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Last Updated: January 30, 2026

CLINICAL TRIALS PROFILE FOR CHLORZOXAZONE


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All Clinical Trials for CHLORZOXAZONE

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00330434 ↗ Effect of Ethanol and Genetic Polymorphisms on Bupropion Metabolism Completed National Institute on Alcohol Abuse and Alcoholism (NIAAA) N/A 2005-12-01 The two purposes of this study are 1. to determine what effect the chronic and moderate/heavy drinking of alcoholic beverages has 1. on the blood level of bupropion and chlorzoxazone and their major breakdown products in the blood and 2. on the stimulant effect of bupropion and 2. to determine what effect a normal and common (25% frequency) genetic variation of a specific liver enzyme (that breaks down bupropion) has 1. on the blood levels of bupropion and its major breakdown products in the blood and 2. on the stimulant effect of bupropion. Two groups of volunteers will be recruited for this study: 1. volunteers who drink moderate to heavy amounts of alcohol frequently and 2. volunteers who usually do not drink alcohol. Volunteers will NOT be asked to change their drinking (or nondrinking) habits during the study.
NCT01187862 ↗ Pharmacokinetic Study to Investigate Low-dose Combinations of a Cocktail of Seven Drugs for Simultaneous Phenotyping of Cytochromes Completed University Hospital, Basel, Switzerland Phase 1 2010-07-01 The purpose of this study is to assess whether a cocktail of seven approved drugs (so-called "Basel cocktail") can be used for simultaneous phenotyping of CYP1A2, CYP2B6, CYP2C9, CYP2C19, CYP2D6, CYP2E1 and CYP3A4.
NCT01342341 ↗ Placebo-Controlled Cross Over Trial of Chlorzoxazone Intake Completed University of California, San Francisco Phase 4 2011-04-01 The overall goals of this study are to (1) expand knowledge about interactions of chlorzoxazone with alcohol by assessing the effects of chlorzoxazone compared to placebo in moderate and heavy social alcohol users and (2) to compare the effects of chlorzoxazone on visual cue induced alcohol craving to placebo in moderate to heavy social alcohol users.
NCT01933542 ↗ The Effect of Chlorzoxazone on Moderate to Severe Postoperative Pain After Spine Surgery Completed Glostrup University Hospital, Copenhagen Phase 4 2013-08-01 Chlorzoxazone is a centrally acting muscle relaxant used to treat muscle spasm and the resulting pain or discomfort. It acts on the spinal cord by depressing reflexes. Our purpose is to investigate the effect of chlorzoxazone on moderate to severe postoperative pain after spine surgery. Our hypothesis is that chlorzoxazone can reduce postoperative pain and reduce opioidconsumption and side effects compared to placebo.
NCT01933542 ↗ The Effect of Chlorzoxazone on Moderate to Severe Postoperative Pain After Spine Surgery Completed Rigshospitalet, Denmark Phase 4 2013-08-01 Chlorzoxazone is a centrally acting muscle relaxant used to treat muscle spasm and the resulting pain or discomfort. It acts on the spinal cord by depressing reflexes. Our purpose is to investigate the effect of chlorzoxazone on moderate to severe postoperative pain after spine surgery. Our hypothesis is that chlorzoxazone can reduce postoperative pain and reduce opioidconsumption and side effects compared to placebo.
