MedPath

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

Clinical Trials

Phase 1
Completed
Posted: 2016/03/14
Sponsor:
Food and Drug Admini...
Phase 1
Posted: 2016/01/01
Sponsor:
Xijing Hospital
Not Applicable
Withdrawn
Posted: 2015/12/31

FDA Approved Products

Topiramate
Manufacturer:Camber Pharmaceuticals, Inc.
Route:ORAL
Strength:50 mg in 1 1
Approved: 2015/10/17
NDC:31722-279
Topiramate
Manufacturer:Camber Pharmaceuticals, Inc.
Route:ORAL
Strength:200 mg in 1 1
Approved: 2015/10/17
NDC:31722-281
Topiramate
Manufacturer:Bryant Ranch Prepack
Route:ORAL
Strength:200 mg in 1 1
Approved: 2018/11/01
NDC:63629-4947
Topiramate
Manufacturer:NuCare Pharmaceuticals,Inc.
Route:ORAL
Strength:100 mg in 1 1
Approved: 2021/02/11
NDC:68071-1612
TOPIRAMATE
Manufacturer:DirectRX
Route:ORAL
Strength:50 mg in 1 1
Approved: 2023/05/23
NDC:61919-369

Singapore Approved Products

No Singapore products found for this drug

Drug Development Updates

Stay informed with timely notifications on clinical trials and research advancements.

© Copyright 2025. All Rights Reserved by MedPath