Repifermin

Summary

Repifermin is a truncated recombinant human KGF-2 (FGF-10) developed by Human Genome Sciences. It was investigated for wound healing, venous leg ulcers, mucositis, and inflammatory bowel disease. Clinical trials showed mixed results and development was largely discontinued.

Mechanism of Action

Truncated recombinant human keratinocyte growth factor-2 (KGF-2/FGF-10) that binds FGFR2b receptors on epithelial cells, stimulating proliferation, migration, and differentiation of keratinocytes and other epithelial cells, promoting wound healing and mucosal repair.

Routes of Administration

Goals & Uses

• Epithelial repairRegenerative MedicineLow
• Wound healing (venous leg ulcers)Tissue RepairModerate
• Oral mucositis preventionOncology Supportive CareLow
• Inflammatory bowel diseaseGastroenterologyLow

Contraindications

• Active malignancy at treatment siteOncologyHigh
• Known hypersensitivity to KGF-2 or FGF analogsAllergyHigh

Adverse Effects

• EdemaFluid BalanceUncommonSwelling from fluid retention
• RashDermatologicUncommonSkin eruption or discoloration
• Local Injection Site ReactionsDermatologicalCommon
• FeverSystemicUncommonElevated body temperature

Drug Interactions

• Other growth factorsLow

Population Constraints

• Pediatric patientsAgeRelative
• Pregnant womenReproductiveRelative
• Patients with epithelial malignanciesOncologyRelative

Regulatory Status

• European UnionInvestigationalNo EMA approval granted; development discontinued.
• United StatesInvestigationalInvestigated in multiple Phase II/III trials; never approved by FDA.

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.