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Drug ReportsDivalproex
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 diseasesD009422
mental disordersD001523
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)
Divalproex sodium
Tradename
Company
Number
Date
Products
DEPAKOTEAbbVieN-019680 RX1989-09-12
1 products, RLD, RS
DEPAKOTEAbbVieN-018723 RX1983-03-10
3 products, RLD, RS
DEPAKOTE ERAbbVieN-021168 RX2000-08-04
2 products, RLD
Show 1 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
depakoteNew Drug Application2024-03-18
depakote er2008-04-07
divalproex sodiumANDA2024-11-15
divalproex sodium delayed-release2008-12-04
divalproex sodium erANDA2023-04-03
divalproex sodium extended-releaseNDA authorized generic2015-01-03
divalproex sodiumdelayed-releaseANDA2013-12-30
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
N: Nervous system drugs
— N03: Antiepileptics
— N03A: Antiepileptics
— N03AG: Fatty acid derivatives, antiepileptics
— N03AG01: Valproic acid
HCPCS
No data
Clinical
Clinical Trials
425 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 disorderD001714EFO_0000289F30.9814423813109
EpilepsyD004827EFO_0000474G40.91088212366
DepressionD003863—F33.915106122
Healthy volunteers/patients———17——3—20
LeukemiaD007938—C95814—1119
Depressive disorderD003866EFO_1002014F32.A2595—19
SeizuresD012640HP_0002069G40.42164517
SyndromeD013577——11411—15
SchizophreniaD012559EFO_0000692F202135415
Migraine disordersD008881EFO_0003821G43—164112
Show 72 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Status epilepticusD013226EFO_0008526G41—23—510
GlioblastomaD005909EFO_0000515—231——6
Muscular atrophyD009133HP_0003202—231—16
Spinal muscular atrophyD009134EFO_0003823G12.1231—16
AtrophyD001284——231—16
AstrocytomaD001254EFO_0000271—121——4
HeadacheD006261HP_0002315R51——1—34
Ovarian neoplasmsD010051EFO_0003893C562—1——3
Ovarian epithelial carcinomaD000077216——2—1——3
Diffuse intrinsic pontine gliomaD000080443———21——3
Show 26 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
NeoplasmsD009369—C80142———15
Myelodysplastic syndromesD009190—D46312———13
Myeloid leukemia acuteD015470—C92.0510———11
Myeloid leukemiaD007951—C92410———11
PreleukemiaD011289——111———11
CarcinomaD002277—C80.052———7
RecurrenceD012008——41———5
Lung neoplasmsD008175HP_0100526C34.9033———5
B-cell chronic lymphocytic leukemiaD015451—C91.132——15
Lymphoid leukemiaD007945—C9132——15
Show 84 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
SarcomaD012509——4———15
MalnutritionD044342EFO_0008572E40-E463————3
Drug interactionsD004347——3————3
Nasopharyngeal carcinomaD000077274——2————2
Nasopharyngeal neoplasmsD009303——2————2
Neoplasm metastasisD009362EFO_0009708—2————2
Hemorrhagic shockD012771——2————2
Mantle-cell lymphomaD020522——1————1
Burkitt lymphomaD002051—C83.71————1
Urologic neoplasmsD014571—C64-C681————1
Show 30 more
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Congenital abnormalitiesD000013EFO_0003915Q89.9————22
Secondary headache disordersD051271——————22
Prescription drug overuseD000067490——————22
Chemical and drug induced liver injuryD056486EFO_0004228—————11
Renal insufficiencyD051437HP_0000083N19————11
Financial stressD000086522——————11
PhotophobiaD020795HP_0000613H53.14————11
Metabolic bone diseasesD001851HP_0000938—————11
OsteoporosisD010024HP_0000939M81.0————11
Addictive behaviorD016739EFO_0004347—————11
Show 27 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameDivalproex sodium
INNvalproate 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)Loading
Structure (InChI/SMILES or Protein Sequence)
CCCC(CCC)C(=O)O.CCCC(CCC)C(=O)[O-].[Na+]
Identifiers
PDB—
CAS-ID76584-70-8
RxCUI—
ChEMBL IDCHEMBL2105613
ChEBI ID4667
PubChem CID3121
DrugBankDB00510
UNII ID644VL95AO6 (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
HDAC1
HDAC1
Organism
Homo sapiens
Gene name
HDAC1
Gene synonyms
RPD3L1
NCBI Gene ID
Protein name
histone deacetylase 1
Protein synonyms
Protein deacetylase HDAC1, Protein decrotonylase HDAC1, reduced potassium dependency, yeast homolog-like 1
Uniprot ID
Mouse ortholog
Hdac1 (433759)
histone deacetylase 1 (P97476)
Variants
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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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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63,171 adverse events reported
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