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Trafermin 0.01% spray
Trafermin 0.01% spray is a growth factor Small molecule drug developed by Olympus Biotech Corporation. It is currently in Phase 3 development for Treatment of diabetic foot ulcers.
Trafermin is a recombinant human fibroblast growth factor 2 (FGF-2) used to promote wound healing.
Trafermin 0.01% spray is a fibroblast growth factor receptor 2 agonist, classified as a protein drug. It has been studied in a Phase III clinical trial for the treatment of diabetic foot ulcers of neuropathic origin.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +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 | Trafermin 0.01% spray |
|---|---|
| Sponsor | Olympus Biotech Corporation |
| Drug class | growth factor |
| Target | FGF-2 |
| Modality | Small molecule |
| Therapeutic area | Wound healing |
| Phase | Phase 3 |
Mechanism of action
Trafermin works by stimulating angiogenesis and promoting the proliferation and migration of various cell types involved in wound healing. This leads to improved tissue repair and regeneration.
Approved indications
- Treatment of diabetic foot ulcers
Common side effects
- Application site reaction
Key clinical trials
- The TRAfermin in Neuropathic Diabetic Foot Ulcer Study - Northern Europe The TRANS-North Study (PHASE3)
- The TRAfermin in Neuropathic Diabetic Foot Ulcer Study - Southern Europe The TRANS-South Study (PHASE3)
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:
- Trafermin 0.01% spray CI brief — competitive landscape report
- Trafermin 0.01% spray updates RSS · CI watch RSS
- Olympus Biotech Corporation portfolio CI
Frequently asked questions about Trafermin 0.01% spray
What is Trafermin 0.01% spray?
How does Trafermin 0.01% spray work?
What is Trafermin 0.01% spray used for?
Who makes Trafermin 0.01% spray?
What drug class is Trafermin 0.01% spray in?
What development phase is Trafermin 0.01% spray in?
What are the side effects of Trafermin 0.01% spray?
What does Trafermin 0.01% spray target?
Related
- Drug class: All growth factor drugs
- Target: All drugs targeting FGF-2
- Manufacturer: Olympus Biotech Corporation — full pipeline
- Therapeutic area: All drugs in Wound healing
- Indication: Drugs for Treatment of diabetic foot ulcers
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing