TheraRadar
Data updated: May 26, 2026

TOPIRAMATE

Cytochrome P450 3A4 Inducers
CNS Approved 2003-12-17

TOPIRAMATE is indicated for the treatment of Partial-onset seizures; Primary generalized tonic-clonic seizures; Seizures associated with Lennox-Gastaut syndrome; Preventive treatment of migraine.

Source: FDA Label • ACCORD HLTHCARE
Jump to: Indications Approvals Trials Competitors Similar Safety Patents

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.

Source: FDA Label
34
Indications
--
Phase 3 Trials
22
Years on Market

Details

Status
Prescription
First Approved
2003-12-17
Routes
ORAL
Dosage Forms
TABLET, CAPSULE, EXTENDED RELEASE, CAPSULE, SOLUTION

Companies

ACCORD HLTHCARE XIAMEN LP PHARM CO Cipla Teva WATSON LABS CHARTWELL RX Hikma GLENMARK PHARMS LTD AIPING PHARM INC UNICHEM LABS LTD ASCENT PHARMS INC ALKEM LABS LTD SENORES PHARMS INVAGEN PHARMS PH HEALTH ZYDUS PHARMS Dr. Reddy's TWI PHARMS Sun Pharma TORRENT PHARMS PHARMACO CHARTWELL ZYDUS Aurobindo Pharma RUBICON RESEARCH NATCO PLIVA HRVATSKA DOO ZYDUS PHARMS USA INC STRIDES PHARMA Lupin ROXANE AJANTA PHARMA LTD AMTA
Active Ingredient: TOPIRAMATE

TOPIRAMATE Approval History

2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
1099 FDA actions from 2003 to 2026
Apr 2026 SUPPL
Label · Labeling
Mar 2026 SUPPL
Label · Labeling
Feb 2026 SUPPL
Label · Labeling

What TOPIRAMATE Treats

4 indications

TOPIRAMATE 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
Source: FDA Label

TOPIRAMATE Competitive Set

Pro

Three rings of competition based on shared molecular targets and treated indications.

Direct competitors

10

Same target(s) AND same indication — head-to-head.

ZONISADE
AZURITY
2022 1 indic.
XCOPRI
SK LIFE
2019 1 indic.

MoA expansion candidates

9

Same target(s), different indications — where else is this mechanism being explored?

DICHLORPHENAMIDE
RISING
2025 2 indic.
ORMALVI
TORRENT
2022 2 indic.

Indication competitors

10

Same indication, different mechanism — what else might this patient receive?

SUBVENITE
OWP PHARMS
2025 5 indic.
PERAMPANEL
MSN
2025 3 indic.
Unlock 23 more competitors across all three rings.
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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 TOPIRAMATE

3 of 20

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

FYCOMPA
PERAMPANEL
2 shared
CATALYST PHARMS
Shared indications:
Partial-Onset SeizuresPrimary Generalized Tonic-Clonic Seizures
KEPPRA
LEVETIRACETAM
2 shared
UCB INC
Shared indications:
Partial-Onset SeizuresPrimary Generalized Tonic-Clonic Seizures
LEVETIRACETAM IN SODIUM CHLORIDE
LEVETIRACETAM
2 shared
Baxter
Shared indications:
Partial-Onset SeizuresPrimary Generalized Tonic-Clonic Seizures
View all 20 similar drugs Pro
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Clinical Trial Registry

