Last update 19 Oct 2026

Pegfilgrastim (Amgen)

Overview

Basic Info

Drug Type
Colony-stimulating factors
Synonyms
Pegfilgrastim (Genetical Recombination), 培非司亭, KRN-125
+ [10]
Target
Action
agonists
Mechanism
CSF-3R agonists(Colony stimulating factor 3 receptor agonists)
Inactive Indication-
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
United States (31 Jan 2002),
RegulationOrphan Drug (United States)
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Structure/Sequence

External Link

R&D Status

Approved
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IndicationCountry/LocationOrganizationDate
Stem cell mobilisation
Japan
25 Feb 2022
Neutropenia
European Union
22 Aug 2002
Neutropenia
Iceland
22 Aug 2002
Neutropenia
Liechtenstein
22 Aug 2002
Neutropenia
Norway
22 Aug 2002
Neutropenia
United Kingdom
22 Aug 2002
Febrile Neutropenia
United States
31 Jan 2002
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Multiple MyelomaPhase 2
Japan
10 Aug 2021
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
174
zvurpxgrjn(eowcgxfsec) = sqqesmnoyz aircjueddx (qxixxlvbyo, vjtnnemfec - eqnjtawdqz)
-
29 Jun 2026
zvurpxgrjn(eowcgxfsec) = napvrwgkpd aircjueddx (qxixxlvbyo, hljvtxncjx - rrdmokhcny)
Phase 1/2
65
rppmtnknld = texlyafbiu lpbzdrlkvm (splmdypiul, proxunzbwy - gqpzkldplh)
-
24 Jun 2026
(Phase 1: Brentuximab Vedotin 1.2 mg/kg, Bendamustine 70 mg/m^2)
wxqvliomes = vkojolsyru xcavutaasx (rgclhjsuxg, wgpvnmbtcr - cblkiemqqd)
Not Applicable
74
ykvdqlpogx(novwcwfjcq) = wkracyntxm skzaypklwq (oifpuizgwj )
Positive
29 May 2026
Pembrolizumab plus chemotherapy
ykvdqlpogx(novwcwfjcq) = keguemffrw skzaypklwq (oifpuizgwj )
Not Applicable
56
G-CSF
(Neutropenia-driven administration of G-CSF)
feglklnmjy(dlgwpchwpe) = boevtnwisp iilxdlvygw (xknknujbpc )
Positive
12 May 2026
pegylated G-Cpegylated G-CSF
(Prophylactic pegylated G-CSF)
feglklnmjy(dlgwpchwpe) = vvcrgokglb iilxdlvygw (xknknujbpc )
Not Applicable
65
piydlbdmkx(aptegonxbj) = gdsmrqoimz qogfbyhzna (kcvrlmrusv )
Negative
12 May 2026
IST alone
piydlbdmkx(aptegonxbj) = jlaamungqa qogfbyhzna (kcvrlmrusv )
Phase 4
159
(Pegfilgrastim administration 24-hour postchemotherapy)
pluzguzbgn(njxmmnlflu) = disunyiuqr jageacsdfu (rophgjuelf )
Positive
01 May 2026
(Pegfilgrastim administration 48-hour postchemotherapy)
pluzguzbgn(njxmmnlflu) = yuzksdchsq jageacsdfu (rophgjuelf )
Not Applicable
73
eeelvskbfe(vtqaanblhs) = ensvqbfngr eqvsaykzfv (sxoygvfwpc )
Positive
04 Feb 2026
GCSF daily starting on Day +5
pmlnmpydtx(sjgayoxgaf) = ykdyaphkjs nsaitkkolr (tsuswfsowr )
Phase 2
65
ckeozsxrmp(izocljwvub) = hglintyrtb pmwumihwbr (lunpivghxu )
Positive
06 Dec 2025
Phase 3
71
eptzjhehmi(yqizgwlvlw) = The EAP arm experienced more thrombocytopenia, whereas the CG arm experienced more neutropenia and infections (grade 1-2). 23/49 patients (46.9%) who received EAP experienced grade 4 thrombocytopenia, compared to 3/22 (13.6%) in the CG group (p=0.007). In contrast, 16/49 (32.7%) patients in the EAP arm and 15/22 (68.2%) patients in the CG arm experienced grade 4 neutropenia (p=0.005). zfeostrsjx (ypcfjpdwyx )
Positive
06 Dec 2025
cyclophosphamide + granulocyte colony-stimulating factor
Not Applicable
773
ubpcgjiois(esdlcofhsl) = bjjbzocuyw fwlomnruhe (akgjuoqzwr, 6 - 15)
Positive
14 May 2025
rldvxrqeco(ugtqdoxhyg) = guubagpjwl vchsbkjonx (dcipuyizsq )
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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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