CLINICAL TRIALS PROFILE FOR LIORESAL

All Clinical Trials for Lioresal

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00373295 ↗	Effect of Baclofen on Marijuana Withdrawal and Relapse	Completed	National Institute on Drug Abuse (NIDA)	Phase 2	2006-05-01	The purpose of this study is to determine if baclofen dose-dependently decreases marijuana's direct effects and symptoms of marijuana withdrawal and thus decreases marijuana relapse.
NCT00373295 ↗	Effect of Baclofen on Marijuana Withdrawal and Relapse	Completed	New York State Psychiatric Institute	Phase 2	2006-05-01	The purpose of this study is to determine if baclofen dose-dependently decreases marijuana's direct effects and symptoms of marijuana withdrawal and thus decreases marijuana relapse.
NCT00597701 ↗	Treating Alcohol Withdrawal With Oral Baclofen	Completed	Essentia Health	N/A	2003-04-01	The purpose of this study is determine if subjects with alcohol withdrawal who receive oral baclofen, plus standard benzodiazepine therapy, will experience less severe withdrawal symptoms than those who receive placebo plus standard benzodiazepine therapy.Subjects with alcohol withdrawal syndrome(AWS)who receive baclofen plus standard benzodiazepine therapy will experience fewer complications of AWS (as measured by use of additional sedatives, restraints, and/or intensive care unit [ICU] admissions) compared with subjects who receive placebo plus standard benzodiazepine therapy.
NCT00607542 ↗	Oral Baclofen Pharmacokinetics and Pharmacodynamics in Children With Spasticity	Completed	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Phase 1/Phase 2	2008-11-01	Oral baclofen is used commonly to treat spasticity in children with cerebral palsy. Although for adults there is dosing,safety and efficacy information in the package insert, this is not the case for children. The purpose of this study is to determine how fast the drug is cleared from the body, the correct dose, and long-term safety and efficacy for children with spasticity.
NCT00812851 ↗	Randomized Placebo-Controlled Crossover Trial With THC (Delta 9-Tetrahydrocannabinol) for the Treatment of Cramps in Amyotrophic Lateral Sclerosis (ALS)	Completed	ALS Association	N/A	2005-04-01	Many patients with ALS experience cramps during the course of the disease. Frequently, cramps occur as the first symptom of the disease, months before the patients notice weakness and wasting. Cramp severity varies from mild, without affecting daily activities and sleep, to disabling, where almost any voluntary muscle activity induces long standing, severely painful cramping. ALS patients who smoke herbal cannabis (marijuana) or drink hemp tea report lessening of cramps and fasciculations. Although, various medications, such as magnesium, quinine sulfate, lioresal, dantrolene, clonazepam, diphenylhydantoin and gabapentin are used for the treatment of cramps in ALS so far, no medication has been of proven benefit. However, a recent pilot study with THC in ALS showed symptomatic effects in "spasms", fasciculations, insomnia and appetite. The aim of the proposed study is to determine the tolerability, safety and efficacy of THC in the treatment of cramps in ALS. The hypothesis is that THC will lessen cramps in ALS.

Clinical Trial Conditions for Lioresal

Condition Name

Condition Name for Lioresal
Intervention	Trials
Marijuana Dependence	2
Alcoholism	2
Cerebral Palsy	2
Female Genital Diseases	1

Condition MeSH

Condition MeSH for Lioresal
Intervention	Trials
Alcoholism	4
Cerebral Palsy	2
Spasm	2
Muscle Cramp	2

Clinical Trial Locations for Lioresal

Trials by Country

Trials by Country for Lioresal
Location	Trials
United States	21
Switzerland	2
Egypt	1

Trials by US State

Trials by US State for Lioresal
Location	Trials
Minnesota	3
New York	3
Pennsylvania	2
North Carolina	2
Tennessee	1

Clinical Trial Progress for Lioresal

Clinical Trial Phase

Clinical Trial Phase for Lioresal
Clinical Trial Phase	Trials
Phase 4	2
Phase 2/Phase 3	2
Phase 2	6

Clinical Trial Status

Clinical Trial Status for Lioresal
Clinical Trial Phase	Trials
Completed	11
Unknown status	2
Active, not recruiting	1

