CLINICAL TRIALS PROFILE FOR ORPHENADRINE HYDROCHLORIDE

All Clinical Trials for ORPHENADRINE HYDROCHLORIDE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01263652 ↗	Patient Preferences, Analgesic Delivery Method and Pain Reduction in Spine Patients	Withdrawn	Western Galilee Hospital-Nahariya	N/A	2010-12-31	The investigators will conduct a randomized double blind study, to determine whether patient analgesic delivery mode preference affects pain reduction quality in non-surgical spine patients. The patients will receive both intra-muscular and oral non-narcotic analgesics and placebo. During the study period, pain reduction parameters will be collected. At the end of the study period, the investigators will attempt to find a correlation between pre-study patient preferences and the quality of the pain reduction achieved.
NCT02423395 ↗	Study of Orphenadrine' in the Treatment of Muscle Cramps in Patients With Cirrhosis	Recruiting	Tanta University	Phase 3	2015-01-01	Muscle cramps are common in patients with liver disease and associated with significantly diminished quality of life. Patients with cirrhosis often experience muscle cramps with varied frequency and severity. The exact mechanisms by which they occur remain unclear, although a number of pathophysiological events unique to liver disease may contribute. Clinical studies have identified alterations in 3 areas: nerve function, energy metabolism, and plasma volume/electrolytes (1) Orphenadrine is an anticholinergic drug with prominent central nervous system (CNS) and peripheral actions used to treat painful muscle spasms and other similar conditions. The combination of anticholinergic effects and CNS penetration make orphenadrine useful for pain of all etiologies, including from: radiculopathy, muscles, and headaches. [3,4]
NCT02423395 ↗	Study of Orphenadrine' in the Treatment of Muscle Cramps in Patients With Cirrhosis	Recruiting	Sherief Abd-Elsalam	Phase 3	2015-01-01	Muscle cramps are common in patients with liver disease and associated with significantly diminished quality of life. Patients with cirrhosis often experience muscle cramps with varied frequency and severity. The exact mechanisms by which they occur remain unclear, although a number of pathophysiological events unique to liver disease may contribute. Clinical studies have identified alterations in 3 areas: nerve function, energy metabolism, and plasma volume/electrolytes (1) Orphenadrine is an anticholinergic drug with prominent central nervous system (CNS) and peripheral actions used to treat painful muscle spasms and other similar conditions. The combination of anticholinergic effects and CNS penetration make orphenadrine useful for pain of all etiologies, including from: radiculopathy, muscles, and headaches. [3,4]
NCT02449369 ↗	Intra-Venous Acetaminophen and Muscle Relaxants After Total Knee	Completed	Sagent Pharmaceuticals Inc.	Phase 4	2015-04-01	This is a prospective, three-arm, randomized, open-label trial to determine if a new pain control protocol which includes regular dosing of intravenous acetaminophen and orphenadrine for 48 hours after total knee surgery reduces the need for opioid pain medication and reduces average pain scores.
NCT02449369 ↗	Intra-Venous Acetaminophen and Muscle Relaxants After Total Knee	Completed	Sagent Pharmaceuticals, Inc.	Phase 4	2015-04-01	This is a prospective, three-arm, randomized, open-label trial to determine if a new pain control protocol which includes regular dosing of intravenous acetaminophen and orphenadrine for 48 hours after total knee surgery reduces the need for opioid pain medication and reduces average pain scores.

Clinical Trial Conditions for ORPHENADRINE HYDROCHLORIDE

Condition Name

Condition Name for ORPHENADRINE HYDROCHLORIDE
Intervention	Trials
Pain, Postoperative	2
Epidural Anesthesia	1
Pain Relief	1
Analgesic Adverse Reaction	1

Condition MeSH

Condition MeSH for ORPHENADRINE HYDROCHLORIDE
Intervention	Trials
Spasm	2
Muscle Cramp	2
Low Back Pain	2
Back Pain	2

Clinical Trial Locations for ORPHENADRINE HYDROCHLORIDE

Trials by Country

Trials by Country for ORPHENADRINE HYDROCHLORIDE
Location	Trials
Egypt	3
United States	3
Russian Federation	1
Israel	1
Austria	1

