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Drug

Topiramate

Established medicine
ClassGABA-A receptor; anion channel positive modulatorResearchActive indication expansion
Also known as Eprontia, Phentermine-Topiramate, Qsymia, Qudexy+8 more

Eprontia, Phentermine-Topiramate, Qsymia, Qudexy, TPM, Tipiramate, Tipiramato, Topamax, Topiragen, Trokendi, Topiramato, Topiramatum.

RxNorm38404ChEMBLCHEMBL220492ATCN03AX11UNII0H73WJJ391
9
Research papers
9
Active clinical trials
37
Protein targets
36
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Approval: TOPIRAMATE (ANDA219183)

Regulatory2026-09-04FDA

Recall (Class III): TOPIRAMATE

Regulatory2026-08-31FDA

Topiramate in Treatment Refractory Psychotic Illness: Effects on Weight Gain and Psychopathology

Clinical trial2026-08-01Primary completion · ClinicalTrials.gov

A Comparative Effectiveness Study of Oral Medications Used for Migraine Prevention: The APT Comparison Study

Clinical trial2026-07-30Results expected Q1 2029 · ClinicalTrials.gov

[Articles] Tolerability, safety, and efficacy of atogepant versus topiramate in adults with migraine (TEMPLE): a randomised, head-to-head, phase 3b trial

Clinical trial2026-07-23Trial news · The Lancet Neurology

Approval: TOPIRAMATE (ANDA220943)

Regulatory2026-07-22FDA

Recall (Class III): TOPIRAMATE

Regulatory2026-07-06FDA

A Randomized, Double-Blind, Parallel-Group, Active Controlled Trial With Open-Label Safety Extension to Evaluate the Tolerability, Safety, and Efficacy of Atogepant Versus Topiramate in Subjects Requiring Preventive Treatment of Migraine (TEMPLE)

Clinical trial2026-07-02Results posted · ClinicalTrials.gov

Comparative Outcomes of Migraine Preventives and Anti-CGRP Therapies for Tinnitus in Patients With Migraine: A Randomized Active-Comparator Controlled Trial (COMPACT-PM)

Clinical trial2026-06-17Results expected Q3 2031 · ClinicalTrials.gov

A randomized pilot trial of topiramate for alcohol use disorder in veterans with traumatic brain injury: Effects on alcohol use, cognition, and post-concussive symptoms.

Research2020-07-02Drug and alcohol dependence

Topiramate for smoking cessation: a randomized, placebo-controlled pilot study.

Research2013-09-21Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco

Cognitive Effects of Low-dose Topiramate Compared with Oxcarbazepine in Epilepsy Patients.

Research2006-06-20Journal of clinical neurology (Seoul, Korea)

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Topiramate
Aliases & brands
EprontiaPhentermine-TopiramateQsymiaQudexyTPMTipiramateTipiramatoTopamaxTopiragenTrokendiTopiramatoTopiramatum
RxNorm CUI
38404
ChEMBL ID
CHEMBL220492
ATC codes
N03AX11
UNII
0H73WJJ391
Primary mechanism
GABA-A receptor; anion channel positive modulator
Regulatory jurisdictions
mhrafda

Pharmacology & targets

37 targets

Known molecular targets and mechanisms supported by curated pharmacology databases.

