CLINICAL TRIALS PROFILE FOR VALPROATE SODIUM

All Clinical Trials for Valproate Sodium

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000439 ↗	Drug Treatment for Alcoholics With Bipolar Disorder	Completed	University of Pittsburgh	Phase 2	2000-10-01	The purpose of this study is to test the effectiveness of sodium valproate (Depacon) in treating individuals with alcohol dependence and comorbid bipolar disorder.
NCT00000439 ↗	Drug Treatment for Alcoholics With Bipolar Disorder	Completed	National Institute on Alcohol Abuse and Alcoholism (NIAAA)	Phase 2	2000-10-01	The purpose of this study is to test the effectiveness of sodium valproate (Depacon) in treating individuals with alcohol dependence and comorbid bipolar disorder.
NCT00001482 ↗	New Drugs in the Treatment of Mood Disorders	Completed	National Institute of Mental Health (NIMH)	Phase 2	1995-05-01	This clinical study compares the effectiveness of two anticonvulsants Lamotrigine (Lamictal) Monotherapy and Gabapentin (Neurontin) in patients with treatment resistant affective disorders. We initially have found that the response rate to lamotrigine (51%) exceeded that of gabapentin (28%) or placebo (21%). In this study the placebo phase has been dropped so that we examine possible clinical and biological factors predictors of response. The drugs will be given in a randomized order for six weeks each and you will not know when you are on a given one. There will be a 2-4 week "washout" period between treatments. If you respond well to one of these treatments, a longer open continuation period will be offered at the end of this study. This would involve one or both drugs in combination. A variety of rating scales and brain imaging procedures will also be offered before and during each drug evaluation. Both lamotrigine and gabapentin are generally well tolerated. A serious potentially life threatening rash occurs in about 1/500 patients treated with lamotrigine, however. Common side effects are rash, dizziness, unsteadiness, double vision, blurred vision, nausea, vomiting, insomnia, sedation, and headache. These side effects are usually mild, and resolve with continued time on the drug or a decrease in dosage.
NCT00004817 ↗	Phase III Double Blind Trial of Valproate Sodium for Prophylaxis of Post Traumatic Seizures	Completed	Harborview Injury Prevention and Research Center	Phase 3	1991-02-01	OBJECTIVES: I. Determine whether treating head injured patients with valproate sodium will reduce the risk of developing seizures as a result of the head injury. II. Determine the safety of valproate, the appropriate dose, and the effect valproate may have on the recovery of the brain's ability to compute numbers, solve problems, remember information, and control the movement of limbs after head injury.
NCT00004817 ↗	Phase III Double Blind Trial of Valproate Sodium for Prophylaxis of Post Traumatic Seizures	Completed	National Institute of Neurological Disorders and Stroke (NINDS)	Phase 3	1991-02-01	OBJECTIVES: I. Determine whether treating head injured patients with valproate sodium will reduce the risk of developing seizures as a result of the head injury. II. Determine the safety of valproate, the appropriate dose, and the effect valproate may have on the recovery of the brain's ability to compute numbers, solve problems, remember information, and control the movement of limbs after head injury.
NCT00136110 ↗	Trial of Sodium Valproate in Amyotrophic Lateral Sclerosis	Completed	Princess Beatrix Muscle Foundation	Phase 3	2005-04-01	The purpose of this study is to determine whether the use of sodium valproate is effective in slowing the disease progression in Amyotrophic Lateral Sclerosis.
NCT00136110 ↗	Trial of Sodium Valproate in Amyotrophic Lateral Sclerosis	Completed	UMC Utrecht	Phase 3	2005-04-01	The purpose of this study is to determine whether the use of sodium valproate is effective in slowing the disease progression in Amyotrophic Lateral Sclerosis.

