Drugs / Palifermin
Palifermin
also known as
Recombinant Human Keratinocyte Growth Factor · rHuKGF · Keratinocyte growth factor · Kepivance · IND # 6370 · KGF · KGF-hair serum · KGF-HS · +3 more
Protein / enzyme biologic targets FGFR2 via activation
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Withdrawn | EU (EMA) | Kepivance | — | 2016-04-01 | europa.eu ↗ |
| Label expansion | US (FDA) | KEPIVANCE | — | 2011-11-14 | fda.gov ↗ |
| Approved | EU (EMA) | Kepivance | — | 2005-10-25 | europa.eu ↗ |
| Approved | US (FDA) | KEPIVANCE | — | 2004-12-15 | fda.gov ↗ |
Trials 35 · a red edge is where a trial was stopped
Also used as a comparator or background therapy in 24 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 02 trials | ||||||
| Phase 0 | NCT02653196 Background | Sep 2015 → Aug 2017 | neuroepithelial neoplasm | Montefiore Medical Center | Terminated | No outcome recorded |
| Phase 0 | NCT00881556 Background | Aug 2009 → Sep 2015 | epidermolysis bullosa | Columbia University | Terminated | No outcome recorded |
| Phase 15 trials | ||||||
| Phase 1 | NCT05139004 Background | Jul 2022 → Jun 2027 expected | acute lymphoblastic leukemia, acute myeloid leukemia, myelodysplastic syndrome | City of Hope Medical Center | Active not recruiting | No outcome recorded |
| Phase 1 | NCT04177004 Background | Apr 2021 → Dec 2025 overdue | disease related to hematopoietic stem cell transplant, hematopoietic and lymphoid cell neoplasm | City of Hope Medical Center | Active not recruiting | No outcome recorded |
| Phase 1 | NCT03531281 Background | Dec 2018 → Dec 2022 | disease related to hematopoietic stem cell transplant, hematopoietic and lymphoid cell neoplasm | City of Hope Medical Center | Withdrawn | No outcome recorded |
| Phase 1 | NCT01421173 Background | Aug 2011 → Sep 2015 | lymphoma | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 1 | NCT00410982 Background | Dec 2006 → Sep 2012 | leukemia, plasma cell myeloma | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 1/28 trials | ||||||
| Phase 1/2 | NCT06959771 Background | Jul 2025 → Oct 2027 expected | hyper-IgM syndrome type 1 | National Institute of Allergy and Infectious Diseases (NIAID) | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06986382 Background | Jul 2025 → Jul 2037 expected | Crohn disease | Stanford University | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT06851767 Background | May 2025 → Dec 2034 expected | T-B+ severe combined immunodeficiency due to gamma chain deficiency | National Institute of Allergy and Infectious Diseases (NIAID) | Enrolling by invitation | No outcome recorded |
| Phase 1/2 | NCT06325709 Background | Apr 2024 → Dec 2032 expected | granulomatous disease, chronic, X-linked | National Institute of Allergy and Infectious Diseases (NIAID) | Recruiting | No outcome recorded |
| Phase 1/2 | NCT03100877 Background | Jan 2018 → May 2020 | plasma cell leukemia, plasma cell myeloma | City of Hope Medical Center | Withdrawn | No outcome recorded |
| Phase 1/2 | NCT02589145 Background | Jun 2016 → Apr 2019 | lymphoma | M.D. Anderson Cancer Center | Terminated | No outcome recorded |
| Phase 1/2 | NCT01306019 Background | Sep 2012 → Dec 2032 expected | T-B+ severe combined immunodeficiency due to gamma chain deficiency | National Institute of Allergy and Infectious Diseases (NIAID) | Recruiting | No outcome recorded |
| Phase 1/2 | NCT03315078 Background | Apr 2012 → Dec 2022 | combined immunodeficiency, X-linked | National Institute of Allergy and Infectious Diseases (NIAID) | Unknown | No outcome recorded |
| Phase 27 trials | ||||||
| Phase 2 | NCT07582172 Background | Apr 2027 → Apr 2029 expected | acute myeloid leukemia, chronic myelomonocytic leukemia, myelodysplastic syndrome | City of Hope Medical Center | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT02961816 Background | Jun 2017 → Jun 2021 | lymphoma | M.D. Anderson Cancer Center | Withdrawn | No outcome recorded |
