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Phenytoin
Dilantin, Diphenylan, Phenytex (phenytoin) is a small molecule pharmaceutical. Phenytoin was first approved as Dilantin-125 on 1982-01-01. It is used to treat epilepsy, status epilepticus, temporal lobe epilepsy, and tonic-clonic epilepsy in the USA. The pharmaceutical is active against sodium channel protein type 2 subunit alpha.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
nervous system diseasesD009422
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
Dilantin (generic drugs available since 1982-01-01, discontinued: Dilantin, Diphenylan, Phenytex)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Phenytoin
Tradename
Company
Number
Date
Products
DILANTIN-125ViatrisN-008762 RX1982-01-01
1 products, RLD, RS
Show 1 discontinued
Phenytoin sodium
Tradename
Company
Number
Date
Products
DILANTINPfizerN-010151 DISCN1982-01-01
1 products
Hide discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
dilantinANDA2022-05-24
phenytekANDA2022-01-25
phenytoinANDA2023-06-15
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
epilepsyEFO_0000474D004827G40.9
status epilepticusEFO_0008526D013226G41
temporal lobe epilepsyEFO_0000773D004833
tonic-clonic epilepsyEFO_0007262D004830
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
N: Nervous system drugs
N03: Antiepileptics
N03A: Antiepileptics
N03AB: Hydantoin derivatives, antiepileptics
N03AB02: Phenytoin
N03AB52: Phenytoin, combinations
HCPCS
Code
Description
J1165
Injection, phenytoin sodium, per 50 mg
Q2009
Injection, fosphenytoin, 50 mg phenytoin equivalent
S0078
Injection, fosphenytoin sodium, 750 mg
Clinical
Clinical Trials
59 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
EpilepsyD004827EFO_0000474G40.95112211
SeizuresD012640G40.444
Traumatic brain injuriesD000070642S061113
DepressionD003863F33.9112
Subarachnoid hemorrhageD013345EFO_0000713I60112
Cognitive dysfunctionD060825G31.8411
Pneumococcal meningitisD008586EFO_1001114G00.111
AsthmaD001249EFO_0000270J4511
Drug resistant epilepsyD00006927911
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients81312
Post-traumatic epilepsyD00483422
Pancreatic neoplasmsD010190EFO_0003860C25111
DementiaD003704F0311
Psychophysiologic disordersD011602F45.911
SchizophreniaD012559EFO_0000692F2011
Anxiety disordersD001008EFO_0006788F41.111
Craniocerebral traumaD006259S0011
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
LeukemiaD007938C95222
LymphomaD008223C85.9222
Optic neuritisD009902EFO_0007405H4622
Nodding syndromeD06412811
NeuroblastomaD009447EFO_0000621111
AnemiaD000740EFO_0004272D64.9111
Myelodysplastic syndromesD009190D46111
Myeloproliferative disordersD009196D47.1111
Precancerous conditionsD011230111
Plasma cell neoplasmsD054219111
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Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Non-alcoholic fatty liver diseaseD065626EFO_0003095K75.8111
PainD010146EFO_0003843R5211
Wound healingD014945GO_004206011
Cocaine-related disordersD019970F1411
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
CysticercosisD003551EFO_0007231B6911
Renal insufficiencyD051437HP_0000083N1911
Acute kidney injuryD058186HP_0001919N1711
PharmacokineticsD01059911
OsteonecrosisD010020EFO_0004259M8711
Rectal fistulaD012003HP_0010447K60.311
Post-traumatic stress disordersD013313EFO_0001358F43.111
Pressure ulcerD003668L8911
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common namePHENYTOIN
INNphenytoin
Description
Phenytoin is a imidazolidine-2,4-dione that consists of hydantoin bearing two phenyl substituents at position 5. It has a role as an anticonvulsant, a teratogenic agent, a drug allergen and a sodium channel blocker. It is functionally related to a hydantoin.
Classification
Small molecule
Drug classantiepileptics (hydantoin derivatives)
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
O=C1NC(=O)C(c2ccccc2)(c2ccccc2)N1
Identifiers
PDB
CAS-ID57-41-0
RxCUI8183
ChEMBL IDCHEMBL16
ChEBI ID8107
PubChem CID1775
DrugBankDB00252
UNII ID6158TKW0C5 (ChemIDplus, GSRS)
Target
Agency Approved
SCN2A
SCN2A
Organism
Homo sapiens
Gene name
SCN2A
Gene synonyms
NAC2, SCN2A1, SCN2A2
NCBI Gene ID
Protein name
sodium channel protein type 2 subunit alpha
Protein synonyms
HBSC II, Sodium channel protein brain II subunit alpha, Sodium channel protein type II subunit alpha, sodium channel protein, brain type 2 alpha subunit, sodium channel, voltage-gated, type II, alpha 1 polypeptide, sodium channel, voltage-gated, type II, alpha 2 polypeptide, sodium channel, voltage-gated, type II, alpha subunit, voltage-gated sodium channel subtype II, Voltage-gated sodium channel subunit alpha Nav1.2, voltage-gated sodium channel type II alpha subunit
Uniprot ID
Mouse ortholog
Alternate
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
Mock data
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Additional graphs summarizing 28,192 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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3,530 adverse events reported
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