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sumatriptan and Treximet
sumatriptan and Treximet is a Small molecule drug developed by Gary E. Ruoff, M.D.. It is currently in Phase 2 development. Also known as: Imitrex 100mg, Treximet 85/500mg.
Sumatriptan is a small molecule serotonin 1b (5-HT1b) receptor agonist used to treat migraine disorders. Treximet, a combination of sumatriptan and naproxen sodium, is also used to treat migraine disorders.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +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 | sumatriptan and Treximet |
|---|---|
| Also known as | Imitrex 100mg, Treximet 85/500mg |
| Sponsor | Gary E. Ruoff, M.D. |
| Modality | Small molecule |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- i-NEED: NEw migrainE Drugs Database
- Use of the Combination of Sumatriptan and Naproxen in the Acute Treatment of Migraine: Real World Evidence Study
- Treatments of Migraine with Triptans in Individuals with Elevated Cardiovascular Risk and in Pregnant Women
- Study of Sumatriptan Naproxen Sodium Succinate Tablets for the Treatment of Acute Migraine Attacks (PHASE3)
- Does Treximet Improve Productivity and Patient Satisfaction Due to Sustained Response and Consistency of Response? (PHASE4)
- TREXIMA and RELPAX Gastric Scintigraphy Inside and Outside a Migraine (PHASE3)
- A Pharmacokinetic Study to Evaluate TREXIMET in Adolescents With Migraine and Healthy Subjects Administered at Three Doses. (PHASE1)
- Treximet ™ Pharmacy Budget Impact Model Database Validation Study
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:
- sumatriptan and Treximet CI brief — competitive landscape report
- sumatriptan and Treximet updates RSS · CI watch RSS
- Gary E. Ruoff, M.D. portfolio CI
Frequently asked questions about sumatriptan and Treximet
What is sumatriptan and Treximet?
Who makes sumatriptan and Treximet?
Is sumatriptan and Treximet also known as anything else?
What development phase is sumatriptan and Treximet in?
Related
- Manufacturer: Gary E. Ruoff, M.D. — full pipeline
- Also known as: Imitrex 100mg, Treximet 85/500mg
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing