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Topiramate

Generic Name
Topiramate
Brand Names
Eprontia, Qsymia, Qudexy, Topamax, Trokendi
Drug Type
Small Molecule
Chemical Formula
C12H21NO8S
CAS Number
97240-79-4
Unique Ingredient Identifier
0H73WJJ391

Overview

Topiramate is a anti-epileptic drug used to manage seizures and prevent migraines. It was initially approved by the FDA in 1996. In 2004, topiramate was approved for the prevention of migraine in adults. Since 2012, the extended-release formulation has been approved in combination with phentermine for chronic weight management therapy in adults. Characteristics that distinguish topiramate from other antiepileptic drugs are a monosaccharide chemical structure containing a sulfamate, and 40% of its mass accounted for by oxygen. Interestingly, topiramate was discovered by chance when attempts were made to formulate a novel antidiabetic drug.

Background

Topiramate is a anti-epileptic drug used to manage seizures and prevent migraines. It was initially approved by the FDA in 1996. In 2004, topiramate was approved for the prevention of migraine in adults. Since 2012, the extended-release formulation has been approved in combination with phentermine for chronic weight management therapy in adults. Characteristics that distinguish topiramate from other antiepileptic drugs are a monosaccharide chemical structure containing a sulfamate, and 40% of its mass accounted for by oxygen. Interestingly, topiramate was discovered by chance when attempts were made to formulate a novel antidiabetic drug.

Indication

Topiramate is indicated for the following conditions: 1)Monotherapy for partial onset or primary generalized tonic-clonic seizures for patients 2 years of age and above 2)Adjunctive therapy for partial onset seizures or primary generalized tonic-clonic seizures for both adult and pediatric patients above 2 years old 3)Adjunctive therapy for seizures associated with Lennox-Gastaut syndrome in patients above 2 years of age 4)Prophylaxis of migraine in children 12 years of age and older and adults. Topiramate is also used off-label as an adjunct therapy for weight management and for mood disorders.

Associated Conditions

  • Alcohol Dependency
  • Epilepsy, Primary Generalized Tonic-Clonic Seizures
  • Generalized Tonic-Clonic Seizures
  • Lennox-Gastaut Syndrome
  • Migraine
  • Moods Disorders
  • Partial-Onset Seizures
  • Seizures
  • Weight

Research Report

Published: Jun 4, 2025

Topiramate: A Comprehensive Pharmacological and Clinical Review

1. Introduction to Topiramate

Overview and Therapeutic Class

Topiramate is a broad-spectrum antiepileptic drug (AED) widely utilized in the management of various seizure disorders. Beyond its anticonvulsant properties, topiramate is also established for the prophylaxis of migraine headaches and, as a component of a combination product, for chronic weight management.[1] It is classified as a small molecule drug.[1] The therapeutic versatility of topiramate is attributed to its multiple, distinct mechanisms of action, which differentiate it from many other AEDs that often target a single pathway.[1] This multifaceted pharmacological profile allows topiramate to modulate neuronal excitability through several complementary pathways, contributing to its efficacy in conditions characterized by neuronal hyperexcitability.

Historical Background and Discovery

Topiramate first received approval from the U.S. Food and Drug Administration (FDA) in 1996 for the treatment of epilepsy.[1] Its indications were later expanded in 2004 to include the prevention of migraine headaches in adult populations.[1] A significant development occurred in 2012 when an extended-release formulation of topiramate, in combination with phentermine (marketed as Qsymia®), was approved by the FDA for chronic weight management in adults.[1]

Continue reading the full research report

Clinical Trials

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FDA Approved Products

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Product Name
Manufacturer
Route
Strength
Approved
NDC Code
ORAL
100 mg in 1 1
2021/07/28
71335-0337
ORAL
25 mg in 1 1
2024/03/29
70518-3758
ORAL
200 mg in 1 1
2023/05/31
0245-1073
ORAL
15 mg in 1 1
2024/02/19
59651-452
ORAL
25 mg in 1 1
2024/02/22
70518-1718
ORAL
50 mg in 1 1
2024/02/14
70518-1180
ORAL
50 mg in 1 1
2023/06/16
31722-182
ORAL
50 mg in 1 1
2023/06/22
83008-011
ORAL
50 mg in 1 1
2024/02/29
70518-2419
ORAL
50 mg in 1 1
2023/07/19
27241-228

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PPB Approved Products

Product Name
Registration Code
Company
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Sale Type
Reg. Date
HK-54628
trenton-boma ltd
Part 1, Schedule 1 & Schedule 3 Poison
POM
2006/08/11
HK-65187
i & c (hong kong) limited
Part 1, Schedule 1 & Schedule 3 Poison
POM
2017/06/09
HK-65188
i & c (hong kong) limited
Part 1, Schedule 1 & Schedule 3 Poison
POM
2017/06/09

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