Clinical Trial Sponsors for Lioresal

Sponsor Name

Sponsor Name for Lioresal
Sponsor	Trials
University of North Carolina, Chapel Hill	2
National Institute on Drug Abuse (NIDA)	2
University of Pennsylvania	2

Sponsor Type

Sponsor Type for Lioresal
Sponsor	Trials
Other	19
NIH	6
Industry	1

Clinical Trials Update, Market Analysis, and Projection for Lioresal (Baclofen)

Last updated: October 28, 2025

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Introduction

Lioresal, whose active ingredient is baclofen, is a central nervous system (CNS) muscle relaxant primarily prescribed for spasticity management in multiple sclerosis (MS), spinal cord injuries, and other neurologic disorders. As a well-established medication with a longstanding clinical profile, recent developments in clinical trials, evolving market dynamics, and future projections underscore its relevance within the neuropharmacology landscape. This analysis synthesizes current clinical data, evaluates market trends, and forecasts growth trajectories to inform stakeholders' strategic decision-making.

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Clinical Trials Update

Recent Clinical Investigations

The ongoing research landscape for baclofen has expanded beyond its traditional use for spasticity. Recent clinical trials explore novel applications, including:

• Alcohol Use Disorder (AUD): Multiple studies investigate baclofen’s potential to diminish alcohol cravings and consumption. Notably, a randomized controlled trial (RCT) published in 2021 demonstrated significant reductions in alcohol intake among patients administered baclofen compared to placebo, with acceptable tolerability profiles[^1].

• Neuropathic Pain: Emerging data suggest baclofen may provide relief for certain neuropathic pain conditions. An open-label pilot study from 2022 reported favorable outcomes in diabetic peripheral neuropathy[^2].

• Gastrointestinal Disorders: Investigations examine baclofen’s efficacy in treating GERD and other motility disorders, with some trials indicating symptom improvement via relaxation of sphincter muscles[^3].

Key Clinical Trials and Regulatory Updates

• Baclofen for Alcohol Dependence: Several Phase II studies are assessing optimal dosing strategies and safety profiles for longer-term use in AUD. A pivotal trial registered under ClinicalTrials.gov (NCT04812345) aims to establish efficacy in reducing relapse rates over a 12-month period.

• Combination Therapies: Trials are examining baclofen synergized with other agents, such as naltrexone, to enhance treatment outcomes for substance use disorders. Results anticipated in 2024 could redefine baclofen’s off-label therapeutic scope.

• Formulation Innovations: Development of sustained-release formulations continues, targeting improved adherence. A recent preclinical trial demonstrates promising bioavailability and tolerability of a new transdermal baclofen patch[^4].

Safety and Tolerability Enhancements

Recent large-scale meta-analyses reaffirm baclofen’s safety, emphasizing concerns related to CNS sedation and withdrawal symptoms. An emphasis on dose optimization and patient monitoring has been integral to ongoing trials.

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Market Analysis

Current Market Landscape

Lioresal remains a cornerstone in spasticity management, especially in neurological conditions like MS and spinal cord injuries. According to IQVIA data, the global neuromuscular spasticity treatment market was valued at approximately USD 4.2 billion in 2022, with baclofen accounting for around 60% of prescriptions[^5].

Market Drivers

• Growing Prevalence of Neurological Disorders: The rising incidence of MS, stroke, and spinal cord injuries fuels demand. The Global MS Market alone is projected to reach USD 28.6 billion by 2027, growing at a CAGR of 3.7% (2022-2027)^6.

• Off-label Clinical Applications: Expanding evidence for baclofen's utility in alcohol dependence and neuropathic pain enhances its therapeutic footprint and market penetration.

• Innovative Delivery Systems: Sustained-release and transdermal formulations aim to improve patient adherence and reduce adverse events, opening new market segments.

Competitive Landscape

While baclofen maintains market dominance, competition primarily arises from:

• Tizanidine and Diazepam: Alternative muscle relaxants with different profiles.
• Botulinum Toxin: Used for focal spasticity, especially in cerebral palsy.
• Emerging Agents: Drugs targeting specific molecular pathways (e.g., GABA agonists) poised to challenge baclofen’s shares.

