Metaxalone

ApprovedSmall molecule

VViking Therapeutics, Inc.

Metaxalone is one of 134 small molecule programs targeting Total Knee Arthroplasty. It is currently in Approved.

Indications

Total Trials

Active Trials

133

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

Total Knee ArthroplastyActive, not recruiting

Low Back PainActive, not recruiting

CognitionActive, not recruiting

FallNot yet recruiting

Total Knee ArthroplastyPreclinical

Active, not recruiting

Low Back PainApproved

Active, not recruiting

CognitionApproved

Active, not recruiting

FallApproved

Not yet recruiting

Competition

Competitive Landscape

88 competitors in Cognition

#DrugCompanyPhaseTrials

Pitocin

RRetrophin

Approved

6 2

Precedex

MMcNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Approved

2 3

Atropen

FFresenius Kabi Taiwan Ltd.

Approved

1 4

Lipitor

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Approved

1 5

Namenda

AbbVie

Phase 3

3 6

Metaxalone

VViking Therapeutics, Inc.

Approved

1 7

Epidiolex

Jazz Pharmaceuticals

Phase 2

2 8

Nuplazid

AACADIA Pharmaceuticals Inc.

Phase 2

1 9

Remimazolam Tosilate

FFujian Shengdi Pharmaceutical Co., Ltd.

Phase 3

1 10

Psilocybin

COMPASS Pathways

Phase 2

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

ApprovedRecruiting

Sciatica

NCT06157177

Q1 2027

ApprovedNot yet recruiting

Study completion

NCT07801066

Clinical

Trials by Indication[1]

Cognition1 trial

Study to Assess Drowsiness, Cognition, Fall Risk After Metaxalone 640 mg and Metaxalone 800 mg

Completed·PPrimus Pharmaceuticals·Phase 4·NCT06348303·20 enrolled

Pain Control1 trial

Pain Control After Lumbar Spine Fusion

Enrolling by invitation·RRothman Institute Orthopaedics·Phase 4·NCT06484192·428 enrolled

Low back pain1 trial

Ibuprofen Plus Metaxolone, Tizanidine, or Baclofen for Low Back Pain

Completed·MMontefiore Medical Center·Phase 4·NCT03068897·320 enrolled

Total Knee Arthroplasty1 trial

The Effect of Prolonged Multimodal Analgesic Regimen on Post Hospital Discharge Opioid Use and Pain Control After Primary Total Knee Arthroplasty

Completed·RRothman Institute Orthopaedics·N/A·NCT04003350·216 enrolled

Sciatica1 trial

Efficacy of Modified Release Metaxalone 640 mg in Acute Lumbosacral Musculoskeletal Conditions With Spinal Stenosis and Sciatica

Recruiting·PPrimus Pharmaceuticals·Approved·NCT06157177·50 enrolled

1 more indication

Unspecified1 trial

A Prospective, Randomized, Single-blind, Study to Assess Drowsiness, Cognition, Fall Risk, and Electroencephalographic (EEG) Dynamics Following Oral Metaxalone Tablets 640 mg (M640) Versus Metaxalone 800 mg in Healthy Participants: A Bootstrap Validation.

Not yet recruiting·PPrimus Pharmaceuticals·Approved·NCT07801066·20 enrolled

Regulatory

FDA Approval Timeline[4]

Jan 1, 1982

SKELAXIN

NDA NDA013217

Jun 1, 2015

METAXALONE

NDA NDA022503

Sources

References

[1]
ClinicalTrials.gov — 6 trial records for Metaxalone. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Metaxalone compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Metaxalone. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA022503). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Metaxalone. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Viking Therapeutics, Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: VViking Therapeutics, Inc.

Patent Landscape[5]

Patent Cliff

Jul 29, 2039

Earliest patent expiration — generic entry possible after this date

Patent #Expires

7122566Feb 6, 2026

11918559Jul 29, 2039

12485111May 14, 2043

Metaxalone

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2027

Trials by Indication[1]

Cognition1 trial

Pain Control1 trial

Low back pain1 trial

Total Knee Arthroplasty1 trial

Sciatica1 trial

Unspecified1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

Related News