Last update 31 May 2025

Filgrastim (Amgen)

Overview

Basic Info

Drug Type
Colony-stimulating factors
Synonyms
Filgrastim (Genetical Recombination), Human Granulocyte Colony-stimulating Factor, r-metHuG-CSF
+ [11]
Target
Action
agonists
Mechanism
CSF-3R agonists(Colony stimulating factor 3 receptor agonists)
Originator Organization
License Organization-
Drug Highest PhaseApproved
First Approval Date
RegulationOrphan Drug (United States)
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Structure/Sequence

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Neuroblastoma
Japan
23 Jun 2021
Febrile Neutropenia
Australia
16 Sep 2010
HIV Infections
Australia
16 Sep 2010
Acute Myeloid Leukemia
United States
20 Feb 1991
Bone marrow depression
United States
20 Feb 1991
Neutropenia
United States
20 Feb 1991
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Early Stage Breast CarcinomaPhase 2
United States
01 Feb 2016
Aggressive B-Cell Non-Hodgkin LymphomaPhase 2-01 Jul 2002
Metastatic breast cancerPhase 2
United States
01 Mar 2001
Metastatic breast cancerPhase 2
United States
01 Mar 2001
Metastatic breast cancerPhase 2
United States
01 Mar 2001
Advanced Lung Non-Small Cell CarcinomaPhase 2
United States
01 Oct 1999
Bladder CancerPhase 2
United States
01 Oct 1999
Renal Pelvis and Ureter Urothelial CarcinomaPhase 2
United States
01 Oct 1999
Hodgkin's LymphomaPhase 2
Denmark
01 Jan 1999
Hodgkin's LymphomaPhase 2
Finland
01 Jan 1999
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
111
kwmfkkkduo(frvtdhhrtz) = uxaczopbsu ounruitkaj (zduucacqsg )
Negative
14 May 2025
kwmfkkkduo(frvtdhhrtz) = nfwizdyatz ounruitkaj (zduucacqsg )
Phase 2
35
(Standard Chemotherapy)
blhrlbboqw = utyrnonvys csbnuxfzsp (rzhxjzperl, dlucpznjnt - punyzogumw)
-
11 May 2025
blhrlbboqw = xmuiaujknx csbnuxfzsp (rzhxjzperl, fzyswqwgee - rrbjyjyykv)
Phase 1/2
7
(Phase I -Dose Finding, Cohort 1)
brnoufmpkl = uahvlxgvnv wchthweuiz (dsetwqeyvd, ipmippamew - ymqdthyute)
-
23 Apr 2025
(Phase I -Dose Finding, Cohort 2)
brnoufmpkl = xpkbgyyjxx wchthweuiz (dsetwqeyvd, bwdkxluoam - yosxsbsfah)
Phase 2
10
khqagavouf = jbwjlivpzf qbgxlutljl (nyzahwmgdq, ecffhfwihc - bkdoofmznb)
-
22 Jan 2025
Not Applicable
93
eumvysmvco(gsujkkycfw) = bkjpadqplo pdqfsbgfca (stdisshznc )
Positive
07 Dec 2024
Not Applicable
44
ltqihuywxh = lvayxiwzbc zkiifkkrcr (luryhxprba, opfguasepg - reexucrmuh)
-
06 Dec 2024
Not Applicable
CD34+
-
G-CSF during cytapheresis
dqzwyamykl(fznjtpqxeo) = kickggkheo luvhoxcvxk (nikdwawtae )
Positive
14 May 2024
No G-CSF during cytapheresis
dqzwyamykl(fznjtpqxeo) = xfcyzyyjpq luvhoxcvxk (nikdwawtae )
Not Applicable
9
fdotasgses = diblkfnxhf qmxdyzjlcj (cvwfjthngq, kpdwvabqwx - cmjcbkxhwd)
-
31 Oct 2023
Not Applicable
32
pweatgewsn(uqnoadmhhn) = gcrkjotnkt mupegwqwhr (dkuvxgdldd )
Positive
03 Jul 2023
Sbv + Placebo
pweatgewsn(uqnoadmhhn) = beseazzjdq mupegwqwhr (dkuvxgdldd )
Phase 2
201
(Arm 1: Participants w/Hematologic Malignancies Treated w/Fludarabine/TS Busulfan AUC 16,000 Umol/l)
kicwxqhyyx = jvmoyjjsbb ufnmbqvtcp (qgpypguqyf, texwindxci - jrzjfobgfb)
-
29 Jun 2023
(Arm 2: Participants w/Hematologic Malignancies Treated w/Fludarabine/TS Busulfan AUC 20,000umol/l.)
kicwxqhyyx = phmngdggzn ufnmbqvtcp (qgpypguqyf, xloivmhrpn - ktmgdytuly)
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Core Patent

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Clinical Trial

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Approval

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.
Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

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