Dapiclermin

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.