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Strefen
Strefen is a Small molecule drug developed by Pierre Fabre Medicament. It is currently in Phase 2 development.
Strefen is a small molecule that acts as a cyclooxygenase inhibitor, a class of drugs that inhibit the enzyme cyclooxygenase. It has been studied in clinical trials for various conditions, including pain, atrial fibrillation, and deep sedation, and has been administered locally or intravenously in concentrations of 0.33% ropivacaine 250ml.
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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 | Strefen |
|---|---|
| Sponsor | Pierre Fabre Medicament |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- Study to Evaluate the Effect of Repotrectinib on the Drug Levels of Transporter and CYP P450 Probe Substrates in Healthy Adult Participants (PHASE1)
- The Aim of This Study is to Compare the Effects of Two Different Topical Agents (KLOROBEN® and KLORHEX PLUS®) Used in the Surgical Extraction of Mandibular Bilateral Mesioangular Impacted Third Molars on Postoperative Pain, Edema, and Trismus. (NA)
- Efficacy of Flurbiprofen Spray for Postoperative Sore Throat Following Double-Lumen Endobronchial Intubation (NA)
- KF2022#4-trial: Effects of a Beta Blocker and NSAID on CYP Mediated Drug Metabolism (NA)
- A Study on Reducing Opioid Use After Minimally Invasive Ankle Surgery (NA)
- Osellidine is Used for Analgesia During Daytime Hysteroscopic Surgery
- Effect of Dexamethasone on CYP Enzyme Activity in Healthy Male Subjects (PHASE1)
- Drug-drug Interaction Study of Vorasidenib With Bupropion, Repaglinide, Flurbiprofen, Omeprazole, Midazolam, and Rosuvastatin in Healthy Adult Participants (PHASE1)
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:
- Strefen CI brief — competitive landscape report
- Strefen updates RSS · CI watch RSS
- Pierre Fabre Medicament portfolio CI
Frequently asked questions about Strefen
What is Strefen?
Who makes Strefen?
What development phase is Strefen in?
Related
- Manufacturer: Pierre Fabre Medicament — full pipeline
- Therapeutic area: All drugs in Other
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing