Repifermin
Also known as: FGF-10 truncated, KGF-2, recombinant human keratinocyte growth factor, rHuKGF, rHuKGF-2, SY-002
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Summary
Recombinant human keratinocyte growth factor (KGF-2) investigated for mucosal protection and wound healing, particularly for oral mucositis in cancer patients.
Mechanism of Action
Binds to FGFR2b (fibroblast growth factor receptor 2 isoform b) on epithelial cells, stimulating proliferation, differentiation, and migration of mucosal epithelium.
Routes of Administration
Goals & Uses
- Prevention of oral mucositisOncology Supportive CareModerate
- Epithelial repairRegenerative MedicineLow
- Wound healing (venous leg ulcers)Tissue RepairModerate
- Gastrointestinal mucosal injury repairGastroenterologyLow
- Accelerated wound healingDermatologyLow
- Oral mucositis preventionOncology Supportive CareLow
- Inflammatory bowel diseaseGastroenterologyLow
Contraindications
- Known hypersensitivity to the drugAllergyHigh
- Active malignancy at treatment siteOncologyHigh
- Known hypersensitivity to KGF-2 or FGF analogsAllergyHigh
- Active malignancy with high FGFR2b expressionOncologyModerate
Adverse Effects
- EdemaFluid BalanceUncommonSwelling from fluid retention
- RashDermatologicUncommonSkin eruption or discoloration
- Local Injection Site ReactionsDermatologicalCommon
- Taste alteration (dysgeusia)SensoryCommon
- HypotensionCardiovascularRareLow blood pressure
- Erythema / skin rashDermatologicCommon
- FeverSystemicUncommonElevated body temperature
Drug Interactions
- Other growth factorsLow
- Other growth factor therapiesLow
- Concurrent chemotherapyModerate
Population Constraints
- Pediatric patientsAgeRelative
- Lactating mothersReproductiveRelative
- Pregnant womenReproductiveRelative
- Patients with epithelial malignanciesOncologyRelative
Regulatory Status
- European UnionInvestigationalNo EMA marketing authorization
- United StatesInvestigationalNot FDA‑approved; clinical trials ongoing
- United KingdomInvestigationalNot authorized for clinical use
Never received FDA or EMA approval. Development was halted after Phase II/III trials failed to demonstrate sufficient efficacy for the primary indications pursued.
Evidence & Sources
No sources recorded yet.
Frequently Asked Questions
What is Repifermin?
Recombinant human keratinocyte growth factor (KGF-2) investigated for mucosal protection and wound healing, particularly for oral mucositis in cancer patients.
What is Repifermin used for?
Repifermin is educationally associated with: Prevention of oral mucositis, Epithelial repair, Wound healing (venous leg ulcers), Gastrointestinal mucosal injury repair, Accelerated wound healing, Oral mucositis prevention, Inflammatory bowel disease. Educational only — not medical advice.
How is Repifermin administered?
Recorded routes of administration: Intravenous, Subcutaneous, Topical.
What are the potential side effects of Repifermin?
Reported adverse effects include: Edema, Rash, Local Injection Site Reactions, Taste alteration (dysgeusia), Hypotension, Erythema / skin rash, Fever. This list is not exhaustive — consult a qualified clinician.
Who should avoid Repifermin?
Recorded contraindications: Known hypersensitivity to the drug, Active malignancy at treatment site, Known hypersensitivity to KGF-2 or FGF analogs, Active malignancy with high FGFR2b expression. Consult a qualified clinician before use.