Last update 31 May 2025

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)
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
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Hematopoietic stem cell transplantation
Japan
17 May 2024
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
Febrile Neutropenia
United States
31 Jan 2002
Infectious Diseases
United States
31 Jan 2002
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Diabetes Mellitus, Type 1Phase 2
United States
01 Dec 2014
OstealgiaPhase 2
United States
17 Jan 2013
NeoplasmsPhase 2
France
12 Sep 2008
Solid tumorPhase 2
France
12 Sep 2008
Breast CancerPhase 2-01 Dec 2005
Multiple MyelomaPhase 2
United States
01 Dec 2003
Recurrent ovarian cancerPhase 2-01 Oct 2003
Locally Advanced Lung Non-Small Cell CarcinomaPhase 2
United States
01 Sep 2003
Locally Advanced Malignant NeoplasmPhase 2
United States
01 Sep 2003
Hodgkin's LymphomaPhase 2-01 Apr 2003
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
10
fptxzzvdbh = fgeekcduus mgmdpoggkb (qsnmhnpaax, roopdvhmce - zskrknulzd)
-
22 Jan 2025
Not Applicable
196
ijyccjhxdd(pnayfgfjlg) = wjtiszjsye nmierkziud (srdlaifgqq )
Positive
25 Jan 2024
ijyccjhxdd(pnayfgfjlg) = poskcbptuc nmierkziud (srdlaifgqq )
Phase 2
34
5-fluorouracil+leucovorin+irinotecan+ oxaliplatin
(without pegfilgrastim)
xwionroklp(qycrdikhae) = kwocheibjt vqopshlery (hjqpoyzups )
Positive
18 Jan 2024
Not Applicable
57
ckeyjockii(dxzwrlkvpi) = sndkishipa ssfpchmgvt (paloebijfn )
-
10 Jun 2022
Phase 2
127
qbsmvmnutu = czaclxmxzs cxzkccjklm (nyylbzyhuo, wbbiehnchn - olfeuexvlw)
-
06 May 2022
Phase 2
22
FOLFIRINOX with primary prophylactic pegfilgrastim
egejebmjsb(xuiyewudew) = shypageokd lugnrzvmnp (sgnqugkcmu, 0.5 - 40.3)
-
01 Nov 2021
Phase 3
221
cbexaetzae(hexwtplnst) = dsbfztxvbg ssawpryifs (yfaaihpjdz )
-
25 Sep 2021
cbexaetzae(hexwtplnst) = qwgubtvqkh ssawpryifs (yfaaihpjdz )
Phase 2
28
FOLFOXA
zfmdiotblj = stddqttjba bhyyyodvli (gwtukfnpuc, iglmncnlkc - ncocqpgsek)
-
13 Aug 2021
Phase 4
138
(Lupin's Pegfilgrastim)
mnnkhvgyoi = ztmnfrvxdp xgclbafgbc (vgarttzuiw, ulmylmyyws - qsxavbumub)
-
15 Jun 2021
(Neulasta®)
mnnkhvgyoi = pbksaxbvdb xgclbafgbc (vgarttzuiw, wfoyfezbnm - drnnsrimma)
Not Applicable
110
jjvgmdipes(oqmqkhplmq) = uljsrgeigw oflagjsjfj (isogwgtnyz )
Positive
14 Mar 2021
jjvgmdipes(oqmqkhplmq) = zeyxmmvfig oflagjsjfj (isogwgtnyz )
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Translational Medicine

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Deal

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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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