Drug Type Colony-stimulating factors |
Synonyms C.E.R.A.(continuous erythropoietin receptor activator), CERA, CERA-pegylated-epoetin-beta + [14] |
Target |
Action agonists |
Mechanism EPO receptor agonists(Erythropoietin receptor agonists) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
Drug Highest PhaseApproved |
First Approval Date European Union (20 Jul 2007), |
Regulation- |
KEGG | Wiki | ATC | Drug Bank |
---|---|---|---|
- | Methoxy Polyethylene Glycol-Epoetin Beta |
Indication | Country/Location | Organization | Date |
---|---|---|---|
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 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Chronic kidney disease, Stage V | Phase 3 | United States | 01 Mar 2007 | |
Peritoneal dialysis complication | Phase 3 | Japan | 01 Feb 2007 | |
Nephrosis | Phase 3 | Japan | 01 Jan 2007 | |
Chronic Kidney Diseases | Phase 3 | United States | 01 Feb 2004 | |
Chronic Kidney Diseases | Phase 3 | Brazil | 01 Feb 2004 | |
Chronic Kidney Diseases | Phase 3 | Canada | 01 Feb 2004 | |
Chronic Kidney Diseases | Phase 3 | Czechia | 01 Feb 2004 | |
Chronic Kidney Diseases | Phase 3 | France | 01 Feb 2004 | |
Chronic Kidney Diseases | Phase 3 | Germany | 01 Feb 2004 | |
Chronic Kidney Diseases | Phase 3 | Greece | 01 Feb 2004 |
Not Applicable | Chronic Kidney Diseases hemoglobin | eGFR | 225 | rrkpkbcagi(iuuzahjiaz) = bxocjotdem yjofimigwj (chddumivhb, 1.05) View more | Positive | 01 Mar 2023 | ||
Not Applicable | Maintenance erythropoietin resistance index (ERI) | hemoglobin (Hb) | transferrin saturation (TSAT) | - | dfhirtfctq(acgxeldtxe) = xxbkkdwljc vjpwhdcyae (aqctepdrzj ) View more | - | 03 Nov 2022 | ||
Darbepoetin alfa (DPO) | dfhirtfctq(acgxeldtxe) = mmabwuivwx vjpwhdcyae (aqctepdrzj ) View more | ||||||
Phase 2 | Anemia in chronic kidney disease Maintenance | - | C.E.R.A. SC every 4 weeks | ngwvvbpcuy(sppxpybqgz) = pdoozcubiu qbsxcpxark (sitcpzbrrn, 1.03) View more | 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 ) View more | 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) View more | - | 07 Mar 2022 | ||
Not Applicable | - | 260 | IV PEG-epoetin beta | ghrkezrche(xcpcvldtri) = csygmuahuw lchsqimfsn (lrbfgbrubh ) View more | Positive | 27 Oct 2021 | |
ghrkezrche(xcpcvldtri) = hciakachfw lchsqimfsn (lrbfgbrubh ) View more | |||||||
Not Applicable | - | (CKD stages G1-2) | alnvrncxgi(izymffassa) = vtehogoedt mvfocnxrik (plvihpaxdb ) | Positive | 19 Oct 2020 | ||
(CKD stage G3a) | 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) ... View more | 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 ) View more | Positive | 05 Nov 2019 | |
(Maintenance treatment group (target Hb level: 9-10g/dL)) | olqzhwfjrk(fikalegvqa) = igvwkmkyfu cpzmefjvye (ylwhgynoyu ) View more |