CLINICAL TRIALS PROFILE FOR LIORESAL

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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.
NCT00812851 ↗	Randomized Placebo-Controlled Crossover Trial With THC (Delta 9-Tetrahydrocannabinol) for the Treatment of Cramps in Amyotrophic Lateral Sclerosis (ALS)	Completed	Cantonal Hospital of St. Gallen	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
Gastro Esophageal Reflux	1

Condition MeSH

Condition MeSH for LIORESAL
Intervention	Trials
Alcoholism	4
Spasm	2
Muscle Cramp	2
Marijuana Abuse	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
North Dakota	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
National Institute on Drug Abuse (NIDA)	2
University of Pennsylvania	2
Essentia Health	2

Sponsor Type

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

Last updated: May 23, 2026

Lioresal (baclofen) Clinical Trials Update, Market Analysis and Price/Revenue Projections (2026)

Lioresal (baclofen) is an established, off-patent oral spasm therapy. Current market outcomes are driven less by new exclusivity and more by generic penetration, payer dynamics, and supply/contracting behavior. No credible, current clinical-trial “signal” at the phase-appropriate level for a new baclofen IP milestone can be stated from the information provided.

What is Lioresal (baclofen) and how is it used in the market?

Lioresal is the brand for baclofen, a GABA_B receptor agonist used to treat spasticity from upper motor neuron disorders. Commercially, the market is dominated by low-cost generics in most countries, which constrains brand pricing and limits upside from incremental clinical activity unless a new delivery system or indication meaningfully changes prescribing behavior.

Which indications drive demand for baclofen/spasticity treatment?

Baclofen’s demand is primarily linked to:

• Multiple sclerosis (MS)-related spasticity
• Spinal cord injury spasticity
• Cerebral palsy spasticity (often pediatric)
• Other neurologic spasticity syndromes

How do formularies typically manage baclofen?

Payers usually prefer tiered generics for oral baclofen. Where coverage is restricted, it is typically tied to:

• prior authorization for dose escalation
• step edits across antispasticity alternatives
• switching requirements toward contract generics

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What clinical trials are ongoing for Lioresal (baclofen) and what phase matters commercially?

No complete, verifiable clinical-trials dataset is provided in the input. Without trial identifiers (NCT numbers), phase, intervention details, endpoints, sites/regions, and sponsor status, a definitive “clinical trials update” for Lioresal cannot be produced.

Which trial types would move baclofen’s market outlook?

For an established generic-dominant drug, only certain trial categories typically change the commercial trajectory:

• New indication trials with clear responder definitions and payer-relevant endpoints
• Reformulation or delivery-system trials (eg, extended-release oral, intrathecal approaches, novel prodrugs)
• Head-to-head data versus competing antispasticity classes (tizanidine, dantrolene, diazepam-based regimens, botulinum toxin strategies)

What endpoints would typically support uptake?

• Modified Ashworth Scale (MAS)
• Penn Spasm Frequency Scale (PSFS)
• patient-reported spasm impact and sleep interference
• functional outcome measures (walking aids, care burden, ADL measures)
• adverse-event profile (sedation, weakness, dizziness)

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What is the patent and exclusivity status of Lioresal (baclofen) in key jurisdictions?

No patent, Orange Book, or jurisdictional exclusivity data is included in the prompt, so a complete patent-exclusivity analysis cannot be generated.

Why patent status is decisive for “projection”

If baclofen is fully generic in a market, near-term revenue growth is structurally limited. Market projections then depend on:

• total treated spasticity pool size
• substitution rates among generics
• price erosion pace
• tender/contract wins
• supply stability

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When does Lioresal (baclofen) lose exclusivity and how fast do generics erode price?

No exclusivity timeline or regulatory status inputs were provided. A precise “loss of exclusivity” answer cannot be stated.

What usually determines the erosion curve for mature generics

• first-generic launch timing
• number of ANDA filers
• mandatory switch policies and pharmacy benefit design
• average wholesale price versus net price capture
• wholesaler contract structures and risk-sharing terms

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What is the Orange Book status of Lioresal (baclofen) and how many ANDAs exist?

Orange Book listings, strength/dosage form granularity, and ANDA counts are not provided in the input, so this section cannot be populated with hard facts.

How Orange Book granularity affects commercial risk

Even for mature molecules, different dosage forms (eg, tablets vs suspensions), strengths, and labeling carve-outs change:

• which generics can launch
• which method-of-use arguments exist
• which settlement terms govern pediatric or titration regimens

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How does Lioresal (baclofen) compare with other antispasticity drugs in clinical and payer terms?

No comparative clinical or payer dataset is supplied in the prompt, so a quantified competitor comparison cannot be built.

Key competitive set typically considered by payers

• Tizanidine
• Dantrolene
• Benzodiazepine-based adjuncts (where used)
• Botulinum toxin procedures for focal spasticity
• Intrathecal baclofen (where available)
• Physiotherapy and rehabilitation pathways that reduce pharmacologic escalation

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What generic entry risks exist for Lioresal (baclofen) and what could block launches?

No ANDA/Paragraph IV litigation or Orange Book blocking patents are provided. Launch risk cannot be assessed from the input.

Typical blockers for established small-molecule brands

• remaining formulation or method-of-use patents
• pediatric exclusivity tied to specific labeling
• manufacturing process restrictions that affect approvals

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What market size and growth projections apply to baclofen/spasticity treatment through 2026–2031?

No market size baselines, regional shares, pricing levels, or volume assumptions are provided. Without them, numeric projections would be fabricated.

What can be said from structure of the category

For mature oral baclofen in most geographies:

• growth typically tracks underlying spasticity prevalence and treated patient share
• net price declines tend to dominate without a new IP event
• growth is more sensitive to contracting and tender wins than to trial results

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Commercial projection framework for Lioresal (baclofen): what drives net revenue in a generic-heavy market

A reliable projection model requires inputs (brand net price, unit volumes, competitor pricing, payer mix, tender share, and regulatory landscape). The prompt provides none of these, so a numeric forecast cannot be issued.

Key drivers that must be modeled

• Unit volume growth from spasticity prevalence and switching rates
• Net price after rebates, payer discounts, and pharmacy reimbursement mechanics
• Generic substitution rate and contract migration
• Formulary tier position and prior authorization burden
• Safety communications and labeling constraints impacting titration

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Key Takeaways

• Lioresal (baclofen) is a mature antispasticity therapy with market outcomes primarily shaped by generic penetration and payer contracting.
• The prompt does not include sufficient, verifiable clinical-trials or regulatory/IP data to produce a factual “clinical trials update” or a quantified revenue projection.
• Any credible forward-looking analysis for 2026–2031 requires hard inputs on trial status (NCT, phase, sponsor), Orange Book listings and ANDA activity, and market baseline metrics (net price and volume).

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FAQs

1. Is Lioresal (baclofen) still under patent protection in the US?
2. Are there new baclofen delivery-system trials that could change the market?
3. How do payers typically treat oral baclofen versus intrathecal baclofen?
4. What drives net price erosion for mature generic spasticity medicines?
5. Which spasticity endpoints most influence clinical adoption for antispasticity drugs?

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References

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration.
2. ClinicalTrials.gov. Lioresal (baclofen) and baclofen clinical studies database. National Library of Medicine.