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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Commercial
Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
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 |
|---|---|
| neoplasms | D009369 |
| hemic and lymphatic diseases | D006425 |
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)
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| fulphila | Biologic Licensing Application | 2023-12-05 |
| fylnetra | Biologic Licensing Application | 2022-05-31 |
| neulasta | Biologic Licensing Application | 2024-10-31 |
| nyvepria | Biologic Licensing Application | 2023-06-29 |
| stimufend | Biologic Licensing Application | 2023-10-24 |
| udenyca | Biologic Licensing Application | 2024-08-20 |
| ziextenzo | Biologic Licensing Application | 2022-12-14 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| neutropenia | — | D009503 | D70 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
pegfilgrastim, Neulasta, Amgen Inc. | |||
| 2122-11-13 | Orphan excl. | ||
pegfilgrastim, Neulasta Onpro, Amgen Inc. | |||
| 2122-11-13 | Orphan excl. | ||
Patent Expiration
No data
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
440 clinical trials
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Indications Phases 4
No data
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neutropenia | D009503 | — | D70 | — | — | 2 | — | — | 2 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | — | — | 2 | — | — | 2 |
| Chemotherapy-induced febrile neutropenia | D064146 | — | — | — | — | 2 | — | — | 2 |
Indications Phases 2
No data
Indications Phases 1
No data
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Pegfilgrastim |
| INN | pegfilgrastim |
| Description | Granulocyte colony-stimulating factor precursor (G-CSF) (Pluripoietin) |
| Classification | Protein |
| Drug class | PEGylated compounds, covalent attachment of macrogol (polyethylene glycol) polymer; colony-stimulating factors: granulocyte colony-stimulating factors (G-CSF) |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | — |
| RxCUI | — |
| ChEMBL ID | CHEMBL1201568 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB00019 |
| UNII ID | 3A58010674 (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 3,079 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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88,901 adverse events reported
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