Clinical Trial Conditions for Valproate Sodium

Condition Name

Condition Name for Valproate Sodium
Intervention	Trials
Epilepsy	10
Bipolar Disorder	7
Schizophrenia	5
Mania	3

Condition MeSH

Condition MeSH for Valproate Sodium
Intervention	Trials
Epilepsy	13
Bipolar Disorder	10
Disease	6
Schizophrenia	5

Clinical Trial Locations for Valproate Sodium

Trials by Country

Trials by Country for Valproate Sodium
Location	Trials
United States	26
Australia	5
France	5
United Kingdom	5
China	5

Trials by US State

Trials by US State for Valproate Sodium
Location	Trials
New York	3
Maryland	3
California	2
North Carolina	2
Virginia	2

Clinical Trial Progress for Valproate Sodium

Clinical Trial Phase

Clinical Trial Phase for Valproate Sodium
Clinical Trial Phase	Trials
PHASE1	1
Phase 4	16
Phase 3	9

Clinical Trial Status

Clinical Trial Status for Valproate Sodium
Clinical Trial Phase	Trials
Completed	33
Unknown status	10
Not yet recruiting	7

Clinical Trial Sponsors for Valproate Sodium

Sponsor Name

Sponsor Name for Valproate Sodium
Sponsor	Trials
United States Department of Defense	4
Abbott	3
Stanley Medical Research Institute	3

Sponsor Type

Sponsor Type for Valproate Sodium
Sponsor	Trials
Other	76
Industry	23
U.S. Fed	5

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

Last updated: October 28, 2025

Introduction

Valproate Sodium, a widely prescribed anticonvulsant and mood stabilizer, has maintained its prominence in managing epilepsy, bipolar disorder, and migraine prophylaxis for decades. As the landscape of neurology and psychiatry evolves with novel therapies, a comprehensive assessment of Valproate Sodium’s current clinical trial activity, market dynamics, and future projections is essential for stakeholders. This article synthesizes recent updates, analyzes market trends, and forecasts Valproate Sodium's trajectory into the coming years.

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Clinical Trials Update on Valproate Sodium

Recent Clinical Trial Landscape

Over the past two years, clinical trials involving Valproate Sodium have primarily focused on expanding its therapeutic indications, optimizing safety profiles, and exploring combination therapies. According to ClinicalTrials.gov, approximately 25 ongoing or recently completed studies focus on Valproate Sodium as of 2023, spanning indications such as epilepsy, bipolar disorder, migraine, and neurodegenerative diseases.

Key Areas of Active Investigation

• Epilepsy and Seizure Disorders: Most trials aim to compare efficacy and safety profiles of Valproate Sodium against newer antiepileptics or in polytherapy regimens. Studies are evaluating long-term neurocognitive outcomes, especially in pediatric populations, aligned with growing concerns about neurodevelopmental effects.

• Bipolar Disorder: Trials are assessing Valproate Sodium's efficacy as monotherapy versus combination approaches, particularly its ability to mitigate mood episodes in treatment-resistant patients.

• Migraine: Research is ongoing into optimizing dosing protocols to reduce adverse effects, especially tremor and weight gain.

• Neurodegeneration and Psychiatry: Emerging studies are investigating Valproate Sodium's neuroprotective and epigenetic mechanisms in conditions such as Alzheimer’s disease.

Safety and Tolerability Focus

Recent trials increasingly emphasize neurotoxicity and hepatotoxicity mitigation. For example, recent phase IV studies examine dose adjustments and coadministration strategies to enhance tolerability, especially in pediatric and elderly cohorts.

Regulatory and Approval Advancements

While no major regulatory upgrades have occurred since 2021, the FDA granted Orphan Drug designation to Valproate Sodium for specific rare neurological conditions, signaling ongoing developmental interest.

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Market Analysis of Valproate Sodium

Market Size and Segmentation

Valproate Sodium remains a dominant antiepileptic drug (AED), with an estimated global market valuation of approximately $1.2 billion in 2022 [1]. The segment distribution includes:

• Epilepsy Management: Accounts for roughly 65% of sales, driven by its broad-spectrum efficacy.
• Bipolar Disorder: Constitutes about 20%, mainly in North America and Europe.
• Migraine Prophylaxis: Represents approximately 10%.
• Off-label and Emerging Uses: The remaining 5%, including neurodegenerative and psychiatric applications.

Regional Market Dynamics

• North America: Holds the largest market share (~50%) due to high prevalence rates, extensive healthcare infrastructure, and established prescribing patterns.
• Europe: Accounts for roughly 25%, with increasing use in Spain, Germany, and the UK.
• Asia-Pacific: Fastest-growing segment (~15%), driven by rising epilepsy and psychiatric disorder prevalence, along with expanding healthcare access.
• Rest of the World: Constitutes the remaining share, with growth potential hindered by regulatory and affordability constraints.

