Data updated: May 26, 2026
TOPAMAX (topiramate)
Cytochrome P450 3A4 Inducers
CNS
Approved 1996-12-24
TOPAMAX is indicated for the treatment of Epilepsy; Partial-Onset Seizures; Generalized Tonic-Clonic Seizures; Lennox-Gastaut Syndrome; Migraine.
Source: FDA Label • Johnson & Johnson
How TOPAMAX Works
The precise mechanisms of topiramate are unknown, but preclinical studies suggest it exerts its effects through four distinct properties. The drug blocks voltage-dependent sodium channels and augments the activity of the neurotransmitter gamma-aminobutyrate at specific GABA-A receptors. Furthermore, it antagonizes the AMPA/kainate subtype of the glutamate receptor and inhibits carbonic anhydrase enzymes. These combined actions help regulate neuronal excitability to provide anticonvulsant and migraine-preventive effects.
12
Indications
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Phase 3 Trials
1
Priority Reviews
29
Years on Market
Details
- Status
- Prescription
- First Approved
- 1996-12-24
- Routes
- ORAL
- Dosage Forms
- CAPSULE, TABLET
TOPAMAX Approval History
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Original
New Indication
New Form
Label Update
416 FDA actions from 1996 to 2026 · 8 indication expansions
May 2015 SUPPL
Mfg
Jul 2013 SUPPL
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Jun 2011 SUPPL
Update
Mar 2011 SUPPL
Label
Feb 2001 SUPPL
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Oct 2000 SUPPL
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Oct 2000 SUPPL
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Jul 2000 SUPPL
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May 2000 SUPPL
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May 2000 SUPPL
Label
Mar 2000 SUPPL
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Jan 2000 SUPPL
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Dec 1999 SUPPL
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Oct 1999 SUPPL
Efficacy
Dec 1996 ORIGINAL
New Drug
What TOPAMAX Treats
5 indicationsTOPAMAX is approved for 5 conditions since its original approval in 1996. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Epilepsy
- Partial-Onset Seizures
- Generalized Tonic-Clonic Seizures
- Lennox-Gastaut Syndrome
- Migraine
Source: FDA Label
TOPAMAX Competitive Set
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MoA expansion candidates
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Indication competitors
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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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Trial Timeline
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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.
TOPAMAX FDA Label Details
Indications & Usage
FDA Label (PDF)TOPAMAX is indicated for the treatment of Epilepsy; Partial-Onset Seizures; Generalized Tonic-Clonic Seizures; Lennox-Gastaut Syndrome; Migraine.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.