Valproic acid

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.

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

Title	Posted	Study ID	Phase	Status	Sponsor
Efficacy Comparison Between Levetiracetam and Valproic Acid in Pediatric Patients With Status Epilepticus	2025/07/04	NCT07052136	Not Applicable	Completed	RESnTEC, Institute of Research
Pharmacogenetics-Based Study on Individualized Use of Sodium Valproate	2025/07/01	NCT07046676	Not Applicable	Recruiting	The First Affiliated Hospital of University of South China
A Safety and Pharmacokinetics Study of RC220 Combined With Doxorubicin in Adult Participants With Solid Tumours.	2025/02/07	NCT06815575	Phase 1	Recruiting	Race Oncology Ltd
A Study to Evaluate the Effects of Lithium, Valproic Acid, and Lamotrigine on the Pharmacokinetics of KarXT and Effects of KarXT on the Pharmacokinetics of Lithium, Valproic Acid, and Lamotrigine in Healthy Participants	2024/12/12	NCT06729970	Phase 1	Recruiting	Karuna Therapeutics
Levetiracetam Versus Valproate in Idiopathic Generalized Epilepsy	2024/05/01	NCT06393309	N/A	Completed	Mazandaran University of Medical Sciences
Safety and Efficacy of Continued CS1 Treatment of Patients With Pulmonary Arterial Hypertension	2024/03/20	NCT06321705	N/A	AVAILABLE	Cereno Scientific AB
Valproate Versus Topiramate in Migraine	2024/02/08	NCT06248931	Phase 3	Completed	Kafrelsheikh University
Bioavailability and Food Effect of Sodium Valproate Minitablets in Healthy Subjects.	2024/01/18	NCT06211283	Phase 1	Completed	Desitin Arzneimittel GmbH
A Study to Investigate Treatment of HU and VPA, or 6-MP and VPA in Unfit AML/HR-MDS Patients	2024/01/10	NCT06199557	Phase 1	Recruiting	Haukeland University Hospital
Zolmitriptane as Prophylaxis for Chilhood Migraine	2023/10/18	NCT06089356	Phase 4	Recruiting	Tanta University

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
VALPROIC ACID	Rebel Distributors Corp	21695-417	ORAL	250 mg in 1 1	2/25/2008
Valproic	Bryant Ranch Prepack	63629-7597	ORAL	250 mg in 1 1	5/1/2021
Valproic Acid	Aphena Pharma Solutions - Tennessee, LLC	67544-479	ORAL	250 mg in 1 1	3/31/2014
VALPROIC ACID	PAI Holdings, LLC	0121-0675	ORAL	250 mg in 5 mL	2/1/2023
Valproate Sodium	Athenex Pharmaceutical Division, LLC.	70860-784	INTRAVENOUS	100 mg in 1 mL	3/5/2024
VALPROIC ACID	Lannett Company, Inc.	0527-5250	ORAL	250 mg in 5 mL	9/21/2020
valproic acid	Upsher-Smith Laboratories, LLC	0832-0310	ORAL	250 mg in 1 1	7/31/2020
Valproate Sodium	Hikma Pharmaceuticals USA Inc.	0143-9637	INTRAVENOUS	100 mg in 1 mL	11/20/2023
VALPROIC ACID	PAI Holdings, LLC	0121-4675	ORAL	250 mg in 5 mL	2/1/2023
VALPROIC ACID	Bryant Ranch Prepack	71335-2250	ORAL	250 mg in 5 mL	2/1/2023