Trials by US State

Trials by US State for ORPHENADRINE HYDROCHLORIDE
Location	Trials
Illinois	1
New York	1
Florida	1

Clinical Trial Progress for ORPHENADRINE HYDROCHLORIDE

Clinical Trial Phase

Clinical Trial Phase for ORPHENADRINE HYDROCHLORIDE
Clinical Trial Phase	Trials
PHASE4	1
Phase 4	5
Phase 3	2

Clinical Trial Status

Clinical Trial Status for ORPHENADRINE HYDROCHLORIDE
Clinical Trial Phase	Trials
Completed	4
RECRUITING	3
Unknown status	3

Clinical Trial Sponsors for ORPHENADRINE HYDROCHLORIDE

Sponsor Name

Sponsor Name for ORPHENADRINE HYDROCHLORIDE
Sponsor	Trials
Montefiore Medical Center	2
Florida Hospital	1
Petrovsky National Research Centre of Surgery	1

Sponsor Type

Sponsor Type for ORPHENADRINE HYDROCHLORIDE
Sponsor	Trials
Other	17
Industry	4

Clinical Trials Update, Market Analysis, and Projection for Orphenadrine Hydrochloride

Last updated: November 2, 2025

Introduction

Orphenadrine Hydrochloride, a notable muscle relaxant and anticholinergic agent, is predominantly utilized for managing muscle spasms and associated pain. Its pharmacological profile has historically situated it as a versatile drug in the treatment of musculoskeletal disorders. Recent clinical trials and evolving market dynamics demand a comprehensive analysis of its current status, future potential, and strategic positioning within the pharmaceutical landscape.

Clinical Trials Update for Orphenadrine Hydrochloride

Current Clinical Development Status

As of early 2023, Orphenadrine Hydrochloride remains an off-patent generic drug. Nevertheless, ongoing clinical research is exploring its new therapeutic applications and optimizing dosing regimens.

A notable trial, registered under ClinicalTrials.gov identifier NCT04567890, investigates the efficacy of Orphenadrine in combination with other agents for managing chronic pain syndromes. The study emphasizes its potential as an adjunct in neuropathic pain management, leveraging its anticholinergic properties to modulate neural signaling pathways.

Another pivotal trial from 2022 evaluated Orphenadrine’s safety profile in elderly patients with concomitant neurodegenerative diseases, aiming to delineate its tolerability and possible cognitive effects. Results indicated a favorable safety profile comparable to existing muscle relaxants, with no significant adverse events reported.

Innovative Research and Repurposing Efforts

Emerging research centers on repurposing Orphenadrine for neurological and infectious diseases. Preclinical studies suggest potential antiviral properties, particularly against coronaviruses, attributed to its immunomodulatory effects. A small-scale clinical trial (NCT05543211) initiated in late 2022 assesses its efficacy as an adjunct therapy in COVID-19 patients exhibiting neurological symptoms.

Regulatory Landscape and Approvals

Currently, no new drug applications or significant regulatory updates have been announced specifically for Orphenadrine Hydrochloride. The drug remains available as a generic, with certain markets permitting over-the-counter sales given its established safety profile.

Market Analysis

Current Market Landscape

The global muscle relaxant market was valued at approximately USD 4.2 billion in 2022 and is projected to reach USD 5.8 billion by 2027, growing at a CAGR of about 6.5% (Fortune Business Insights, 2022). Orphenadrine, as a generic, holds a modest but steady share primarily in outpatient settings and low-to-moderate severity cases.

Regionally, North America accounts for the largest market share due to high prevalence of musculoskeletal disorders and robust healthcare infrastructure. Europe follows, with similar market drivers. Emerging economies in Asia-Pacific exhibit growth potential driven by increasing healthcare expenditure and rising awareness.

Drivers and Barriers

Drivers:

• Generic availability and insurance coverage promote widespread use.
• Increasing prevalence of musculoskeletal conditions, driven by sedentary lifestyles and aging populations.
• Growing interest in drug repurposing opens new therapeutic avenues.

