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 |
---|---|---|---|---|---|
2016/08/19 | Phase 1 | Terminated | Dr. Hasan Alam | ||
2016/08/17 | Phase 4 | Completed | Federal University of Rio Grande do Sul | ||
2016/07/28 | Phase 2 | UNKNOWN | Shanghai Jiao Tong University School of Medicine | ||
2016/06/03 | Phase 2 | Completed | Prof. Dominique de Quervain, MD | ||
2016/05/04 | Phase 1 | UNKNOWN | Chang Gung Memorial Hospital | ||
2016/01/07 | Phase 1 | Terminated | |||
2015/12/09 | Phase 2 | Withdrawn | |||
2015/12/08 | Phase 2 | Active, not recruiting | National Cancer Institute, Naples | ||
2015/11/20 | Early Phase 1 | Completed | Barretos Cancer Hospital | ||
2015/08/11 | Phase 1 | Completed |
FDA Drug Approvals
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No FDA approvals found for this drug. |
EMA Drug Approvals
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HSA Drug Approvals
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NMPA Drug Approvals
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PPB Drug Approvals
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Health Canada Drug Approvals
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CIMA AEMPS Drug Approvals
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Philippines FDA Drug Approvals
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Saudi SFDA Drug Approvals
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UK EMC Drug Information
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