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Divalproex sodium

Generic Name
Divalproex sodium

Overview

No overview information available.

Indication

No indication information available.

Associated Conditions

No associated conditions information available.

Research Report

Published: Aug 21, 2025

A Comprehensive Clinical and Pharmacological Review of Divalproex Sodium

Executive Summary

Divalproex sodium is a broad-spectrum antiepileptic agent with significant utility in the management of neurological and psychiatric disorders. Chemically, it is a stable coordination compound of sodium valproate and valproic acid, classified as a fatty acid derivative anticonvulsant.[1] Its primary indications, as approved by the U.S. Food and Drug Administration (FDA), include the treatment of acute manic or mixed episodes associated with bipolar disorder; monotherapy and adjunctive therapy for complex partial seizures and simple and complex absence seizures; and the prophylaxis of migraine headaches in adults.[3]

The therapeutic efficacy of divalproex sodium is attributed to a multifaceted mechanism of action that is not yet fully elucidated. The principal proposed mechanisms include the potentiation of inhibitory neurotransmission by increasing brain concentrations of gamma-aminobutyric acid (GABA), the modulation of voltage-gated sodium and calcium channels to stabilize neuronal membranes, and epigenetic regulation through the inhibition of histone deacetylase (HDAC) enzymes.[6] This combination of actions allows it to exert control over neuronal hyperexcitability, mood dysregulation, and nociceptive pathways.

Continue reading the full research report

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2019/04/18
Phase 1
Recruiting
2017/01/06
Phase 4
Completed
2014/06/18
Phase 1
Withdrawn
2014/03/24
Phase 2
Withdrawn
2014/03/05
Phase 4
Completed
2013/01/04
Not Applicable
Completed
2012/05/01
Phase 4
Completed
2012/04/27
Phase 4
Withdrawn
Bo-Hyun Yoon
2012/04/20
Phase 1
Completed
2012/04/20
Phase 1
Completed

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
NCS HealthCare of KY, LLC dba Vangard Labs
0615-8377
ORAL
500 mg in 1 1
3/13/2023
Sun Pharmaceutical Industries, Inc.
62756-796
ORAL
125 mg in 1 1
8/5/2025
TYA Pharmaceuticals
64725-0798
ORAL
500 mg in 1 1
1/21/2010
Wockhardt USA LLC.
64679-724
ORAL
250 mg in 1 1
11/26/2019
REMEDYREPACK INC.
70518-2513
ORAL
250 mg in 1 1
3/1/2024
Lupin Pharmaceuticals, Inc.
68180-260
ORAL
250 mg in 1 1
1/2/2024
Direct_Rx
72189-459
ORAL
500 mg in 1 1
4/3/2023
BluePoint Laboratories
68001-472
ORAL
125 mg in 1 1
9/30/2023
DIRECT RX
61919-809
ORAL
250 mg in 1 1
8/11/2015
Alembic Pharmaceuticals Inc.
62332-821
ORAL
125 mg in 1 1
5/15/2025

EMA Drug Approvals

Approved Product
Authorization Holder
Status
Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product
ARTG ID
Sponsor
Registration Type
Status
Registration Date
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
No Health Canada approvals found for this drug.

CIMA AEMPS Drug Approvals

Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product
Company
Registration Number
Dosage Form
Strength
Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name
MA Holder
MA Number
Pharmaceutical Form
Active Ingredient
Authorization Date
No UK EMC drug information found for this drug.

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