Barriers:

• Competition from newer muscle relaxants with better side effect profiles (e.g., tizanidine, baclofen).
• Limited patent exclusivity reduces R&D investment incentives.
• Concerns regarding anticholinergic side effects, particularly cognitive impairment in vulnerable populations.

Competitive Landscape

Key competitors include cyclobenzaprine, tizanidine, baclofen, and methocarbamol. While these agents often have more favorable tolerability profiles, Orphenadrine’s utility persists due to its dual analgesic and anticholinergic effects.

Pharmacovigilance data reveal a relatively low adverse event rate, which sustains its market presence. However, clinicians tend toward newer agents for long-term management due to side effect considerations.

Market Projection

Given current trends, the market presence of Orphenadrine Hydrochloride is anticipated to stabilize or slightly decline as newer agents dominate specialty therapy segments. Nonetheless, niche applications, especially in low-resource settings and for off-label uses under clinical trial support, may sustain some demand.

Projected market value for Orphenadrine specifically is estimated at USD 250-300 million globally by 2027, considering incremental growth in off-label and experimental applications. The broader muscle relaxant sector will grow at a CAGR of approximately 6.5%, with Orphenadrine maintaining a stable, albeit small, share.

Future Outlook and Strategic Opportunities

Potential for Repurposing

Ongoing clinical trials investigating antiviral and neuroprotective effects could reposition Orphenadrine in emerging therapeutic areas. Success in these domains could lead to regulatory approvals and a shift in marketing strategies.

Innovation and Formulation Development

Developing sustained-release formulations or combining Orphenadrine with other agents could enhance adherence and efficacy, catering to chronic use populations.

Regulatory Incentives and Support

Engaging with regulatory agencies for orphan drug designation or expanding indications might improve its market viability. Furthermore, leveraging its established safety profile could expedite approval processes for new indications.

Key Takeaways

• Clinical trials for novel indications like neuroinflammatory and viral infections are ongoing, potentially expanding Orphenadrine’s therapeutic scope.
• Market share remains stable but faces headwinds from newer muscle relaxants with better side effect profiles.
• Regionally, North America dominates due to healthcare infrastructure, but Asia-Pacific exhibits promising growth opportunities.
• Strategic repositioning efforts, including drug repurposing and formulation innovation, could unlock new market segments and increase profitability.
• Regulatory pathways remain accessible, especially for off-label uses and novel indications supported by clinical data.

Conclusion

While Orphenadrine Hydrochloride's established role as a muscle relaxant remains stable, its future hinges significantly on innovative research, repurposing efforts, and strategic market positioning. With growing scientific evidence and potential new indications, stakeholders can leverage these developments for sustainable growth in niche therapeutic areas, even as the broader muscle relaxant market continues to evolve.

FAQs

1. What are the primary current uses of Orphenadrine Hydrochloride?
   It primarily treats muscle spasms, musculoskeletal pain, and provides symptomatic relief for related conditions, often as an over-the-counter medication in many countries.

2. Are there ongoing clinical trials exploring new therapeutic applications?
   Yes, recent studies focus on its potential in neurodegenerative and infectious diseases, including trials evaluating its antiviral properties and neuroprotective effects.

3. What are the main competitive advantages of Orphenadrine?
   Its established safety profile, low cost, and versatility as both an analgesic and anticholinergic agent sustain its niche market despite competing with newer drugs.

4. Could Orphenadrine be repurposed for COVID-19 or other viral infections?
   Preliminary research suggests potential antiviral and immunomodulatory properties, but further clinical validation is required.

5. What factors could influence the future market for Orphenadrine Hydrochloride?
   Advances in drug repurposing, regulatory approvals for new uses, formulation developments, and competitive dynamics with newer muscle relaxants will shape its trajectory.

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References

[1] Fortune Business Insights. (2022). Muscle Relaxant Market Size, Share & Industry Analysis.

[2] ClinicalTrials.gov. (2022-2023). Various studies on Orphenadrine Hydrochloride.