palifermin
Trade name: Kepivance
Recombinant proteinapproved
Approved
Dec 15, 2004
The keratinocyte growth factor (KGF), also known as FGF7, is a growth factor present in the epithelialization-phase of wound healing. In this phase, keratinocytes are covering the wound, forming the epithelium. — Wikipedia
Clinical trial activity
60 trials · 37 clinical orgs · 3 marketing orgs
Phase 1
30
Phase 2
43
Phase 3
9
Phase 4
1
Earliest trial started May 1, 1999 (NCT00004061)
Timeline
1990s
- Jan 1, 1999
Earliest Phase 2 Sponsor(trial)
2000s
- Jan 1, 2000
Earliest Phase 1 Sponsor(trial)
- Jan 1, 2002
- Dec 15, 2004
Amgen — Earliest FDA Approval
- Dec 15, 2004
Biovitrum AB — Marketing Organization
- Dec 15, 2004
Amgen — NDA Organization
- Dec 15, 2004
Swedish Orphan Biovitrum — NDA Secondary Org
Indications
Approved for
Studied for
- Alopecia · Early Phase 1
- Asthma · Phase 2
- Carcinoma, Non-Small-Cell Lung · Phase 2
- Carcinoma, Squamous Cell · Phase 3
- Colonic Neoplasms · Phase 2/Phase 3
- Crohn Disease · Phase 1/Phase 2
- Deglutition Disorders · Phase 2
- Drug-Related Side Effects and Adverse Reactions · Phase 3
- Epidermolysis Bullosa · Early Phase 1
- Graft vs Host Disease · Phase 2
- Granuloma · Phase 1/Phase 2
- Granulomatous Disease, Chronic · Phase 1/Phase 2
- Head and Neck Neoplasms · Phase 3
- Healthy Volunteers · Phase 1
- Hematologic Neoplasms · Phase 2
- Hematopoietic Stem Cell Transplantation · Phase 1
- HIV Infections · Phase 2
- Hodgkin Disease · Phase 1/Phase 2
- Intestinal Neoplasms · Phase 2
- Leukemia · Phase 3
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive · Phase 2
- Leukemia, Myeloid, Acute · Phase 2
- Leukemia, Plasma Cell · Phase 2
- Lung Neoplasms · Phase 2
- Lymphoma · Phase 3
- Lymphoma, Non-Hodgkin · Phase 4
- Mucositis · Phase 3
- Multiple Myeloma · Phase 4
- Multiple Sclerosis · Phase 1/Phase 2
- Myelodysplastic Syndromes · Phase 2
- Neoplasms · Phase 3
- Neoplasms, Neuroepithelial · Early Phase 1
- Pain · Phase 3
- Plasmacytoma · Phase 2
- Precursor Cell Lymphoblastic Leukemia-Lymphoma · Phase 2
- Primary Myelofibrosis · Phase 2
- Sarcoma · Phase 2
- Stevens-Johnson Syndrome · Phase 1/Phase 2
- Stomatitis · Phase 3
- X-Linked Combined Immunodeficiency Diseases · Phase 1/Phase 2
Mechanism of action
FGFR2 agonist
- Fibroblast growth factor 7Supplementation
FGF7 supplementation
Approval history
- approvedDec 15, 2004
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Parenteral
- Availability
- Prescription Only
- Multi-specific
- No
Oral
No
Parenteral
Yes
Topical
No
Sources
- WikipediaKeratinocyte growth factor ↗
- NCATSQMS40680K6 ↗
- ChEMBLCHEMBL1201821 ↗
- WikipediaPalifermin ↗
Also known as
- 24-163 fibroblast growth factor 7 (human)
- 24-163-keratinocyte growth factor (human)
- fgf-7
- fibroblast growth factor- 7
- hbgf-7
- kepivance
- kepivance
- kepivance
- keratinocyte growth factor
- keratinocyte growth factor precursor
- kgf
- palifermin
- palifermin
- palifermin
- palifermin
- palifermin
- palifermin
- palifermin
- palifermin
- qms40680k6
- qms40680k6
- qms40680k6
- qms40680k6
- qms40680k6
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT06986382 | Phase 1/Phase 2 (Phase 2) | Jul 31, 2025 | Stanford University |
| NCT06959771 | Phase 1/Phase 2 (Phase 2) | Jul 16, 2025 | National Institute of Allergy and Infectious Diseases (NIAID) |
| NCT06851767 | Phase 1/Phase 2 (Phase 2) | Mar 20, 2025 | National Institute of Allergy and Infectious Diseases (NIAID) |
