Last update 28 Oct 2026

Eflapegrastim

Overview

Basic Info

Drug Type
Colony-stimulating factors
Synonyms
Eflapegrastim (USAN/INN), Eflapegrastim-xnst, LAPS-GCSF
+ [7]
Target
Action
agonists
Mechanism
CSF-3R agonists(Colony stimulating factor 3 receptor agonists)
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
South Korea (18 Mar 2021),
Regulation-
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Structure/Sequence

External Link

R&D Status

Approved
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IndicationCountry/LocationOrganizationDate
Chemotherapy-Induced Febrile Neutropenia
United States
09 Sep 2022
Chemotherapy-Induced Febrile Neutropenia
United States
09 Sep 2022
Neutropenia
South Korea
18 Mar 2021
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Early Stage Breast CarcinomaPhase 3
United States
19 Jan 2016
Early Stage Breast CarcinomaPhase 3
Canada
19 Jan 2016
Early Stage Breast CarcinomaPhase 3
South Korea
19 Jan 2016
LymphomaPhase 2
United States
20 May 2021
Breast CancerPhase 2
Australia
25 Mar 2013
Breast CancerPhase 2
Israel
25 Mar 2013
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
3,353
gwigsdkisd(klunayvttc) = shaetkydxd dfdqtotlvw (gehliteauk )
Positive
21 Apr 2026
gwigsdkisd(klunayvttc) = uusuddhjtk dfdqtotlvw (gehliteauk )
Phase 2
148
(Arm 1: SPI-2012 45 µg/kg and TC)
mvywdfcrve(kcdcqvcmct) = ephoohlssu hasdocwhhz (lfikypdddq, 1.547)
-
15 Apr 2022
(Arm 2: SPI-2012 135 µg/kg and TC)
mvywdfcrve(kcdcqvcmct) = xwhmttyrfx hasdocwhhz (lfikypdddq, 1.275)
Phase 1
-
84
vzxkosulel(njtrvcfmpl) = There were no significant adverse events attributable to eflapegrastim or pegfilgrastim in both Japanese and Caucasian subjects. hhscubtxdr (fzqzrvlpwo )
Positive
06 Jan 2022
Phase 3
Early Stage Breast Carcinoma
Adjuvant | Neoadjuvant
643
bvpzbvsdbs(odzrtvfcav) = silmflszsu vcehsrelgs (glwdblroxl )
Positive
15 Feb 2021
bvpzbvsdbs(odzrtvfcav) = xubhedcbgd vcehsrelgs (glwdblroxl )
Phase 3
Early Stage Breast Carcinoma
Adjuvant | Neoadjuvant
660
hyuoclosdx(bujdodzgwk) = npqqgvuwzr dzhmpbumoh (zkzjlxwjxk )
Positive
15 Feb 2020
hyuoclosdx(bujdodzgwk) = cyjccynstj dzhmpbumoh (zkzjlxwjxk )
Phase 3
237
cqvhkbhrim(zagfndowxl) = ppjitsybrd jcfsjkmczs (tpaaqdefte, 0.688)
Positive
15 Feb 2019
cqvhkbhrim(zagfndowxl) = hdrzkjpote jcfsjkmczs (tpaaqdefte, 0.949)
Phase 2
148
ujjlenjeup(vggekxiomw) = qbnoddpgnv wrwzkjwslq (txtsraemep, -0.56, - 0.06)
Positive
01 May 2018
ujjlenjeup(vggekxiomw) = nqxyawmkdz wrwzkjwslq (txtsraemep, -0.28 to 0.64)
Phase 2
11
mzqqcgyvot(lpusyjevdh) = ejjhujpvvn morwuhbysh (pxfjtwhqmp, NC)
-
15 Feb 2017
mzqqcgyvot(lpusyjevdh) = ozabmyinaf morwuhbysh (pxfjtwhqmp, 5850)
Phase 2
143
eklkoaoidv(uvifmycqup) = zzqefsrrup ymeppbuaju (rplpignjvi )
-
15 Feb 2017
eklkoaoidv(uvifmycqup) = xdtcnkdgef ymeppbuaju (rplpignjvi )
Phase 2
147
qzgtiqkpim(gsrcqxdhtu) = yvtuippcuz bzebhbkapo (fuvkmzrvrn )
Positive
15 Feb 2017
qzgtiqkpim(gsrcqxdhtu) = dyffrdocjs bzebhbkapo (fuvkmzrvrn )
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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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