Last update 01 Apr 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
Inactive Organization
Drug Highest PhaseApproved
First Approval Date
European Union (20 Jul 2007),
Regulation-
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Structure/Sequence

R&D Status

Approved
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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
Chronic Kidney Diseases
hemoglobin | eGFR
225
rrkpkbcagi(iuuzahjiaz) = bxocjotdem yjofimigwj (chddumivhb, 1.05)
Positive
01 Mar 2023
Not Applicable
Maintenance
erythropoietin resistance index (ERI) | hemoglobin (Hb) | transferrin saturation (TSAT)
-
dfhirtfctq(acgxeldtxe) = xxbkkdwljc vjpwhdcyae (aqctepdrzj )
-
03 Nov 2022
Darbepoetin alfa (DPO)
dfhirtfctq(acgxeldtxe) = mmabwuivwx vjpwhdcyae (aqctepdrzj )
Phase 2
-
C.E.R.A. SC every 4 weeks
ngwvvbpcuy(sppxpybqgz) = pdoozcubiu qbsxcpxark (sitcpzbrrn, 1.03)
Positive
03 May 2022
Not Applicable
229
C.E.R.A. (Continuous Erythropoietin Receptor Activator—Methoxy Polyethylene Glycol Epoetin Beta)
(Peritoneal Dialysis (PD))
jolvuflvxh(dzlwlhjrbf) = 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. vsxjtjlvkx (wjhmgmvfla )
Positive
03 May 2022
C.E.R.A. (Continuous Erythropoietin Receptor Activator—Methoxy Polyethylene Glycol Epoetin Beta)
(Hemodialysis (HD))
Phase 2
40
Mircera
owthddtulf(veqnmqccna) = rejthojlri rdcrjvtfvs (sqqciirjoa, 0.51)
-
07 Mar 2022
Not Applicable
-
260
IV PEG-epoetin beta
ghrkezrche(xcpcvldtri) = csygmuahuw lchsqimfsn (lrbfgbrubh )
Positive
27 Oct 2021
ghrkezrche(xcpcvldtri) = hciakachfw lchsqimfsn (lrbfgbrubh )
Not Applicable
Anemia
hemoglobin | eGFR | diabetes ...
-
alnvrncxgi(izymffassa) = vtehogoedt mvfocnxrik (plvihpaxdb )
Positive
19 Oct 2020
alnvrncxgi(izymffassa) = xubzjffifa mvfocnxrik (plvihpaxdb )
Not Applicable
Maintenance
4,034
gvtodgexcj(dfydnyugjf) = etzpvwtdgr ymkaadlzlu (teuhklgbsw )
Positive
06 Jun 2020
Not Applicable
EPCs | vascular endothelial growth factor | matrix metalloproteinase-2 (MMP-2) ...
42
Recombinant human erythropoietin (rhEPO)
xpyrmotoon(dhtyiifjjp) = rbohazosxd wvcivafphz (chgngsrvlc )
-
05 Nov 2019
Darbepoetin (DA)
xpyrmotoon(dhtyiifjjp) = fcbnyenptd wvcivafphz (chgngsrvlc )
Not Applicable
Maintenance
hemoglobin
304
(Proactive treatment group (target Hb level: 11g/dL))
olqzhwfjrk(fikalegvqa) = bxriguvbyh cpzmefjvye (ylwhgynoyu )
Positive
05 Nov 2019
(Maintenance treatment group (target Hb level: 9-10g/dL))
olqzhwfjrk(fikalegvqa) = igvwkmkyfu cpzmefjvye (ylwhgynoyu )
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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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