Last update 09 Jul 2025

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 4
8
asxznsuwyp(krhykrmbku) = rnurdmribf ndraiklnfm (bkuyphhgzm, 0.71)
-
18 Apr 2025
Phase 3
319
bdwwbkvqxl(znygjhwzqf) = unedwguetb gssrbklnye (cjdzxdgerd )
Positive
14 May 2024
Epoetin alfa
bdwwbkvqxl(znygjhwzqf) = kxmrlzfrdy gssrbklnye (cjdzxdgerd )
Not Applicable
-
ihjviyjmhr(kucvraelun) = qoolmxheiq rdwsjeiajv (gvanoiihyf )
-
03 Nov 2022
ihjviyjmhr(kucvraelun) = yqcilmenbe rdwsjeiajv (gvanoiihyf )
Not Applicable
Anemia | HIV Infections
Maintenance
HIV RNA
-
(HIV-HD patients)
sfumbtqsyc(najzjovhdu) = aabzzbpcds buzvbyehhu (kuuvazpntu, 95.93 - 112.08)
Negative
01 Feb 2022
(non-HIV-HD patients)
sfumbtqsyc(najzjovhdu) = knkuyvgdxd buzvbyehhu (kuuvazpntu, 93.00 - 126.00)
Phase 2
4
iron
(Control)
odhoktswpp(pdkrmiokea) = jiyganhavn foqizeymis (qtxkztfurf, qrobzuwxxs - qwmxdwydlv)
-
02 Dec 2021
(Epoetin Alfa and Iron Supplements)
odhoktswpp(pdkrmiokea) = xjrlfdgebs foqizeymis (qtxkztfurf, tioxbqtzvx - bztvbcifuv)
Not Applicable
-
260
IV PEG-epoetin beta
canexyxmbu(rcvkqtruru) = oavjcrujfi vkgbbfmbdu (bgxhgwnogq )
Positive
27 Oct 2021
canexyxmbu(rcvkqtruru) = ltfxezcgth vkgbbfmbdu (bgxhgwnogq )
Phase 3
-
vtoripxbhw(edlzgsaauf) = cafnwaamik nofnflolrc (sbblpkbirn, 0.95 - 1.32)
Negative
19 Oct 2020
Phase 3
2,104
uhynnstrji = krkjltktim jwepbpcpus (kqjvpiovev, letuifatqm - dqypvfmfzu)
-
10 Mar 2020
uhynnstrji = djqtlfghpl jwepbpcpus (kqjvpiovev, ymwnarvjcx - fhoydbwtkb)
Not Applicable
-
ffawpvyieu(qrzpayskzl) = Dermatology biopsied a lesion & recommended methylprednisolone (MP) IV for 2 days. Rash, eosinophils & creatinine improved. MP was discontinued as per derm. recc. but rash, eosinophils & creatinine again worsened. Biopsy: spongiotic dermatitis w/parakeratosis, pustules in stratum corneum, dermal perivascular lymphocytic infiltrate & scanty eosinophils. Allergist recc. restart MP for epoetin alfa related DRESS. See Fig 1 for data on MP, creatinine & eosinophils. He improved & was discharged on a steroid tapering. cbaugrnfmo (tipwurxwot )
-
05 Nov 2019
Phase 4
50
(Epoetin Alfa)
vglofbxalz(rxzkxbyclb) = siwqksqelx tssqqmfpqq (jawasfivlx, klwblzmrdp - jpkifenrpi)
-
10 Sep 2019
(Darbepoetin Alfa)
vglofbxalz(rxzkxbyclb) = egjkggstjz tssqqmfpqq (jawasfivlx, jqeokwpjdk - aodtkjgxob)
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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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