metaxalone
Trade name: skelaxin
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
Earliest trial started May 3, 2017 (NCT03068897)
Timeline
1960s
- Aug 13, 1962
King Pharmaceuticals — Earliest FDA Approval
- Aug 13, 1962
King Pharmaceuticals — NDA Organization
- Aug 13, 1962
King Pharmaceuticals — NDA Secondary Org
2010s
- Mar 31, 2010
Sandoz — Marketing Organization
- Mar 31, 2010
Novartis — Marketing Organization
- Jun 21, 2013
Amneal Pharmaceuticals — Marketing Organization
- Feb 27, 2015
Rocky Mountain Labs — Marketing Organization
- Jun 1, 2015
Primus Pharmaceuticals — NDA Secondary Org
- Nov 22, 2016
Lannett Company, Inc. — Marketing Organization
- Jun 15, 2017
Actavis — Marketing Organization
- Jun 15, 2017
Allergan PLC (2015) — Marketing Organization
- Aug 31, 2017
Sciegen Pharmaceticals — Marketing Organization
- Sep 24, 2018
Appco Pharma — Marketing Organization
- Sep 24, 2018
Rising Pharmaceuticals — Marketing Organization
2020s
- Oct 21, 2020
Ingenus Pharmaceuticals — Marketing Organization
- Oct 21, 2020
Novast Labs — Marketing Organization
Indications
Approved for
Mechanism of action
- Unspecified targetOTHER
Unknown
Approval history
- approvedAug 13, 1962
Chemistry & pharmacology
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
- WikipediaMetaxalone ↗
- NCATS1NMA9J598Y ↗
- ChEMBLCHEMBL1079604 ↗
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 ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT06484192 | Phase 4 | Jun 28, 2024 | Thomas Jefferson University |
| NCT06382662 | Phase 4 | Apr 15, 2024 | Primus Pharmaceuticals, Sponsor GmbH |
| NCT06348303 | Phase 4 | Mar 15, 2024 | Primus Pharmaceuticals |
| NCT06157177 | Phase 4 | Nov 15, 2023 | Illumination Health, Primus Pharmaceuticals |
| NCT04003350 | N/A | Dec 21, 2017 | Thomas Jefferson University |
| NCT03068897 | Phase 4 | May 3, 2017 | Yeshiva University |
Organizations
Research & Development (5)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Primus Pharmaceuticals | For profit | 3 | 3 | 1 | 2023 |
| Thomas Jefferson University | Academic/Hospital | 2 | 2 | 2 | 2017 |
| Illumination Health | For profit | 1 | 0 | 1 | 2023 |
| Sponsor GmbH | Academic/Hospital | 1 | 0 | 1 | 2024 |
| Yeshiva University | Academic/Hospital | 1 | 1 | 1 | 2017 |
Marketing (16)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Actavis | For profit | MKTG | Jun 15, 2017 |
| Allergan PLC (2015) | For profit | MKTG | Jun 15, 2017 |
| Amneal Pharmaceuticals | For profit | MKTG | Jun 21, 2013 |
| Appco Pharma | For profit | MKTG | Sep 24, 2018 |
| Appco Pharma | For profit | SYN | Sep 24, 2018 |
| Ingenus Pharmaceuticals | For profit | MKTG | Oct 21, 2020 |
| King Pharmaceuticals | For profit | NDA | Aug 13, 1962 |
| King Pharmaceuticals | For profit | NDA2 | Aug 13, 1962 |
| Lannett Company, Inc. | For profit | MKTG | Nov 22, 2016 |
| Novartis | For profit | MKTG | Mar 31, 2010 |
| Novast Labs | For profit | MKTG | Oct 21, 2020 |
| Primus Pharmaceuticals | For profit | NDA2 | Jun 1, 2015 |
| Rising Pharmaceuticals | For profit | MKTG | Sep 24, 2018 |
| Rocky Mountain Labs | Academic/Hospital | MKTG | Feb 27, 2015 |
| Sandoz | For profit | MKTG | Mar 31, 2010 |
| Sciegen Pharmaceticals | For profit | MKTG | Aug 31, 2017 |