Filgrastim - PharmaKB

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.

Download report

Favorite

Events Timeline

Commercial

Clinical

Drug

Target

Variants

Financial

Trends

Safety

Events Timeline

YTD

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

Mock data
Subscribe for the real data

Commercial

Therapeutic Areas

Therapeutic Area	MeSH
neoplasms	D009369
hemic and lymphatic diseases	D006425
therapeutics	D013812
operative surgical procedures	D013514

Trade Name

FDA

EMA

Neupogen, Nivestym, Releuko, Zarxio (discontinued: Zarxio)

Drug Products

FDA

EMA

Reference product - 351(a)

Interchangeable product - 351(k)

Biosimilar product - 351(k)

Filgrastim

Tradename	Proper name	Company	Number	Date	Products
Neupogen	filgrastim	Amgen	N-103353 RX	1991-02-20	4 products

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
releuko	Biologic Licensing Application	2023-08-25
zarxio	Biologic Licensing Application	2024-10-25

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

ATC Codes

L: Antineoplastic and immunomodulating agents

— L03: Immunostimulants

— L03A: Immunostimulants

— L03AA: Colony stimulating factors

— L03AA02: Filgrastim

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

1522 clinical trials

View more details

Mock data
Subscribe for the real data

Indications Phases 4

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Lymphoma	D008223	—	C85.9	82	222	47	6	26	346
Leukemia	D007938	—	C95	103	206	52	5	30	343
Myeloid leukemia acute	D015470	—	C92.0	48	99	29	1	12	167
Multiple myeloma	D009101	—	C90.0	39	94	22	2	16	155
Myelodysplastic syndromes	D009190	—	D46	45	88	18	2	12	140
Non-hodgkin lymphoma	D008228	—	C85.9	34	91	18	3	10	137
Plasma cell neoplasms	D054219	—	—	34	80	22	2	13	137
Breast neoplasms	D001943	EFO_0003869	C50	32	63	37	12	8	135
Neoplasms	D009369	—	C80	58	53	14	1	10	120
Preleukemia	D011289	—	—	34	68	13	1	9	106

Show 53 more

Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Myeloid leukemia	D007951	—	C92	47	102	29	—	10	166
Hodgkin disease	D006689	—	C81	12	46	12	—	3	65
Sarcoma	D012509	—	—	18	38	11	—	3	65
Recurrence	D012008	—	—	26	31	4	—	3	55
Myeloproliferative disorders	D009196	—	D47.1	21	29	4	—	7	55
Central nervous system neoplasms	D016543	—	—	17	30	5	—	2	50
Ovarian neoplasms	D010051	EFO_0003893	C56	23	29	5	—	3	49
Bcr-abl positive chronic myelogenous leukemia	D015464	EFO_0000340	—	12	33	4	—	3	48
Nervous system neoplasms	D009423	—	—	16	29	5	—	1	47
Large b-cell lymphoma diffuse	D016403	—	C83.3	18	25	5	—	4	43

Show 130 more

Indications Phases 2

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
B-cell lymphoma marginal zone	D018442	—	C88.4	7	7	—	—	3	14
Hiv infections	D015658	EFO_0000764	B20	4	6	—	—	4	14
Biphenotypic leukemia acute	D015456	—	C95.0	6	10	—	—	—	12
Pancreatic neoplasms	D010190	EFO_0003860	C25	6	6	—	—	1	11
Waldenstrom macroglobulinemia	D008258	HP_0005508	C88.0	5	7	—	—	2	11
Fanconi anemia	D005199	Orphanet_84	D61.09	5	8	—	—	1	11
Fanconi syndrome	D005198	—	—	5	8	—	—	1	11
Fallopian tube neoplasms	D005185	—	—	6	3	—	—	1	9
Pancytopenia	D010198	HP_0001876	D61.81	1	7	—	—	2	9
Acute disease	D000208	—	—	5	3	—	—	2	8

Show 176 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
Rheumatoid arthritis	D001172	EFO_0000685	M06.9	2	—	—	—	2	4
Arthritis	D001168	HP_0001369	M05-M14	2	—	—	—	2	4
Primitive neuroectodermal tumors peripheral	D018241	—	—	2	—	—	—	1	3
Peripheral arterial disease	D058729	EFO_0004265	—	2	—	—	—	—	2
Peripheral vascular diseases	D016491	EFO_0003875	I73.9	2	—	—	—	—	2
Neoplasms by histologic type	D009370	—	—	2	—	—	—	—	2
Meningioma	D008579	EFO_0003098	D32.9	2	—	—	—	—	2
Vasculitis	D014657	HP_0002633	—	1	—	—	—	1	2
Juvenile arthritis	D001171	EFO_1002007	M08	1	—	—	—	1	2

Show 43 more

Indications Without Phase

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Arterial occlusive diseases	D001157	EFO_0009085	—	—	—	—	—	2	2
Hemophagocytic lymphohistiocytosis	D051359	—	D76.1	—	—	—	—	2	2
Diabetic neuropathies	D003929	EFO_1000783	—	—	—	—	—	2	2
Brain injuries	D001930	—	S06.9	—	—	—	—	2	2
Intermittent claudication	D007383	EFO_0003876	I73.9	—	—	—	—	1	1
Abnormal karyotype	D059786	—	—	—	—	—	—	1	1
Lupus nephritis	D008181	EFO_0005761	—	—	—	—	—	1	1
Nephritis	D009393	—	N05	—	—	—	—	1	1
Chediak-higashi syndrome	D002609	Orphanet_167	D72.0	—	—	—	—	1	1
Arteritis	D001167	EFO_0009011	I77.6	—	—	—	—	1	1

Show 31 more

Epidemiology

Epidemiological information for investigational and approved indications

View more details

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)	—