| NCT06325709 | Phase 1/Phase 2 (Phase 2) | Apr 17, 2024 | National Institute of Allergy and Infectious Diseases (NIAID) |
| NCT05139004 | Phase 1 | Dec 15, 2021 | City of Hope National Medical Center, National Cancer Institute (NCI) |
| NCT04554732 | Early Phase 1 (Phase 1) | Apr 27, 2020 | University of Arizona |
| NCT04177004 | Phase 1 | Jan 1, 2020 | City of Hope National Medical Center, National Cancer Institute (NCI) |
| NCT03531281 | Phase 1 | Dec 30, 2018 | City of Hope National Medical Center, National Cancer Institute (NCI) |
| NCT03417284 | Phase 1/Phase 2 (Phase 2) | Nov 30, 2018 | Spectrum Pharmaceuticals, University of Texas at Houston |
| NCT03342196 | Phase 2 | Mar 21, 2018 | Case Western Reserve University |
| NCT02961816 | Phase 2 | Jun 1, 2017 | University of Texas at Houston |
| NCT03100877 | Phase 1/Phase 2 (Phase 2) | May 24, 2017 | City of Hope National Medical Center, National Cancer Institute (NCI) |
| NCT02589145 | Phase 1/Phase 2 (Phase 2) | Jun 1, 2016 | Celgene, University of Texas at Houston |
| NCT02506959 | Phase 2 | Sep 1, 2015 | Novartis, University of Texas at Houston |
| NCT02653196 | Early Phase 1 (Phase 1) | Sep 1, 2015 | Ohio State University, University of Southern California, Yeshiva University |
| NCT02356159 | Phase 1/Phase 2 (Phase 2) | Jan 9, 2015 | National Cancer Institute (NCI) |
| NCT02313792 | Phase 3 | Jan 1, 2015 | Catholic University of Korea |
| NCT02114502 | Phase 2 | Sep 1, 2014 | University of Texas at Houston |
| NCT01746173 | Phase 2 | Feb 1, 2013 | Harvard University |
| NCT01746849 | Phase 2 | Dec 1, 2012 | Cornell University, Swedish Orphan Biovitrum |
Showing 20 of 60 trials
Page 1 / 3
Organizations
Research & Development (37)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Swedish Orphan Biovitrum | For profit | 14 | 12 | 4 | 2001 |
| Amgen | For profit | 12 | 3 | 3 | 2000 |
| University of Texas at Houston | Academic/Hospital | 12 | 11 | 3 | 2000 |
| National Cancer Institute (NCI) | Government | 11 | 2 | 4 | 1999 |
| National Institute of Allergy and Infectious Diseases (NIAID) | Government | 5 | 5 | 1 | 2006 |
| City of Hope National Medical Center | Academic/Hospital | 4 | 4 | 2 | 2017 |
| Biovitrum AB | For profit | 3 | 0 | 3 | 2005 |
| Cornell University | Academic/Hospital | 3 | 3 | 1 | 1999 |
| AIDS Clinical Trials Group | Academic/Hospital | 1 | 0 | 1 | 2006 |
| Case Western Reserve University | Academic/Hospital | 1 | 1 | 1 | 2018 |
| Catholic University of Korea | Academic/Hospital | 1 | 1 | 1 | 2015 |
| Celgene | For profit | 1 | 0 | 1 | 2016 |
| Columbia University | Academic/Hospital | 1 | 1 | 1 | 2009 |
| Drexel University | Academic/Hospital | 1 | 0 | 1 | 2006 |
| European Group for Blood and Marrow Transplantation | Academic/Hospital | 1 | 1 | 1 | 2008 |
| Food and Drug Administration | Government | 1 | 1 | 1 | 2001 |
| Harvard University | Academic/Hospital | 1 | 1 | 1 | 2013 |
| Indiana University | Academic/Hospital | 1 | 1 | 1 | 2007 |
| Moorgreen Hospital, Southampton | Academic/Hospital | 1 | 1 | 1 | 2009 |
| Novartis | For profit | 1 | 0 | 1 | 2015 |
37 organizations
Page 1 / 2
Marketing (3)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Amgen | For profit | NDA | Dec 15, 2004 |
| Biovitrum AB | For profit | MKTG | Dec 15, 2004 |
| Swedish Orphan Biovitrum | For profit | NDA2 | Dec 15, 2004 |