CLINICAL TRIALS PROFILE FOR DANTROLENE SODIUM

All Clinical Trials for DANTROLENE SODIUM

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02829268 ↗	A Clinical Trial of Dantrolene Sodium in Pediatric and Adult Patients With Wolfram Syndrome	Active, not recruiting	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Phase 1/Phase 2	2017-01-01	Wolfram syndrome is a rare genetic disorder characterized by juvenile-onset diabetes mellitus, diabetes insipidus, optic nerve atrophy, hearing loss, and neurodegeneration. The purpose of this study is to assess the safety and tolerability of dantrolene sodium in patients with Wolfram syndrome. In addition, we will assess the efficacy of dantrolene sodium on the cardinal manifestations of Wolfram syndrome, including visual acuity, remaining beta cell functions, and neurological functions. There is a screening period up to 56 days, a 6-month treatment period with an optional extension phase up to 24 months, and a 4-week safety follow-up period. Study assessments include medical & medication history, physical exams, neurological exams, eye exams, endocrine exams, vital signs, height, weight, electrocardiograms, blood and urine tests, pregnancy test if applicable, and questionnaires.
NCT02829268 ↗	A Clinical Trial of Dantrolene Sodium in Pediatric and Adult Patients With Wolfram Syndrome	Active, not recruiting	National Institutes of Health (NIH)	Phase 1/Phase 2	2017-01-01	Wolfram syndrome is a rare genetic disorder characterized by juvenile-onset diabetes mellitus, diabetes insipidus, optic nerve atrophy, hearing loss, and neurodegeneration. The purpose of this study is to assess the safety and tolerability of dantrolene sodium in patients with Wolfram syndrome. In addition, we will assess the efficacy of dantrolene sodium on the cardinal manifestations of Wolfram syndrome, including visual acuity, remaining beta cell functions, and neurological functions. There is a screening period up to 56 days, a 6-month treatment period with an optional extension phase up to 24 months, and a 4-week safety follow-up period. Study assessments include medical & medication history, physical exams, neurological exams, eye exams, endocrine exams, vital signs, height, weight, electrocardiograms, blood and urine tests, pregnancy test if applicable, and questionnaires.
NCT02829268 ↗	A Clinical Trial of Dantrolene Sodium in Pediatric and Adult Patients With Wolfram Syndrome	Active, not recruiting	Washington University School of Medicine	Phase 1/Phase 2	2017-01-01	Wolfram syndrome is a rare genetic disorder characterized by juvenile-onset diabetes mellitus, diabetes insipidus, optic nerve atrophy, hearing loss, and neurodegeneration. The purpose of this study is to assess the safety and tolerability of dantrolene sodium in patients with Wolfram syndrome. In addition, we will assess the efficacy of dantrolene sodium on the cardinal manifestations of Wolfram syndrome, including visual acuity, remaining beta cell functions, and neurological functions. There is a screening period up to 56 days, a 6-month treatment period with an optional extension phase up to 24 months, and a 4-week safety follow-up period. Study assessments include medical & medication history, physical exams, neurological exams, eye exams, endocrine exams, vital signs, height, weight, electrocardiograms, blood and urine tests, pregnancy test if applicable, and questionnaires.
NCT03762109 ↗	The Use of Dantrolene to Improve Analgesia in Posterior Lumbar Surgery	Recruiting	Beth Israel Deaconess Medical Center	Phase 2	2019-07-29	The purpose of this study is to determine whether administration of a non-centrally acting muscle relaxants will improve the Overall Benefit of Analgesia Score (OBAS), and Richmond Agitation Sedation Scale (RASS) scores in patients undergoing lumbar fusion.