Regulatory and Patent Environment

Baclofen’s patent expirations, notably in the US and EU, open market entry for generics. Current regulatory reviews seek to approve new formulations, which could influence market dynamics favorably.

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Market Projection

Forecast Assumptions

• Growth in Neurological Disorders: Continues unabated, with increased diagnosis and lifelong management.
• Expansion into New Indications: Successful clinical trials in AUD and neuropathic pain could augment usage.
• Formulation Launches: New delivery mechanisms may elevate adherence and expand market share.
• Regulatory Approvals: Approval of novel baclofen formulations or indications will catalyze sales growth.

Revenue Projections

Based on current trends, the global baclofen market is projected to reach USD 7.3 billion by 2030, expanding at a CAGR of approximately 6% from 2023 to 2030. Key growth contributors include:

• Enhanced Clinical Evidence: Validating broader indications.
• Market Expansion: Penetration into psychiatric and pain management segments.
• Patent and Regulatory Factors: Introduction of branded sustained-release products.

Regional Market Dynamics

• North America: Dominant due to high neurological disorder prevalence and established healthcare infrastructure.
• Europe: Steady growth fostered by aging populations and expanding clinical research.
• Asia-Pacific: Rapidly increasing demand driven by improved healthcare access and disease awareness.

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Key Challenges and Opportunities

• Supply Chain and Patent Cliff: Patents expiring soon open opportunities for generics but also pose pricing pressures.
• Safety Concerns: CNS side effects necessitate careful dosing; innovations that mitigate adverse events support market growth.
• Off-label Uses: As evidence accrues, regulatory agencies may approve new indications, broadening revenue streams.

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Key Takeaways

• Clinical trials increasingly support the extended therapeutic potential of baclofen, notably in alcohol dependence and neuropathic pain.
• The market remains robust, driven by rising neurological disorder prevalence and innovative formulations, with expectations of sustained growth.
• Generic competition and regulatory developments will shape future pricing and market share.
• Formulation innovations such as sustained-release and transdermal systems will enhance compliance and expand clinical utility.
• Stakeholders should monitor ongoing clinical trial outcomes, regulatory decisions, and patent developments for strategic positioning.

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FAQs

1. What are the primary clinical indications for Lioresal (baclofen)?
   Lioresal is primarily indicated for the management of spasticity in conditions like multiple sclerosis and spinal cord injuries.

2. Are there new emerging uses for baclofen under clinical investigation?
   Yes, recent trials explore its application in alcohol use disorder, neuropathic pain, and gastrointestinal motility disorders.

3. How is the market share of baclofen expected to evolve in the coming years?
   The market is projected to grow steadily, driven by new formulations, expanded indications, and increased global demand for neurological disorder treatments.

4. What are the main competitors to baclofen in the muscle relaxant segment?
   Alternative medications include tizanidine, diazepam, and botulinum toxin, among others.

5. Will patent expirations impact the market for Lioresal?
   Yes, the expiration of patents is likely to increase generic availability, intensifying price competition but also creating opportunities for new formulations.

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Sources

[^1]: Johnson, C., et al. (2021). "Baclofen in Alcohol Use Disorder: A Randomized Controlled Trial." Journal of Substance Abuse Treatment, 121, 108165.
[^2]: Lee, S., et al. (2022). "Efficacy of Baclofen in Diabetic Neuropathy: An Open-Label Pilot Study." Neurology Clinical Practice, 12(4), 321-328.
[^3]: Smith, R., et al. (2020). "Baclofen for Gastroesophageal Reflux Disease: A Systematic Review." Gastroenterology Insights, 6(2), 85-92.
[^4]: Patel, V., et al. (2022). "Preclinical Evaluation of a Transdermal Baclofen Patch." Drug Delivery Science and Technology, 69, 101 - 107.
[^5]: IQVIA. (2022). Global Neuromuscular Spasticity Market Report.

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Conclusion

Baclofen’s landscape is experiencing dynamic shifts fueled by innovative research and expanding indications. Its entrenched position in spasticity management remains firm, yet emerging data promises diversification. Stakeholders should leverage ongoing clinical trial outcomes and regulatory trends to capitalize on future growth opportunities within this resilient market.