Drugs / Metaxalone
Metaxalone
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | SKELAXIN | — | 1962-08-13 | fda.gov ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase not applicable1 trial · 1 missed | ||||||
| — | NCT04003350 | Dec 2017 → Nov 2018 | osteoarthritis, knee | Rothman Institute Orthopaedics | Completed | Missed primary |
| Comparator or background therapy7 trials | ||||||
| Phase 4 | NCT07801066 Comparator | Sep 2026 → Jan 2027 expected | — | Primus Pharmaceuticals | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT06484192 Comparator | Jun 2024 → Jun 2025 | — | Rothman Institute Orthopaedics | Unknown | No outcome recorded |
| Phase 4 | NCT06348303 Comparator | May → Sep 2024 | — | Primus Pharmaceuticals | Completed | No outcome recorded |
| Phase 4 | NCT06382662 Comparator | Apr → Dec 2024 | cognitive disorder | Primus Pharmaceuticals | Completed | No outcome recorded |
| Phase 4 | NCT06157177 Comparator | Nov 2023 → Nov 2026 expected | lumbar spinal stenosis, sciatica | Primus Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 4 | NCT04990804 Background | Aug 2021 → Feb 2022 | spinal cord disorder, substance-related disorder | Vanderbilt University Medical Center | Terminated | No outcome recorded |
| Phase 4 | NCT03068897 Comparator | May 2017 → Jul 2018 | — | Montefiore Medical Center | Completed | No outcome recorded |
Press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2016-11-28 | Lannett Company, Inc. | Lannett Announces Approval For Metaxalone Tablets USP, 800 Mg investorroom.com ↗ |
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 9 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Metaxalone | “Alternative muscle relaxers (Metaxalone 800 mg TID or Tizanidine 2-6 mg TID)” NCT04990804 ↗ |
| Known as | AHR-438 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1079604 ↗ |
| Known as | Flexura | ChEMBL registry synonym — accepted as the source's own label CHEMBL1079604 ↗ |
| Known as | Metaxalona | ChEMBL registry synonym — accepted as the source's own label CHEMBL1079604 ↗ |
| Known as | NSC-170959 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1079604 ↗ |
| Known as | Skelaxin | ChEMBL registry synonym — accepted as the source's own label CHEMBL1079604 ↗ |
| Known as | Zorane | ChEMBL registry synonym — accepted as the source's own label CHEMBL1079604 ↗ |
| Modality | Small molecule | — CHEMBL1079604 ↗ |
| Route | Oral | “Metaxalone 800mg PO TID” NCT04003350 ↗ |