TOPIRAMATE
Topiramate is an anticonvulsant indicated for the treatment of epilepsy and the preventive treatment of migraine. It is approved as initial monotherapy for partial-onset or primary generalized tonic-clonic seizures in patients aged 2 years and older. It is also indicated as adjunctive therapy for partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome in patients aged 2 years and older. Additionally, topiramate is indicated for the preventive treatment of migraine in patients 12 years of age and older.
How TOPIRAMATE Works
The precise mechanisms by which topiramate exerts its effects are unknown, though preclinical studies suggest four properties contribute to its efficacy. At pharmacologically relevant concentrations, the drug blocks voltage-dependent sodium channels, augments the activity of the neurotransmitter gamma-aminobutyrate (GABA) at specific GABA-A receptor subtypes, and antagonizes the AMPA/kainate subtype of the glutamate receptor. Additionally, topiramate inhibits the carbonic anhydrase enzyme, particularly isozymes II and IV.
Details
- Status
- Prescription
- First Approved
- 2003-12-17
- Routes
- ORAL
- Dosage Forms
- TABLET, CAPSULE, CAPSULE, EXTENDED RELEASE, SOLUTION
Companies
TOPIRAMATE Approval History
What TOPIRAMATE Treats
4 indicationsTOPIRAMATE is approved for 4 conditions since its original approval in 2003. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Partial-onset seizures
- Primary generalized tonic-clonic seizures
- Seizures associated with Lennox-Gastaut syndrome
- Preventive treatment of migraine
Drugs Similar to TOPIRAMATE
FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
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.
TOPIRAMATE FDA Label Details
ProIndications & Usage
Topiramate tablets are indicated for: Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older ; adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome in patients 2 years of age and older Preventive treatment of migraine in patients 12 years of age and older 1.1 Monotherapy Epilepsy Topiramate tablets are indicated as initial monotherapy for the treatment of partial-onset or primary generalized tonic-c...
Want competitive intelligence?
See who's developing similar drugs and track their progress
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.