Gamma-aminobutyric acid receptor subunit alpha-1
GABRA1 · P14867
POSITIVE MODULATORGABA-A receptor; anion channel positive modulator
Gamma-aminobutyric acid receptor subunit beta-2
GABRB2 · P47870
POSITIVE MODULATORGABA-A receptor; anion channel positive modulator
Gamma-aminobutyric acid receptor subunit gamma-2
GABRG2 · P18507
POSITIVE MODULATORGABA-A receptor; anion channel positive modulator
Gamma-aminobutyric acid receptor subunit beta-3
GABRB3 · P28472
POSITIVE MODULATORGABA-A receptor; anion channel positive modulator
Gamma-aminobutyric acid receptor subunit alpha-4
GABRA4 · P48169
POSITIVE MODULATORGABA-A receptor; anion channel positive modulator
Gamma-aminobutyric acid receptor subunit gamma-3
GABRG3 · Q99928
POSITIVE MODULATORGABA-A receptor; anion channel positive modulator
Gamma-aminobutyric acid receptor subunit theta
GABRQ · Q9UN88
POSITIVE MODULATORGABA-A receptor; anion channel positive modulator
Gamma-aminobutyric acid receptor subunit alpha-3
GABRA3 · P34903
POSITIVE MODULATORGABA-A receptor; anion channel positive modulator
Gamma-aminobutyric acid receptor subunit pi
GABRP · O00591
POSITIVE MODULATORGABA-A receptor; anion channel positive modulator
Gamma-aminobutyric acid receptor subunit delta
GABRD · O14764
POSITIVE MODULATORGABA-A receptor; anion channel positive modulator
Gamma-aminobutyric acid receptor subunit gamma-1
GABRG1 · Q8N1C3
POSITIVE MODULATORGABA-A receptor; anion channel positive modulator
Gamma-aminobutyric acid receptor subunit beta-1
GABRB1 · P18505
POSITIVE MODULATORGABA-A receptor; anion channel positive modulator
Gamma-aminobutyric acid receptor subunit epsilon
GABRE · P78334
POSITIVE MODULATORGABA-A receptor; anion channel positive modulator
Gamma-aminobutyric acid receptor subunit alpha-2
GABRA2 · P47869
POSITIVE MODULATORGABA-A receptor; anion channel positive modulator
Gamma-aminobutyric acid receptor subunit alpha-5
GABRA5 · P31644
POSITIVE MODULATORGABA-A receptor; anion channel positive modulator
Gamma-aminobutyric acid receptor subunit alpha-6
GABRA6 · Q16445
POSITIVE MODULATORGABA-A receptor; anion channel positive modulator
Sodium channel protein type 1 subunit alpha
SCN1A · P35498
BLOCKERSodium channel alpha subunit blocker
Sodium channel protein type 5 subunit alpha
SCN5A · Q14524
BLOCKERSodium channel alpha subunit blocker
Sodium channel protein type 4 subunit alpha
SCN4A · P35499
BLOCKERSodium channel alpha subunit blocker
Sodium channel protein type 7 subunit alpha
SCN7A · Q01118
BLOCKERSodium channel alpha subunit blocker
Sodium channel protein type 2 subunit alpha
SCN2A · Q99250
BLOCKERSodium channel alpha subunit blocker
Sodium channel protein type 9 subunit alpha
SCN9A · Q15858
BLOCKERSodium channel alpha subunit blocker
Sodium channel protein type 3 subunit alpha
SCN3A · Q9NY46
BLOCKERSodium channel alpha subunit blocker
Sodium channel protein type 11 subunit alpha
SCN11A · Q9UI33
BLOCKERSodium channel alpha subunit blocker
Sodium channel protein type 8 subunit alpha
SCN8A · Q9UQD0
BLOCKERSodium channel alpha subunit blocker
Sodium channel protein type 10 subunit alpha
SCN10A · Q9Y5Y9
BLOCKERSodium channel alpha subunit blocker
Carbonic anhydrase 2
CA2 · P00918
INHIBITORCarbonic anhydrase II inhibitor
Carbonic anhydrase 4
CA4 · P22748
INHIBITORCarbonic anhydrase IV inhibitor
Glutamate receptor 4
GRIA4 · P48058
ANTAGONISTGlutamate receptor ionotropic AMPA antagonist
Glutamate receptor 3
GRIA3 · P42263
ANTAGONISTGlutamate receptor ionotropic AMPA antagonist
Glutamate receptor 2
GRIA2 · P42262
ANTAGONISTGlutamate receptor ionotropic AMPA antagonist
Glutamate receptor 1
GRIA1 · P42261
ANTAGONISTGlutamate receptor ionotropic AMPA antagonist
Glutamate receptor ionotropic, kainate 1
GRIK1 · P39086
ANTAGONISTGlutamate receptor ionotropic kainate antagonist
Glutamate receptor ionotropic, kainate 5
GRIK5 · Q16478
ANTAGONISTGlutamate receptor ionotropic kainate antagonist
Glutamate receptor ionotropic, kainate 4
GRIK4 · Q16099
ANTAGONISTGlutamate receptor ionotropic kainate antagonist
Glutamate receptor ionotropic, kainate 2
GRIK2 · Q13002
ANTAGONISTGlutamate receptor ionotropic kainate antagonist
Glutamate receptor ionotropic, kainate 3
GRIK3 · Q13003
ANTAGONISTGlutamate receptor ionotropic kainate antagonist

Regulatory timeline

36 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2010-01-07
Latest approval
2026-09-04
Authorities
FDA · MHRA
Total events
36
fdaU.S. Food and Drug Administration· 34 events
2026-09-04Approval
Approval: TOPIRAMATE (ANDA219183)
Evidence ↗
2026-08-31RecallSafety
Recall (Class III): TOPIRAMATE
Evidence ↗
2026-07-22Approval
Approval: TOPIRAMATE (ANDA220943)
Evidence ↗
mhraMedicines and Healthcare products Regulatory Agency· 2 events
2024-06-20Safety communicationSafety
Drug Safety Update: Topiramate (Topamax): introduction of new safety measures, including a Pregnancy Prevention Programme
Evidence ↗
2022-07-21Safety communicationSafety
Drug Safety Update: Topiramate (Topamax): start of safety review triggered by a study reporting an increased risk of neurodevelopmental disabilities in children with prenatal exposure
Evidence ↗

Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).

Contains public sector information from the Medicines and Healthcare products Regulatory Agency (MHRA) licensed under the Open Government Licence (OGL v3).