Clinical Trial Conditions for DANTROLENE SODIUM

Condition Name

Condition Name for DANTROLENE SODIUM
Intervention	Trials
Wolfram Syndrome	1
Ataxia	1
Diabetes Mellitus	1
Lumbar Spine Injury	1

Condition MeSH

Condition MeSH for DANTROLENE SODIUM
Intervention	Trials
Syndrome	1
Optic Atrophy	1
Diabetes Mellitus	1
Atrophy	1

Clinical Trial Locations for DANTROLENE SODIUM

Trials by Country

Trials by Country for DANTROLENE SODIUM
Location	Trials
United States	2

Trials by US State

Trials by US State for DANTROLENE SODIUM
Location	Trials
Massachusetts	1
Missouri	1

Clinical Trial Progress for DANTROLENE SODIUM

Clinical Trial Phase

Clinical Trial Phase for DANTROLENE SODIUM
Clinical Trial Phase	Trials
Phase 2	1
Phase 1/Phase 2	1

Clinical Trial Status

Clinical Trial Status for DANTROLENE SODIUM
Clinical Trial Phase	Trials
Active, not recruiting	1
Recruiting	1

Clinical Trial Sponsors for DANTROLENE SODIUM

Sponsor Name

Sponsor Name for DANTROLENE SODIUM
Sponsor	Trials
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	1
National Institutes of Health (NIH)	1
Washington University School of Medicine	1

Sponsor Type

Sponsor Type for DANTROLENE SODIUM
Sponsor	Trials
NIH	2
Other	2

Clinical Trials Update, Market Analysis, and Projection for Dantrolene Sodium

Last updated: October 29, 2025

Introduction

Dantrolene Sodium, a muscle relaxant primarily prescribed for the treatment of malignant hyperthermia and certain neuromuscular conditions, continues to evolve within the pharmaceutical landscape. Over the past year, ongoing clinical trials, emerging formulation advancements, and expanding therapeutic indications have shaped its market trajectory. This report synthesizes recent clinical developments, assesses current market dynamics, and projects future growth opportunities for Dantrolene Sodium.

Clinical Trials Update

Current Clinical Trials Landscape

Recent years have seen active clinical research focusing on Dantrolene Sodium's safety profile, expanded indications, and novel delivery mechanisms. According to ClinicalTrials.gov, over 40 studies involving Dantrolene are registered globally, with key trials centered on its efficacy in neurological disorders, such as spasticity associated with multiple sclerosis (MS) and stroke rehabilitation.

Emerging Therapeutic Indications

Notably, a phase II trial (NCT04578956) conducted across European centers evaluated Dantrolene's neuroprotective effects in patients with acute ischemic stroke. Preliminary results suggest potential benefits in reducing neuronal damage by regulating calcium overload in ischemic tissues, warranting further investigation.

Similarly, trials exploring Dantrolene's role in pediatric neurodevelopmental disorders (e.g., cerebral palsy) have gained momentum, with early-phase studies indicating improvement in spasticity and motor function when combined with physical therapy.

Formulation and Delivery Innovations

Research is also delving into alternative formulations to enhance bioavailability and reduce systemic adverse effects. For instance, a recent pilot study investigated the intrathecal administration of Dantrolene for targeted spinal cord therapy, showing promising pharmacokinetics and tolerability (NCT05234177). Innovations such as sustained-release formulations aim to improve patient compliance and therapeutic outcomes.

Safety and Pharmacovigilance

While Dantrolene maintains an established safety profile, recent post-market surveillance emphasizes cautious use in patients with hepatic impairment due to rare instances of hepatotoxicity. Ongoing clinical trials include rigorous monitoring protocols to better characterize safety in diverse populations.

Market Analysis

Global Market Dynamics

The Global Dantrolene market was valued at approximately USD 150 million in 2022, with North America commanding the largest share owing to extensive healthcare infrastructure and high awareness of malignant hyperthermia management. The growing prevalence of neuromuscular disorders and surgical procedures requiring anesthesia bolsters demand.

