Phenytoin
Dilantin, Phenytek, Phenytoin (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 diseases | D009422 |
| signs and symptoms pathological conditions | D013568 |
Trade Name
FDA
EMA
Dilantin, Extended phenytoin, Phenytek, Phenytoin (discontinued: Dilantin, Diphenylan, Extended phenytoin, Phenytek, Phenytex, Phenytoin, Prompt phenytoin)
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 |
|---|---|---|
| dilantin | ANDA | 2024-09-25 |
| dilantin infatabs | ANDA | 2024-08-05 |
| dilantin kapseals | 2009-05-28 | |
| dilantin-125 | New Drug Application | 2023-02-02 |
| extended phenytoin sodium | ANDA | 2024-10-18 |
| phenytek | ANDA | 2024-10-15 |
| phenytoin | ANDA | 2024-11-19 |
| phenytoin infatabs | ANDA | 2024-07-26 |
| phenytoin sodium | ANDA | 2024-10-30 |
Indications
FDA
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Agency Specific
FDA
EMA
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Clinical
Clinical Trials
112 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Epilepsy | D004827 | EFO_0000474 | G40.9 | 6 | 3 | 5 | 5 | 7 | 26 |
| Seizures | D012640 | HP_0002069 | G40.4 | — | 2 | 4 | 5 | 3 | 14 |
| Status epilepticus | D013226 | EFO_0008526 | G41 | — | — | 4 | 3 | 3 | 10 |
| Traumatic brain injuries | D000070642 | — | S06 | 1 | — | 1 | 1 | 1 | 4 |
| Brain injuries | D001930 | — | S06.9 | 1 | — | 1 | 1 | 1 | 4 |
| Drug resistant epilepsy | D000069279 | — | — | — | — | — | 2 | 1 | 3 |
| Depression | D003863 | — | F33.9 | — | — | 1 | 1 | — | 2 |
| Hemorrhage | D006470 | MP_0001914 | R58 | — | — | — | 1 | 1 | 2 |
| Subarachnoid hemorrhage | D013345 | EFO_0000713 | I60 | — | — | — | 1 | 1 | 2 |
| Asthma | D001249 | EFO_0000270 | J45 | — | — | — | 2 | — | 2 |
Show 6 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 12 | — | 1 | — | 3 | 16 |
| Wounds and injuries | D014947 | — | T14.8 | 3 | 1 | 1 | — | 1 | 6 |
| Post-traumatic epilepsy | D004834 | — | — | — | 1 | 2 | — | — | 3 |
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | — | 1 | 2 | — | — | 2 |
| Sclerosis | D012598 | — | — | — | 1 | 1 | — | — | 2 |
| Gingival overgrowth | D019214 | — | K06.1 | — | — | 1 | — | 1 | 2 |
| Tuberous sclerosis | D014402 | HP_0009720 | Q85.1 | — | — | 1 | — | — | 1 |
| Dementia | D003704 | EFO_0003862 | F03 | — | — | 1 | — | — | 1 |
| Psychophysiologic disorders | D011602 | — | F45.9 | — | — | 1 | — | — | 1 |
| Schizophrenia | D012559 | EFO_0000692 | F20 | — | — | 1 | — | — | 1 |
Show 4 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Leukemia | D007938 | — | C95 | 2 | 4 | — | — | — | 4 |
| Lymphoma | D008223 | — | C85.9 | 2 | 4 | — | — | — | 4 |
| Syndrome | D013577 | — | — | 1 | 3 | — | — | — | 3 |
| Central nervous system neoplasms | D016543 | — | — | 1 | 2 | — | — | — | 2 |
| Nervous system neoplasms | D009423 | — | — | 1 | 2 | — | — | — | 2 |
| Myelodysplastic syndromes | D009190 | — | D46 | 1 | 2 | — | — | — | 2 |
| Neoplasms | D009369 | — | C80 | 1 | 2 | — | — | — | 2 |
| Myeloproliferative disorders | D009196 | — | D47.1 | 1 | 2 | — | — | — | 2 |
| Multiple myeloma | D009101 | — | C90.0 | 1 | 2 | — | — | — | 2 |
| Myelodysplastic-myeloproliferative diseases | D054437 | — | — | 1 | 2 | — | — | — | 2 |
Show 24 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Glioma | D005910 | EFO_0000520 | — | 5 | — | — | — | — | 5 |
| Glioblastoma | D005909 | EFO_0000515 | — | 4 | — | — | — | — | 4 |
| Gliosarcoma | D018316 | — | — | 4 | — | — | — | — | 4 |
| Astrocytoma | D001254 | EFO_0000271 | — | 3 | — | — | — | — | 3 |
| Pharmacokinetics | D010599 | — | — | 1 | — | — | — | 1 | 2 |
| Wound healing | D014945 | GO_0042060 | — | 2 | — | — | — | — | 2 |
| Oligodendroglioma | D009837 | EFO_0000631 | — | 1 | — | — | — | — | 1 |
| Non-alcoholic fatty liver disease | D065626 | EFO_0003095 | K75.81 | 1 | — | — | — | — | 1 |
| Pain | D010146 | EFO_0003843 | R52 | 1 | — | — | — | — | 1 |
| Cocaine-related disorders | D019970 | — | F14 | 1 | — | — | — | — | 1 |
Show 1 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Drug-related side effects and adverse reactions | D064420 | — | T88.7 | — | — | — | — | 2 | 2 |
| Heart arrest | D006323 | EFO_0009492 | I46 | — | — | — | — | 2 | 2 |
| Drug interactions | D004347 | — | — | — | — | — | — | 1 | 1 |
| Neurocysticercosis | D020019 | — | — | — | — | — | — | 1 | 1 |
| Cysticercosis | D003551 | EFO_0007231 | B69 | — | — | — | — | 1 | 1 |
| Taeniasis | D013622 | EFO_1001433 | B68 | — | — | — | — | 1 | 1 |
| Chemical and drug induced liver injury | D056486 | EFO_0004228 | — | — | — | — | — | 1 | 1 |
| Renal insufficiency | D051437 | HP_0000083 | N19 | — | — | — | — | 1 | 1 |
| Acute kidney injury | D058186 | HP_0001919 | N17 | — | — | — | — | 1 | 1 |
| Financial stress | D000086522 | — | — | — | — | — | — | 1 | 1 |
Show 20 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Phenytoin |
| INN | phenytoin |
| 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 class | antiepileptics (hydantoin derivatives) |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | O=C1NC(=O)C(c2ccccc2)(c2ccccc2)N1 |
Identifiers
| PDB | — |
| CAS-ID | 57-41-0 |
| RxCUI | — |
| ChEMBL ID | CHEMBL16 |
| ChEBI ID | 8107 |
| PubChem CID | 1775 |
| DrugBank | DB00252 |
| UNII ID | 6158TKW0C5 (ChemIDplus, GSRS) |
Target
Agency Approved
SCN2A
SCN2A
Organism
Homo sapiens
Gene name
SCN2A
Gene synonyms
HBA, 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
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Alternate
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Variants
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Financial
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Estimated US medical usage
Phenytoin
Total medical expenditures per year (USD, in millions)
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 32,756 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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29,102 adverse events reported
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