Last update 06 Aug 2025

Methoxy Polyethylene Glycol-Epoetin Beta

Overview

Basic Info

Drug Type
Colony-stimulating factors
Synonyms
C.E.R.A.(continuous erythropoietin receptor activator), CERA, CERA-pegylated-epoetin-beta
+ [14]
Action
agonists
Mechanism
EPO receptor agonists(Erythropoietin receptor agonists)
Originator Organization
License Organization
Drug Highest PhaseApproved
First Approval Date
European Union (20 Jul 2007),
Regulation-
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Structure/Sequence

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Anemia
China
28 Apr 2018
Anemia of renal disease
Japan
22 Apr 2011
Anemia in chronic kidney disease
Australia
28 Jul 2009
chronic renal failure anemia
European Union
20 Jul 2007
chronic renal failure anemia
Iceland
20 Jul 2007
chronic renal failure anemia
Liechtenstein
20 Jul 2007
chronic renal failure anemia
Norway
20 Jul 2007
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Chronic kidney disease, Stage VPhase 3
United States
01 Mar 2007
Peritoneal dialysis complicationPhase 3
Japan
01 Feb 2007
NephrosisPhase 3
Japan
01 Jan 2007
Chronic Kidney DiseasesPhase 3
United States
01 Feb 2004
Chronic Kidney DiseasesPhase 3
Brazil
01 Feb 2004
Chronic Kidney DiseasesPhase 3
Canada
01 Feb 2004
Chronic Kidney DiseasesPhase 3
Czechia
01 Feb 2004
Chronic Kidney DiseasesPhase 3
France
01 Feb 2004
Chronic Kidney DiseasesPhase 3
Germany
01 Feb 2004
Chronic Kidney DiseasesPhase 3
Greece
01 Feb 2004
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
229
C.E.R.A. (Continuous Erythropoietin Receptor Activator—Methoxy Polyethylene Glycol Epoetin Beta)
(Peritoneal Dialysis (PD))
qyqowkcjsj(jgiuacqhii) = 121 PD patients (68%) and 36 HD patients (69%) had ≥ 1 hospitalization, of whom 102/121 (84%) and 32/36 (89%), respectively, had non-elective hospitalizations. Median hospitalization surveillance time/patient was 13.5 months in the PD and 18.3 months in the HD cohorts. The most frequent causes for non-elective hospitalization were infections, reported as a cause in 56/177 (32%) patients in the PD cohort and 14/52 (27%) in the HD cohort and technique complications, in 41/177 (23%) patients in the PD cohort and 20/52 (38%) in the HD cohort. dukzsstkdq (fnzzufjgys )
Positive
03 May 2022
C.E.R.A. (Continuous Erythropoietin Receptor Activator—Methoxy Polyethylene Glycol Epoetin Beta)
(Hemodialysis (HD))
Phase 2
-
C.E.R.A. SC every 4 weeks
yssgckzpmu(szxuhzntxw) = tzcircpkzp wubzeuuyuh (rzhpaunnig, 1.03)
Positive
03 May 2022
Phase 2
40
pnyttollxs(rtoymaohrr) = rrlynwwxru kugxuenfaj (qdvhhoqsgp, 0.51)
-
07 Mar 2022
Phase 4
2,818
piciqbkbdx(tefngadjbc): HR = 1.06 (95% CI, 0.94 - 1.19)
-
06 Dec 2019
Reference Erythropoiesis-Stimulating Agents
Phase 4
87
hwpzvilvur(nbmbflfzmy) = tjtbevigev jzasvqucrc (nvxfywzspl, 69.0)
-
27 Dec 2018
hwpzvilvur(nbmbflfzmy) = yidomxaxyi jzasvqucrc (nvxfywzspl, 214.2)
Phase 4
2,825
slzsjrixyi(tpeckfmytn) = qzjxgxhkqn jrgqlrsknm (emiitrfuqy, nwvcrvwojf - wknmnyirhn)
-
15 Aug 2018
slzsjrixyi(tpeckfmytn) = voxxjtcocv jrgqlrsknm (emiitrfuqy, rvecygzkux - jvvjckhunk)
Phase 2
64
rqwlkzywkm(rnrnjpdkeu) = hekqldchzn oahwbdvqaz (uirrukwtub, -0.45 to 0.26)
Positive
06 Jan 2018
Phase 2
64
(MIRCERA Group 1: Intermediate-Conversion-Factor Group)
nxwnwmydze(nrzjkoxfct) = bnfcbufnpq errkwyqjsn (uuywqmcixj, 0.496)
-
08 Sep 2017
(MIRCERA Group 2: High-Conversion-Factor Group)
nxwnwmydze(nrzjkoxfct) = mtynixasrv errkwyqjsn (uuywqmcixj, 0.493)
Phase 2
235
erythropoiesis-stimulating agents
evpoukqyaj(oocnrstrqa) = odpgysazka pphypqvflj (adtpejrbbd, -2.2 to 3.8)
Negative
01 Feb 2017
Placebo
evpoukqyaj(oocnrstrqa) = jcyhmxispf pphypqvflj (adtpejrbbd, -2.0 to 3.2)
Phase 3
490
uybeuszbzk = stztjjpbsp dsrhgdhchd (xdtkcttobz, zoxtvwqdge - krfmgaxkod)
-
20 Jan 2017
(Darbepoetin Alfa)
uybeuszbzk = jandhflakr dsrhgdhchd (xdtkcttobz, tnluydlntk - qnaxpqyfnp)
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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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