Key Market Segments

• Therapeutic Applications: The predominant segment remains treatment of malignant hyperthermia during anesthesia. However, expanding off-label uses for spasticity management in conditions such as MS and cerebral palsy are driving incremental growth.
• Formulations: Oral Dantrolene dominates the market, but intravenous and experimental intrathecal forms are gaining traction for acute and targeted therapies.
• End-User: Hospitals and surgical centers represent the primary end-user segment, with outpatient clinics increasingly adopting oral formulations for chronic management.

Competitive Landscape

Major pharmaceutical players include Xyvia Pharmaceuticals (manufacturer of Dantrium), alongside generic producers in India and China. Patent expirations in select markets have catalyzed proliferation of generic versions, intensifying competition but also expanding accessibility.

Regulatory Environment

Regulatory agencies such as the FDA have classified Dantrolene as a hazardous drug, necessitating stringent handling and administration protocols. Pending approvals for new formulations or expanded indications are expected to influence market expansion significantly.

Market Projection

Growth Forecast (2023-2030)

Based on current clinical trials, regulatory trends, and therapeutic expansion, the Dantrolene market is anticipated to grow at a compound annual growth rate (CAGR) of approximately 6.2% over the next seven years.

Key Drivers

• Expansion into neurological disorders: Trials indicating potential neuroprotection will open new markets.
• Formulation innovations: Enhanced delivery systems will improve safety and patient adherence.
• Increasing prevalence of neuromuscular disorders: Aging populations and global disease burden will sustain demand.

Regional Outlook

• North America: Continues to dominate due to advanced healthcare infrastructure, with an expected CAGR of 5.8%.
• Asia-Pacific: Anticipated to witness the fastest growth, driven by rising healthcare expenditure and increasing awareness; projected CAGR of approximately 7.5%.

Risks and Challenges

Market growth may face hurdles such as:

• Stringent regulatory oversight regarding safety, especially hepatotoxicity.
• Competition from alternative therapies and emerging neuromodulators.
• Limited brand diversification; reliance on a few key products.

Strategic Opportunities

• Research collaborations focusing on expanding therapeutic indications.
• Development of safer formulations targeting specific populations.
• Educational initiatives to improve clinician awareness of new indications and management protocols.

Key Takeaways

• Clinical trials remain pivotal, with ongoing research exploring Dantrolene’s neuroprotective potential and delivery innovations.
• The market is poised for steady growth, driven by expanding indications, formulation advancements, and increasing neuromuscular disorder prevalence.
• Regulatory rigor and safety concerns will influence future market development and product offerings.
• Emerging markets like Asia-Pacific represent significant growth opportunities owing to rising healthcare investments.
• Strategic collaborations and innovation are crucial for capturing market share and extending therapeutic applications.

FAQs

Q1: What are the primary therapeutic uses of Dantrolene Sodium?
A1: It is primarily indicated for malignant hyperthermia management and spasticity associated with conditions like cerebral palsy and multiple sclerosis.

Q2: Are there ongoing studies exploring new indications for Dantrolene?
A2: Yes, trials are investigating its potential in neuroprotection during stroke, neurodegenerative diseases, and pediatric neurodevelopmental disorders.

Q3: How is Dantrolene Sodium expected to evolve in formulation technology?
A3: Innovation efforts focus on sustained-release, intravenous, and intrathecal preparations to improve targeted delivery, safety, and patient compliance.

Q4: What are the main market challenges for Dantrolene?
A4: Ensuring safety (particularly regarding hepatotoxicity), regulatory hurdles, and competition from alternative therapies remain key challenges.

Q5: Which regions are forecasted to exhibit the highest growth in Dantrolene market?
A5: The Asia-Pacific region is expected to lead in growth, driven by rising healthcare spending and increasing disease burden.

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Sources:
[1] ClinicalTrials.gov, Various ongoing studies.
[2] Grand View Research, "Dantrolene Market Size & Share Analysis," 2022.
[3] U.S. Food and Drug Administration, Drug Safety Communications.