Fosphenytoin
Cerebyx, Fosphenytoin (fosphenytoin) is a small molecule pharmaceutical. Fosphenytoin was first approved as Cerebyx on 1996-08-05. It is used to treat epilepsy, seizures, and status epilepticus in the USA.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| nervous system diseases | D009422 |
| signs and symptoms pathological conditions | D013568 |
Trade Name
FDA
EMA
Cerebyx, Fosphenytoin (discontinued: Fosphenytoin, Sesquient)
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| cerebyx | New Drug Application | 2025-08-28 |
| fosphenytoin | ANDA | 2023-03-31 |
| fosphenytoin sodium | ANDA | 2025-07-15 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| epilepsy | EFO_0000474 | D004827 | G40.9 |
| seizures | — | D012640 | G40.4 |
| status epilepticus | EFO_0008526 | D013226 | G41 |
Agency Specific
FDA
EMA
No data
Clinical
Clinical Trials
15 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Seizures | D012640 | — | G40.4 | — | 1 | — | 2 | 2 | 5 |
| Status epilepticus | D013226 | EFO_0008526 | G41 | — | — | 2 | 1 | — | 3 |
| Traumatic brain injuries | D000070642 | — | S06 | — | — | — | 1 | 1 | 2 |
| Brain injuries | D001930 | — | S06.9 | — | — | — | 1 | 1 | 2 |
| Hemorrhage | D006470 | MP_0001914 | R58 | — | — | — | 1 | 1 | 2 |
| Subarachnoid hemorrhage | D013345 | EFO_0000713 | I60 | — | — | — | 1 | 1 | 2 |
| Emergencies | D004630 | — | — | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Epilepsy | D004827 | EFO_0000474 | G40.9 | — | — | 2 | — | — | 2 |
| Acute pain | D059787 | — | R52 | — | — | 1 | — | — | 1 |
| Herpes zoster | D006562 | EFO_0006510 | B02 | — | — | 1 | — | — | 1 |
| Herpes simplex | D006561 | — | B00 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Lymphoma | D008223 | — | C85.9 | 1 | 2 | — | — | — | 2 |
| Leukemia | D007938 | — | C95 | 1 | 1 | — | — | — | 1 |
| Neuroblastoma | D009447 | EFO_0000621 | — | 1 | 1 | — | — | — | 1 |
| Anemia | D000740 | EFO_0004272 | D64.9 | 1 | 1 | — | — | — | 1 |
| Immunologic deficiency syndromes | D007153 | — | D84.9 | 1 | 1 | — | — | — | 1 |
| Myelodysplastic syndromes | D009190 | — | D46 | — | 1 | — | — | — | 1 |
| Myeloid leukemia acute | D015470 | — | C92.0 | — | 1 | — | — | — | 1 |
| Myeloproliferative disorders | D009196 | — | D47.1 | — | 1 | — | — | — | 1 |
| Primary myelofibrosis | D055728 | — | D47.4 | — | 1 | — | — | — | 1 |
| Precursor cell lymphoblastic leukemia-lymphoma | D054198 | — | C91.0 | — | 1 | — | — | — | 1 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Glioblastoma | D005909 | EFO_0000515 | — | 1 | — | — | — | — | 1 |
| Glioma | D005910 | EFO_0000520 | — | 1 | — | — | — | — | 1 |
| Gliosarcoma | D018316 | — | — | 1 | — | — | — | — | 1 |
| Astrocytoma | D001254 | EFO_0000271 | — | 1 | — | — | — | — | 1 |
| Oligodendroglioma | D009837 | EFO_0000631 | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Brain diseases | D001927 | — | G93.40 | — | — | — | — | 1 | 1 |
| Neuralgia | D009437 | EFO_0009430 | — | — | — | — | — | 1 | 1 |
| Trigeminal neuralgia | D014277 | EFO_1001219 | G50.0 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Fosphenytoin |
| INN | fosphenytoin |
| Description | Fosphenytoin is an imidazolidine-2,4-dione. |
| Classification | Small molecule |
| Drug class | phosphoro-derivatives; antiepileptics (hydantoin derivatives) |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | O=C1NC(c2ccccc2)(c2ccccc2)C(=O)N1COP(=O)(O)O |
Identifiers
| PDB | — |
| CAS-ID | 93390-81-9 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1201336 |
| ChEBI ID | 5165 |
| PubChem CID | 56339 |
| DrugBank | DB01320 |
| UNII ID | B4SF212641 (ChemIDplus, GSRS) |
Target
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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: Cerebyx, Fosphenytoin, Fosphenytoin sodium
Adverse Events
Top Adverse Reactions
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1,863 adverse events reported
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