| Phase 2 | NCT02114502 Background | Sep 2014 → Sep 2018 | plasma cell myeloma | M.D. Anderson Cancer Center | Withdrawn | No outcome recorded |
| Phase 2 | NCT01746173 Background | Jul 2013 → Oct 2014 | T-cell non-Hodgkin lymphoma | Dana-Farber Cancer Institute | Terminated | No outcome recorded |
| Phase 2 | NCT01200329 Background | Jun 2011 → Dec 2018 | lymphoma | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT01237951 Background | Nov 2010 → Sep 2017 | plasma cell myeloma | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT01386151 Comparator | Aug 2009 → Jul 2011 | asthma | University Hospital Southampton NHS Foundation Trust | Completed | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT02313792 Comparator | Jan → Mar 2015 | mucositis | The Catholic University of Korea | Unknown | No outcome recorded |
| Phase 3 | NCT00434161 Comparator | Dec 2006 → Mar 2009 | plasma cell myeloma | Swedish Orphan Biovitrum | Completed | No outcome recorded |
Evidence & citations 16 cited values
Every value below carries the sentence it was read from. 63 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Palifermin | “Kepivance (Palifermin)” NCT00352703 ↗51 |
| Known as | IND # 6370 | “Palifermin (NSC# 740548; IND # 6370)” NCT00360971 ↗ |
| Known as | Kepivance | “a keratinocyte growth factor (Palifermin or Kepivance®)” NCT00570999 ↗ |
| Known as | Keratinocyte growth factor | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04554732 ↗ |
| Known as | KGF | “Keratinocyte growth factor (KGF) has been shown to have cytoprotective effects on human hair follicles and reduce alopecia in preclinical models.” PMID 41834767 ↗ Mar 2026 |
| Known as | KGF-hair serum | “We hypothesized that KGF-hair serum (KGF-HS) will prevent CIA.” PMID 41834767 ↗ Mar 2026 |
| Known as | KGF-HS | “We hypothesized that KGF-hair serum (KGF-HS) will prevent CIA.” PMID 41834767 ↗ Mar 2026 |
| Known as | NSC# 740548 | “Palifermin (NSC# 740548; IND # 6370)” NCT00360971 ↗ |
| Known as | Palifermina | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201821 ↗ |
| Known as | Palifermine | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201821 ↗ |
| Known as | Recombinant Human Keratinocyte Growth Factor | “A double-blind, randomized trial showed that, compared with placebo, palifermin (recombinant human keratinocyte growth factor) reduced the frequency and duration of oral...” PMID 17580258 ↗ Apr 20075“A Phase 1/2 Study to Evaluate Safety, Pharmacokinetics and Preliminary Efficacy of Weekly Doses of Palifermin (Recombinant Human Keratinocyte Growth Factor, rHuKGF) for the...” NCT00540332 ↗ “Recombinant Human Keratinocyte Growth Factor (Palifermin; rHuKGF)” NCT00070616 ↗ |
| Known as | rHuKGF | “A Phase 1/2 Study to Evaluate Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of Weekly Doses of Palifermin (rHuKGF) for the Reduction of Oral Mucositis in...” NCT00626639 ↗5“A Phase 1/2 Study to Evaluate Safety, Pharmacokinetics and Preliminary Efficacy of Weekly Doses of Palifermin (Recombinant Human Keratinocyte Growth Factor, rHuKGF) for the...” NCT00540332 ↗ “Multiple Doses of Palifermin (rHuKGF) for the Treatment of Inadequate CD4+ Lymphocyte Recovery” NCT00376935 ↗ “Recombinant Human Keratinocyte Growth Factor (Palifermin; rHuKGF)” NCT00070616 ↗ “palifermin (recombinant human keratinocyte growth factor, rHuKGF)” NCT00393822 ↗ “Keratinocyte Growth Factor (rHuKGF)” NCT00031148 ↗ |
| Action | Activate | “cellular proliferation induced by the KGF mitogenic signal” PMID 25880826 ↗ May 20151“Fibroblast growth factor receptor 2 agonist” CHEMBL1201821 ↗ |
| Modality | Protein / enzyme biologic | “recombinant human keratinocyte growth factor (rHuKGF)” NCT00004061 ↗ |
| Route | Intravenous | “Patients receive recombinant human keratinocyte growth factor (rHuKGF) IV on days -11 to -9, -5, and 0 to 2.” NCT00004061 ↗ |
| Target | FGFR2 | “Fibroblast growth factor receptor 2 agonist” CHEMBL1201821 ↗ |