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
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Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2023/10/18 | Phase 4 | Recruiting | |||
2023/10/13 | Phase 4 | Terminated | |||
2023/09/01 | Phase 2 | Recruiting | |||
2023/08/03 | Phase 3 | Recruiting | Dr. Inge Winter | ||
2023/06/27 | Phase 1 | Recruiting | Xue-chun Lu | ||
2023/04/20 | 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 |
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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Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
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Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| SODIUM VALPROATE-RJIC sodium valproate 500 mg tablet blister pack | 422119 | Medicine | A | 12/15/2023 | |
| VALPROATE-AFT sodium valproate 300 mg/3 ml solution for intravenous infusion or injection ampoules | 297320 | Medicine | A | 2/14/2019 | |
| VALPROATE HMH sodium valproate 300 mg/3 mL solution for injection vial | 422097 | Medicine | A | 8/19/2024 | |
| SODIUM VALPROATE-DWRN sodium valproate 200 mg tablet blister pack | 422121 | Medicine | A | 12/15/2023 | |
| VALPRO EC500 sodium valproate 500 mg enteric coated tablet blister pack | 286316 | Medicine | A | 7/11/2017 | |
| EPILIM EC500 sodium valproate 500mg tablet blister pack (OF) | 15370 | Medicine | A | 9/30/1991 | |
| EPILIM EC200 sodium valproate 200mg tablet blister pack (OF) | 15369 | Medicine | A | 9/30/1991 | |
| VALPROATE WINTHROP EC 200 sodium valproate 200mg tablet | 125620 | Medicine | A | 4/4/2007 | |
| VALPROATE SXP sodium valproate 400 mg/4 mL solution for injection vial | 422115 | Medicine | A | 8/19/2024 | |
| VALPRO EC200 sodium valproate 200 mg enteric coated tablet blister pack | 286315 | Medicine | A | 7/11/2017 |
Health Canada Drug Approvals
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Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| NOVO-VALPROIC | teva canada limited | 02100630 | Capsule - Oral | 250 MG | 12/31/1995 |
| FTP-VALPROIC ACID | ftp-pharmacal inc. | 02238448 | Capsule - Oral | 250 MG / CAP | 10/9/1998 |
| PHL-VALPROIC ACID E.C. | pharmel inc | 02260662 | Capsule (Enteric-Coated) - Oral | 500 MG | 12/6/2004 |
| PENTA-VALPROIC CAPSULES | pentapharm ltd. | 02231248 | Capsule - Oral | 250 MG / CAP | N/A |
| VALPROIC-250 | PRO DOC LIMITEE | 02238546 | Capsule - Oral | 250 MG | 11/25/1998 |
| SANDOZ VALPROIC | 02239714 | Capsule - Oral | 250 MG | 1/28/2000 | |
| PMS-VALPROIC ACID E.C. | 02229628 | Capsule (Enteric-Coated) - Oral | 500 MG | 12/13/1996 | |
| RATIO-VALPROIC - ECC 500MG | ratiopharm inc division of teva canada limited | 02140055 | Capsule (Enteric-Coated) - Oral | 500 MG | 7/17/1996 |
| DOM-VALPROIC ACID | dominion pharmacal | 02231030 | Capsule - Oral | 250 MG | 4/25/1998 |
| RATIO-VALPROIC | teva canada limited | 02231489 | Capsule (Enteric-Coated) - Oral | 500 MG | 8/28/1997 |
CIMA AEMPS Drug Approvals
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Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
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Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
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Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
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Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
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UK EMC Drug Information
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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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