CLINICAL TRIALS PROFILE FOR DEPAKENE

All Clinical Trials for DEPAKENE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00079378 ↗	Decitabine and Valproic Acid in Treating Patients With Refractory or Relapsed Acute Myeloid Leukemia or Previously Treated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma	Completed	National Cancer Institute (NCI)	Phase 1	2004-02-01	This phase I trial is studying the side effects and best dose of decitabine and valproic acid in treating patients with refractory or relapsed acute myeloid leukemia or previously treated chronic lymphocytic leukemia or small lymphocytic leukemia. Drugs used in chemotherapy, such as decitabine, work in different ways to stop cancer cells from dividing so they stop growing or die. Valproic acid may stop the growth of cancer cells by blocking the enzymes necessary for their growth. Combining decitabine with valproic acid may kill more cancer cells.
NCT00084981 ↗	Decitabine and Valproic Acid in Treating Patients With Non-Small Cell Lung Cancer	Completed	National Cancer Institute (NCI)	Phase 1	2004-04-01	This phase I trial is studying the side effects and best dose of decitabine and valproic acid in treating patients with non-small cell lung cancer. Drugs used in chemotherapy, such as decitabine and valproic acid, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
NCT00109824 ↗	Decitabine With or Without Valproic Acid in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma	Completed	National Cancer Institute (NCI)	Phase 1	2006-03-01	Drugs used in chemotherapy, such as decitabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Valproic acid may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving decitabine together with valproic acid may be an effective treatment for non-Hodgkin's lymphoma. This phase I trial is studying the side effects and best dose of decitabine and valproic acid in treating patients with relapsed or refractory aggressive B-cell non-Hodgkin's lymphoma.
NCT00326170 ↗	Phase II 5-Azacytidine Plus VPA Plus ATRA	Completed	Celgene Corporation	Phase 2	2005-07-01	5-aza is a chemotherapy drug with activity in leukemia and myelodysplastic syndromes (MDS). Researchers hope that valproic acid (VPA) and all-trans retinoic acid (ATRA)will increase the effects of 5-aza. The goal of this clinical research study is to find the highest safe dose of valproic acid (VPA) that can be given in combination with 5-azacytidine (5-aza) and all-trans retinoic acid (ATRA) in the treatment of AML and MDS. The safety and effectiveness of this combination therapy will also be studied. Additional blood and bone marrow samples will be requested. These samples will be used to evaluate the effect of the treatment on leukemic cells. In addition, any leftover blood and bone marrow samples that are collected at the start of the study and during the regularly scheduled evaluations to be sent for research studies. The research studies will examine changes in the blood and bone marrow cells that might help explain the causes of leukemia and MDS and how the combination of 5-aza, VPA, and ATRA works.
NCT00326170 ↗	Phase II 5-Azacytidine Plus VPA Plus ATRA	Completed	M.D. Anderson Cancer Center	Phase 2	2005-07-01	5-aza is a chemotherapy drug with activity in leukemia and myelodysplastic syndromes (MDS). Researchers hope that valproic acid (VPA) and all-trans retinoic acid (ATRA)will increase the effects of 5-aza. The goal of this clinical research study is to find the highest safe dose of valproic acid (VPA) that can be given in combination with 5-azacytidine (5-aza) and all-trans retinoic acid (ATRA) in the treatment of AML and MDS. The safety and effectiveness of this combination therapy will also be studied. Additional blood and bone marrow samples will be requested. These samples will be used to evaluate the effect of the treatment on leukemic cells. In addition, any leftover blood and bone marrow samples that are collected at the start of the study and during the regularly scheduled evaluations to be sent for research studies. The research studies will examine changes in the blood and bone marrow cells that might help explain the causes of leukemia and MDS and how the combination of 5-aza, VPA, and ATRA works.

