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Valproic acid

Generic Name
Valproic acid
Brand Names
Depakene, Depakote, Epival
Drug Type
Small Molecule
Chemical Formula
C8H16O2
CAS Number
99-66-1
Unique Ingredient Identifier
614OI1Z5WI

Overview

Valproic acid, or valproate, is an fatty acid derivative and anticonvulsant originally synthesized in 1881 by Beverly S. Burton. It enjoyed use as a popular organic solvent in industry and pharmaceutical manufacturing for nearly a century. In 1963, a serendipitous discovery was made by George Carraz during his investigations into the anticonvulsant effects of khelline when he found that all of his samples, dissolved in valproic acid, exerted a similar degree of anticonvulsive activity. It first received approval on February 28, 1978 from the FDA under the trade name Depakene. Since then, it has been investigated for neuroprotective, anti-manic, and anti-migraine effects. It is currently a compound of interest in the field of oncology for its anti-proliferative effects and is the subject of many clinical trials in a variety of cancer types.

Background

Valproic acid, or valproate, is an fatty acid derivative and anticonvulsant originally synthesized in 1881 by Beverly S. Burton. It enjoyed use as a popular organic solvent in industry and pharmaceutical manufacturing for nearly a century. In 1963, a serendipitous discovery was made by George Carraz during his investigations into the anticonvulsant effects of khelline when he found that all of his samples, dissolved in valproic acid, exerted a similar degree of anticonvulsive activity. It first received approval on February 28, 1978 from the FDA under the trade name Depakene. Since then, it has been investigated for neuroprotective, anti-manic, and anti-migraine effects. It is currently a compound of interest in the field of oncology for its anti-proliferative effects and is the subject of many clinical trials in a variety of cancer types.

Indication

Indicated for: 1) Use as monotherapy or adjunctive therapy in the management of complex partial seizures and simple or complex absence seizures. 2) Adjunctive therapy in the management of multiple seizure types that include absence seizures. 3) Prophylaxis of migraine headaches. 4) Acute management of mania associated with bipolar disorder. Off-label uses include: 1) Maintenance therapy for bipolar disorder. 2) Treatment for acute bipolar depression. 3) Emergency treatment of status epilepticus.

Associated Conditions

  • Bipolar Disorder (BD)
  • Complex Partial Seizure Disorder
  • Depressive Episodes
  • Migraine
  • Petit Mal Epilepsy
  • Seizure, multiple types
  • Acute Manic episode

Clinical Trials

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Title
Posted
Study ID
Phase
Status
Sponsor
2023/10/13
Phase 4
Active, not recruiting
2023/09/01
Phase 2
Recruiting
2023/08/03
Phase 3
Recruiting
Dr. Inge Winter
2023/06/27
Phase 1
Recruiting
Xue-chun Lu
2024/11/15
Phase 2
Recruiting
2023/01/26
Phase 4
Recruiting
Dr Cipto Mangunkusumo General Hospital
2023/01/23
Phase 2
Recruiting
2022/11/02
Phase 3
Recruiting
Dr. Inge Winter
2022/06/24
Phase 2
Recruiting
2022/01/06
Phase 1
Completed
Haisco Pharmaceutical Group Co., Ltd.

FDA Drug Approvals

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Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
NCS HealthCare of KY, Inc dba Vangard Labs
0615-8205
ORAL
250 mg in 1 1
4/30/2018
Banner Life Sciences LLC.
69387-107
ORAL
250 mg in 1 1
6/8/2015
ATLANTIC BIOLOGICALS CORP.
17856-0152
ORAL
250 mg in 1 1
6/10/2021
REMEDYREPACK INC.
70518-0079
ORAL
250 mg in 1 1
1/3/2024
Morton Grove Pharmaceuticals, Inc.
60432-621
ORAL
250 mg in 5 mL
1/22/2021
Actavis Pharma, Inc.
0591-4012
ORAL
250 mg in 1 1
5/1/2021
Fresenius Kabi USA, LLC
63323-494
INTRAVENOUS
100 mg in 1 mL
5/31/2019
Aphena Pharma Solutions - Tennessee, LLC
71610-906
ORAL
250 mg in 1 1
5/23/2025
Bryant Ranch Prepack
63629-2454
ORAL
250 mg in 1 1
6/29/2020
Direct_Rx
72189-010
ORAL
250 mg in 1 1
9/16/2021

EMA Drug Approvals

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

HSA Drug Approvals

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Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
SODIUM VALPROATE WOCKHARDT SOLUTION FOR INJECTION OR INFUSION 100mg/ml
SIN15343P
INJECTION, SOLUTION
100.0mg/ml
10/13/2017
EPILIM CHRONO TABLET 300 mg
SIN08484P
TABLET, FILM COATED
199.8 mg
12/16/1995
EPILIM CHRONO TABLET 200 mg
SIN08537P
TABLET, FILM COATED
133.2 mg
2/5/1996
VALPARIN XR 500 TABLET 500 mg
SIN12559P
TABLET, FILM COATED
333 mg
6/26/2004
EPILIM CHRONO TABLET 500 mg
SIN08112P
TABLET, FILM COATED
145 mg
4/11/1995

NMPA Drug Approvals

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

PPB Drug Approvals

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Company
Licence No.
Strength
Registration Date
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