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Drug ReportsPalifermin
Kepivance(palifermin)
Kepivance (palifermin) is a protein pharmaceutical. Palifermin was first approved as Kepivance on 2004-12-15. It is used to treat mucositis in the USA. It has been approved in Europe to treat mucositis. The pharmaceutical is active against fibroblast growth factor receptor 2.
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5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
digestive system diseasesD004066
stomatognathic diseasesD009057
Trade Name
FDA
EMA
Kepivance
Drug Products
FDA
EMA
Reference product - 351(a)
Reference product - 351(a)
Interchangeable product - 351(k)
Interchangeable product - 351(k)
Biosimilar product - 351(k)
Biosimilar product - 351(k)
Palifermin
Tradename
Proper name
Company
Number
Date
Products
KepivancepaliferminOrphan MedicalN-125103 RX2004-12-15
1 products
Labels
FDA
EMA
Brand Name
Status
Last Update
kepivanceBiologic Licensing Application2024-12-20
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
mucositisEFO_1001898D052016—
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
V: Various drug classes in atc
— V03: All other therapeutic products
— V03A: All other therapeutic products
— V03AF: Detoxifying agents for antineoplastic treatment
— V03AF08: Palifermin
HCPCS
Code
Description
J2425
Injection, palifermin, 50 micrograms
Clinical
Clinical Trials
56 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
MucositisD052016EFO_1001898—5591—17
LymphomaD008223—C85.95711214
Multiple myelomaD009101—C90.05611112
Plasma cell neoplasmsD054219——241118
Non-hodgkin lymphomaD008228—C85.914—127
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
LeukemiaD007938—C95572—114
StomatitisD013280EFO_1001904K12.1457——13
NeoplasmsD009369—C80322——7
Hematologic neoplasmsD019337——221——5
Head and neck neoplasmsD006258——223——5
Precursor cell lymphoblastic leukemia-lymphomaD054198——111—14
Lymphoid leukemiaD007945—C91——1—12
Radiation effectsD011830———11——2
Colonic neoplasmsD003110—C18—11——1
PainD010146EFO_0003843R52——1——1
Show 2 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Myelodysplastic syndromesD009190—D4625——17
Graft vs host diseaseD006086—D89.8134——15
Hodgkin diseaseD006689—C8113——14
Myeloid leukemia acuteD015470—C92.012——14
Myeloid leukemiaD007951—C9212——14
PreleukemiaD011289——11——13
SyndromeD013577——11——13
Bcr-abl positive chronic myelogenous leukemiaD015464EFO_0000340——2——13
Large b-cell lymphoma diffuseD016403—C83.311——12
B-cell lymphomaD016393——11——12
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Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Hematopoietic stem cell transplantationD018380——4————4
Neuroepithelial neoplasmsD018302——1————1
Healthy volunteers/patients———1————1
Epidermolysis bullosaD004820—Q811————1
Epidermolysis bullosa dystrophicaD016108—Q81.21————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
MycosesD009181—B35-B49————11
RecurrenceD012008——————11
Myeloproliferative disordersD009196—D47.1————11
Primary myelofibrosisD055728—D47.4————11
Sezary syndromeD012751—C84.1————11
B-cell chronic lymphocytic leukemiaD015451—C91.1————11
Myelomonocytic leukemia chronicD015477—C93.1————11
Leukemia myeloid chronic atypical bcr-abl negativeD054438—C92.2————11
Myelodysplastic-myeloproliferative diseasesD054437——————11
B-cell lymphoma marginal zoneD018442—C88.4————11
Show 19 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common namePalifermin
INNpalifermin
Description
Palifermin (trade name Kepivance, marketed by Biovitrum) is a truncated human recombinant keratinocyte growth factor (KGF) produced in Escherichia coli. KGF stimulates the growth of cells that line the surface of the mouth and intestinal tract.
Classification
Protein
Drug classgrowth factors: fibroblast growth factors
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)—
Identifiers
PDB—
CAS-ID—
RxCUI—
ChEMBL IDCHEMBL1201821
ChEBI ID—
PubChem CID—
DrugBankDB00039
UNII IDQMS40680K6 (ChemIDplus, GSRS)
Target
Agency Approved
FGFR2
FGFR2
Organism
Homo sapiens
Gene name
FGFR2
Gene synonyms
BEK, KGFR, KSAM
NCBI Gene ID
Protein name
fibroblast growth factor receptor 2
Protein synonyms
bacteria-expressed kinase, BEK fibroblast growth factor receptor, CD332, K-sam, Keratinocyte growth factor receptor, KGFR, protein tyrosine kinase, receptor like 14
Uniprot ID
Mouse ortholog
Fgfr2 (14183)
fibroblast growth factor receptor 2 (P21803)
Alternate
No data
Variants
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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498 adverse events reported
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