PHENYTEK (phenytoin sodium)
PHENYTEK (phenytoin sodium) is an extended-release capsule indicated for the management of specific seizure disorders and for use in neurosurgical settings. It is approved for the treatment of tonic-clonic (grand mal) and psychomotor (temporal lobe) seizures. Additionally, the medication is used for the prevention and treatment of seizures that may occur during or following neurosurgery.
How PHENYTEK Works
The precise mechanism of phenytoin has not been fully established, but it is thought to involve the voltage-dependent blockade of membrane sodium channels. By interacting with these channels, the drug reduces sustained high-frequency neuronal discharges in the brain. This stabilization of neuronal activity helps to prevent the excessive electrical signaling associated with seizures.
Details
- Status
- Prescription
- First Approved
- 1998-12-28
- Routes
- ORAL
- Dosage Forms
- CAPSULE
PHENYTEK Approval History
What PHENYTEK Treats
3 indicationsPHENYTEK is approved for 3 conditions since its original approval in 1998. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Tonic-Clonic Seizures
- Psychomotor Seizures
- Seizures
PHENYTEK Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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Clinical Trial Registry
1 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04573803 MAST | A095460 | Ph 3 | not yet recruiting | Pharmacological Management of Seizures Post Traumatic Brain Injury |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
PHENYTEK FDA Label Details
Indications & Usage
FDA Label (PDF)PHENYTEK is indicated for the treatment of Tonic-Clonic Seizures; Psychomotor Seizures; Seizures.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.