Last reviewed · How we verify
Topamax (topiramate)
At a glance
| Generic name | topiramate |
|---|---|
| Sponsor | Janssen |
| Target | Nuclear receptor subfamily 1 group I member 2, Carbonic anhydrase 1, Carbonic anhydrase 12 |
| Therapeutic area | Neuroscience |
| Phase | FDA-approved |
Approved indications
- Epilepsy characterized by intractable complex partial seizures
- Lennox-Gastaut syndrome
- Migraine Prevention
- Simple partial seizure
- Tonic-clonic epilepsy
Common side effects
- Paresthesia
- Weight loss
- Anorexia
- Somnolence
- Abnormal vision
- Fever
- Dizziness
- Difficulty with memory
- Psychomotor slowing
- Speech disorders/related speech problems
- Nervousness
- Fatigue
Serious adverse events
- Difficulty with concentration/attention
- Flushing
- Asthenia
Key clinical trials
- BMI Reduction With Meal Replacements + Topiramate in Adolescents With Severe Obesity (Phase 2)
- Double-Blind Parallel Comparison of Topiramate 200 mg Twice Daily to Placebo in Patients With Refractory Partial Epilepsy (Phase 2)
- Open-label Phentermine/Topiramate Extended Release (PHEN/TPM ER; Qsymia®) in Ten Subjects With Overweight or Obesity and DSM-V Binge Eating Disorder (BED) (Phase 2)
- A Prospective, Observational, Multi-center Study to Assess Long-term Retention Rate of Topiramate in Patients With Epilepsy (N/A)
- A Phase-1, Open-label, Drug Interaction Study Between Eslicarbazepine Acetate 1200 mg and Topiramate 200 mg Following Multiple Dose Administrations in Healthy Male (Phase 1)
- Phentermine/Topiramate in Children, Adolescents, and Young Adults With Hypothalamic Obesity: a Pilot and Feasibility Study (Phase 2)
- Phase I/II Study of Intravenous Infusion of Tetra-o-Methyl Nordihydroguaiaretic Acid (EM-1421) in Subjects With Recurrent High Grade Glioma (Phase 1)
- A Phase 3, Double-Blind, Placebo-Controlled, Multicenter Extension Study (From Study OB-303 [NCT00553787]) to Determine the Safety and Efficacy Of VI-0521 for the Long-Term Treatment Of Obesity in Adu (Phase 3)
Patents
| Patent | Expiry | Type |
|---|---|---|
| 9622983 | 2027-11-16 | Formulation |
| 8298576 | 2028-04-04 | Formulation |
| 8663683 | 2027-11-16 | Formulation |
| 8992989 | 2027-11-16 | Formulation |
| 8889191 | 2027-11-16 | Method of Use |
| 9549940 | 2027-11-16 | Formulation |
| 8298580 | 2027-11-16 | Formulation |
| 8877248 | 2027-11-16 | Formulation |
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Topamax CI brief — competitive landscape report
- Topamax updates RSS · CI watch RSS
- Janssen portfolio CI