DILANTIN (phenytoin sodium)
DILANTIN is indicated for the treatment of Tonic-Clonic Seizures; Psychomotor Seizures.
How DILANTIN Works
The precise mechanism of this medication has not been established, but it is thought to involve the voltage-dependent blockade of membrane sodium channels. This blockade results in a reduction in sustained high-frequency neuronal discharges. By limiting these discharges, the drug exerts its therapeutic effect in the treatment and prevention of seizures.
Details
- Status
- Prescription
- First Approved
- 1956-03-01
- Routes
- ORAL, INJECTION
- Dosage Forms
- CAPSULE, INJECTABLE, TABLET, CHEWABLE
DILANTIN Approval History
What DILANTIN Treats
2 indicationsDILANTIN is approved for 2 conditions since its original approval in 1956. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Tonic-Clonic Seizures
- Psychomotor Seizures
DILANTIN 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.
Drugs Similar to DILANTIN
3 of 4FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
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.
DILANTIN FDA Label Details
Indications & Usage
FDA Label (PDF)DILANTIN is indicated for the treatment of Tonic-Clonic Seizures; Psychomotor Seizures.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.