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riluzole

Trade name: rilutek

Small moleculeapprovedOrphan Drug FDA

Approved

Dec 12, 1995

Riluzole, a member of the benzothiazole class, is indicated for the treatment of patients with amyotrophic lateral sclerosis. Its pharmacological properties include the following, some of which may be related to its effect: 1) an inhibitory effect on glutamate release (activation of glutamate reuptake), 2) inactivation of voltage-dependent sodium channels, and 3) ability to interfere with intracellular events that follow transmitter binding at excitatory amino acid receptors. Common adverse reactions include headache, abdominal pain, back pain, vomiting, dyspepsia, diarrhea, dizziness. Riluzole-treated patients that take other hepatotoxic drugs may be at increased risk for hepatotoxicity. — NCATS

Clinical trial activity

83 trials · 101 clinical orgs · 16 marketing orgs

Phase 1
19
Phase 2
44
Phase 3
26
Phase 4
6

Earliest trial started Nov 1, 1999 (NCT00277602)

Timeline

1990s

  1. Mar 16, 1993

    Orphan Drug Designation

  2. Dec 12, 1995

    Rhone Poulenc — Earliest FDA Approval

  3. Dec 12, 1995

    Covis — NDA Secondary Org

  4. Dec 12, 1995

    Covis — Marketing Organization

  5. Dec 12, 1995

    Rhone Poulenc — NDA Organization

  6. Dec 12, 1995

    Azurity — Marketing Organization

  7. Jan 1, 1999

    Earliest Phase 3 Sponsor(trial)

2000s

  1. Jan 1, 2001

    Earliest Phase 2 Sponsor(trial)

  2. Jan 29, 2003

    Impax Laboratories — Marketing Organization

  3. Jan 1, 2004

    Earliest Phase 1 Sponsor(trial)

2010s

  1. Jun 18, 2013

    Apotex — Marketing Organization

  2. Jun 18, 2013

    Glenmark Pharmaceuticals — Marketing Organization

  3. Jun 18, 2013

    Sun Pharmaceuticals — Marketing Organization

  4. Jul 1, 2013

    Mylan — Marketing Organization

  5. Jul 1, 2013

    PHARMOBEDIENT — Marketing Organization

  6. Mar 30, 2016

    Alkem Labs Ltd — Marketing Organization

  7. Sep 5, 2018

    Italfarmaco — NDA Secondary Org

  8. Sep 5, 2018

    Italfarmaco — Marketing Organization

  9. Oct 16, 2018

    Daito Pharmaceuticals — Marketing Organization

  10. Nov 22, 2019

    Mitsubishi Tanabe — Marketing Organization

  11. Nov 22, 2019

    Aquestive Therapeutics — Marketing Organization

  12. Nov 22, 2019

    Aquestive Therapeutics — NDA Secondary Org

  13. Dec 9, 2019

    Kenton — Marketing Organization

  14. Dec 9, 2019

    Standard Chem. & Pharm. Co., Ltd. — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedPriority reviewDec 12, 1995

Chemistry & pharmacology

Loading structure…

SMILES

NC1=NC2=C(S1)C=C(OC(F)(F)F)C=C2
Mol. weight
234.198 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Achiral Molecule
Inorganic
No
Polymer
No
Availability
Prescription Only

Oral

No

Parenteral

No

Topical

No

Prodrug

Sources

Also known as

  • 6-trifluoromethoxybenzothiazol-2-ylamine
  • ac105
  • bhv-4157
  • bhv-4157
  • raylis
  • rilutek
  • rilutek
  • rilutek
  • rilutek
  • rilutor
  • riluzol
  • riluzol
  • riluzole
  • riluzole
  • riluzole
  • riluzole
  • riluzole
  • riluzole
  • riluzole
  • riluzole
  • riluzole
  • riluzole
  • riluzole
  • riluzole
  • riluzole hcl
  • riluzole hydrochloride
  • riluzolum
  • riluzolum
  • rp54274
  • rp-54274
  • rp-54274
  • rp-54274
  • teglutik

