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.
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
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]
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/05/14 | Phase 4 | Recruiting | |||
2025/01/29 | Phase 4 | Recruiting | |||
2024/10/03 | Phase 4 | Recruiting | Institut Universitari D Investigacio En Atencion Primaria Jordi Gol | ||
2024/04/04 | Phase 3 | Recruiting | |||
2024/02/28 | Phase 1 | Not yet recruiting | |||
2024/02/08 | Phase 3 | Completed | |||
2024/02/06 | Phase 3 | Recruiting | |||
2023/10/18 | Phase 4 | Recruiting | |||
2023/08/04 | Phase 4 | Recruiting | |||
2023/07/24 | Phase 2 | Recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| PD-Rx Pharmaceuticals, Inc. | 43063-997 | ORAL | 50 mg in 1 1 | 7/14/2023 | |
| Aphena Pharma Solutions - Tennessee, LLC | 43353-696 | ORAL | 100 mg in 1 1 | 12/30/2010 | |
| NuCare Pharmaceuticals, Inc. | 68071-3196 | ORAL | 50 mg in 1 1 | 3/1/2024 | |
| DIRECT RX | 61919-817 | ORAL | 100 mg in 1 1 | 1/21/2020 | |
| NuCare Pharmaceuticals,Inc. | 68071-5165 | ORAL | 50 mg in 1 1 | 2/22/2021 | |
| PD-Rx Pharmaceuticals, Inc. | 43063-605 | ORAL | 100 mg in 1 1 | 6/28/2023 | |
| Denton Pharma, Inc. DBA Northwind Pharmaceuticals | 70934-733 | ORAL | 50 mg in 1 1 | 8/12/2021 | |
| Dispensing Solutions Inc. | 68258-7056 | ORAL | 100 mg in 1 1 | 1/28/2010 | |
| Unit Dose Services | 50436-9950 | ORAL | 50 mg in 1 1 | 10/17/2015 | |
| Proficient Rx LP | 71205-187 | ORAL | 50 mg in 1 1 | 2/1/2020 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| TOPAMAX 100 TABLET 100 mg | SIN09687P | TABLET, FILM COATED | 100 mg | 3/24/1998 | |
| Topiron film-coated tablets 25mg | SIN14132P | TABLET, FILM COATED | 25mg | 4/9/2012 | |
| TROKENDI XR® EXTENDED-RELEASE CAPSULE 100MG | SIN16664P | CAPSULE, EXTENDED RELEASE | 100mg | 1/5/2023 | |
| TOPAMAX 25 TABLET 25 mg | SIN09688P | TABLET, FILM COATED | 25 mg | 3/24/1998 | |
| TOPAMAX 50 TABLET 50 mg | SIN09689P | TABLET, FILM COATED | 50 mg | 3/24/1998 | |
| TROKENDI XR® EXTENDED-RELEASE CAPSULE 200MG | SIN16665P | CAPSULE, EXTENDED RELEASE | 200mg | 1/5/2023 | |
| TROKENDI XR® EXTENDED-RELEASE CAPSULE 25MG | SIN16662P | CAPSULE, EXTENDED RELEASE | 25.00mg | 1/5/2023 | |
| TROKENDI XR® EXTENDED-RELEASE CAPSULE 50MG | SIN16663P | CAPSULE, EXTENDED RELEASE | 50mg | 1/5/2023 | |
| Topiron film-coated tablets 100mg | SIN14311P | TABLET, FILM COATED | 100.0mg | 2/14/2013 | |
| Topiron film-coated tablets 50mg | SIN14131P | TABLET, FILM COATED | 50mg | 4/9/2012 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| PMS-TOPIRAMATE TAB 25MG | N/A | N/A | N/A | 8/11/2006 | |
| TORAMAT TABLETS 50MG | N/A | i & c (hong kong) limited | N/A | N/A | 6/9/2017 |
| TORAMAT TABLETS 100MG | N/A | i & c (hong kong) limited | N/A | N/A | 6/9/2017 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| EPIRAMAX 50 topiramate 50 mg capsule bottle | 137712 | Medicine | A | 2/11/2008 | |
| APO-TOPIRAMATE topiramate 100 mg tablet bottle | 124735 | Medicine | A | 7/20/2007 | |
| TAMATE topiramate 200mg tablet blister pack | 150444 | Medicine | A | 6/1/2009 | |
| TOPIRAMATE-LAPL topiramate 100 mg tablet blister | 155209 | Medicine | A | 4/19/2010 | |
