Filgrastim
Biograstim, Granix, Neupogen, Nivestym, Releuko, Zarxio (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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Commercial
Therapeutic Areas
Trade Name
FDA
EMA
Granix, Neupogen, Nivestym, Releuko, Zarxio
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)
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| neutropenia | — | D009503 | D70 |
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
1503 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Lymphoma | D008223 | — | C85.9 | 46 | 133 | 27 | 3 | 17 | 207 |
| Leukemia | D007938 | — | C95 | 50 | 103 | 16 | 3 | 13 | 164 |
| Myeloid leukemia acute | D015470 | — | C92.0 | 42 | 74 | 23 | 1 | 9 | 130 |
| Myelodysplastic syndromes | D009190 | — | D46 | 41 | 78 | 16 | 1 | 12 | 125 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 30 | 60 | 32 | 11 | 8 | 125 |
| Multiple myeloma | D009101 | — | C90.0 | 26 | 63 | 13 | 1 | 12 | 101 |
| Non-hodgkin lymphoma | D008228 | — | C85.9 | 16 | 48 | 7 | 2 | 10 | 76 |
| Precursor cell lymphoblastic leukemia-lymphoma | D054198 | — | C91.0 | 19 | 46 | 11 | 2 | 7 | 73 |
| Neoplasms | D009369 | — | C80 | 33 | 19 | 7 | 1 | 3 | 58 |
| Neuroblastoma | D009447 | EFO_0000621 | — | 22 | 21 | 11 | 1 | 3 | 55 |
Show 29 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Sarcoma | D012509 | — | — | 16 | 35 | 10 | — | 2 | 58 |
| Hodgkin disease | D006689 | — | C81 | 11 | 37 | 8 | — | 3 | 52 |
| Central nervous system neoplasms | D016543 | — | — | 17 | 28 | 5 | — | 1 | 47 |
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | 22 | 27 | 3 | — | 3 | 45 |
| Large b-cell lymphoma diffuse | D016403 | — | C83.3 | 14 | 19 | 3 | — | 4 | 33 |
| B-cell chronic lymphocytic leukemia | D015451 | — | C91.1 | 9 | 16 | 2 | — | 5 | 29 |
| Bcr-abl positive chronic myelogenous leukemia | D015464 | EFO_0000340 | — | 5 | 20 | 3 | — | 2 | 28 |
| Lung neoplasms | D008175 | HP_0100526 | C34.90 | 2 | 17 | 3 | — | 4 | 25 |
| Follicular lymphoma | D008224 | — | C82 | 10 | 14 | 3 | — | 3 | 24 |
| Myeloproliferative disorders | D009196 | — | D47.1 | 9 | 10 | 2 | — | 5 | 24 |
Show 89 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Mantle-cell lymphoma | D020522 | — | C83.1 | 8 | 15 | — | — | 3 | 22 |
| Myelodysplastic-myeloproliferative diseases | D054437 | — | — | 5 | 9 | — | — | 2 | 15 |
| Hiv infections | D015658 | EFO_0000764 | B20 | 3 | 5 | — | — | 4 | 12 |
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | 6 | 6 | — | — | 1 | 11 |
| Biphenotypic leukemia acute | D015456 | — | C95.0 | 6 | 9 | — | — | — | 11 |
| Fanconi anemia | D005199 | Orphanet_84 | D61.09 | 5 | 8 | — | — | 1 | 11 |
| Fallopian tube neoplasms | D005185 | — | — | 6 | 3 | — | — | 1 | 9 |
| B-cell lymphoma marginal zone | D018442 | — | C88.4 | 3 | 3 | — | — | 3 | 8 |
| Waldenstrom macroglobulinemia | D008258 | HP_0005508 | C88.0 | 3 | 4 | — | — | 2 | 8 |
| Ewing sarcoma | D012512 | EFO_0000173 | — | 4 | 2 | — | — | 2 | 8 |
Show 124 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hairy cell leukemia | D007943 | — | C91.4 | 1 | — | — | — | 3 | 4 |
| Astrocytoma | D001254 | EFO_0000271 | — | 3 | — | — | — | — | 3 |
| Primitive neuroectodermal tumors | D018242 | — | — | 2 | — | — | — | 1 | 3 |
| Coronary artery disease | D003324 | — | I25.1 | 1 | — | — | — | 2 | 3 |
| Rheumatoid arthritis | D001172 | EFO_0000685 | M06.9 | 1 | — | — | — | 2 | 3 |
| Neoplasms by histologic type | D009370 | — | — | 2 | — | — | — | — | 2 |
| Glioma | D005910 | EFO_0000520 | — | 2 | — | — | — | — | 2 |
| Rhabdoid tumor | D018335 | — | — | 2 | — | — | — | — | 2 |
| Oligodendroglioma | D009837 | EFO_0000631 | — | 2 | — | — | — | — | 2 |
| Juvenile arthritis | D001171 | EFO_1002007 | M08 | 1 | — | — | — | 1 | 2 |
Show 28 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hemophagocytic lymphohistiocytosis | D051359 | — | D76.1 | — | — | — | — | 2 | 2 |
| Diabetic neuropathies | D003929 | EFO_1000783 | — | — | — | — | — | 2 | 2 |
| Intermittent claudication | D007383 | EFO_0003876 | I73.9 | — | — | — | — | 1 | 1 |
| Lupus nephritis | D008181 | EFO_0005761 | — | — | — | — | — | 1 | 1 |
| Chediak-higashi syndrome | D002609 | Orphanet_167 | D72.0 | — | — | — | — | 1 | 1 |
| Iga vasculitis | D011695 | EFO_1000965 | D69.0 | — | — | — | — | 1 | 1 |
| Giant cell arteritis | D013700 | EFO_1001209 | M31.6 | — | — | — | — | 1 | 1 |
| Thrombocytopenic purpura idiopathic | D016553 | EFO_0007160 | D69.3 | — | — | — | — | 1 | 1 |
| Churg-strauss syndrome | D015267 | EFO_0007208 | M30.1 | — | — | — | — | 1 | 1 |
| Polyarteritis nodosa | D010488 | EFO_0009012 | M30.0 | — | — | — | — | 1 | 1 |
Show 13 more
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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Tabular view
Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 6,808 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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73,519 adverse events reported
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