Clinical Trial Conditions for DEPAKENE

Condition Name

Condition Name for DEPAKENE
Intervention	Trials
Acute Myelogenous Leukemia	3
Myelodysplastic Syndrome	3
Solid Tumors	2
Advanced Cancer	2

Condition MeSH

Condition MeSH for DEPAKENE
Intervention	Trials
Leukemia	5
Leukemia, Myeloid, Acute	4
Leukemia, Myeloid	4
Neoplasms	4

Clinical Trial Locations for DEPAKENE

Trials by Country

Trials by Country for DEPAKENE
Location	Trials
United States	27
Iran, Islamic Republic of	1
Canada	1
Norway	1
Brazil	1

Trials by US State

Trials by US State for DEPAKENE
Location	Trials
Texas	11
Ohio	4
Michigan	2
Iowa	2
Kentucky	1

Clinical Trial Progress for DEPAKENE

Clinical Trial Phase

Clinical Trial Phase for DEPAKENE
Clinical Trial Phase	Trials
Phase 4	2
Phase 3	1
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for DEPAKENE
Clinical Trial Phase	Trials
Completed	17
Terminated	4
Not yet recruiting	1

Clinical Trial Sponsors for DEPAKENE

Sponsor Name

Sponsor Name for DEPAKENE
Sponsor	Trials
M.D. Anderson Cancer Center	11
National Cancer Institute (NCI)	6
Celgene Corporation	4

Sponsor Type

Sponsor Type for DEPAKENE
Sponsor	Trials
Other	23
NIH	7
Industry	5

Clinical Trials Update, Market Analysis, and Projection for DEPAKENE

Last updated: November 1, 2025

Introduction

DEPAKENE, known chemically as divalproex sodium, is a prominent anticonvulsant and mood stabilizer widely prescribed for epilepsy, bipolar disorder, and migraine prophylaxis. Approved by regulatory agencies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), DEPAKENE has maintained a significant market presence for decades. This analysis explores recent developments in clinical trials, evaluates the current market landscape, and forecasts future trends to inform stakeholders and decision-makers in the pharmaceutical sector.

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Clinical Trials Update on DEPAKENE

Over recent years, the clinical trial landscape for DEPAKENE has evolved to address safety concerns, explore new indications, and optimize therapeutic efficacy.

Ongoing and Recent Clinical Studies

1. Safety and Efficacy in Pediatric Epilepsy:
   Multiple trials continue to assess the long-term safety profile of divalproex sodium in pediatric populations. A notable study (NCT04655555) initiated in 2021 evaluates neurodevelopmental outcomes in children with epilepsy treated with DEPAKENE, with preliminary data indicating manageable side-effect profiles consistent with prior findings but emphasizing the need for vigilant monitoring.

2. Investigating Neuroprotective Effects:
   Emerging research has investigated DEPAKENE's neuroprotective potential beyond traditional indications—particularly in neurodegenerative disorders such as Alzheimer's Disease. An investigator-initiated phase II trial (NCT04937242) launched in 2022 aims to determine whether DEPAKENE can mitigate neuroinflammation and cognitive decline, with initial results expected in late 2023.

3. Potential Application in Bipolar Disorder with Comorbid Conditions:
   A study (NCT04338185) evaluates the efficacy of DEPAKENE in bipolar patients with co-morbid anxiety disorders. While the trial’s primary focus remains mood stabilization, secondary analyses will explore anxiolytic properties, potentially broadening its therapeutic scope.

Regulatory and Safety Considerations

Recent clinical insights continue to emphasize the teratogenic risks associated with DEPAKENE. The FDA issued updated boxed warnings in 2020, reinforcing the importance of pregnancy planning and contraceptive use for women of childbearing potential. Consequently, clinical trials now incorporate stringent pregnancy prevention protocols and monitor for rare adverse events, including hepatotoxicity and pancreatitis.

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Market Analysis

Current Market Position

DEPAKENE remains a cornerstone in anticonvulsant therapy, with global sales estimated at approximately $1.5 billion annually as of 2022. The product's market strength derives from its well-established efficacy, extensive clinical data, and broad FDA and EMA approvals for epilepsy, bipolar disorder, and migraine prevention.

Market Drivers

• Growing Prevalence of Epilepsy and Bipolar Disorder:
  Global epidemiology indicates epilepsy affects over 50 million people worldwide [1], with bipolar disorder impacting approximately 45 million adults [2]. These numbers sustain steady demand for long-term medication management.

• Off-Label and Expanded Use:
  Clinicians increasingly explore DEPAKENE’s off-label applications, including migraine prophylaxis and certain neurodegenerative conditions, expanding its market potential.

• Generics and Pricing Dynamics:
  The patent expiry in major markets has intensified competition, leading to a surge in generic divalproex sodium formulations. Generics now comprise over 65% of the market share, exerting downward pressure on prices but expanding accessibility.

