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
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 | 2025-04-25 |
| neulasta | Biologic Licensing Application | 2025-04-14 |
| nyvepria | Biologic Licensing Application | 2023-06-29 |
| stimufend | Biologic Licensing Application | 2023-10-24 |
| udenyca | Biologic Licensing Application | 2025-08-14 |
| 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
484 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 neoplasms | D001943 | EFO_0003869 | C50 | — | 7 | 1 | 1 | 4 | 13 |
| Neutropenia | D009503 | — | D70 | — | 4 | 2 | 2 | 1 | 9 |
| Non-hodgkin lymphoma | D008228 | — | C85.9 | — | 5 | — | 1 | 3 | 9 |
| Lung neoplasms | D008175 | — | C34.90 | — | 3 | — | 2 | 2 | 7 |
| Non-small-cell lung carcinoma | D002289 | — | — | — | 4 | — | 1 | 1 | 6 |
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | — | 2 | — | 1 | — | 3 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neoplasms | D009369 | — | C80 | — | 3 | 1 | — | — | 4 |
| Fever | D005334 | — | R50.9 | — | 1 | 1 | — | 1 | 3 |
| Colorectal neoplasms | D015179 | — | — | — | 1 | 1 | — | — | 2 |
| Colonic neoplasms | D003110 | — | C18 | — | 1 | 1 | — | — | 2 |
| Rectal neoplasms | D012004 | — | — | — | 1 | 1 | — | — | 2 |
| Febrile neutropenia | D064147 | — | — | — | — | 1 | — | 1 | 2 |
| Leukemia | D007938 | — | C95 | — | — | 1 | — | — | 1 |
| Precursor cell lymphoblastic leukemia-lymphoma | D054198 | — | C91.0 | — | — | 1 | — | — | 1 |
| Lymphoid leukemia | D007945 | — | C91 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Lymphoma | D008223 | — | C85.9 | 2 | 5 | — | — | — | 6 |
| Sarcoma | D012509 | — | — | — | 2 | — | — | 1 | 3 |
| B-cell lymphoma | D016393 | — | — | 1 | 2 | — | — | 1 | 3 |
| Multiple myeloma | D009101 | — | C90.0 | — | 3 | — | — | — | 3 |
| Plasma cell neoplasms | D054219 | — | — | — | 3 | — | — | — | 3 |
| Large b-cell lymphoma diffuse | D016403 | — | C83.3 | 1 | 2 | — | — | — | 2 |
| Bone neoplasms | D001859 | EFO_0003820 | D16 | — | 2 | — | — | — | 2 |
| Male breast neoplasms | D018567 | — | — | — | 1 | — | — | — | 1 |
| Recurrence | D012008 | — | — | 1 | 1 | — | — | — | 1 |
| B-cell lymphoma marginal zone | D018442 | — | C88.4 | 1 | 1 | — | — | — | 1 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Aggression | D000374 | EFO_0003015 | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Chemotherapy-induced febrile neutropenia | D064146 | — | — | — | — | — | — | 1 | 1 |
| Hyperthermia | D000084462 | — | — | — | — | — | — | 1 | 1 |
| Adenocarcinoma | D000230 | — | — | — | — | — | — | 1 | 1 |
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
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Udenyca – Coherus Oncology
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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 3,358 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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92,786 adverse events reported
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