Velafermin

Fibroblast Growth Factor (FGF) AnalogRx: ResearchCompound: Investigational

Also known as: CG53135, CG53135-05, Recombinant human FGF-20, rhFGF-20

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

Summary

Velafermin (CG53135-05) is a recombinant human FGF-20 analog investigated primarily for the prevention and treatment of oral mucositis in patients undergoing hematopoietic stem cell transplantation (HSCT) with high-dose chemotherapy. It aims to protect and regenerate mucosal epithelial cells damaged by cytotoxic conditioning regimens.

Mechanism of Action

Recombinant human fibroblast growth factor 20 (FGF-20) analog that binds FGF receptors, promoting epithelial cell proliferation and differentiation, particularly in the gastrointestinal mucosa, to support mucosal integrity and healing.

Routes of Administration

Intravenous

Goals & Uses

  • Prevention of oral mucositisOncology Supportive CareModerate
  • Gastrointestinal mucosal healingMucosal RegenerationLow
  • Reduction of chemotherapy-induced mucosal toxicityOncology Supportive CareModerate

Contraindications

  • Active malignancy with FGF receptor-driven tumor growthOncologicModerate
  • Known hypersensitivity to FGF analogs or E. coli-derived proteinsAllergy / ImmunologicHigh

Adverse Effects

  • Fever / PyrexiaSystemicUncommon
  • Hypersensitivity / allergic reactionImmunologicalRare
  • Injection site reactionsLocalCommon
  • NauseaGastrointestinalUncommonFeeling of sickness or urge to vomit

Drug Interactions

  • High-dose chemotherapy agents (busulfan, cyclophosphamide)Low

Population Constraints

  • Pediatric patientsAgeRelative
  • Pregnant or lactating womenReproductiveRelative
  • Patients with active FGF receptor-driven malignanciesOncologicRelative

Regulatory Status

  • European UnionUnknownNo EMA approval or marketing authorization known; no public EMA review record identified.
  • United StatesInvestigationalEvaluated in FDA IND-phase clinical trials for oral mucositis in HSCT; no NDA filed or approved.
  • United KingdomUnknownNo MHRA approval identified; development appears inactive.

Velafermin has not received FDA, EMA, or MHRA approval. It was evaluated in Phase II clinical trials for oral mucositis prevention in HSCT patients. Development appeared to stall after mixed clinical trial results; no approved indication exists in any major jurisdiction.

Evidence & Sources

No sources recorded yet.

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