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Drug

Topiramate

Approved · FDA
Emerging researchLate-stage developmentCooling momentum
Also known as Eprontia, Phentermine-Topiramate, Qsymia, Qudexy+8 more

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

RxNorm38404ChEMBLCHEMBL220492UNII0H73WJJ391
9
Research papers
9
Active clinical trials
33
Regulatory events
Latest activity
beta

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

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

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

Approval: TOPIRAMATE (ANDA220943)

Regulatory2026-07-22FDA

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

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

Clinical trial2026-06-29Results expected Q1 2029 · ClinicalTrials.gov

Supplemental approval: PHENTERMINE AND TOPIRAMATE (NDA022580)

Regulatory2026-06-29FDA

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

Label change: TOPIRAMATE (ANDA078499)

Regulatory2026-06-15FDA

Label change: PHENTERMINE AND TOPIRAMATE (NDA022580)

Regulatory2026-03-06FDA

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)

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

Research2006-01-01Epilepsia

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
UNII
0H73WJJ391
Regulatory jurisdictions
mhrafda

Regulatory timeline

33 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
2026-07-22
Authorities
FDA · MHRA
Total events
33
fdaU.S. Food and Drug Administration· 31 events
2026-07-22Approval
Approval: TOPIRAMATE (ANDA220943)
Evidence ↗
2026-06-29Supplemental approval
Supplemental approval: PHENTERMINE AND TOPIRAMATE (NDA022580)
Evidence ↗
2026-06-15Label change
Label change: TOPIRAMATE (ANDA078499)
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.