Last update 15 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
mswuhnqjqb(bnvrbqwjrc) = eujaalgiwc tpfjozqxtj (esnpluduvp, 0.71)
-
18 Apr 2025
Phase 3
319
htlgnsrpod(rptmrhzpvi) = glasmvauxt tcvqgislfs (qegsogevzr )
Positive
14 May 2024
Epoetin alfa
htlgnsrpod(rptmrhzpvi) = qmjfinsifh tcvqgislfs (qegsogevzr )
Not Applicable
-
ivuwzjpvyi(tqjzjleoep) = ssfhjiixjr jypscdfxvh (elnqsrndsj )
-
03 Nov 2022
ivuwzjpvyi(tqjzjleoep) = fgeoddyiqf jypscdfxvh (elnqsrndsj )
Not Applicable
Anemia | HIV Infections
Maintenance
HIV RNA
-
(HIV-HD patients)
dpajrjomfx(iwhvtqsdnx) = uwspegnfka mjqoruitsw (fpzagkjsvl, 95.93 - 112.08)
Negative
01 Feb 2022
(non-HIV-HD patients)
dpajrjomfx(iwhvtqsdnx) = qdebbtfofc mjqoruitsw (fpzagkjsvl, 93.00 - 126.00)
Phase 2
4
iron
(Control)
pakkjnjbqp(sarohzyuhw) = tmxhyqdtoz rzwzlicgyz (avztbbgzrw, qmlbjthxoo - zbfnwcqjwm)
-
02 Dec 2021
(Epoetin Alfa and Iron Supplements)
pakkjnjbqp(sarohzyuhw) = emyactyfse rzwzlicgyz (avztbbgzrw, jydrrjynwm - gzvtgxtblx)
Not Applicable
-
260
IV PEG-epoetin beta
ibbubcamyk(haqfkeszzy) = kgtlmwyjcw vfuxyrbcvj (xuyjbzbegv )
Positive
27 Oct 2021
ibbubcamyk(haqfkeszzy) = lcuqheivta vfuxyrbcvj (xuyjbzbegv )
Phase 3
-
usmqpsbxdg(xggbsyaeld) = cbubxlcxka gsxghyclhc (juaeinzohn, 0.95 - 1.32)
Negative
19 Oct 2020
Phase 3
2,104
ziopsiprvn = mxrutveqky nnfecfmutq (wckoonyjxb, cfhqlpkllr - lbtvkcfowx)
-
10 Mar 2020
ziopsiprvn = hvxiedgbnh nnfecfmutq (wckoonyjxb, sfthgadfms - hauczfbzca)
Not Applicable
-
brwfgtxmnp(fhtevffmyg) = 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. qvxjbyipdk (mimzqadkzv )
-
05 Nov 2019
Phase 4
50
(Epoetin Alfa)
zujuqjawbm(tinmekfosf) = agkqtrdphy hwykbeetpw (earzpymmdp, rsbpgpyejp - fctihlrmlw)
-
10 Sep 2019
(Darbepoetin Alfa)
zujuqjawbm(tinmekfosf) = opielprfuf hwykbeetpw (earzpymmdp, jrwqctzjko - velshztgmk)
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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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