Clinical trials

187 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
187
registered trials across all phases
LATEST COMPLETION 2026
9
Active studies
7
Recruiting
125
Late-stage (III+)
133
Completed
45
Discontinued
PHASE DISTRIBUTIONn = 187
Early Phase 13Phase 118Phase 1 / 24Phase 237Phase 2 / 38Phase 351Phase 447Phase N / A19

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Comparative Outcomes of Migraine Preventives and Anti-CGRP Therapies for Tinnitus in Patients With Migraine: A Randomized Active-Comparator Controlled Trial (COMPACT-PM)

Not yet recruitingPH IVStanford Universityn=1202031

A Comparative Effectiveness Study of Oral Medications Used for Migraine Prevention: The APT Comparison Study

RecruitingPH IVKey trialMayo Clinicn=1,3352029

Individualized Pharmacological Approach to Obesity in Patients With Bipolar Disorder - OBOE-Mayo

RecruitingPH IVMayo Clinicn=1002029

Pharmacotherapy in Conjunction With Lifestyle Counseling for Management of Weight Regain After Bariatric Surgery

RecruitingPH IVUniversity of California, Irvinen=1202028

Management of Acute Tinnitus With Migraine Medications: A Randomized Clinical Trial

Active, not recruitingPH IVUniversity of California, Irvinen=1002026

Recent completions

Trials that read out recently, adding to the completed evidence base.

A Randomized, Double-Blind, Parallel-Group, Active Controlled Trial With Open-Label Safety Extension to Evaluate the Tolerability, Safety, and Efficacy of Atogepant Versus Topiramate in Subjects Requiring Preventive Treatment of Migraine (TEMPLE)

CompletedPH IIIAbbVien=5452026

Role of Pharmacotherapy in Counteracting Weight Regain in Adolescents With Severe Obesity

CompletedPH IIUniversity of Minnesotan=1002026

Safety and Efficacy of Zonisamide Versus Topiramate in Migraine

CompletedPH IIIKafrelsheikh Universityn=6002026

Pharmacokinetics and Pharmacodynamics of Topiramate for Weight Loss in Youth: PHARMATOP

CompletedPH IUniversity of Minnesotan=622024

Valproate Versus Topiramate in Migraine, a Randomized Controlled Trial

CompletedPH IIIKafrelsheikh Universityn=6002024

Efficacy and Tolerability of Low vs. Standard Daily Doses of Antiepileptic Drugs in Newly Diagnosed, Previously Untreated Epilepsy (STANDLOW). A Multicenter, Randomized, Single-blind, Parallel-group Trial

CompletedPH IVMario Negri Institute for Pharmacological Researchn=582024

Research activity

9 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time
19992020
Most influential

A double-blind, randomized trial of topiramate in Lennox-Gastaut syndrome. Topiramate YL Study Group.

Neurology · 1999 · 245 cites

A randomized, placebo-controlled study of topiramate in primary generalized tonic-clonic seizures. Topiramate YTC Study Group.

Neurology · 1999 · 207 cites

Cognitive and behavioral effects of lamotrigine and topiramate in healthy volunteers.

Neurology · 2005 · 95 cites

Effectiveness, tolerability, and safety of topiramate in children with partial-onset seizures. Topiramate YP Study Group.

Epilepsia · 2000 · 51 cites

Topiramate for smoking cessation: a randomized, placebo-controlled pilot study.

Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco · 2014 · 43 cites

Nonfocal generalized tonic-clonic seizures: response during long-term topiramate treatment. Topiramate YTC/YTCE Study Group.

Epilepsia · 2000 · 31 cites
Recent papers

A randomized pilot trial of topiramate for alcohol use disorder in veterans with traumatic brain injury: Effects on alcohol use, cognition, and post-concussive symptoms.

Drug and alcohol dependence · 2020 · 6 cites

Topiramate for smoking cessation: a randomized, placebo-controlled pilot study.

Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco · 2014 · 43 cites

Cognitive Effects of Low-dose Topiramate Compared with Oxcarbazepine in Epilepsy Patients.

Journal of clinical neurology (Seoul, Korea) · 2006 · 27 cites

The Effect of Antiepileptic Drugs on Cognition: Patient Perceived Cognitive Problems of Topiramate versus Levetiracetam in Clinical Practice.

Epilepsia · 2006 · 25 cites

Cognitive and behavioral effects of lamotrigine and topiramate in healthy volunteers.

Neurology · 2005 · 95 cites

Effectiveness, tolerability, and safety of topiramate in children with partial-onset seizures. Topiramate YP Study Group.

Epilepsia · 2000 · 51 cites
Journals, researchers & institutions
Top journals
  • Epilepsia3
  • Neurology3
  • Drug and alcohol dependence1
  • Journal of clinical neurology (Seoul, Korea)1
  • Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco1
Leading researchers
  • Ritter F3
  • Biton V2
  • Glauser TA2
  • Lim P2
  • Montouris GD2
  • Pledger G2
  • Reife R2
  • Abrams G1
Leading institutions
free-text, unnormalised
  • Department of Neurology of the Epilepsy Centre Kempenhaeghe1
  • Georgetown University1
  • School of Medicine1
  • The Comprehensive Epilepsy Care Center for Children and Adults1
  • University of California1
  • University of Connecticut Health Center1
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.