| NOUMED TOPIRAMATE topiramate 25 mg tablet blister pack | 284339 | Medicine | A | 6/7/2017 | |
| TOPIRAMATE-WGR topiramate 200 mg tablet blister pack | 124648 | Medicine | A | 7/20/2007 | |
| APO-TOPIRAMATE topiramate 50 mg tablet bottle | 124734 | Medicine | A | 7/20/2007 | |
| TOPIRAMATE-WGR topiramate 100 mg tablet blister pack | 124647 | Medicine | A | 7/20/2007 | |
| RBX TOPIRAMATE topiramate 25 mg tablets blister pack | 157963 | Medicine | A | 5/10/2010 | |
| TAMATE topiramate 100mg tablet blister pack | 150446 | Medicine | A | 6/1/2009 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| AG-TOPIRAMATE | angita pharma inc. | 02475952 | Tablet - Oral | 200 MG | N/A |
| ZYM-TOPIRAMATE | zymcan pharmaceuticals inc | 02325152 | Tablet - Oral | 200 MG | 6/23/2009 |
| GD-TOPIRAMATE | genmed a division of pfizer canada ulc | 02352885 | Tablet - Oral | 200 MG | 5/10/2012 |
| JAMP TOPIRAMATE TABLETS | 02345250 | Tablet - Oral | 25 MG | 3/1/2023 | |
| TOPIRAMATE | meliapharm inc | 02345447 | Tablet - Oral | 200 MG | 6/11/2010 |
| TOPIRAMATE TABLETS USP | 02430800 | Tablet - Oral | 100 MG | 11/14/2014 | |
| TOPAMAX 100MG | 02230894 | Tablet - Oral | 100 MG | 3/25/1997 | |
| PHL-TOPIRAMATE | pharmel inc | 02271206 | Tablet - Oral | 200 MG | 10/11/2005 |
| RAN-TOPIRAMATE | ranbaxy pharmaceuticals canada inc. | 02396084 | Tablet - Oral | 100 MG | 3/22/2013 |
| AG-TOPIRAMATE | angita pharma inc. | 02475944 | Tablet - Oral | 100 MG | 7/26/2018 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| TOPAMAX 100 mg COMPRIMIDOS RECUBIERTOS CON PELICULA | Janssen-Pharma S.L. | 61875 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Commercialized |
| TOPIRAMATO AUROVITAS SPAIN 200 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Aurovitas Spain, S.A.U. | 69970 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
| TOPIRAMATO TECNIGEN 200 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Tecnimede España Industria Farmaceutica S.A. | 70647 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Commercialized |
| TOPIRAMATO SANDOZ 50 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Sandoz Farmaceutica S.A. | 69179 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Commercialized |
| TOPIRAMATO KERN PHARMA 100 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | 68723 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Commercialized | |
| TOPIRAMATO QUALIGEN 50 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Neuraxpharm Spain S.L. | 70889 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Commercialized |
| TOPIRAMATO CINFA 25 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Laboratorios Cinfa S.A. | 69135 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Commercialized |
| TOPIRAMATO PHARMA COMBIX 100 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Laboratorios Combix S.L.U. | 73765 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Commercialized |
| TOPIRAMATO VIATRIS 50 MG COMPRIMIDOS RECUBIERTOS CON PELÍCULA EFG | Viatris Pharmaceuticals S.L.U. | 69035 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Commercialized |
| TOPIRAMATO TARBIS 25 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Tarbis Farma S.L. | 69884 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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