Velafermin
Also known as: CG53135, CG53135-05, Recombinant human FGF-20, rhFGF-20
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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
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.
Frequently Asked Questions
What is Velafermin?
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.
What is Velafermin used for?
Velafermin is educationally associated with: Prevention of oral mucositis, Gastrointestinal mucosal healing, Reduction of chemotherapy-induced mucosal toxicity. Educational only — not medical advice.
How is Velafermin administered?
Recorded routes of administration: Intravenous.
What are the potential side effects of Velafermin?
Reported adverse effects include: Fever / Pyrexia, Hypersensitivity / allergic reaction, Injection site reactions, Nausea. This list is not exhaustive — consult a qualified clinician.
Who should avoid Velafermin?
Recorded contraindications: Active malignancy with FGF receptor-driven tumor growth, Known hypersensitivity to FGF analogs or E. coli-derived proteins. Consult a qualified clinician before use.