Filgrastim
Accofil, Filgrastim, Granix, Grastofil, Neupogen, Nivestim, Nivestym, Nypozi, Ratiograstim, Releuko, Tevagrastim, Zarxio, Zarzio (filgrastim) is a protein pharmaceutical. Filgrastim was first approved as Neupogen on 1991-02-20. It is used to treat neutropenia in the USA. It has been approved in Europe to treat hematopoietic stem cell transplantation, neoplasms, and neutropenia. It is known to target macrophage colony-stimulating factor 1 receptor and granulocyte colony-stimulating factor receptor.
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Events Timeline
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Commercial
Therapeutic Areas
Trade Name
FDA
EMA
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Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
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Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| granix | Biologic Licensing Application | 2023-11-30 |
| neupogen | Biologic Licensing Application | 2024-10-30 |
| nivestym | Biologic Licensing Application | 2024-02-28 |
| nypozi | Biologic Licensing Application | 2024-12-18 |
| releuko | Biologic Licensing Application | 2023-08-25 |
| zarxio | Biologic Licensing Application | 2024-10-25 |
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
filgrastim, Neupogen, Amgen Inc. | |||
| 2122-03-30 | Orphan excl. | ||
filgrastim, Granix, UAB Teva Baltics | |||
| 2024-08-29 | Reference product excl. | ||
Patent Expiration
No data
HCPCS
Code | Description |
|---|---|
| J1442 | Injection, filgrastim (g-csf), excludes biosimilars, 1 microgram |
| J1447 | Injection, tbo-filgrastim, 1 microgram |
| J2506 | Injection, pegfilgrastim, excludes biosimilar, 0.5 mg |
| Q5101 | Injection, filgrastim-sndz, biosimilar, (zarxio), 1 microgram |
| Q5108 | Injection, pegfilgrastim-jmdb, biosimilar, (fulphila), 0.5 mg |
| Q5110 | Injection, filgrastim-aafi, biosimilar, (nivestym), 1 microgram |
| 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
1543 clinical trials
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Indications Phases 4
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Indications Phases 3
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Indications Phases 2
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Indications Phases 1
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hematopoietic stem cell mobilization | D019650 | — | — | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Filgrastim |
| INN | filgrastim |
| Description | Filgrastim, sold under the brand name Neupogen among others, is a medication used to treat low neutrophil count. Low neutrophil counts may occur with HIV/AIDS, following chemotherapy or radiation poisoning, or be of an unknown cause. It may also be used to increase white blood cells for gathering during leukapheresis. It is given either by injection into a vein or under the skin.
|
| Classification | Protein |
| Drug class | 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 | CHEMBL1201567 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB00099 |
| UNII ID | PVI5M0M1GW (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
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)
Variants
No data
Financial
Revenue by drug
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Neupogen – Amgen
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Estimated US medical usage
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Trends
PubMed Central
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Additional graphs summarizing 7,381 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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102,700 adverse events reported
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