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Drug ReportsPegfilgrastim
Neulasta(pegfilgrastim)
Cegfila, Fulphila, Fylnetra, Grasustek, Neulasta, Nyvepria, Pegfilgrastim, Pelgraz, Pelmeg, Stimufend, Udenyca, Ziextenzo (pegfilgrastim) is a protein pharmaceutical. Pegfilgrastim was first approved as Neulasta on 2002-01-31. It is used to treat neutropenia in the USA. It has been approved in Europe to treat neoplasms and neutropenia. The pharmaceutical is active against granulocyte colony-stimulating factor receptor.
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Drug
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Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
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FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
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Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
hemic and lymphatic diseasesD006425
Trade Name
FDA
EMA
Fulphila, Fylnetra, Neulasta onpro, Nyvepria, Stimufend, Udenyca onbody, Ziextenzo
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)
Pegfilgrastim
Tradename
Proper name
Company
Number
Date
Products
NeulastapegfilgrastimAmgenN-125031 RX2002-01-31
1 products
Neulasta OnpropegfilgrastimAmgenN-125031 RX2014-12-23
1 products
Labels
FDA
EMA
Brand Name
Status
Last Update
fulphilaBiologic Licensing Application2023-12-05
fylnetraBiologic Licensing Application2022-05-31
neulastaBiologic Licensing Application2024-10-31
nyvepriaBiologic Licensing Application2023-06-29
stimufendBiologic Licensing Application2023-10-24
udenycaBiologic Licensing Application2024-08-20
ziextenzoBiologic Licensing Application2022-12-14
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
neutropenia—D009503D70
Agency Specific
FDA
EMA
Expiration
Code
pegfilgrastim, Neulasta, Amgen Inc.
2122-11-13Orphan excl.
pegfilgrastim, Neulasta Onpro, Amgen Inc.
2122-11-13Orphan excl.
Patent Expiration
No data
ATC Codes
L: Antineoplastic and immunomodulating agents
— L03: Immunostimulants
— L03A: Immunostimulants
— L03AA: Colony stimulating factors
— L03AA13: Pegfilgrastim
HCPCS
Code
Description
J2506
Injection, pegfilgrastim, excludes biosimilar, 0.5 mg
Q5108
Injection, pegfilgrastim-jmdb, biosimilar, (fulphila), 0.5 mg
Q5111
Injection, pegfilgrastim-cbqv, biosimilar, (udenyca), 0.5 mg
Q5120
Injection, pegfilgrastim-bmez, biosimilar, (ziextenzo), 0.5 mg
Q5122
Injection, pegfilgrastim-apgf, biosimilar, (nyvepria), 0.5 mg
Clinical
Clinical Trials
441 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Breast neoplasmsD001943EFO_0003869C50—811414
Non-hodgkin lymphomaD008228—C85.916—1310
NeutropeniaD009503—D70—22217
Lung neoplasmsD008175—C34.90—2—226
Non-small-cell lung carcinomaD002289———3—115
Ovarian neoplasmsD010051EFO_0003893C56—2—1—3
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
NeoplasmsD009369—C80—21——3
FeverD005334—R50.9—11—13
LeukemiaD007938—C95—11——2
Colorectal neoplasmsD015179———11——2
Colonic neoplasmsD003110—C18—11——2
Rectal neoplasmsD012004———11——2
Precursor cell lymphoblastic leukemia-lymphomaD054198—C91.0——1——1
Lymphoid leukemiaD007945—C91——1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
LymphomaD008223—C85.928——110
SarcomaD012509———2——13
B-cell lymphomaD016393——13———3
Multiple myelomaD009101—C90.0—3———3
Plasma cell neoplasmsD054219———3———3
Large b-cell lymphoma diffuseD016403—C83.312———2
AggressionD000374EFO_0003015—21———2
Male breast neoplasmsD018567———1———1
B-cell lymphoma marginal zoneD018442—C88.411———1
Mantle-cell lymphomaD020522—C83.111———1
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Indications Phases 1
No data
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Chemotherapy-induced febrile neutropeniaD064146——————11
Febrile neutropeniaD064147——————11
HyperthermiaD000084462——————11
AdenocarcinomaD000230——————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common namePegfilgrastim
INNpegfilgrastim
Description
Granulocyte colony-stimulating factor precursor (G-CSF) (Pluripoietin)
Classification
Protein
Drug classPEGylated compounds, covalent attachment of macrogol (polyethylene glycol) polymer; colony-stimulating factors: granulocyte colony-stimulating factors (G-CSF)
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)—
Identifiers
PDB—
CAS-ID—
RxCUI—
ChEMBL IDCHEMBL1201568
ChEBI ID—
PubChem CID—
DrugBankDB00019
UNII ID3A58010674 (ChemIDplus, GSRS)
Target
Agency Approved
CSF3R
CSF3R
Organism
Homo sapiens
Gene name
CSF3R
Gene synonyms
GCSFR
NCBI Gene ID
Protein name
granulocyte colony-stimulating factor receptor
Protein synonyms
CD114, CD114 antigen, colony stimulating factor 3 receptor (granulocyte), G-CSF receptor, G-CSF-R
Uniprot ID
Mouse ortholog
Csf3r (12986)
granulocyte colony-stimulating factor receptor (P40223)
Alternate
No data
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
Udenyca – Coherus BioSciences
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Neulasta – Amgen
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Tabular view
Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 3,133 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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88,920 adverse events reported
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