaxiaPhase 3

Completed

Alzheimer DiseaseApproved

Approved

Fragile X SyndromeApproved

Completed

Progressive Supranuclear PalsyApproved

Approved

Tourette SyndromeApproved

Completed

Amyotrophic Lateral SclerosisPhase 3

Unknown status

Showing 10 of 22 indications

Competition

Competitive Landscape

706 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Rilutek

AAzurity Pharmaceuticals

Adenocard

Lexiscan

Voltaren

Zolymbus

MS Contin

HHikma Pharmaceuticals LLC

Methylthioninium Chloride

PProvepharm SAS

Duragesic-100

MS Contin

HHikma Pharmaceuticals LLC

Spravato

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q2 2027

Phase 2Recruiting

Amyotrophic Lateral Sclerosis (ALS)

NCT07142291

Q3 2027

Phase 1Active, not recruiting

Advanced Malignant Solid Neoplasm

NCT01303341

Q4 2027

Phase 1/2Recruiting

Amyotrophic Lateral Sclerosis

NCT07414212

Phase 3Recruiting

Efficacy and Safety

NCT03127267

Phase 2Recruiting

Breast Cancer

NCT06580002

Q4 2028

Phase 2Recruiting

Cognitive Dysfunction

NCT07447050

Clinical

Trials by Indication[1]

Amyotrophic Lateral Sclerosis14 trials

Study to Investigate the Safety and Efficacy of Lithium in Volunteers With Amyotrophic Lateral Sclerosis (ALS)

Terminated·MMassachusetts General Hospital·Phase 2/3·NCT00818389·84 enrolled

Expanded Access Protocol of BHV-0223 for Patients With Amyotrophic Lateral Sclerosis (ALS)

No longer available·BBiohaven Pharmaceuticals, Inc.··NCT03537807

Masitinib in Combination With Riluzole for the Treatment of Patients Suffering From Amyotrophic Lateral Sclerosis (ALS)

Completed·AAB Science·Phase 2/3·NCT02588677·394 enrolled

Show 11 more trials

Study of Safety, Tolerability & Efficacy of CK-2017357 in Amyotrophic Lateral Sclerosis (ALS)

Completed·CCytokinetics·Phase 2·NCT01709149·711 enrolled

Evaluation of the Combined Therapy of EH-301 and N-acetylcysteine Together With Riluzole in Amyotrophic Lateral Sclerosis (ALS)

Recruiting·—·Phase 1/2·NCT07414212·90 enrolled

Memantine for Disability in Amyotrophic Lateral Sclerosis (MEDALS)

Completed·UUniversity of Lisbon·Phase 2/3·NCT00353665·63 enrolled

Treatment of Intravenous Infusion Plasma in Amyotrophic Lateral Sclerosis

Completed·PPeking University Third Hospital·Phase 1·NCT04454840·20 enrolled

The Treatment of Amyotrophic Lateral Sclerosis With Huollingshengji Granules

Unknown status·PPeking University Third Hospital·Phase 2/3·NCT04950933·144 enrolled

Dose Titration Study to Test Safety and Effects of CK-2017357 in Patients With Amyotrophic Lateral Sclerosis (ALS)

Completed·CCytokinetics·Phase 2·NCT01486849·27 enrolled

A Study to Evaluate the Effects of Multiple Doses of CK-2017357 in Patients With Amyotrophic Lateral Sclerosis (ALS)

Completed·CCytokinetics·Phase 2·NCT01378676·49 enrolled

Trial of Safety, Tolerability and Efficacy of Trametinib (SNR1611) in Patients With Amyotrophic Lateral Sclerosis (ALS)

Terminated·GGenuv Inc.·Phase 1/2·NCT04326283·23 enrolled

Treatment Effect of Edaravone in Patients With Amyotrophic Lateral Sclerosis (ALS)

Unknown status·IIsfahan University of Medical Sciences·Phase 2/3·NCT03272802·20 enrolled

Ibudilast (MN-166) in Subjects With Amyotrophic Lateral Sclerosis (ALS)

Completed·MMediciNova·Phase 2·NCT02238626·70 enrolled

Efficacy and Safety of Cyclophosphamide in Amyotrophic Lateral Sclerosis: A Multicenter, Open-Label, Randomized, Parallel-Controlled Trial With Blinded Endpoint Assessment (CORTEX-ALS)