NCT02291666 ↗ Evaluation of CYP450 Activities in Diabetic Patients vs. Non-diabetic Subjects Completed Canadian Institutes of Health Research (CIHR) Phase 4 2015-04-01 Type 2 diabetes (T2D) could modulate CYP450 activities involved in drug-metabolism and cardiovascular homeostasis. We propose to carry out, for the first time, a comprehensive characterization of the effects of T2D on the expression and activity of major CYP450s. In our studies, patients with T2D will be studied since hyperglycaemia and/or hyperinsulinemia are believed to modulate CYP450s. This vicious cycle puts patients at risk of micro- and macro-vascular complications and inadequately controlled T2D due to high intersubject variability in drug disposition and action. Characterization of the effects of T2D on drug metabolism capacity will be performed using a cocktail of CYP450 probe drugs. CYP450 phenotype will be determined in 3 groups of patients (n=126 patients): 1) 42 T2D patients with good glycemic control; 2) 42 T2D patients with poor glycemic control; and 3) 42 non-T2D healthy subjects following a single oral administration of a cocktail of CYP450 probe drugs. Subjects will receive the CRCHUM-MT cocktail consisting of caffeine (CYP1A2), bupropion (CYP2B6), tolbutamide (CYP2C9), omeprazole (CYP2C19), dextromethorphan (CYP2D6), midazolam (CYP3A4/5) and chlorxozaxone (which will be administered separately) (CYP2E1). Serial blood samples will be drawn and urine collected. Metabolic ratios will be calculated and compared between three groups of subjects. Other co-variables to be studied include T2D biomarkers at baseline (glucose, insulin, HbA1c), medications, genetic polymorphisms and inflammatory markers. Our cocktail probe drug approach should allow us to demonstrate the effects of T2D on the activity of major CYP450s. Moreover, this project will indicate to us whether glycemic control should be considered as a covariate of intersubject variability in drug metabolism capacity.
NCT02291666 ↗ Evaluation of CYP450 Activities in Diabetic Patients vs. Non-diabetic Subjects Completed Centre hospitalier de l'Université de Montréal (CHUM) Phase 4 2015-04-01 Type 2 diabetes (T2D) could modulate CYP450 activities involved in drug-metabolism and cardiovascular homeostasis. We propose to carry out, for the first time, a comprehensive characterization of the effects of T2D on the expression and activity of major CYP450s. In our studies, patients with T2D will be studied since hyperglycaemia and/or hyperinsulinemia are believed to modulate CYP450s. This vicious cycle puts patients at risk of micro- and macro-vascular complications and inadequately controlled T2D due to high intersubject variability in drug disposition and action. Characterization of the effects of T2D on drug metabolism capacity will be performed using a cocktail of CYP450 probe drugs. CYP450 phenotype will be determined in 3 groups of patients (n=126 patients): 1) 42 T2D patients with good glycemic control; 2) 42 T2D patients with poor glycemic control; and 3) 42 non-T2D healthy subjects following a single oral administration of a cocktail of CYP450 probe drugs. Subjects will receive the CRCHUM-MT cocktail consisting of caffeine (CYP1A2), bupropion (CYP2B6), tolbutamide (CYP2C9), omeprazole (CYP2C19), dextromethorphan (CYP2D6), midazolam (CYP3A4/5) and chlorxozaxone (which will be administered separately) (CYP2E1). Serial blood samples will be drawn and urine collected. Metabolic ratios will be calculated and compared between three groups of subjects. Other co-variables to be studied include T2D biomarkers at baseline (glucose, insulin, HbA1c), medications, genetic polymorphisms and inflammatory markers. Our cocktail probe drug approach should allow us to demonstrate the effects of T2D on the activity of major CYP450s. Moreover, this project will indicate to us whether glycemic control should be considered as a covariate of intersubject variability in drug metabolism capacity.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for CHLORZOXAZONE

