metaxalone

Trade name: skelaxin

Small moleculeapproved

Approved

Aug 13, 1962

Metaxalone (marketed by King Pharmaceuticals under the brand name Skelaxin) is a muscle relaxant used to relax muscles and relieve pain caused by strains, sprains, and other musculoskeletal conditions. The mechanism of action of metaxalone in humans has not been established, but may be due to general central nervous system depression. Metaxalone has no direct action on the contractile mechanism of striated muscle, the motor end plate, or the nerve fiber. Skelaxin is available in an 800 mg scored tablet. Metaxalone relatively low incidence of side effects. The most common adverse reactions to Metaxalone tablets include drowsiness, dizziness, headache, and nervousness or “irritability”, nausea, vomiting, gastrointestinal upset. — NCATS

Clinical trial activity

6 trials · 5 clinical orgs · 14 marketing orgs

Phase 1
0
Phase 2
0
Phase 3
0
Phase 4
5

Earliest trial started May 3, 2017 (NCT03068897)

Timeline

1960s

  1. Aug 13, 1962

    King Pharmaceuticals — Earliest FDA Approval

  2. Aug 13, 1962

    King Pharmaceuticals — NDA Organization

  3. Aug 13, 1962

    King Pharmaceuticals — NDA Secondary Org

2010s

  1. Mar 31, 2010

    Sandoz — Marketing Organization

  2. Mar 31, 2010

    Novartis — Marketing Organization

  3. Jun 21, 2013

    Amneal Pharmaceuticals — Marketing Organization

  4. Feb 27, 2015

    Rocky Mountain Labs — Marketing Organization

  5. Jun 1, 2015

    Primus Pharmaceuticals — NDA Secondary Org

  6. Nov 22, 2016

    Lannett Company, Inc. — Marketing Organization

  7. Jun 15, 2017

    Actavis — Marketing Organization

  8. Jun 15, 2017

    Allergan PLC (2015) — Marketing Organization

  9. Aug 31, 2017

    Sciegen Pharmaceticals — Marketing Organization

  10. Sep 24, 2018

    Appco Pharma — Marketing Organization

  11. Sep 24, 2018

    Rising Pharmaceuticals — Marketing Organization

2020s

  1. Oct 21, 2020

    Ingenus Pharmaceuticals — Marketing Organization

  2. Oct 21, 2020

    Novast Labs — Marketing Organization

Indications

Mechanism of action

  • Unspecified targetOTHER

    Unknown

Approval history

  • approvedAug 13, 1962

Chemistry & pharmacology

Loading structure…

SMILES

CC1=CC(OCC2CNC(=O)O2)=CC(C)=C1
Mol. weight
221.2524 g/mol
Lipinski Ro5
Pass
Rule of 3
Yes
Chirality
Racemic Mixture
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

Sources

Also known as

  • 5-((3,5-dimethylphenoxy)methyl)-2-oxazolidinone
  • ahr 438
  • ahr 438
  • ahr-438
  • ahr-438
  • metassalone
  • metassalone
  • metaxalon
  • metaxalon
  • metaxalon
  • metaxalona
  • metaxalona
  • metaxalone
  • metaxalone
  • metaxalone
  • metaxalone
  • metaxalone
  • metaxalone
  • metaxalone
  • metaxalone
  • metaxalone
  • metaxalone
  • metaxalonum
  • metaxalonum
  • metazalone
  • metazolone
  • skelaxin
  • skelaxin
  • skelaxin
  • skelaxin
  • skelaxin
  • zorane

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06484192Phase 4Jun 28, 2024Thomas Jefferson University
NCT06382662Phase 4Apr 15, 2024Primus Pharmaceuticals, Sponsor GmbH
NCT06348303Phase 4Mar 15, 2024Primus Pharmaceuticals
NCT06157177Phase 4Nov 15, 2023Illumination Health, Primus Pharmaceuticals
NCT04003350N/ADec 21, 2017Thomas Jefferson University
NCT03068897Phase 4May 3, 2017Yeshiva University
Showing 6 of 6 trials
Page 1 / 1

Organizations

Research & Development (5)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Primus PharmaceuticalsFor profit3312023
Thomas Jefferson UniversityAcademic/Hospital2222017
Illumination HealthFor profit1012023
Sponsor GmbHAcademic/Hospital1012024
Yeshiva UniversityAcademic/Hospital1112017
5 organizations
Page 1 / 1

Marketing (16)

OrganizationOrg typeRelationshipDate
ActavisFor profitMKTGJun 15, 2017
Allergan PLC (2015)For profitMKTGJun 15, 2017
Amneal PharmaceuticalsFor profitMKTGJun 21, 2013
Appco PharmaFor profitMKTGSep 24, 2018
Appco PharmaFor profitSYNSep 24, 2018
Ingenus PharmaceuticalsFor profitMKTGOct 21, 2020
King PharmaceuticalsFor profitNDAAug 13, 1962
King PharmaceuticalsFor profitNDA2Aug 13, 1962
Lannett Company, Inc.For profitMKTGNov 22, 2016
NovartisFor profitMKTGMar 31, 2010
Novast LabsFor profitMKTGOct 21, 2020
Primus PharmaceuticalsFor profitNDA2Jun 1, 2015
Rising PharmaceuticalsFor profitMKTGSep 24, 2018
Rocky Mountain LabsAcademic/HospitalMKTGFeb 27, 2015
SandozFor profitMKTGMar 31, 2010
Sciegen PharmaceticalsFor profitMKTGAug 31, 2017