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Topiramate ER
Topiramate ER is a Small molecule drug developed by Supernus Pharmaceuticals, Inc.. It is currently in Phase 1 development. Also known as: SPN-538T.
Topiramate ER is a small molecule medication used to treat conditions such as Binge Eating Disorder, Obesity, Cocaine Dependence, and Polycystic Ovary Syndrome, often in combination with other medications like phentermine. It is available under the brand name Qsymia, which is an extended-release formulation of phentermine and topiramate.
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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 ER |
|---|---|
| Also known as | SPN-538T |
| Sponsor | Supernus Pharmaceuticals, Inc. |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- EQW, DAPA, EQW/DAPA, DAPA/MET ER and PHEN/TPM ER in Obese Women With PolycysticOvary Syndrome (PCOS) (PHASE3)
- Multicenter Trial of Combined Pharmacotherapy to Treat Cocaine Dependence (PHASE2, PHASE3)
- Effect of VI-0521 (Qsymia®) on Glomerular Filtration Rate (GFR) in Overweight or Obese Healthy Subjects (PHASE4)
- A Conversion Study of Immediate Release (IR) and Modified Release (MR) Forms of Topiramate (TPM) (PHASE1)
- Phentermine/Topiramate Extended Release in Binge Eating Disorder (BED) (PHASE2)
- Peripheral Pharmacodynamics of Phentermine-Topiramate in Obese Patients (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 ER CI brief — competitive landscape report
- Topiramate ER updates RSS · CI watch RSS
- Supernus Pharmaceuticals, Inc. portfolio CI
Frequently asked questions about Topiramate ER
What is Topiramate ER?
Who makes Topiramate ER?
Is Topiramate ER also known as anything else?
What development phase is Topiramate ER in?
Related
- Manufacturer: Supernus Pharmaceuticals, Inc. — full pipeline
- Also known as: SPN-538T
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing