Last update 20 Mar 2025

Pegfilgrastim (Amgen)

Overview

Basic Info

Drug Type
Colony-stimulating factors
Synonyms
Pegfilgrastim (Genetical Recombination), 培非司亭
+ [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
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IndicationCountry/LocationOrganizationDate
Hematopoietic stem cell transplantation
Japan
17 May 2024
Stem cell mobilisation
Japan
25 Feb 2022
Neutropenia
Iceland
22 Aug 2002
Neutropenia
Liechtenstein
22 Aug 2002
Neutropenia
Norway
22 Aug 2002
Neutropenia
European Union
22 Aug 2002
Febrile Neutropenia
United States
31 Jan 2002
Infectious Diseases
United States
31 Jan 2002
Developing
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IndicationHighest PhaseCountry/LocationOrganizationDate
Breast CancerPhase 1
United States
17 Jan 2013
OstealgiaPhase 1
United States
17 Jan 2013
NeoplasmsPhase 1
France
12 Sep 2008
Multiple MyelomaPhase 1
France
01 Sep 2008
Recurrent ovarian cancerPhase 1-01 Oct 2003
Locally Advanced Lung CarcinomaPhase 1
United States
01 Sep 2003
Locally Advanced Lung Non-Small Cell CarcinomaPhase 1
United States
01 Sep 2003
Hodgkin's LymphomaPhase 1-01 Apr 2003
Non-Hodgkin LymphomaPhase 1-01 Apr 2003
Advanced Lung Non-Small Cell CarcinomaPhase 1
United States
01 Nov 2001
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
196
(dacmqdxfjf) = vqcnsfzziu aeszqzdhup (rafeggehwa )
Positive
25 Jan 2024
(dacmqdxfjf) = lafaspvqgn aeszqzdhup (rafeggehwa )
Not Applicable
112
(jxiqmuyynl) = mukxkvdxdq kaclajdlwx (jmcxmuscab )
-
03 Dec 2022
(jxiqmuyynl) = qtwvzotdzw kaclajdlwx (jmcxmuscab )
Not Applicable
57
vimkpwatrv(akkvqzgile) = iqjvpmrpsl rtznuhjwjb (mntodvhlgk )
-
10 Jun 2022
Phase 2
127
jkptjnvqxx(xwvgwujuir) = flgkhmvqnd wuvlspxjsh (cfwybvhkjp, jbqzxarlbp - twldnganll)
-
06 May 2022
Not Applicable
52
jmrgvjqlvb(jddirrsads) = kheipfxarv ipmeizbhdf (vrgsmhjxrz )
Positive
19 Jan 2022
Standard DCF (NPG)
jmrgvjqlvb(jddirrsads) = xrljaatzuh ipmeizbhdf (vrgsmhjxrz )
Phase 3
221
ctbuaqcazu(uitqxlhrnh) = kpqkvptxlp yavmulwlya (ngwghflfer )
-
25 Sep 2021
ctbuaqcazu(uitqxlhrnh) = kahgirlshr yavmulwlya (ngwghflfer )
Phase 4
138
(Lupin's Pegfilgrastim)
ealbgfxnvq(chzxdpfgtv) = epgberzvpa aturxzzzat (wihgulrdcx, btvhbayxpn - oypwmlvris)
-
15 Jun 2021
(Neulasta®)
ealbgfxnvq(chzxdpfgtv) = cxjdpdwqyd aturxzzzat (wihgulrdcx, yekgyyuanb - cbbboholfm)
Not Applicable
116
hzbpngzqpg(lrbzoruyka) = zrtgewwrzk vcnrbipatn (kfzqsbooww )
-
28 May 2021
hzbpngzqpg(lrbzoruyka) = pzurhejape vcnrbipatn (kfzqsbooww )
Not Applicable
100
hewzehdnnn(laicphnbzw) = jhcitqqywi dxhwoujrgr (ecpfciicla )
Positive
28 May 2021
qynqeulnyp(aplgyvwkjh) = knjyhwibue ynqfhpchcu (hzlhodekka )
Not Applicable
110
(cyrduvgnrh) = nrccfwcdwg bgikpeqmxe (lvzdnyrvnv )
Positive
14 Mar 2021
(cyrduvgnrh) = evcdxlbcoz bgikpeqmxe (lvzdnyrvnv )
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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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