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
Sodium Valproate ADVAGEN Solution for Injection or Infusion 100mg/ml	Sichuan Huiyu Pharmaceutical Co., Ltd.	SIN16992P	INJECTION, SOLUTION	100mg/ml	4/25/2024
Epilim® 400 mg Powder for injection / infusion	sanofi S.R.L, Chinoin Pharmaceutical and Chemical Works Private Co. Ltd (Solvent)	SIN05215P	INJECTION, POWDER, FOR SOLUTION	400 mg/vial	11/23/1990
EPILIM SYRUP 200 mg/5 ml	Unither Liquid Manufacturing	SIN05434P	SYRUP	200 mg/5 ml	2/22/1991
VALPROATE-AFT Solution for Infusion/ Injection 100mg/ml	LABIANA Pharmaceuticals	SIN16642P	INJECTION, SOLUTION	100 mg/ml	11/16/2022
EPILIM CHRONO TABLET 300 mg	SANOFI-SYNTHELABO LTD, Sanofi Winthrop Industrie	SIN08484P	TABLET, FILM COATED	87 mg	12/16/1995
EPILIM 200 TABLET 200 mg	Sanofi-Aventis S.A	SIN05690P	ENTERIC COATED TABLET	200.00 mg	4/8/1991
EPILIM CHRONO TABLET 200 mg	SANOFI-SYNTHELABO LTD, Sanofi Winthrop Industrie	SIN08537P	TABLET, FILM COATED	58 mg	2/5/1996
VALPARIN XR 500 TABLET 500 mg	TORRENT PHARMACEUTICALS LTD	SIN12559P	TABLET, FILM COATED	145 mg	6/26/2004
SODIUM VALPROATE AGUETTANT SOLUTION FOR INJECTION 400MG/4ML	Laboratoire Aguettant	SIN15525P	INJECTION, SOLUTION	400mg/4ml	8/16/2018
EPILIM CHRONO TABLET 500 mg	SANOFI WINTHROP INDUSTRIE	SIN08112P	TABLET, FILM COATED	333 mg	4/11/1995

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
EPILIM FREEZE-DRIED PDR FOR IV INJ 400MG	N/A	Sanofi Hong Kong Limited	N/A	N/A	11/24/1988

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
EPILIM sodium valproate 100mg crushable tablet blister pack	15373	Sanofi-Aventis Australia Pty Ltd	Medicine	A	9/30/1991
VALPROATE LWS sodium valproate 300 mg/3 mL solution for injection vial	422116	Southern XP IP Pty Ltd	Medicine	A	8/19/2024
VALPROATE LWS sodium valproate 400 mg/4 mL solution for injection vial	422117	Southern XP IP Pty Ltd	Medicine	A	8/19/2024
SODIUM VALPROATE-DWRN sodium valproate 500 mg tablet blister pack	422122	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	12/15/2023
SODIUM VALPROATE SANDOZ sodium valproate 500mg enteric coated tablet blister pack	134368	Sanofi-Aventis Australia Pty Ltd	Medicine	A	4/23/2007
VALPROATE-AFT sodium valproate 400 mg/4 ml solution for intravenous infusion or injection vials	297321	AFT Pharmaceuticals Pty Ltd	Medicine	A	2/14/2019
VALPROATE-AFT sodium valproate 300 mg/3 ml solution for intravenous infusion or injection vials	297324	AFT Pharmaceuticals Pty Ltd	Medicine	A	2/14/2019
VALPROATE SXP sodium valproate 300 mg/3 mL solution for injection vial	422114	Southern XP IP Pty Ltd	Medicine	A	8/19/2024
SODIUM VALPROATE WOCKHARDT sodium valproate 1000 mg/10 mL solution for injection ampoule	279285	Wockhardt Bio Pty Ltd	Medicine	A	6/2/2017
SODIUM VALPROATE WOCKHARDT sodium valproate 400 mg/4 mL solution for injection ampoule	279248	Wockhardt Bio Pty Ltd	Medicine	A	6/2/2017

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
DOM-VALPROIC ACID E.C.	dominion pharmacal	02231031	Capsule (Enteric-Coated) - Oral	500 MG	10/22/1998
SANDOZ VALPROIC	Sandoz Canada, Inc.	02239713	Capsule (Enteric-Coated) - Oral	500 MG	1/28/2000
MYLAN-VALPROIC	Mylan Pharmaceuticals ULC	02184648	Capsule - Oral	250 MG	12/31/1995
APO-VALPROIC ACID	Apotex Inc	02238048	Capsule - Oral	250 MG	6/1/1998
VALPROIC ACID	Apotex Inc	02237830	Capsule - Oral	250 MG	N/A
RATIO-VALPROIC	teva canada limited	02217414	Capsule - Oral	250 MG	11/4/1996
RATIO-VALPROIC-CAP 250MG	ratiopharm inc division of teva canada limited	02140047	Capsule - Oral	250 MG	12/31/1995
PHL-VALPROIC ACID	pharmel inc	02260654	Capsule - Oral	250 MG	12/2/2004
DEPAKENE CAP 500MG	ABBOTT LABORATORIES, LIMITED	00507989	Capsule (Enteric-Coated) - Oral	500 MG	12/31/1981
PMS-VALPROIC ACID	Pharmascience Inc	02230768	Capsule - Oral	250 MG	2/27/1997

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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