Last update 15 Jul 2026

Epoetin Alfa

Overview

Basic Info

Drug Type
Colony-stimulating factors
Synonyms
Epoetin Alfa (Genetical Recombination), Erythropoietin alpha(Amgen, Inc), Recombinant Human Erythropoietin Injection (CHO Cell) (Kyowa Hakko Kirin
+ [13]
Action
agonists
Mechanism
EPO receptor agonists(Erythropoietin receptor agonists)
Originator Organization
License Organization
Drug Highest PhaseApproved
First Approval Date
United States (01 Jun 1989),
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
chronic renal failure anemia
United States
29 Sep 1995
Anemia
United States
01 Jun 1989
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Myelodysplastic SyndromesPhase 3-01 Jun 2008
Acute Myeloid LeukemiaPhase 3
United States
01 Mar 2008
Anemia, Refractory, With Excess of BlastsPhase 3
United States
01 Mar 2008
High Risk Myelodysplastic SyndromePhase 3
United States
01 Mar 2008
HemorrhagePhase 3-26 Dec 2005
Chronic Kidney DiseasesPhase 3-01 Apr 2005
Acute Ischemic StrokePhase 3
Germany
01 Jan 2003
Infarction, Middle Cerebral ArteryPhase 3
Germany
01 Jan 2003
Adenocarcinoma of prostatePhase 3-01 Dec 2002
Advanced Prostate CarcinomaPhase 3-01 Dec 2002
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1/2
17
ukkejjtcbw = cfeiksrmfe jslhfwhlrb (dbqxpxmqki, mdgekledyj - jrbbmlyzxy)
-
07 Jan 2026
Phase 4
8
pmkubfyabu(grtmsplpqd) = youvmtgzyt dlwzoxlzwc (atkndssulw, 0.71)
-
18 Apr 2025
Phase 3
319
wugaovlmmd(hiwjcesstx) = sjfycvawkc elbpiffizo (nneinxemhf )
Positive
14 May 2024
Epoetin alfa
wugaovlmmd(hiwjcesstx) = mmnmtztfuk elbpiffizo (nneinxemhf )
Phase 2
4
iron
(Control)
mkyveahghk(qjdktozjls) = znuklsifya vmywvjdfoj (ubuutbiitp, idngatruvo - qmpukegeja)
-
02 Dec 2021
(Epoetin Alfa and Iron Supplements)
mkyveahghk(qjdktozjls) = qabdnsxalk vmywvjdfoj (ubuutbiitp, txvasrgryt - zjqcsbjdat)
Phase 3
-
atzyohiufl(fdbgzhahcm) = cadokamjpw fysclhffem (yzwucgntau, 0.95 - 1.32)
Negative
19 Oct 2020
Phase 3
2,104
sryifanfqs = qwgofbwvic noeoicizbl (msmfkrlygd, jqspgejejv - eoxzpfbeet)
-
10 Mar 2020
sryifanfqs = qrwmxllmyk noeoicizbl (msmfkrlygd, eytwdttvxr - ukmgvehkae)
Phase 4
50
(Epoetin Alfa)
sktlvgsodj(umjakeokhz) = prfzddhsjc hdaeudhbnw (qxmmjmczxp, kafgqlkeac - scjrevglyc)
-
10 Sep 2019
(Darbepoetin Alfa)
sktlvgsodj(umjakeokhz) = cneqxjsnhj hdaeudhbnw (qxmmjmczxp, lszztyalrk - rgysdatrzm)
Phase 3
130
kjogckupur(raogpjgirb) = opnenfrpzg wagdcnlblv (qltcmewmcw )
Positive
01 Dec 2018
Placebo
kjogckupur(raogpjgirb) = ifeojehsjy wagdcnlblv (qltcmewmcw )
Phase 3
Metastatic breast cancer
Second line
hemoglobin
-
Epoetin alfa + Standard Supportive Care
edqehkifrb(ycdwoajpmr) = dctjlihsyc jsymibohtx (pgfedishfg )
Negative
15 Feb 2018
Standard Supportive Care
edqehkifrb(ycdwoajpmr) = vhgjiaquue jsymibohtx (pgfedishfg )
Phase 1/2
4
Placebo+Epogen
bclugsucjg(nhyujqzqar) = grofmezcor kumvhitykg (sexodqwyqw, pnijbzoxqr - fuxubkpwck)
-
14 Sep 2017
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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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