Riluzole
GET
/api/v1/drug/riluzoleMechanism of action
Sourced from openFDAMechanism-of-action class: Sodium Channel Antagonists.
Sodium Channel
Approval history
Sourced from openFDA- Jun 18, 2013ANDAANDA091394Glenmark Pharms Ltd
- Jun 18, 2013ANDAANDA091417Sun Pharm Inds Ltd
- Mar 30, 2016ANDAANDA204048Alkem Labs Ltd
- Sep 5, 2018NDANDA209080Italfarmaco Sa
- Dec 9, 2019ANDAANDA206045Kenton
FDA shortages
Reference statistics from the openFDA drug-shortage dataset. For a live view, consult the FDA database directly. Not clinical guidance.
- Teglutik, Oral Suspension, 5 mg/1 mL (NDC 70726-0304-1)ActiveSponsor: EDW Pharma, Inc. (formerly Italfarmaco Pharma, Inc.)Updated
- Teglutik, Oral Suspension, 5 mg/1 mL (NDC 70726-0305-1)ActiveSponsor: EDW Pharma, Inc. (formerly Italfarmaco Pharma, Inc.)Updated
- Teglutik, Oral Suspension, 5 mg/1 mL (NDC 70726-0306-1)ActiveSponsor: EDW Pharma, Inc. (formerly Italfarmaco Pharma, Inc.)Updated
- Tiglutik, Oral Suspension, 50 mg/10 mL (NDC 70726-0303-1)ActiveSponsor: EDW Pharma, Inc. (formerly Italfarmaco Pharma, Inc.) · Reason: Requirements related to complying with good manufacturing practicesUpdated
FAERS reports
Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
2,085 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
- 1Death30515%
- 2Nausea1517.2%
- 3Diarrhoea1356.5%
- 4Drug Ineffective994.7%
- 5Disease Progression934.5%
- 6Fatigue894.3%
- 7Dyspnoea854.1%
- 8Amyotrophic Lateral Sclerosis844.0%
- 9Asthenia783.7%
- 10Dizziness743.5%
- 11Abdominal Discomfort683.3%
- 12Muscular Weakness673.2%
- 13Off Label Use633.0%
- 14Headache552.6%
- 15Fall492.4%
Literature
Recent PubMed references pinned to Riluzole as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.
- Riluzole in neuroinflammation and neurodegeneration: Mechanistic insights and experimental validation.Current opinion in pharmacology · 2026 · Abd-Eldayem AM, Mohammed RAPMID 42142504DOI 10.1016/j.coph.2026.102632
- 3D Glioblastoma Molecular Responses to Carbon Dot-Delivered Riluzole Probed by Synchrotron FTIR.Analytical chemistry · 2026 · Dučić T, Algarra M, Pérez Guaita D, et al.PMID 42009312DOI 10.1021/acs.analchem.6c00176
- Single-Cell Transcriptomics Reveals Riluzole as an Osteoarthritis Candidate Drug via OB-NE Signaling Modulation and CTSS/NOS1 Inhibition.Drug design, development and therapy · 2026 · Liu K, Li JL, Chen Y, et al.PMID 41993107DOI 10.2147/DDDT.S544803
- First-in-Human Combination of Lead-212-Labeled PSMA Radioligand Therapy and Metabotropic Glutamate Receptor Inhibitor Riluzole as Radiosensitizer in Metastatic Castration-resistant Prostate Cancer.Clinical nuclear medicine · 2026 · Perrone E, Greifenstein L, Ghai K, et al.PMID 41921940DOI 10.1097/RLU.0000000000006222
- Riluzole Restores Circuit and Behavioral Function Altered by Allele-Specific Expression-Mediated LINC02449-CPLX1 Dysregulation.Schizophrenia bulletin · 2026 · Ni C, Liu JM, Yang T, et al.PMID 41863379DOI 10.1093/schbul/sbag021
- Anti-inflammatory treatment confirms rsfMRI and TSPO PET as biomarkers of functional connectivity and neuroinflammation in rat contusion spinal cord injuries.Scientific reports · 2026 · Mu C, Reed JL, Wang F, et al.PMID 41851217DOI 10.1038/s41598-026-42844-x
- How to improve statistical power in a trial with SCA2 patients using natural history data.Trials · 2026 · Tran M, Poulet PE, Petit E, et al.PMID 41787540DOI 10.1186/s13063-026-09591-w
- Riluzole preserves brain endothelial integrity in ischemic stroke via SLC7A11-dependent GPX4 and HIF-1α/VEGFA signaling.Cellular signalling · 2026 · Wang H, Feng Y, Jiang W, et al.PMID 41628676DOI 10.1016/j.cellsig.2026.112378
Clinical trials
The 10 most recently updated of 101 ClinicalTrials.gov registrations naming Riluzole as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.
