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Topiramate Tablets
Topiramate Tablets is a Small molecule drug developed by University of Minnesota. It is currently in Phase 1 development.
Topiramate is a small molecule that inhibits carbonic anhydrase II, a validated target according to ChEMBL. It has been studied as a potential treatment for various conditions, including Post Traumatic Stress Disorder, Alcohol Use Disorder, Bipolar Disorder, Migraine, and has been investigated in clinical trials registered on ClinicalTrials.gov.
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Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Topiramate Tablets |
|---|---|
| Sponsor | University of Minnesota |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
- Nasopharyngitis
- Diarrhoea
- Fatigue
- Constipation
- Pyrexia
- Nausea
- Stomatitis
- Mouth ulceration
- Dizziness
- Upper respiratory tract infection
- Abdominal pain upper
- Weight loss
Key clinical trials
- Pharmacokinetics and Pharmacodynamics of Topiramate for Weight Loss in Youth: PHARMATOP (EARLY_PHASE1)
- Phentermine/Topiramate for Uric Acid Stones (PHASE3)
- Low vs. Standard Daily Doses of Antiepileptic Drugs in Newly Diagnosed, Previously Untreated Epilepsy(STANDLOW) (PHASE4)
- Comparative Study of Oral Atogepant Versus Oral Topiramate to Assess Adverse Events in Adult Participants With Migraine (PHASE3)
- Adjunct Phentermine + Topiramate After Bariatric Surgery in 12-24 Year Olds (PHASE2)
- Role of Pharmacotherapy in Counteracting Weight Regain in Adolescents With Severe Obesity (PHASE2)
- Leveraging Biomarkers for Personalized Treatment of Alcohol Use Disorder Comorbid With PTSD (PHASE2)
- A Study to Assess Tolerability and Efficacy of Topiramate Monotherapy in Recently Diagnosed Patients With Epilepsy (PHASE4)
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 |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Topiramate Tablets CI brief — competitive landscape report
- Topiramate Tablets updates RSS · CI watch RSS
- University of Minnesota portfolio CI
Frequently asked questions about Topiramate Tablets
What is Topiramate Tablets?
Who makes Topiramate Tablets?
What development phase is Topiramate Tablets in?
What are the side effects of Topiramate Tablets?
Related
- Manufacturer: University of Minnesota — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing