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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YTD
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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 diseases | D004066 |
| stomatognathic diseases | D009057 |
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 |
|---|---|---|---|---|---|
| Kepivance | palifermin | Orphan Medical | N-125103 RX | 2004-12-15 | 1 products |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| kepivance | Biologic Licensing Application | 2024-12-20 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| mucositis | EFO_1001898 | D052016 | — |
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
HCPCS
Code | Description |
|---|---|
| J2425 | Injection, palifermin, 50 micrograms |
Clinical
Clinical Trials
60 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Mucositis | D052016 | EFO_1001898 | — | 3 | 2 | 3 | 1 | — | 7 |
| Multiple myeloma | D009101 | — | C90.0 | 1 | 1 | 1 | 1 | — | 4 |
| Lymphoma | D008223 | — | C85.9 | 1 | — | 1 | 1 | — | 3 |
| Plasma cell neoplasms | D054219 | — | — | — | — | 1 | 1 | — | 2 |
| Non-hodgkin lymphoma | D008228 | — | C85.9 | — | 1 | — | 1 | — | 2 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Stomatitis | D013280 | EFO_1001904 | K12.1 | 3 | 2 | 3 | — | — | 6 |
| Leukemia | D007938 | — | C95 | 2 | 1 | 1 | — | — | 4 |
| Neoplasms | D009369 | — | C80 | — | 1 | 2 | — | — | 3 |
| Head and neck neoplasms | D006258 | — | — | 2 | 2 | 1 | — | — | 3 |
| Squamous cell carcinoma | D002294 | — | — | — | — | 1 | — | — | 1 |
| Squamous cell neoplasms | D018307 | — | — | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hematologic neoplasms | D019337 | — | — | — | 1 | — | — | — | 1 |
| Graft vs host disease | D006086 | — | D89.81 | — | 1 | — | — | — | 1 |
| Non-small-cell lung carcinoma | D002289 | — | — | — | 1 | — | — | — | 1 |
| Lung neoplasms | D008175 | — | C34.90 | — | 1 | — | — | — | 1 |
| Deglutition disorders | D003680 | — | R13.1 | — | 1 | — | — | — | 1 |
| Myelodysplastic syndromes | D009190 | — | D46 | — | 1 | — | — | — | 1 |
| Stevens-johnson syndrome | D013262 | EFO_0004276 | L51.1 | 1 | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Palifermin |
| INN | palifermin |
| 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 class | growth factors: fibroblast growth factors |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | — |
| RxCUI | — |
| ChEMBL ID | CHEMBL1201821 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB00039 |
| UNII ID | QMS40680K6 (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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Additional graphs summarizing 844 documents
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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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