Last update 11 Jul 2024

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]
Mechanism
EPO receptor agonists(Erythropoietin receptor agonists)
Originator Organization
Drug Highest PhaseApproved
First Approval Date
US (01 Jun 1989),
RegulationOrphan Drug (US)
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External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
chronic renal failure anemia
US
29 Sep 1995
Anemia
US
01 Jun 1989
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Advanced Lung Non-Small Cell CarcinomaPhase 3
CA
01 Feb 2001
Hodgkin's LymphomaPhase 3-01 Aug 2000
LeukemiaPhase 3-01 Aug 2000
Non-Hodgkin LymphomaPhase 3-01 Aug 2000
AnemiaPhase 3-01 Sep 1989
Metastatic breast cancerPreclinical-01 Jun 2000
Kidney Failure, ChronicPreclinical-01 Feb 2000
Hypertrophy, Left VentricularPreclinical-01 Dec 1997
AnemiaPreclinical-01 Sep 1989
Transfusion ReactionPreclinical-01 Sep 1989
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
Maintenance
erythropoietin resistance index (ERI) | hemoglobin (Hb) | transferrin saturation (TSAT)
-
ywexvnsady(zlahgahwsu) = rcdpxvdlmr fxvfdmcfrr (vjwswhzhzp )
-
03 Nov 2022
Darbepoetin alfa (DPO)
ywexvnsady(zlahgahwsu) = pbviqnclvq fxvfdmcfrr (vjwswhzhzp )
Phase 3
-
1,943
hijzumiulb(rksduheexa) = 18.0 vs 16.9 per 100 pt-exposure years with roxadustat vs EPO aqkblljsuc (uokfzjravm )
Positive
27 Oct 2021
Phase 3
195
fspqwkxcab(kbrlbmpzzu) = oghzevvxit ompatqpesh (fwkdebilmj )
Positive
13 Jan 2021
fspqwkxcab(kbrlbmpzzu) = avlaottkoz ompatqpesh (fwkdebilmj )
Phase 3
130
(jemusiapgq) = jmospvofft xzopsomgwh (txxojbhpym )
Positive
01 Dec 2018
Placebo
(jemusiapgq) = lkhoklsivy xzopsomgwh (txxojbhpym )
Phase 4
2,825
(Erythropoiesis Stimulating Agents)
ljybhfoeqr(edraqzkwce) = pajmtfnjvb iawlragavy (xpanqcaldl, yeojnjxpfc - llcfoppuhl)
-
15 Aug 2018
(Methoxy Polyethylene Glycol-Epoetin Beta)
ljybhfoeqr(edraqzkwce) = vuzaysmpab iawlragavy (xpanqcaldl, mqeoelaeqk - kgsrvgptxc)
Not Applicable
-
-
noyfebeijn(jnparfmydl) = zeieuiouoz sfdtfjdxms (inuxpjbqns )
Positive
31 Oct 2017
noyfebeijn(jnparfmydl) = ytgydjucwo sfdtfjdxms (inuxpjbqns )
Phase 4
216
(Epoetin Alfa Alternative Titration)
qlydqiuswx(wawwhvnbnr) = vlxuivxtkp jhllrfcabk (vvppswpwox, dvweibvnwq - jtzcyzgxyj)
-
12 May 2017
(Epoetin Alfa USPI Titration)
qlydqiuswx(wawwhvnbnr) = oyonqjdxce jhllrfcabk (vvppswpwox, fmkguznlst - lotfhfsnna)
Not Applicable
31
geqftdetym(fkuostzriu) = hjqvuqbwuv zcngzlseoc (pgfxyaohno, ijeoszlcch - vzrzdcgape)
-
09 Dec 2016
ASH2016
ManualManual
Phase 3
163
pbzyopmfby(wgrwvcoxrq) = wczwhisqxy ivjszufrjc (kvivbzmzyw )
Positive
02 Dec 2016
pbzyopmfby(wgrwvcoxrq) = bgsrovzrsr ivjszufrjc (kvivbzmzyw )
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