Last reviewed 2026-04-20 · How we verify

Kepivance (PALIFERMIN)

Kepivance works by binding to fibroblast growth factor receptor 2, stimulating the growth and proliferation of mucosal cells.

Kepivance (Palifermin) is a mucocutaneous epithelial cell growth factor developed by BioVitrum AB. It targets fibroblast growth factor receptor 2 and works as a small molecule to stimulate the growth of mucosal cells. Kepivance is FDA-approved for the prevention and treatment of drug-induced and radiation therapy-induced mucositis. It is currently owned by BioVitrum AB and has been approved since 2004. Kepivance is a valuable treatment option for patients undergoing chemotherapy or radiation therapy.

At a glance

Mechanism of action

KGF is an endogenous protein in the fibroblast growth factor (FGF) family that binds to the KGF receptor. Binding of KGF to its receptor has been reported to result in proliferation, differentiation, and migration of epithelial cells. The KGF receptor, one of four receptors in the FGF family, has been reported to be present on epithelial cells in many tissues examined including the tongue, buccal mucosa, esophagus, stomach, intestine, salivary gland, lung, liver, pancreas, kidney, bladder, mammary gland, skin (hair follicles and sebaceous gland), and the lens of the eye. The KGF receptor has been reported to not be present on cells of the hematopoietic lineage. Endogenous KGF is produced by mesenchymal cells and is upregulated in response to epithelial tissue injury.In mice and rats, Kepivance enhanced proliferation of epithelial cells (as measured by Ki67 immunohistochemical staining and BrDU uptake) and demonstrated an increase in tissue thickness of the ton

Approved indications

• Drug-induced mucositis
• Mucositis following radiation therapy
• Prevention of Radiation Therapy-Induced Mucositis

Common side effects

• Rash
• Elevated serum amylase
• Pain
• Edema
• Fever
• Pruritus
• Erythema
• Mouth/Tongue Thickness or Discoloration
• Arthralgia
• Dysesthesia
• Hyperesthesia
• Hypoesthesia

Key clinical trials

• Lentiviral Gene Transfer for Treatment of Children Older Than Two Years of Age With X-Linked Severe Combined Immunodeficiency (XSCID) (PHASE1,PHASE2)
• Base Editing Hematopoietic Stem Cell and T Cell Gene Therapy for CD40L-HyperIgM Syndrome: Single Patient Study (PHASE1,PHASE2)
• Base Editing for Mutation Repair in Hematopoietic Stem & Progenitor Cells for X-Linked Chronic Granulomatous Disease (PHASE1,PHASE2)
• A Platform Protocol to Investigate Post-Transplant Cyclophosphamide-Based Graft-Versus-Host Disease Prophylaxis in Patients With Hematologic Malignancies Undergoing Mismatched Unrelated Donor Peripheral Blood Stem Cell Transplantation (PHASE2)
• Base-Edited Hematopoietic Stem/Progenitor Cell X-Linked Severe Combined Immunodeficiency Gene Therapy (PHASE1,PHASE2)
• Palifermin With Leuprolide Acetate for the Promotion of Immune Recovery Following Total Body Irradiation Based T-Cell Depleted Allogeneic Hematopoietic Stem Cell Transplantation (PHASE2)
• Human Lysozyme Goat Milk for the Prevention of Graft Versus Host Disease in Patients With Blood Cancer Undergoing a Donor Stem Cell Transplant (PHASE1)
• Study of Palifermin (Kepivance) in Persons Undergoing Unrelated Donor Allogeneic Hematopoietic Cell Transplantation (PHASE1,PHASE2)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• Kepivance CI brief — competitive landscape report
• Kepivance updates RSS · CI watch RSS
• Biovitrum Ab portfolio CI