Divalproex sodium
Depakote (divalproex sodium) is a small molecule pharmaceutical. Divalproex sodium was first approved as Depakote on 1983-03-10. It is used to treat absence epilepsy, bipolar disorder, complex partial epilepsy, epilepsy, and mood disorders in the USA. It is known to target histone deacetylase 1.
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Commercial
Trade Name
FDA
EMA
Depakote (generic drugs available since 2008-07-29, discontinued: Depakote cp)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| depakote | New Drug Application | 2023-06-19 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| absence epilepsy | HP_0011147 | D004832 | G40.A |
| bipolar disorder | EFO_0000289 | D001714 | F30.9 |
| complex partial epilepsy | EFO_1000877 | D017029 | — |
| epilepsy | EFO_0000474 | D004827 | G40.9 |
| mood disorders | EFO_0004247 | D019964 | F30-F39 |
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
HCPCS
No data
Clinical
Clinical Trials
308 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Bipolar disorder | D001714 | EFO_0000289 | F30.9 | 5 | 5 | 22 | 30 | 7 | 68 |
| Epilepsy | D004827 | EFO_0000474 | G40.9 | 7 | 2 | 3 | 7 | 9 | 27 |
| Healthy volunteers/patients | — | 17 | — | — | 3 | — | 20 | ||
| Schizophrenia | D012559 | EFO_0000692 | F20 | 2 | 1 | 2 | 5 | 2 | 12 |
| Alcoholism | D000437 | EFO_0003829 | F10.1 | — | 3 | 3 | 1 | 1 | 7 |
| Dementia | D003704 | F03 | 1 | — | 2 | 2 | — | 5 | |
| Alzheimer disease | D000544 | EFO_0000249 | F03 | 1 | 1 | 1 | 2 | — | 5 |
| Autistic disorder | D001321 | EFO_0003758 | F84.0 | — | 3 | 1 | 1 | — | 5 |
| Glioma | D005910 | EFO_0000520 | 1 | 2 | — | 1 | — | 4 | |
| Mania | D000087122 | F30 | — | — | — | 4 | — | 4 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Seizures | D012640 | G40.4 | 1 | — | 3 | — | 2 | 6 | |
| Migraine disorders | D008881 | EFO_0003821 | G43 | — | 1 | 5 | — | — | 6 |
| Glioblastoma | D005909 | EFO_0000515 | 2 | 2 | 1 | — | — | 5 | |
| Status epilepticus | D013226 | EFO_0008526 | G41 | — | 2 | 1 | — | 2 | 5 |
| Spinal muscular atrophy | D009134 | EFO_0008525 | G12.1 | 1 | 2 | 1 | — | — | 4 |
| Astrocytoma | D001254 | EFO_0000271 | 1 | 1 | 1 | — | — | 3 | |
| Diffuse intrinsic pontine glioma | D000080443 | — | 1 | 1 | — | — | 2 | ||
| Neuroepithelial neoplasms | D018302 | — | 1 | 1 | — | — | 2 | ||
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | 1 | — | 1 | — | — | 2 |
| Uterine cervical neoplasms | D002583 | — | 1 | 1 | — | — | 2 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neoplasms | D009369 | C80 | 13 | 2 | — | — | — | 14 | |
| Myelodysplastic syndromes | D009190 | D46 | 2 | 8 | — | — | — | 9 | |
| Myeloid leukemia acute | D015470 | C92.0 | 4 | 8 | — | — | — | 9 | |
| B-cell chronic lymphocytic leukemia | D015451 | C91.1 | 3 | 2 | — | — | 1 | 5 | |
| Hiv infections | D015658 | EFO_0000764 | B20 | 3 | 3 | — | — | — | 5 |
| Brain neoplasms | D001932 | EFO_0003833 | C71 | 3 | 1 | — | — | — | 4 |
| Leukemia | D007938 | C95 | 1 | 3 | — | — | — | 3 | |
| Acute kidney injury | D058186 | HP_0001919 | N17 | — | 2 | — | — | 1 | 3 |
| Non-hodgkin lymphoma | D008228 | C85.9 | 1 | 1 | — | — | — | 2 | |
| Large b-cell lymphoma diffuse | D016403 | C83.3 | 2 | 1 | — | — | — | 2 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Sarcoma | D012509 | 3 | — | — | — | 1 | 4 | ||
| Drug interactions | D004347 | 3 | — | — | — | — | 3 | ||
| Nasopharyngeal neoplasms | D009303 | 2 | — | — | — | — | 2 | ||
| Central nervous system neoplasms | D016543 | 2 | — | — | — | — | 2 | ||
| Traumatic brain injuries | D000070642 | S06 | 1 | — | — | — | 1 | 2 | |
| Hemorrhagic shock | D012771 | 2 | — | — | — | — | 2 | ||
| Mantle-cell lymphoma | D020522 | C83.1 | 1 | — | — | — | — | 1 | |
| Burkitt lymphoma | D002051 | C83.7 | 1 | — | — | — | — | 1 | |
| Non-small-cell lung carcinoma | D002289 | 1 | — | — | — | — | 1 | ||
| Urologic neoplasms | D014571 | C64-C68 | 1 | — | — | — | — | 1 |
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Renal insufficiency | D051437 | HP_0000083 | N19 | — | — | — | — | 1 | 1 |
| Metabolic bone diseases | D001851 | HP_0000938 | — | — | — | — | 1 | 1 | |
| Osteoporosis | D010024 | EFO_0003882 | M81.0 | — | — | — | — | 1 | 1 |
| Insulin resistance | D007333 | EFO_0002614 | — | — | — | — | 1 | 1 | |
| Body composition | D001823 | — | — | — | — | 1 | 1 | ||
| Alveolar bone loss | D016301 | — | — | — | — | 1 | 1 | ||
| Subarachnoid hemorrhage | D013345 | EFO_0000713 | I60 | — | — | — | — | 1 | 1 |
| Nocturnal enuresis | D053206 | N39.44 | — | — | — | — | 1 | 1 | |
| Borderline personality disorder | D001883 | HP_0012076 | F60.3 | — | — | — | — | 1 | 1 |
| Cluster headache | D003027 | HP_0012199 | G44.00 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | DIVALPROEX SODIUM |
| INN | valproate semisodium |
| Description | Valproic acid is a branched-chain saturated fatty acid that comprises of a propyl substituent on a pentanoic acid stem. It has a role as an anticonvulsant, a GABA agent, an EC 3.5.1.98 (histone deacetylase) inhibitor, a teratogenic agent, a psychotropic drug, a neuroprotective agent and an antimanic drug. It is a branched-chain saturated fatty acid and a branched-chain fatty acid. It is functionally related to a valeric acid. It is a conjugate acid of a valproate. |
| Classification | Small molecule |
| Drug class | — |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | CCCC(CCC)C(=O)O.CCCC(CCC)C(=O)[O-].[Na+] |
Identifiers
| PDB | — |
| CAS-ID | 99-66-1 |
| RxCUI | 11118 |
| ChEMBL ID | CHEMBL2105613 |
| ChEBI ID | 4667 |
| PubChem CID | 3121 |
| DrugBank | DB00510 |
| UNII ID | 644VL95AO6 (ChemIDplus, GSRS) |
Target
Agency Approved
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Alternate
HDAC1
HDAC1
Variants
Clinical Variant
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Financial
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Trends
PubMed Central
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Safety
Black-box Warning
Black-box warning for: Depakote
Adverse Events
Top Adverse Reactions
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17,387 adverse events reported
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