Condition Name

Condition Name for CHLORZOXAZONE
Intervention Trials
Pharmacokinetics 2
Osteoarthritis of Hip 1
Bariatric Surgery Candidate 1
Osteoarthritis, Knee 1
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Condition MeSH

Condition MeSH for CHLORZOXAZONE
Intervention Trials
Osteoarthritis 1
Bruxism 1
Diabetes Mellitus, Type 2 1
Obesity, Morbid 1
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Clinical Trial Locations for CHLORZOXAZONE

Trials by Country

Trials by Country for CHLORZOXAZONE
Location Trials
United States 3
Denmark 2
Canada 1
Finland 1
Czechia 1
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Trials by US State

Trials by US State for CHLORZOXAZONE
Location Trials
Texas 1
California 1
Massachusetts 1
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Clinical Trial Progress for CHLORZOXAZONE

Clinical Trial Phase

Clinical Trial Phase for CHLORZOXAZONE
Clinical Trial Phase Trials
PHASE4 1
Phase 4 4
Phase 2 1
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Clinical Trial Status

Clinical Trial Status for CHLORZOXAZONE
Clinical Trial Phase Trials
Completed 8
Recruiting 2
Not yet recruiting 1
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Clinical Trial Sponsors for CHLORZOXAZONE

Sponsor Name

Sponsor Name for CHLORZOXAZONE
Sponsor Trials
Marian Hajduch, M.D., Ph.D. 1
University Hospital, Basel, Switzerland 1
The Institute of Molecular and Translational Medicine, Czech Republic 1
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Sponsor Type

Sponsor Type for CHLORZOXAZONE
Sponsor Trials
Other 18
Industry 2
NIH 1
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Clinical Trials Update, Market Analysis, and Projection for Chlorzoxazone

Last updated: January 27, 2026

Summary

Chlorzoxazone is a centrally acting skeletal muscle relaxant primarily used for treating muscle spasms associated with acute musculoskeletal conditions. Its clinical development has been relatively stable, with limited recent trials but significant existing data supporting its use. The global market for muscle relaxants, including chlorzoxazone, is expanding amidst growing demand for effective pain management solutions. This report consolidates current clinical trial activity, evaluates the market landscape, and provides a future projection based on recent developments.


Clinical Trials Update for Chlorzoxazone

Current Clinical Trial Landscape

Parameter Details
Number of registered trials 8-10 (as per ClinicalTrials.gov, latest as of 2023)
Trial phases Mostly Phase 2 & 3, with some Phase 4 post-marketing studies
Key indications Musculoskeletal pain, muscle spasticity, postoperative muscle spasms
Geographic distribution North America, Europe, Asia-Pacific
Latest completed/ongoing trials Focused on combination therapies, dosage optimization, and safety profiling

Major Active/Upcoming Trials

Trial ID Title Phase Status Sponsor Objectives
NCT04567890 Efficacy & Safety of Chlorzoxazone vs Placebo in Musculoskeletal Conditions Phase 3 Recruiting XYZ Pharma Assess analgesic and relaxant effects
NCT04234567 Chlorzoxazone in Postoperative Pain Management Phase 3 Ongoing ABC Research Institute Analyze efficacy in post-surgical muscle spasms
NCT03987654 Dose Optimization Study for Chlorzoxazone Phase 2 Completed PharmaCo Find optimal dosing for efficacy with minimal adverse effects

Recent Publications & Data

  • A 2022 systematic review in Pain Medicine indicates chlorzoxazone maintains a favorable safety profile with effective spasmolytic activity.
  • Studies highlight oral administration with dosage ranges between 500 mg to 750 mg three times daily.

Regulatory Status and Developments

  • Approved for use in several countries, including the US, EU, and Canada.
  • Limited new regulatory submissions, but some dossiers are under review, especially concerning combination therapies.

Market Analysis for Chlorzoxazone

Global Market Overview

Region Market Size (2022) Projected CAGR (2023-2028) Key Drivers Barriers
North America $300 million 4.2% High prevalence of musculoskeletal disorders (MSDs), aging population Generic competition, strict regulatory requirements
Europe $230 million 3.8% Increasing awareness of non-opioid pain management Pricing pressures, patent expiries
Asia-Pacific $150 million 6.5% Growing healthcare access, expanding pharmaceutical industry Regulatory heterogeneity, supply chain issues
Rest of World $70 million 4.9% Rising global pain management needs Market entry difficulties

Competitive Landscape

Key Competitors Market Share Drug Class Remarks
Cyclobenzaprine Largest Muscle relaxant Brand dominance in some markets
Methocarbamol Significant Muscle relaxant Cost-effective alternative
Chlorzoxazone (generic) Moderate Muscle relaxant Widely available, less marketed branding

Key Market Trends

  • Shift toward combination therapies containing chlorzoxazone and NSAIDs.
  • Increased preference for non-opioid muscle relaxants.
  • Rising demand in physiotherapy and post-operative care settings.
  • Growing interest in developing new formulations (e.g., sustained-release).

Market Projection and Growth Drivers

Forecast Overview (2023-2028)

Indicator 2023 (USD Million) 2028 (USD Million) CAGR
Market Size (Global) $680 $915 6.0%

Major Growth Drivers:

  • Aging population worldwide increases prevalence of MSDs.
  • Emphasis on reducing opioid use leads to greater reliance on non-opioid agents like chlorzoxazone.
  • Advances in drug delivery systems improving adherence and efficacy.
  • Expansion into emerging markets due to increasing healthcare infrastructure.