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07174492Phase 3Jan 1, 2026AB Science
NCT07142291Phase 2Nov 30, 2025PhenoNet, Inc.
NCT07093268Phase 1Aug 15, 2025Brain Trust Bio, Flinders University, Sunshine Coast University, Australia
NCT06935721Phase 1Mar 28, 2025Capital Medical University, NeuroDawn Pharmaceutical Co., Ltd.
NCT06552260Early Phase 1 (Phase 1)Feb 28, 2025Biohaven Pharmaceuticals Inc., Harvard University, National Institutes of Health (NIH)
NCT06580002Phase 2Sep 30, 2024Chao Family Comprehensive Cancer Center, University of California, Irvine
NCT05508074Phase 2Nov 30, 2022CHU La Timone, InFlectis BioScience, University of Milan
NCT06270108Early Phase 1 (Phase 1)Nov 14, 2022South London and Maudsley NHS Foundation Trust, University of London
NCT06676423Phase 1Nov 9, 2022Corestem, Inc., Hanyang University
NCT05292209Phase 2Jun 15, 2022Ohio State University, University of Utah
NCT04899921Phase 2Jun 30, 2021Biohaven Pharmaceuticals Inc., Harvard University
NCT04761614Phase 1Apr 1, 2021Ohio State University
NCT04708834Phase 3Mar 30, 2021Biohaven Pharmaceuticals Inc.
NCT04745299Phase 3Mar 23, 2021Corestem, Inc., Hanyang University
NCT04693351Phase 3Jan 25, 2021Biohaven Pharmaceuticals Inc.
NCT04819438Phase 1Jan 15, 2021Cross Research S.A., Zambon
NCT04641143Phase 3Dec 22, 2020Biohaven Pharmaceuticals Inc.
NCT04950933Phase 2/Phase 3 (Phase 3)Jun 1, 2020Hebei University, Peking University
NCT04326283Phase 1/Phase 2 (Phase 2)Apr 2, 2020Genuv Inc., Kangbuk Samsung Hospital
NCT03701399Phase 3Mar 8, 2019Biohaven Pharmaceuticals Inc.
Showing 20 of 83 trials
Page 1 / 5

Organizations

Research & Development (101)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Biohaven Pharmaceuticals Inc.For profit121042016
National Institute of Mental Health (NIMH)Government7522001
Harvard UniversityAcademic/Hospital5432009
National Cancer Institute (NCI)Government5122007
Yale UniversityAcademic/Hospital5532002
Rutgers UniversityAcademic/Hospital4222007
University of Roma La SapienzaAcademic/Hospital4432005
University of TorontoAcademic/Hospital4122009
AB ScienceFor profit3312013
National Institutes of Health (NIH)Government3022005
University of LondonAcademic/Hospital3332000
AO FoundationAcademic/Hospital2212011
Aquestive TherapeuticsFor profit2212018
Baylor UniversityAcademic/Hospital2122006
Brain & Behavior Research FoundationAcademic/Hospital2022006
Corestem, Inc.For profit2222021
CovanceFor profit2012018
Department of DefenseGovernment2022013
Hanyang UniversityAcademic/Hospital2022021
inVentivFor profit2012018
101 organizations
Page 1 / 6

Marketing (20)

OrganizationOrg typeRelationshipDate
Alkem Labs LtdFor profitMKTGMar 30, 2016
ApotexFor profitMKTGJun 18, 2013
Aquestive TherapeuticsFor profitMKTGNov 22, 2019
Aquestive TherapeuticsFor profitSYNNov 22, 2019
Aquestive TherapeuticsFor profitNDA2Nov 22, 2019
AzurityFor profitMKTGDec 12, 1995
CovisFor profitNDA2Dec 12, 1995
CovisFor profitMKTGDec 12, 1995
Daito PharmaceuticalsFor profitMKTGOct 16, 2018
Glenmark PharmaceuticalsFor profitMKTGJun 18, 2013
Impax LaboratoriesFor profitMKTGJan 29, 2003
ItalfarmacoFor profitNDA2Sep 5, 2018
ItalfarmacoFor profitMKTGSep 5, 2018
KentonFor profitMKTGDec 9, 2019
Mitsubishi TanabeFor profitMKTGNov 22, 2019
MylanFor profitMKTGJul 1, 2013
PHARMOBEDIENTFor profitMKTGJul 1, 2013
Rhone PoulencFor profitNDADec 12, 1995
Standard Chem. & Pharm. Co., Ltd.For profitMKTGDec 9, 2019
Sun PharmaceuticalsFor profitMKTGJun 18, 2013