Dapiclermin
Also known as: FGF-10 (truncated), KGF-2, Repifermin, SB-415083
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Summary
Dapiclermin is a recombinant truncated form of human keratinocyte growth factor-2 (KGF-2, also known as FGF-10). It was investigated primarily for the treatment of chronic wounds such as venous leg ulcers. Clinical trials showed mixed results, and it did not achieve regulatory approval. It promotes re-epithelialization through selective stimulation of epithelial cell growth.
Mechanism of Action
Binds and activates fibroblast growth factor receptors (FGFR1b and FGFR2b) on epithelial cells, stimulating proliferation, migration, and differentiation of keratinocytes and other epithelial cells to promote wound healing and tissue repair.
Routes of Administration
Goals & Uses
- Promotion of re-epithelializationTissue RepairModerate
- Wound healing (venous leg ulcers)Tissue RepairModerate
- Oral mucositis prevention/treatmentSupportive Oncology CareLow
Contraindications
- Hypersensitivity to dapiclermin or excipientsAllergy / ImmunologicHigh
- Known malignancy at or near wound siteOncologicHigh
Adverse Effects
- Local application site reactionsDermatologicCommon
- Wound exudate changesDermatologicUncommon
- Immunogenicity / antibody formationImmunologicUncommon
Drug Interactions
- Heparin / heparin-containing wound productsLow
Population Constraints
- Patients with active or recent malignancyOncologicRelative
- Pediatric patientsAgeRelative
- Pregnant womenReproductiveRelative
Regulatory Status
- European UnionInvestigationalNo EMA marketing authorization granted. Clinical trials conducted but no approval pursued.
- United StatesInvestigationalNever received FDA approval. Investigated under IND for venous leg ulcers; development discontinued.
Dapiclermin was investigated by Human Genome Sciences and later Shire. It did not receive FDA or EMA approval. Phase II/III trials for venous leg ulcers were conducted but did not demonstrate sufficient efficacy to support a marketing application.
Evidence & Sources
No sources recorded yet.
Frequently Asked Questions
What is Dapiclermin?
Dapiclermin is a recombinant truncated form of human keratinocyte growth factor-2 (KGF-2, also known as FGF-10). It was investigated primarily for the treatment of chronic wounds such as venous leg ulcers. Clinical trials showed mixed results, and it did not achieve regulatory approval. It promotes re-epithelialization through selective stimulation of epithelial cell growth.
What is Dapiclermin used for?
Dapiclermin is educationally associated with: Promotion of re-epithelialization, Wound healing (venous leg ulcers), Oral mucositis prevention/treatment. Educational only — not medical advice.
How is Dapiclermin administered?
Recorded routes of administration: Topical.
What are the potential side effects of Dapiclermin?
Reported adverse effects include: Local application site reactions, Wound exudate changes, Immunogenicity / antibody formation. This list is not exhaustive — consult a qualified clinician.
Who should avoid Dapiclermin?
Recorded contraindications: Hypersensitivity to dapiclermin or excipients, Known malignancy at or near wound site. Consult a qualified clinician before use.