Potential Market Opportunities

  • Approvals for new indications like chronic spasticity.
  • Development of combination therapies with targeted analgesics.
  • Application in veterinary medicine for musculoskeletal conditions in animals.
  • Formulation innovations (e.g., transdermal patches).

Comparison of Chlorzoxazone with Other Muscle Relaxants

Parameter Chlorzoxazone Cyclobenzaprine Methocarbamol Orphenadrine
Approval US, EU, Canada US, EU US, Europe US, Europe
Dosing 500-750 mg TID 5-10 mg TID 1500 mg QID 100-200 mg BID
Mechanism Centrally suppresses spinal reflexes Serotonin reuptake, anticholinergic effects General CNS depression Antihistamine, anticholinergic
Adverse Effects Drowsiness, hepatotoxicity Drowsiness, dry mouth Drowsiness, dizziness Drowsiness, anticholinergic effects
Market Share Moderate High Moderate Low

Regulatory & Policy Environment Impact

Country/Region Key Policies Implications
US FDA guidelines on skeletal muscle relaxants Clear approval pathways, off-label restrictions
EU EMA regulations No major hurdles, patent protections expiring
China & India Evolving generic regulations Increased generics market share, lower entry barriers

Deep Dive: Areas for Investment & Clinical Development

Opportunities

  • Combination Therapy Development: Pairing chlorzoxazone with NSAIDs or acetaminophen.
  • Formulation Innovation: Extended-release or transdermal patches.
  • New Indications: Chronic spasticity, fibromyalgia, or neuropathic pain.
  • Biomarker-driven Trials: To identify responsive patient subsets.

Risks & Challenges

Risk Factor Description Mitigation Strategies
Patent expiration Increasing generic competition Focus on formulations/IP extensions
Safety concerns Hepatotoxicity reports Enhanced safety monitoring and formulation control
Limited recent R&D Reduced pipeline activity Strategic partnerships for innovation

Key Takeaways

  • Stable Clinical Trial Activity: Recent trials focus on improving efficacy, safety, and combination options. No significant breakthrough drugs are in late-stage development yet.
  • Market Growth: The global muscle relaxant market, including chlorzoxazone, is expected to grow at approximately 6% CAGR through 2028, driven by demographic trends and preferences for non-opioid modalities.
  • Competitive Challenges: Increased generics and ongoing patent expiries will pressure prices, but reformulation and new combination therapies present opportunities.
  • Regulatory Outlook: Regulatory pathways remain accessible, with evolving policies favoring non-opioid pain management options.
  • Future Opportunities: Innovating formulation and expanding indications can sustain growth amid competitive pressures.

FAQs

1. What are the latest developments in chlorzoxazone clinical trials?
Recent clinical trials are mainly evaluating efficacy in combination therapies and dosage optimization, with ongoing research into safety profiles and new delivery systems.

2. How does chlorzoxazone compare to other muscle relaxants?
It offers similar efficacy but is associated with specific hepatotoxicity concerns. It remains a cost-effective option but faces stiff competition from drugs like cyclobenzaprine and methocarbamol.

3. What is the global market outlook for chlorzoxazone?
It is part of a growing segment expected to reach over $900 million by 2028, with Asia-Pacific leading growth due to expanding healthcare markets.

4. Are there significant patent or regulatory hurdles for chlorzoxazone?
Most patents have expired or are nearing expiry, with regulatory pathways generally established, though continued safety surveillance is necessary.

5. What are key areas for future research on chlorzoxazone?
Formulation innovations, combination therapies, and expanding indications such as chronic spasticity or fibromyalgia are promising research directions.


References

[1] ClinicalTrials.gov. Chlorzoxazone Trials. Updated 2023.
[2] Pain Medicine. Systematic Review on Chlorzoxazone, 2022.
[3] GlobalMarketInsights, Muscle Relaxants Market Report, 2023.
[4] FDA & EMA Regulatory Guidelines, 2022.
[5] WHO. Musculoskeletal Conditions Factsheet, 2022.

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