Mephenytoin
Mesantoin (mephenytoin) is a small molecule pharmaceutical. Mephenytoin was first approved as Mesantoin on 1982-01-01. It is used to treat epilepsy, post-traumatic epilepsy, temporal lobe epilepsy, and tonic-clonic epilepsy in the USA.
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Drug Products
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New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Mephenytoin
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| MESANTOIN | Novartis | N-006008 DISCN | 1982-01-01 | 1 products, RLD |
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Labels
FDA
EMA
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Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| epilepsy | EFO_0000474 | D004827 | G40.9 |
| post-traumatic epilepsy | — | D004834 | — |
| temporal lobe epilepsy | EFO_0000773 | D004833 | — |
| tonic-clonic epilepsy | EFO_0007262 | D004830 | — |
Agency Specific
FDA
EMA
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Patent Expiration
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HCPCS
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Clinical
Clinical Trials
152 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Atrial fibrillation | D001281 | EFO_0000275 | I48.0 | — | 2 | 5 | 3 | 13 | 23 |
| Vascular calcification | D061205 | — | 1 | 2 | 3 | — | 6 | ||
| Osteoporosis | D010024 | EFO_0003882 | M81.0 | — | — | 2 | 1 | 3 | 6 |
| Venous thrombosis | D020246 | HP_0004936 | I82.40 | 1 | 1 | 1 | 1 | — | 4 |
| Cardiovascular diseases | D002318 | EFO_0000319 | I98 | — | — | 1 | 1 | 2 | 4 |
| Chronic kidney failure | D007676 | EFO_0003884 | N18.6 | — | 2 | 1 | 1 | — | 3 |
| Aortic valve disease | D000082862 | — | 1 | — | 1 | — | 2 | ||
| Transcatheter aortic valve replacement | D065467 | — | — | 1 | 1 | — | 2 | ||
| Pulmonary embolism | D011655 | EFO_0003827 | I26 | — | — | — | 1 | 1 | 2 |
| St elevation myocardial infarction | D000072657 | — | — | 1 | 1 | — | 2 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Thrombosis | D013927 | — | 2 | 2 | — | 1 | 5 | ||
| Neoplasms | D009369 | C80 | 2 | — | 1 | — | 1 | 4 | |
| Venous thromboembolism | D054556 | EFO_0004286 | I74 | — | 1 | 1 | — | 1 | 3 |
| Covid-19 | D000086382 | U07.1 | — | 1 | 1 | — | 1 | 3 | |
| Inflammation | D007249 | — | — | 1 | — | 2 | 3 | ||
| Calciphylaxis | D002115 | — | — | 1 | — | 1 | 2 | ||
| Postmenopausal osteoporosis | D015663 | EFO_0003854 | — | 1 | 2 | — | — | 2 | |
| Hemorrhage | D006470 | MP_0001914 | R58 | — | — | 2 | — | — | 2 |
| Rheumatic heart disease | D012214 | EFO_1001161 | I09.9 | — | — | 1 | — | — | 1 |
| Percutaneous coronary intervention | D062645 | — | — | 1 | — | — | 1 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Vitamin k deficiency | D014813 | E56.1 | — | 2 | — | — | 2 | 4 | |
| Aortic valve stenosis | D001024 | EFO_0000266 | Q25.1 | — | 1 | — | — | 2 | 3 |
| Vascular stiffness | D059289 | — | 1 | — | — | 2 | 3 | ||
| Atherosclerosis | D050197 | EFO_0003914 | I25.1 | — | 1 | — | — | 1 | 2 |
| Folliculitis | D005499 | — | 1 | — | — | — | 1 | ||
| Glioblastoma | D005909 | EFO_0000515 | — | 1 | — | — | — | 1 | |
| Bicuspid aortic valve disease | D000082882 | — | 1 | — | — | — | 1 | ||
| Caroli disease | D016767 | EFO_1001286 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | 4 | — | — | — | 6 | 10 | ||
| Rheumatoid arthritis | D001172 | EFO_0000685 | M06.9 | 3 | — | — | — | — | 3 |
| Dysmenorrhea | D004412 | HP_0100607 | N94.6 | 1 | — | — | — | 1 | 2 |
| Ulcerative colitis | D003093 | EFO_0000729 | K51 | 1 | — | — | — | — | 1 |
| Alzheimer disease | D000544 | EFO_0000249 | F03 | 1 | — | — | — | — | 1 |
| Prostatic neoplasms | D011471 | C61 | 1 | — | — | — | — | 1 | |
| Cerebral hemorrhage | D002543 | 1 | — | — | — | — | 1 | ||
| Chronic hepatitis b | D019694 | EFO_0004197 | B18.1 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | — | — | — | — | 3 | 3 |
| Obesity | D009765 | EFO_0001073 | E66.9 | — | — | — | — | 3 | 3 |
| Insulin resistance | D007333 | EFO_0002614 | — | — | — | — | 3 | 3 | |
| Oxidative stress | D018384 | EFO_1001905 | — | — | — | — | 2 | 2 | |
| Prediabetic state | D011236 | EFO_1001121 | R73.03 | — | — | — | — | 2 | 2 |
| Chronic renal insufficiency | D051436 | N18 | — | — | — | — | 2 | 2 | |
| Coronary artery disease | D003324 | I25.1 | — | — | — | — | 2 | 2 | |
| Pain | D010146 | EFO_0003843 | R52 | — | — | — | — | 1 | 1 |
| Stroke | D020521 | EFO_0000712 | I63.9 | — | — | — | — | 1 | 1 |
| Fibrosis | D005355 | — | — | — | — | 1 | 1 |
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | MEPHENYTOIN |
| INN | mephenytoin |
| Description | Mephenytoin is an imidazolidine-2,4-dione (hydantoin) in which the imidazolidine nucleus carries a methyl group at N-3 and has ethyl and phenyl substituents at C-5. An anticonvulsant, it is no longer available in the USA or the UK but is still studied largely because of its interesting hydroxylation polymorphism. It has a role as an anticonvulsant. |
| Classification | Small molecule |
| Drug class | antiepileptics (hydantoin derivatives) |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | CCC1(c2ccccc2)NC(=O)N(C)C1=O |
Identifiers
| PDB | — |
| CAS-ID | 50-12-4 |
| RxCUI | 6757 |
| ChEMBL ID | CHEMBL861 |
| ChEBI ID | — |
| PubChem CID | 4060 |
| DrugBank | DB00532 |
| UNII ID | R420KW629U (ChemIDplus, GSRS) |
Target
Agency Approved
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Alternate
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Variants
Clinical Variant
Identifier | Target mutation | Effect | Evaluation | Status |
|---|---|---|---|---|
| VCV000016900 | CYP2C19, Met1Val | drug response | 2019-08-26 | P |
| VCV000016899 | CYP2C19, Trp212Ter | drug response | 2022-09-03 | P |
| VCV000016898 | CYP2C19, Arg433Trp | drug response | 2019-06-22 | P |
Financial
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Trends
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Safety
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Adverse Events
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192 adverse events reported
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