Trafermin

Fibroblast Growth Factor (FGF 2 / Basic FGF)Rx: PrescriptionCompound: Approved

Also known as: Basic Fibroblast Growth Factor, bFGF, FGF-2, Fiblast Spray, Recombinant Human bFGF

Educational Only — Not medical advice. Consult a qualified clinician before using any peptide.

Summary

Trafermin is a recombinant human basic fibroblast growth factor (bFGF) approved in Japan for the treatment of pressure ulcers (bedsores) and skin ulcers. It promotes wound healing by stimulating angiogenesis, granulation tissue formation, and epithelialization. It has also been investigated for periodontal tissue regeneration and other indications.

Mechanism of Action

Recombinant human basic fibroblast growth factor (bFGF/FGF-2) that binds to FGF receptors (FGFR1–4), activating downstream signaling pathways (MAPK/ERK, PI3K/Akt) to promote angiogenesis, fibroblast proliferation, collagen synthesis, and tissue regeneration.

Routes of Administration

IntravenousSubcutaneousTopical

Goals & Uses

  • Pressure ulcer / skin ulcer healingWound HealingHigh
  • Burn wound healingWound HealingModerate
  • Angiogenesis promotion in ischemic tissueCardiovascular / IschemiaLow
  • Periodontal tissue regenerationDentistry / RegenerationModerate
  • Diabetic foot ulcer treatmentWound HealingModerate

Contraindications

  • PregnancyPopulationModeratePotential fetal risk or insufficient safety data
  • Hypersensitivity to trafermin or excipientsAllergyHigh
  • Known malignancy or tumor at wound siteOncologyHigh

Adverse Effects

  • Hypersensitivity / allergic reactionImmunologicalRare
  • Wound exudate increaseLocal ReactionCommon
  • Application site erythema / irritationLocal ReactionCommon
  • FeverSystemicUncommonElevated body temperature

Drug Interactions

  • HeparinLow
  • Corticosteroids (topical)Moderate

Population Constraints

  • Pediatric patientsAgeRelative
  • Patients with active cancerOncologicalAbsolute
  • Elderly patients with multiple comorbiditiesAge / ComorbidityRelative

Regulatory Status

  • European UnionUnapprovedNot approved by the EMA. Remains investigational in Europe.
  • United StatesUnapprovedNot approved by the FDA. Investigated under IND programs for various wound healing and cardiovascular indications.
  • United KingdomUnapprovedNot approved by the MHRA. No marketing authorization in the UK.

Approved in Japan (marketed as Fiblast Spray by Kaken Pharmaceutical) for skin ulcers and pressure ulcers. Not approved by the FDA or EMA for any indication. Investigational studies ongoing for periodontal and ischemic conditions.

Evidence & Sources

No sources recorded yet.

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