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
Myelodysplastic Syndrome	3
Acute Myelogenous Leukemia	3
Advanced Cancer	2
Advanced Cancers	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
Brazil	1
Iran, Islamic Republic of	1
Canada	1
Norway	1

Trials by US State

Trials by US State for Depakene
Location	Trials
Texas	11
Ohio	4
Michigan	2
Iowa	2
Maryland	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
Unknown status	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

Depakene (Valproic Acid): Clinical Trials, Market Analysis, and Projections

Overview of Depakene

Depakene, also known as valproic acid, is an antiepileptic medication used to treat various types of seizure disorders, including complex partial seizures, simple and complex absence seizures, and multiple seizure types that include absence seizures[1][3][4].

Clinical Trials and Research

Current Status and Ongoing Trials

Valproic acid has been extensively studied and is currently in various phases of clinical trials for different indications. Here are some key points:

• Epilepsy: The primary use of Depakene is in the management of epilepsy. It has been systematically studied and is approved for monotherapy and adjunctive therapy in complex partial seizures and simple and complex absence seizures[1][3].
• Other Indications: Valproic acid is also investigated for its neuroprotective, anti-manic, and anti-migraine effects. It is a compound of interest in oncology for its anti-proliferative effects and is the subject of many clinical trials in various cancer types[4].
• Phase Trials: According to DrugBank, valproic acid has been involved in numerous clinical trials across different phases. This includes 6 Phase 0 trials, 108 Phase 1 trials, 107 Phase 2 trials, 65 Phase 3 trials, and 83 Phase 4 trials[4].

Safety and Efficacy

Clinical trials have highlighted several important aspects of valproic acid's safety and efficacy:

• Dosage and Titration: The recommended initial dose is 10 to 15 mg/kg/day, with increases of 5 to 10 mg/kg/week to achieve optimal clinical response. The maximum recommended dosage is 60 mg/kg/day[1][3].
• Risk Profiles: Children under two years of age are at a significantly increased risk of fatal hepatotoxicity, especially those with congenital metabolic disorders or severe seizure disorders. Patients with mitochondrial disorders caused by POLG mutations are contraindicated for Depakene[1][3].

Market Analysis

Market Size and Growth

The market for valproic acid, particularly in its formulation as divalproex sodium, is projected to grow significantly:

• CAGR: The divalproex sodium market is expected to register a Compound Annual Growth Rate (CAGR) of 6.2% during the forecast period from 2022 to 2027[5].
• Regional Market: North America, particularly the United States, holds a significant market share due to the high prevalence of epilepsy and migraine headaches, as well as increased government initiatives and research activities[5].

Key Drivers

Several factors are driving the growth of the divalproex sodium market:

• Increasing Prevalence of Epilepsy and Migraine: The global burden of epilepsy, with approximately 50 million people affected worldwide, and the high prevalence of migraine headaches in the United States, contribute significantly to the demand for divalproex sodium[5].
• Bipolar Disorders: The growing incidence of bipolar disorders, with a lifetime prevalence of about 1% and a one-year prevalence of about 0.5% worldwide, also propels market growth[5].
• COVID-19 Impact: The COVID-19 pandemic has accelerated the use of telemedicine, which has maintained or even increased the demand for antiepileptic medications like divalproex sodium during the pandemic[5].

Market Players

The divalproex sodium market is dominated by several key players:

• AbbVie Inc., Lupin Pharmaceuticals, Inc., Dr. Reddy's Laboratories Ltd., Zydus Cadila, and Aurobindo Pharma are among the major companies operating in this market[5].

Projections

Future Demand

The demand for divalproex sodium is expected to rise due to several factors:

• Growing Patient Pool: The increasing patient pool affected by epilepsy, migraine headaches, and bipolar disorders will drive the demand for divalproex sodium[5].
• Research and Development: Ongoing research and development aimed at introducing new products and formulations will further boost the market[5].

Regional Growth

• Asia-Pacific: This region is expected to grow at the highest CAGR during the forecast period, driven by increasing government initiatives and a growing patient pool[5].
• North America: This region will continue to hold a significant market share due to the high prevalence of neurological disorders and strong research and development activities[5].

Key Takeaways

• Clinical Trials: Valproic acid is extensively studied in various clinical trials for epilepsy and other indications.
• Market Growth: The divalproex sodium market is projected to grow at a CAGR of 6.2% from 2022 to 2027.
• Key Drivers: Increasing prevalence of epilepsy, migraine headaches, and bipolar disorders, along with COVID-19 impacts, drive market growth.
• Regional Focus: North America and Asia-Pacific are key regions for market growth.

FAQs

What is the primary use of Depakene?

Depakene (valproic acid) is primarily used to treat various types of seizure disorders, including complex partial seizures and simple and complex absence seizures.

What are the risks associated with Depakene in children under two years of age?

Children under two years of age are at a significantly increased risk of fatal hepatotoxicity, especially those with congenital metabolic disorders or severe seizure disorders.

What is the projected CAGR for the divalproex sodium market from 2022 to 2027?

The divalproex sodium market is expected to register a CAGR of 6.2% during the forecast period from 2022 to 2027.

Which region is expected to grow at the highest CAGR in the divalproex sodium market?

The Asia-Pacific region is estimated to grow at the highest CAGR during the forecast period.

What are the key drivers of the divalproex sodium market growth?

The key drivers include the increasing prevalence of epilepsy, migraine headaches, and bipolar disorders, as well as the impact of the COVID-19 pandemic and ongoing research and development activities.

Sources

1. RxList: Depakene (Valproic Acid): Side Effects, Uses, Dosage...
2. PharmExec: Depression Drugs Sales in the US to Reach $4.6 billion by 2025
3. FDA: DEPAKENE (valproic acid) Label
4. DrugBank: Valproic acid: Uses, Interactions, Mechanism of Action
5. Mordor Intelligence: Divalproex Sodium Market Size & Share Analysis

Last updated: 2025-01-01