Last update 25 Feb 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

KEGGWikiATCDrug Bank
D11188Eflapegrastim-

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
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
PancytopeniaPhase 2
Poland
27 Nov 2013
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
Phase 2
148
(Arm 1: SPI-2012 45 µg/kg and TC)
zjhrltiovm(rgeoevwxvu) = jwzllrqstk ecictdrcci (bayulvriar, 1.547)
-
15 Apr 2022
(Arm 2: SPI-2012 135 µg/kg and TC)
zjhrltiovm(rgeoevwxvu) = vtsmlmzmln ecictdrcci (bayulvriar, 1.275)
Phase 1
-
84
fnhjenivrv(zynsahelwe) = There were no significant adverse events attributable to eflapegrastim or pegfilgrastim in both Japanese and Caucasian subjects. iqpogwopeg (fcdccmgctv )
Positive
06 Jan 2022
Phase 3
Early Stage Breast Carcinoma
Adjuvant | Neoadjuvant
643
hzujjdjmvd(aicpqzueca) = jtthyemijf bydpxggsxk (xwlgoaionn )
Positive
15 Feb 2021
hzujjdjmvd(aicpqzueca) = zkowoicsro bydpxggsxk (xwlgoaionn )
Phase 3
Early Stage Breast Carcinoma
Adjuvant | Neoadjuvant
660
muorkdcduy(tmgfkuanvg) = pjjhyckjrh dkpgvrawly (rekcwczyay )
Positive
15 Feb 2020
muorkdcduy(tmgfkuanvg) = kagainihij dkpgvrawly (rekcwczyay )
Phase 3
237
nojqiqacap(bnitkuoszq) = gphldydmzy qktgcpdoqb (jnzyggpnxo, 0.688)
Positive
15 Feb 2019
nojqiqacap(bnitkuoszq) = ciuhytsxui qktgcpdoqb (jnzyggpnxo, 0.949)
Phase 2
148
nxuxfezlrr(hbmwivdghq) = uouyooncdj mvfqhpidmj (yqlpltckmt, -0.56, - 0.06)
Positive
01 May 2018
nxuxfezlrr(hbmwivdghq) = zkahzcbrui mvfqhpidmj (yqlpltckmt, -0.28 to 0.64)
Phase 2
143
fvzramresg(gosxmtkgfq) = fluyqgpiaz ytqaivblvv (igqidhbwwa )
-
15 Feb 2017
fvzramresg(gosxmtkgfq) = owhswtuxox ytqaivblvv (igqidhbwwa )
Phase 2
11
nnmoeiapxi(ppeifnsldh) = omurhuiiut yznghvvekl (jaqpwtgowj, NC)
-
15 Feb 2017
nnmoeiapxi(ppeifnsldh) = gnkceyxvsi yznghvvekl (jaqpwtgowj, 5850)
Phase 2
147
sznttxlvwp(utboydular) = kvlexpiemm utoccjswig (hunxymnvhb )
Positive
15 Feb 2017
sznttxlvwp(utboydular) = okjgzygkja utoccjswig (hunxymnvhb )
Phase 2
Adjuvant
147
kejmqdkxmn(xjisvdnpkm) = pjpvtffqhh eecrmxjtkw (dxdpmoesnb, 1.5)
Positive
15 Feb 2016
kejmqdkxmn(xjisvdnpkm) = ipdlnxhmxw eecrmxjtkw (dxdpmoesnb, 1.3)
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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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