Not yet recruiting·HHuashan Hospital·Phase 2·NCT07834450·60 enrolled

Efficacy and Safety3 trials

Evaluation the Efficacy and Safety of Mutiple Lenzumestrocel (Neuronata-R® Inj.) Treatment in Patients with ALS

Active, not recruiting·CCorestemchemon, Inc.·Phase 3·NCT04745299·115 enrolled

Efficacy and Safety of Masitinib Versus Placebo in the Treatment of ALS Patients

Recruiting·AAB Science·Phase 3·NCT03127267·495 enrolled

Efficacy and Safety of Masitinib in Combination With SoC Versus Placebo in the Treatment of ALS Patients

Not yet recruiting·AAB Science·Phase 3·NCT07174492·412 enrolled

Spinal Cord Injury3 trials

Riluzole in Spinal Cord Injury Study

Terminated·AAOSpine North America Research Network·Phase 2/3·NCT01597518·193 enrolled

Riluzole in the Treatment of Spasticity in the Traumatic Chronic Spinal Cord Injury Condition

Unknown status·AAssistance Publique Hopitaux De Marseille·Phase 2·NCT02859792·90 enrolled

Safety of Riluzole in Patients With Acute Spinal Cord Injury

Completed·TThe Methodist Hospital Research Institute··NCT00876889·36 enrolled

Breast Cancer3 trials

Effects of Riluzole on CNS Glutamate and Fatigue in Breast Cancer Survivors With High Inflammation

Completed·EEmory University·Phase 4·NCT02796755·30 enrolled

Riluzole in Women With Stage I, Stage II, or Stage IIIA Breast Cancer

Withdrawn·BBarbara Ann Karmanos Cancer Institute·Phase 1·NCT00903214

Repurposing Riluzole for Augmenting Brain-Derived Neuropathic Factor (BDNF) Levels and Cognitive Function in Patients Experiencing Cancer-Related Cognitive Impairment: An Interventional Pilot Clinical Trial

Recruiting·UUniversity of California, Irvine·Phase 2·NCT06580002·75 enrolled

Cerebellar Ataxia3 trials

Efficacy of Riluzole in Hereditary Cerebellar Ataxia

Completed·SS. Andrea Hospital·Phase 2/3·NCT01104649·60 enrolled

Riluzole in Patients With Spinocerebellar Ataxia Type 7

Recruiting·SS. Andrea Hospital·Phase 2/3·NCT03660917·34 enrolled

Effect of Riluzole as a Symptomatic Approach in Patients With Chronic Cerebellar Ataxia

Completed·SS. Andrea Hospital·Phase 2·NCT00202397·40 enrolled

38 more indications

Bipolar Disorder2 trials

Double-Blind Placebo-Controlled Trial of Riluzole in Pediatric Bipolar Disorder

Terminated·NNational Institute of Mental Health (NIMH)·Phase 2·NCT00805493·6 enrolled

Riluzole to Treat Depression in Bipolar Disorder

Terminated·NNational Institute of Mental Health (NIMH)·Phase 2·NCT00054704·19 enrolled

Obsessive-Compulsive Disorder2 trials

Riluzole to Treat Child and Adolescent Obsessive-Compulsive Disorder With or Without Autism Spectrum Disorders

Completed·NNational Institute of Mental Health (NIMH)·Phase 2·NCT00251303·78 enrolled

Riluzole Augmentation in Treatment-refractory Obsessive-compulsive Disorder

Completed·YYale University·Phase 2·NCT00523718·40 enrolled

Melanoma2 trials

Riluzole in Treating Patients With Stage III or Stage IV Melanoma That Can Be Removed by Surgery

Terminated·UUniversity of Medicine and Dentistry of New Jersey·Phase 1·NCT00667901·15 enrolled

Riluzole in Treating Patients With Stage III or Stage IV Melanoma That Cannot Be Removed by Surgery

Completed·RRutgers, The State University of New Jersey·Phase 2·NCT00866840·13 enrolled

Multiple Sclerosis2 trials

Neuroprotection With Riluzole Patients With Early Multiple Sclerosis

Completed·UUniversity of California, San Francisco·Phase 2·NCT00501943·43 enrolled