52 trials
Trial Sponsor ID Phase Status Title
NCT01351753 REVIVE results posted 201012738 Ph 2 terminated Drug Therapy Induced Weight Loss to Improve Blood Vessel Function in Subjects With Obesity
NCT05975580 PROJECT-BARI 1849 R01DK129936 Ph 4 recruiting Pharmacotherapy in Conjunction With Lifestyle Counseling for Management of Weight Regain After Bariatric Surgery
NCT02273804 TOBI P091122 2011-006193-36 Ph 3 completed Topiramate and Severe Obesity
NCT06799169 4863 Ph 4 active not recruiting Management of Acute Tinnitus With Migraine Medications
NCT04572217 MAABS Protocol 54967 1092951-100- KHAAX Ph 2 withdrawn Medications After Adolescent Bariatric Surgery
NCT05748483 ATO-TOPIRAMATE M22-061 2022-501172-25-00 Ph 3 active not recruiting Comparative Study of Oral Atogepant Versus Oral Topiramate to Assess Adverse Events in Adult Participants With Migraine
NCT02201251 results posted CR104425 TOPMATEPY4067, 2012-001552-19 Ph 3 completed A Study to Investigate the Safety of the Drugs Topiramate and Levetiracetam in Treating Children Recently Diagnosed With Epilepsy
NCT03667846 18-01405 P01AA027057 Ph 2 recruiting Leveraging Biomarkers for Personalized Treatment of Alcohol Use Disorder Comorbid With PTSD
NCT01689649 results posted CR017830 TOPMATEPY4049, TOP-VN -0107 Ph 4 completed A Study to Assess Tolerability and Efficacy of Topiramate Monotherapy in Recently Diagnosed Patients With Epilepsy
NCT01950520 results posted 130200 13-DK-0200 Ph 2 completed Study of Human Non-Shivering Thermogenesis and Basal Metabolic Rate
NCT06499116 PREMI IJG-PREMI-2024 2024-513597-22-00 Ph 4 not yet recruiting Comparison of the Effectiveness of First-line Preventive Treatment of Migraine in Primary Care
NCT01765218 results posted 1182678 Ph 1, Ph 2 terminated Topiramate in Neonates Receiving Whole Body Cooling for Hypoxic Ischemic Encephalopathy
NCT03176953 TOP results posted D2412-R Ph 2, Ph 3 completed Topiramate and Prolonged Exposure
NCT02878798 TopCSPN results posted URNN001 / HM20014083 1U01NS095388 Ph 2 completed Topiramate for Cryptogenic Sensory Peripheral Neuropathy in Metabolic Syndrome (CSPN)
NCT05663749 AIIMS BBSR/PG Thesis/2021-22 Ph 4 completed Topiramate vs Metformin on Cardio-Metabolic Profile in Schizophrenia on Atypical Antipsychotics
NCT03018704 results posted NURA-010-16S Ph 4 terminated Topiramate Treatment of Alcohol Use Disorders in African Americans
NCT03335163 results posted 17-1047 Ph 1 completed The Effect of Topiramate on Etonogestrel Concentrations in Contraceptive Implant Users
NCT02371889 TOPG results posted 821035 821035, R01AA023192 Ph 2 completed A Randomized, Double-blind Placebo-Controlled Pharmacogenetic Study of Topiramate in European-American Heavy Drinkers
NCT03828539 HER-MES results posted CAMG334ADE01 2018-000943-15 Ph 4 completed Head-to-head Study of Erenumab Against Topiramate in Patients With Episodic and Chronic Migraine
NCT01749215 TAP2 results posted PT110423 W81XWH-11-PHTBI-BAPHA Ph 4 completed A Controlled Trial of Topiramate Treatment for Alcohol Dependence in Veterans With PTSD
NCT00571246 0705002634 Ph 3 withdrawn The Use of Anticonvulsants for Treatment of Patients With Alcohol Dependence and Post Traumatic Stress Disorder
NCT04401137 QDX001 Ph 1 completed The Evaluation of Pharmacokinetic/Pharmacodynamic Characteristics and Safety of QDX in Healthy Korean Male Subjects
NCT01641445 IMPACT results posted R01AA007850-21 Ph 1, Ph 2 completed Effects of Topiramate on Adolescent Alcohol Use: Efficacy and Mechanisms
NCT01750268 VAT results posted W81XWH-11-2-0145 Ph 4 completed Topiramate Treatment of Hazardous and Harmful Alcohol Use in Veterans With TBI
NCT01110434 results posted R01DA026778 R01DA026778 Ph 2 completed Biobehavioral Effects of Topiramate on Cannabis-Related Outcomes in Adolescents
