Divalproex sodium
Depakote, Divalproex (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 epilepsy amongst others in the USA. It is known to target histone deacetylase 1.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| nervous system diseases | D009422 |
| mental disorders | D001523 |
Trade Name
FDA
EMA
Depakote, Divalproex (discontinued: Depakote cp, Divalproex)
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 | 2024-03-18 |
| depakote er | 2008-04-07 | |
| divalproex sodium | ANDA | 2024-10-11 |
| divalproex sodium delayed-release | 2008-12-04 | |
| divalproex sodium er | ANDA | 2023-04-03 |
| divalproex sodium extended-release | NDA authorized generic | 2015-01-03 |
| divalproex sodiumdelayed-release | ANDA | 2013-12-30 |
Indications
FDA
EMA
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Agency Specific
FDA
EMA
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Patent Expiration
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HCPCS
No data
Clinical
Clinical Trials
424 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 | 8 | 14 | 42 | 38 | 13 | 109 |
| Epilepsy | D004827 | EFO_0000474 | G40.9 | 10 | 8 | 8 | 21 | 22 | 65 |
| Depression | D003863 | — | F33.9 | 1 | 5 | 10 | 6 | 1 | 22 |
| Healthy volunteers/patients | — | — | — | 17 | — | — | 3 | — | 20 |
| Leukemia | D007938 | — | C95 | 8 | 14 | — | 1 | 1 | 19 |
| Depressive disorder | D003866 | EFO_1002014 | F32.A | 2 | 5 | 9 | 5 | — | 19 |
| Seizures | D012640 | HP_0002069 | G40.4 | 2 | 1 | 6 | 4 | 5 | 17 |
| Syndrome | D013577 | — | — | 1 | 14 | 1 | 1 | — | 15 |
| Schizophrenia | D012559 | EFO_0000692 | F20 | 2 | 1 | 3 | 5 | 4 | 15 |
| Migraine disorders | D008881 | EFO_0003821 | G43 | — | 1 | 6 | 4 | 1 | 12 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Status epilepticus | D013226 | EFO_0008526 | G41 | — | 2 | 3 | — | 5 | 10 |
| Glioblastoma | D005909 | EFO_0000515 | — | 2 | 3 | 1 | — | — | 6 |
| Muscular atrophy | D009133 | HP_0003202 | — | 2 | 3 | 1 | — | 1 | 6 |
| Spinal muscular atrophy | D009134 | EFO_0003823 | G12.1 | 2 | 3 | 1 | — | 1 | 6 |
| Atrophy | D001284 | — | — | 2 | 3 | 1 | — | 1 | 6 |
| Astrocytoma | D001254 | EFO_0000271 | — | 1 | 2 | 1 | — | — | 4 |
| Headache | D006261 | HP_0002315 | R51 | — | — | 1 | — | 3 | 4 |
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | 2 | — | 1 | — | — | 3 |
| Ovarian epithelial carcinoma | D000077216 | — | — | 2 | — | 1 | — | — | 3 |
| Diffuse intrinsic pontine glioma | D000080443 | — | — | — | 2 | 1 | — | — | 3 |
Show 26 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neoplasms | D009369 | — | C80 | 14 | 2 | — | — | — | 15 |
| Myelodysplastic syndromes | D009190 | — | D46 | 3 | 12 | — | — | — | 13 |
| Myeloid leukemia acute | D015470 | — | C92.0 | 5 | 10 | — | — | — | 11 |
| Myeloid leukemia | D007951 | — | C92 | 4 | 10 | — | — | — | 11 |
| Preleukemia | D011289 | — | — | 1 | 11 | — | — | — | 11 |
| Carcinoma | D002277 | — | C80.0 | 5 | 2 | — | — | — | 7 |
| Recurrence | D012008 | — | — | 4 | 1 | — | — | — | 5 |
| Lung neoplasms | D008175 | HP_0100526 | C34.90 | 3 | 3 | — | — | — | 5 |
| B-cell chronic lymphocytic leukemia | D015451 | — | C91.1 | 3 | 2 | — | — | 1 | 5 |
| Lymphoid leukemia | D007945 | — | C91 | 3 | 2 | — | — | 1 | 5 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Sarcoma | D012509 | — | — | 4 | — | — | — | 1 | 5 |
| Malnutrition | D044342 | EFO_0008572 | E40-E46 | 3 | — | — | — | — | 3 |
| Drug interactions | D004347 | — | — | 3 | — | — | — | — | 3 |
| Nasopharyngeal carcinoma | D000077274 | — | — | 2 | — | — | — | — | 2 |
| Nasopharyngeal neoplasms | D009303 | — | — | 2 | — | — | — | — | 2 |
| Neoplasm metastasis | D009362 | EFO_0009708 | — | 2 | — | — | — | — | 2 |
| Hemorrhagic shock | D012771 | — | — | 2 | — | — | — | — | 2 |
| Mantle-cell lymphoma | D020522 | — | — | 1 | — | — | — | — | 1 |
| Burkitt lymphoma | D002051 | — | C83.7 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| Congenital abnormalities | D000013 | EFO_0003915 | Q89.9 | — | — | — | — | 2 | 2 |
| Secondary headache disorders | D051271 | — | — | — | — | — | — | 2 | 2 |
| Prescription drug overuse | D000067490 | — | — | — | — | — | — | 2 | 2 |
| Chemical and drug induced liver injury | D056486 | EFO_0004228 | — | — | — | — | — | 1 | 1 |
| Renal insufficiency | D051437 | HP_0000083 | N19 | — | — | — | — | 1 | 1 |
| Financial stress | D000086522 | — | — | — | — | — | — | 1 | 1 |
| Photophobia | D020795 | HP_0000613 | H53.14 | — | — | — | — | 1 | 1 |
| Metabolic bone diseases | D001851 | HP_0000938 | — | — | — | — | — | 1 | 1 |
| Osteoporosis | D010024 | HP_0000939 | M81.0 | — | — | — | — | 1 | 1 |
| Addictive behavior | D016739 | EFO_0004347 | — | — | — | — | — | 1 | 1 |
Show 27 more
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 | 76584-70-8 |
| RxCUI | — |
| 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
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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, Depakote er, Divalproex sodium, Divalproex sodium delayed-release, Divalproex sodium er, Divalproex sodium extended-release, Divalproex sodiumdelayed-release
Adverse Events
Top Adverse Reactions
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20,084 adverse events reported
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