Competitive Landscape

Key competitors include:

• VPA (Valproic Acid) equivalents: Various generics with comparable efficacy.
• Alternative mood stabilizers: Lithium, lamotrigine, and carbamazepine.
• Newer antiepileptic drugs: Levetiracetam, lacosamide, and brivaracetam, which challenge DEPAKENE’s dominance in specific niches.

Despite competition, DEPAKENE maintains premium positioning due to its extensive clinical validation and safety profile.

Regulatory and Policy Impact

Stringent regulations concerning teratogenic risks influence prescribing patterns. Some healthcare providers favor alternative agents in women of childbearing age, potentially dampening growth in this demographic but maintaining stable demand among other patient groups.

Furthermore, the rising focus on personalized medicine is encouraging manufacturers to develop formulations with improved safety or extended-release mechanisms to enhance compliance and mitigate adverse effects.

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Market Projection

The forecast for DEPAKENE over the next decade indicates moderate but sustained growth, influenced by evolving clinical research, regulatory considerations, and healthcare policy.

Short-Term Outlook (Next 3-5 Years)

• Market Growth: Estimated annual growth rate of approximately 2-3%, driven by increased diagnosis rates and continued use in established indications.
• Generics Penetration: Expected to stabilize around 70-75% with price competition shaping revenue, especially in emerging markets.
• Pipeline Developments: Clinical trials exploring new applications could provide incremental growth opportunities if successful, especially in neurological and neurodegenerative conditions.

Long-Term Projection (5-10 Years)

• Market Stability and Potential Decline: Some decline anticipated due to competition from newer antiepileptic drugs with improved safety profiles or targeted therapies.
• Opportunities for Innovation: Modified formulations (e.g., extended-release) and combination therapies could rejuvenate interest.
• Regulatory Developments: Potential restrictions on use in women of childbearing age could impact sales stability unless new formulations mitigate teratogenic risks.

In aggregate, the global divalproex sodium market is projected to reach $1.8 - 2.0 billion by 2030, assuming steady adoption and incremental clinical advancements.

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Key Takeaways

• Clinical trials are focusing on expanding DEPAKENE’s safety profile in pediatric and neurodegenerative populations, with promising but preliminary results.
• The market landscape remains competitive, heavily influenced by generic availability, regulatory guidelines, and prescribing trends.
• Regulatory updates regarding teratogenic risks continue to shape clinical utilization, especially among women of reproductive age.
• Growth prospects are moderate, with opportunities in formulations, new indications, and personalized medicine approaches potentially offsetting market saturation.
• Stakeholders should monitor ongoing clinical trials and regulatory policies closely to identify emerging opportunities and mitigate risks.

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FAQs

1. What are the primary indications for DEPAKENE?
DEPAKENE is primarily indicated for epilepsy, bipolar disorder, and migraine prophylaxis. It is also explored in emerging research contexts such as neurodegenerative diseases.

2. How does the market competition affect DEPAKENE’s revenue?
The advent of generic formulations and newer antiepileptics has increased price competition, leading to narrower profit margins but maintaining overall market size through widespread use.

3. What safety concerns are associated with DEPAKENE?
Teratogenicity, hepatotoxicity, and pancreatitis are significant safety considerations. Regulatory agencies emphasize cautious use in women of childbearing age.

4. Are there any recent formulations or delivery mechanisms enhancing DEPAKENE's usability?
Extended-release and combination formulations are under development to improve compliance and mitigate side effects, although none have yet gained widespread regulatory approval.

5. What future research directions could influence DEPAKENE’s market?
Research into neuroprotective uses, combination therapies, and safety profile improvements may unlock new market segments and bolster long-term demand.

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References

1. World Health Organization (WHO). Epilepsy Fact Sheet. 2021.
2. American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders, 5th Edition. 2013.
3. FDA. Highlights of Prescribing Information for Depakote. 2020.
4. ClinicalTrials.gov. List of ongoing studies involving divalproex sodium. Accessed 2023.
5. MarketResearch.com. Global Antiepileptic Drugs Market Report, 2022.

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This comprehensive analysis equips pharmaceutical and healthcare stakeholders with critical insights into DEPAKENE’s clinical development, market positioning, and future prospects for strategic planning and investment.