- PHENOGENE-1A (Cromolyn) Treatment in Patients With Mild to Moderate ALSRecruiting · Phase 2 · Interventional · 105 enrolled · PhenoNet, Inc.NCT07142291updated 2026-06-09
- Real-World Data Study of Troriluzole-Treated Patients With Spinocerebellar Ataxia (SCA) Compared to a Matched Natural History ControlActive not recruiting · Observational · 909 enrolled · Biohaven Therapeutics Ltd.NCT06529146updated 2026-06-09
- Pharmacokinetics of Y-4 Tablets With Pregabalin Capsules and Riluzole Tablets in U.S. Healthy ParticipantsNot yet recruiting · Phase 1 · Interventional · 11 enrolled · Neurodawn Pharmaceutical Co., Ltd.NCT07618715updated 2026-06-01
- Effectiveness Assessment of Riluzole in the Prevention of Oxaliplatin-induced Peripheral Neuropathy.Suspended · Phase 2 · Interventional · 80 enrolled · UNICANCERNCT03722680updated 2026-05-20
- Research of Traditional Chinese Medicine Oral Preparation of C. Cicadae in the Treatment of ALS Patients With Elevated Plasma SphingolipidsNot yet recruiting · Phase 2 · Interventional · 84 enrolled · The Third Xiangya Hospital of Central South UniversityNCT07467746updated 2026-05-20
- Y-4 to Treat the Postherpetic NeuralgiaRecruiting · Phase 2 · Interventional · 160 enrolled · Neurodawn Pharmaceutical Co., Ltd.NCT07275762updated 2026-05-13
- Efficacy and Tolerability of Beta Hydroxybutyrate Ester in Patients With Amyotrophic Lateral Sclerosis (ALS)Completed · Interventional · 81 enrolled · University of UlmNCT04820478updated 2026-05-01
- Evaluation the Efficacy and Safety of Mutiple Lenzumestrocel (Neuronata-R® Inj.) Treatment in Patients With ALSCompleted · Phase 3 · Interventional · 123 enrolled · Corestemchemon, Inc.NCT04745299updated 2026-04-30
- Riluzole and Sorafenib Tosylate in Treating Patients With Advanced Solid Tumors or MelanomaActive not recruiting · Phase 1 · Interventional · 35 enrolled · National Cancer Institute (NCI)NCT01303341updated 2026-04-13
- Riluzole For Preventing Cognitive Dysfunction in Ca Pts Receiving Chemo (REFOCUS): Pilot TrialRecruiting · Phase 2 · Interventional · 24 enrolled · University of California, IrvineNCT07447050updated 2026-03-03
Frequently asked questions
- How does Riluzole work?
- Mechanism-of-action class: Sodium Channel Antagonists.
- What class of drug is Riluzole?
- Riluzole is classified as Other nervous system drugs, Benzothiazole, Sodium Channel Antagonists, Decreased Central Nervous System Glutamate Activity.
- What are the brand names for Riluzole?
- Riluzole is marketed under brand names including Exservan, Rilutek, Teglutik, Tiglutik.
Note. Data for
riluzole is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.