MS-SMART: Multiple Sclerosis-Secondary Progressive Multi-Arm Randomisation Trial

Completed·UUniversity College, London·Phase 2·NCT01910259·445 enrolled

Schizophrenia2 trials

The Role of Glutamatergic Function in the Pathophysiology of Treatment-resistant Schizophrenia

Recruiting·KKing's College London·Phase 1·NCT06270108·288 enrolled

Treatment of Refractory Schizophrenia With Riluzole

Completed·YYale University·N/A·NCT00375050·34 enrolled

Bipolar Depression2 trials

A Double-Blind Placebo Controlled Trial of Riluzole in Bipolar Depression

Completed·JJohns Hopkins University·Phase 2·NCT00376220·94 enrolled

Riluzole in the Treatment of Bipolar Depression

Completed·MMclean Hospital·N/A·NCT00544544·14 enrolled

Myelopathy1 trial

Efficacy of Riluzole in Surgical Treatment for Cervical Spondylotic Myelopathy (CSM-Protect)

Completed·AAOSpine North America Research Network·Phase 3·NCT01257828·270 enrolled

Parkinson's1 trial

Neuroprotection and Natural History in Parkinson's Plus Syndromes (NNIPPS)

Terminated·KKing's College London·Phase 3·NCT00211224·800 enrolled

Tourette syndrome1 trial

Developing New Treatments for Tourette Syndrome: Therapeutic Trials With Modulators of Glutamatergic Neurotransmission

Completed·JJohns Hopkins University·Phase 4·NCT01018056·39 enrolled

Memory1 trial

Memantine or Riluzole Prophylaxis for Corticosteroid-induced Mood and Declarative Memory Changes

Terminated·UUniversity of Texas Southwestern Medical Center·Phase 4·NCT00283309·20 enrolled

Metastatic Colorectal Cancer1 trial

Riluzole in Combination With mFOLFOX6 and Bevacizumab in Treating Patients With Metastatic Colorectal Cancer

Completed·NNing Jin·Phase 1·NCT04761614·13 enrolled

Alzheimer's Disease1 trial

Riluzole in Mild Alzheimer's Disease

Completed·IIcahn School of Medicine at Mount Sinai·Phase 2·NCT01703117·50 enrolled

Cognitive Dysfunction1 trial

Riluzole For Preventing Cognitive Dysfunction in Ca Pts Receiving Chemo (REFOCUS): Pilot Trial

Recruiting·UUniversity of California, Irvine·Phase 2·NCT07447050·24 enrolled

Radiation Therapy1 trial

Riluzole and Whole-Brain Radiation Therapy in Treating Patients With Brain Metastases

Terminated·RRutgers, The State University of New Jersey·Phase 1·NCT01018836·9 enrolled

MPA1 trial

Impact of Persistent Conductances on Motor Unit Firing in SCI

Unknown status·SShirley Ryan AbilityLab·N/A·NCT02136823·50 enrolled

Huntington's Disease1 trial

Riluzole in Huntington's Disease

Completed· Sanofi logo

Sanofi·Phase 3·NCT00277602·537 enrolled

CAR1 trial

CARE Canadian ALS Riluzole Evaluation

Completed· Sanofi logo

Sanofi·Phase 4·NCT00542412·414 enrolled

Autism Spectrum Disorder1 trial

Pilot Study of Riluzole for Drug-Refractory Irritability in Autism Spectrum Disorders

Completed·—·Phase 1·NCT02081027·8 enrolled

Post-Traumatic Stress Disorder1 trial

Safety Study of Riluzole to Treat Post-traumatic Stress Disorder (PTSD)

Completed·UUniformed Services University of the Health Sciences·Phase 1/2·NCT02155829·75 enrolled

Post-Traumatic Stress Disorder, PTSD1 trial

A Pilot Study Of Riluzole In Patients With Post Traumatic Stress Disorder (PTSD)

Completed·YYale University·Phase 1·NCT02019940·18 enrolled

Safety and Efficacy1 trial

Safety and Efficacy of TRO19622 as add-on Therapy to Riluzole Versus Placebo in Treatment of Patients Suffering From ALS

Completed· Roche logo

Roche·Phase 3·NCT00868166·512 enrolled

Spinal Muscular Atrophy1 trial

Study to Evaluate the Efficacy of Riluzole in Children and Young Adults With Spinal Muscular Atrophy (SMA)