NCT01700387 results posted 12-001AL 71403 Ph 4 completed A Study to Evaluate the Tolerability of Botox and Topiramate or Botox and Placebo and Effect on Cognitive Efficiency
NCT03308669 results posted 16925 H8H-MC-LAHT Ph 1 completed A Study of Lasmiditan in Healthy Participants When Co-administered With Topiramate
NCT02239913 BED IN 27 R01DA032254 Ph 1 completed Topiramate-Phentermine Combinations for Cocaine Dependence
NCT01811940 TACT2 results posted #6698 1U01DA033310-01A1 Ph 2, Ph 3 completed Multicenter Trial of Combined Pharmacotherapy to Treat Cocaine Dependence
NCT01789047 TOP-DYSK results posted TOP-DYSK Ph 2 terminated Topiramate as an Adjunct to Amantadine in the Treatment of Dyskinesia in Parkinson's Disease
NCT01426542 216534 Ph 1 completed Preventing Brain Injury in Infants With Congenital Heart Disease
NCT02074904 TOPMRI results posted TOP MRI Ph 2 terminated Topiramate's Effects on Heavy Drinking
NCT02191579 results posted GMA-US-NEU-0206 FORWARD Ph 4 completed Efficacy and Safety Study of BOTOX® Compared to Topiramate for the Prevention of Chronic Migraine in Adults
NCT02810483 TOPRADER AOM10088 Ph 3 terminated Study of the Efficacy of Topiramate in Patients With Prader Willi Syndrome Over 8 Weeks
NCT00626925 results posted 08-052-2 P60AA003510, M01RR006192 Ph 4 completed Topiramate Treatment of Problem Drinkers
NCT02374567 GAP GAP-2014 Ph 3 terminated Pharmacovigilance in Gerontopsychiatric Patients
NCT01229735 results posted N01353 Ph 4 completed Levetiracetam Versus Topiramate as Adjunctive Therapy to Evaluate Efficacy and Safety in Subjects With Refractory Partial Onset Seizures
NCT01581281 CHAMP results posted CIN-001 1U01NS076788-01 Ph 3 terminated The Childhood and Adolescent Migraine Prevention Study
NCT01859013 results posted 1304M31241 Ph 2 completed Topiramate in Adolescents With Severe Obesity
NCT02138058 TFO Topiramate for oniomania Ph 2 completed Topiramate Trial for Compulsive Buying
NCT00802412 results posted NEUA-003-08S Ph 2 completed Topiramate to Aid Smoking Cessation in Alcohol Dependent Men
NCT02884050 96-2009 Ph 1 completed Physiologic Effects of Topiramate on Cognition
NCT01764685 results posted 816082 Ph 2 terminated Topiramate to Reduce Heavy Drinking in HIV-Positive Heavy Drinkers
NCT02639598 2012-04-046B Ph 4 completed Flunarizine Versus Topiramate for Chronic Migraine Prophylaxis
NCT00988481 200909-046 Ph 4 withdrawn Topiramate Augmentation in Bulimia Nervosa Partial Responders
NCT00862563 results posted NIAAA-CIR-AA015923 P60AA013759, 1R01AA015923 Ph 2 terminated Interdisciplinary Study of Two Novel Anticonvulsants in Alcoholism
NCT02424318 06-2008-71 Ph 4 completed Topiramate and Cerebrovascular Response in Migraineurs
NCT01087736 TAP results posted H5220-34690-01 DAMD17-03-1-0532 Ph 4 completed Topiramate Treatment of Alcohol Use Disorders in Veterans With Post Traumatic Stress Disorder (PTSD): A Pilot Controlled Trial of Augmentation Therapy
NCT00862095 208075 Ph 4 terminated Medical Therapies for Chronic Post-Traumatic Headaches
NCT00772031 CMTT results posted 08-CRC-01 HHSN265200523641C Ph 3 completed NINDS CRC Chronic Migraine Treatment Trial

Showing 50 of 52 trials

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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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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

Indications & Usage

TOPIRAMATE is indicated for the treatment of Partial-onset seizures; Primary generalized tonic-clonic seizures; Seizures associated with Lennox-Gastaut syndrome; Preventive treatment of migraine.

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Data Sources

FDA Approval: ANDA076311 → Label: DailyMed → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.