Market Drivers

• Established Efficacy and Safety Profile: Long-standing clinical utility sustains demand.
• Increasing Prevalence: Rising incidence of epilepsy (~50 million globally) and bipolar disorder (~60 million adults in the US) sustains core markets.
• Generic Availability: Patent expirations in the 2000s have enhanced affordability, broadening access.

Market Challenges

• Safety Concerns: Teratogenicity and hepatotoxicity limit use, especially in women of childbearing age.
• Regulatory Restrictions: Some regions impose prescribing limitations; alternative therapies gain favor.
• Emergence of Newer Agents: Drugs like lamotrigine, levetiracetam, and oxcarbazepine are eroding market share due to improved safety profiles.

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Market Projection and Future Outlook

Forecast Overview

The global Valproate Sodium market is projected to grow at a compound annual growth rate (CAGR) of approximately 3.2% from 2023 to 2030, reaching about $1.7 billion by 2030 [2]. Key factors influencing this trajectory include:

• Continued Prevalence: Persistent neurological and psychiatric conditions ensure sustained demand.
• Growing Off-label Use and Extended Indications: As trials explore new therapeutic roles, potential off-label applications could augment consumption.
• Regulatory and Safety Evolution: Enhanced formulation modifications and safety monitoring may extend its utility and acceptance.

Potential Catalysts for Growth

• Innovative Formulations: Extended-release and targeted delivery systems could improve adherence and safety.
• Expanded Indication Portfolio: Positive results from ongoing trials in neurodegeneration and psychiatric conditions can diversify applications.
• Global Outreach: Developing countries’ increased healthcare infrastructure will facilitate market penetration.

Risks and Limitations

• Safety Concerns: Mood and seizure control safety remain pivotal; adverse effects could hinder growth.
• Competitive Landscape: Perception shift favoring newer AEDs with better tolerability may curtail market expansion.
• Regulatory Hurdles: Stringent regulations regarding teratogenicity could reduce prescribing in certain demographics.

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Key Takeaways

• Clinical trial activity for Valproate Sodium is focusing on expanding indications and improving safety profiles. A significant number of ongoing studies aim to validate its role in neurodegenerative diseases and optimize tolerability in diverse populations.
• Market dominance in epilepsy remains firm, but increasing competition and safety concerns are shaping its future. Generic affordability sustains its critical position; however, newer therapies with improved safety profiles challenge its market share.
• The global Valproate Sodium market is forecasted to grow modestly, driven by rising prevalence, expanded indications, and emerging formulations. Yet, safety issues and regulatory restrictions pose ongoing obstacles.
• Innovation in formulations and new indications could extend Valproate Sodium’s market relevance. Targeting unmet clinical needs could rejuvenate interest and utilization.
• Stakeholders should monitor clinical developments and regulatory updates closely. The drug’s long-term position depends heavily on balancing efficacy, safety, and evolving clinical guidelines.

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FAQs

1. What are the new therapeutic indications being explored for Valproate Sodium?
Current research investigates its potential in neurodegenerative diseases such as Alzheimer’s and Parkinson’s, mood stabilization in treatment-resistant bipolar disorder, and adjunct therapy in neuropsychiatric conditions [1].

2. How do safety concerns impact the market outlook for Valproate Sodium?
Teratogenic risks and hepatotoxicity limit use in women of childbearing age and certain populations, prompting regulatory restrictions and influencing prescriber preferences toward safer alternatives [2].

3. Are there any recent regulatory changes affecting Valproate Sodium?
Regulatory agencies emphasize risk management strategies, including pregnancy prevention programs in women of reproductive age; no major approvals or withdrawals occurred recently, but safety warnings have intensified [1].

4. What competitive therapies threaten Valproate Sodium’s market share?
Drugs like lamotrigine, levetiracetam, and topiramate offer improved safety profiles and fewer teratogenic risks, gaining preference in certain indications [2].

5. What markets offer the most growth opportunities for Valproate Sodium?
Developing countries in Asia-Pacific present growth opportunities due to increasing disease prevalence and expanding healthcare infrastructure, provided regulatory and safety concerns are effectively managed.

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References

[1] MarketWatch. (2022). Valproate Sodium Market Size, Share & Industry Analysis.

[2] Grand View Research. (2023). Antiepileptic Drugs Market Forecast.