Completed·AAssistance Publique - Hôpitaux de Paris·Phase 2/3·NCT00774423·141 enrolled

Pilot Study1 trial

A Pilot Study of Riluzole Versus Placebo in the Treatment of Children and Adolescents With ASD

Completed·HHolland Bloorview Kids Rehabilitation Hospital·Phase 2·NCT01661855·58 enrolled

Immune Response1 trial

MIROCALS: Modifying Immune Response and OutComes in ALS

Completed·—·Phase 2·NCT03039673·304 enrolled

Pregabalin1 trial

Pharmacokinetics of Y-4 Tablets With Pregabalin Capsules and Riluzole Tablets in Chinese Healthy Subject

Recruiting·—·Phase 1·NCT06935721·10 enrolled

Trial1 trial

RiLuzole to Reduce Atrial FIb Study Using Holter Monitoring

Recruiting·UUniversity of Utah·Phase 2·NCT05292209·78 enrolled

Peripheral Neuropathy1 trial

Effectiveness Assessment of Riluzole in the Prevention of Oxaliplatin-induced Peripheral Neuropathy.

Suspended·UUNICANCER·Phase 2·NCT03722680·80 enrolled

LCH1 trial

Acetylcholine Receptors From Human Muscles as Pharmacological Target for ALS

Completed·UUniversity of Roma La Sapienza·N/A·NCT02645461·50 enrolled

Major Depressive Disorder1 trial

Research Study for Major Depressive Disorder: Investigation of Glutamate Medications

Completed·—·Phase 4·NCT00419003·26 enrolled

Fragile X Syndrome1 trial

Riluzole in Fragile X Syndrome

Completed·IIndiana University·Phase 4·NCT00895752·6 enrolled

ALS1 trial

Evaluate the Safety of Neuronata-R® Inj. Suspended With HypoTHermosol® FRS (HTS-FRS) in Patients With ALS

Completed·CCorestemchemon, Inc.·Phase 1·NCT06676423·8 enrolled

Depression1 trial

Riluzole Augmentation Pilot in Depression (RAPID) Trial

Terminated·—·Phase 2·NCT01703039·21 enrolled

Spinocerebellar Ataxia Type 21 trial

Clinical Trial With Riluzole in Spinocerebellar Ataxia Type 2 (ATRIL)

Completed·AAssistance Publique - Hôpitaux de Paris·Phase 3·NCT03347344·42 enrolled

Treatment Resistant Depression1 trial

Efficacy and Tolerability of Riluzole in Treatment Resistant Depression

Completed·YYale University·Phase 2·NCT01204918·104 enrolled

Biomarkers1 trial

Riluzole Effects on Hippocampus Biomarkers

Completed·MMclean Hospital·Phase 1·NCT04630444·20 enrolled

Major Depression1 trial

Riluzole to Treat Major Depression

Completed·NNational Institute of Mental Health (NIMH)·Phase 2·NCT00026052·31 enrolled

Advanced Malignant Solid Neoplasm1 trial

A Phase I Trial of Riluzole and Sorafenib in Patients With Advanced Solid Tumors and Melanoma

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 1·NCT01303341·35 enrolled

Amyotrophic Lateral Sclerosis (ALS)1 trial

A Phase IIB Randomized, Double-Blind, Placebo-Controlled, Multi-Dose Study to Evaluate the Effects of PHENOGENE-1A (Cromolyn) as an Adjuvant Treatment in Subjects With Mild to Moderate Amyotrophic Lateral Sclerosis (ALS)

Recruiting·PPhenoNet, Inc.·Phase 2·NCT07142291·105 enrolled

Regulatory

FDA Approval Timeline[5]

Dec 12, 1995

RILUTEK

NDA NDA020599

Sep 5, 2018

TIGLUTIK KIT

NDA NDA209080

Nov 22, 2019

EXSERVAN

NDA NDA212640

Sources

References

[1]
ClinicalTrials.gov — 70 trial records for Riluzole. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Rilutek drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Riluzole compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Riluzole. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA212640). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Rilutek. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Azurity Pharmaceuticals company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Sodium Channel Alpha Subunit Blocker[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: AAzurity Pharmaceuticals

Patent Landscape[6]

Patent Cliff

Mar 12, 2029

Earliest patent expiration — generic entry possible after this date

Patent #Expires

8765150Mar 12, 2029

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