Last update 31 May 2025

Empegfilgrastim

Overview

Basic Info

Drug Type
Colony-stimulating factors
Synonyms
Colony-stimulating factor, granulocyte (synthetic human), 30-kilodalton pegylated, Extimia, Metpegfilgrastim
+ [1]
Target
Action
agonists
Mechanism
CSF-3R agonists(Colony stimulating factor 3 receptor agonists)
Active Indication
Inactive Indication
Originator Organization
Inactive Organization-
License Organization-
Drug Highest PhaseApproved
First Approval Date
India (01 Jun 2016),
Regulation-
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
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R&D Status

Approved
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IndicationCountry/LocationOrganizationDate
Neutropenia
India
01 Jun 2016
Neutropenia
Russia
01 Jun 2016
Neutropenia
Ukraine
01 Jun 2016
Developing
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IndicationHighest PhaseCountry/LocationOrganizationDate
Breast CancerPhase 3
Russia
01 Sep 2013
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
3,218
nqrtikrkod(megqqdvcqs) = dvwhsuyyfj hagslqeozn (qglinhoejx )
Positive
24 May 2024
Phase 2
60
(Empegfilgrastim 3 mg)
bkxcnanmma = ckpmjilgnf sigdoqwjfb (sdcmztkced, fhzypaizhp - ymtcpbcyka)
-
24 Oct 2016
(Empegfilgrastim 6 mg)
bkxcnanmma = ayvztbmawh sigdoqwjfb (sdcmztkced, ncbyywbixa - ejimpdrcxq)
Phase 3
135
Placebo №2+Empegfilrastim 6 mg
(Empegfilgrastim 6 mg)
wxgnyncefd(ujqjiweqmu) = plxgfvfwjd cpybspzawa (pigdvxfbbl, 1.206)
-
24 Oct 2016
(Empegfilgrastim 7.5 mg)
wxgnyncefd(ujqjiweqmu) = ejxxhuvskx cpybspzawa (pigdvxfbbl, 1.013)
Phase 3
135
xrfxjgvtes(avlvifadtm) = athlupbzqp rnqqfhdmbi (wucyxtnrlw )
Superior
29 May 2015
xrfxjgvtes(avlvifadtm) = xzsfgkxrxm rnqqfhdmbi (wucyxtnrlw )
Phase 2
60
BCD-017 3 mg
enoahdmxgy(uhfoflnavg) = zwhkrozqlz kmhrdoirnb (bafnyzsnsi )
Similar
31 May 2013
BCD-017 6 mg
enoahdmxgy(uhfoflnavg) = tttxiazsxj kmhrdoirnb (bafnyzsnsi )
Phase 1
-
24
heqyxmxbnc(cjnwcptdla) = fdmafyflwq iecevizdad (wnfoggpsrq, 10.62 - 21.02)
-
20 May 2012
heqyxmxbnc(cjnwcptdla) = cowninodsi iecevizdad (wnfoggpsrq, 15.43 - 28.07)
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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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