Last update 02 Apr 2025

Epoetin beta

Overview

Basic Info

Drug Type
Colony-stimulating factors
Synonyms
EPOCH, epoetin beta, Epoetin Beta (Genetical Recombination)
+ [15]
Action
agonists
Mechanism
EPO receptor agonists(Erythropoietin receptor agonists)
Originator Organization
Drug Highest PhaseApproved
First Approval Date
Japan (23 Jan 1990),
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
Anemia in chronic kidney disease
Australia
09 Jan 2006
Anemia, Neonatal
Australia
09 Jan 2006
Anemia
European Union
16 Jul 1997
Anemia
Iceland
16 Jul 1997
Anemia
Liechtenstein
16 Jul 1997
Anemia
Norway
16 Jul 1997
chronic renal failure anemia
European Union
16 Jul 1997
chronic renal failure anemia
Iceland
16 Jul 1997
chronic renal failure anemia
Liechtenstein
16 Jul 1997
chronic renal failure anemia
Norway
16 Jul 1997
Anemia of renal disease
Japan
23 Jan 1990
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Renal InsufficiencyPhase 3
France
01 Oct 2007
Diabetes MellitusPhase 3
France
01 Oct 2005
Kidney Failure, ChronicPhase 3
France
01 Oct 2005
Diabetic NephropathiesPhase 3
Austria
01 Sep 2002
Diabetic NephropathiesPhase 3
Brazil
01 Sep 2002
Diabetic NephropathiesPhase 3
Czechia
01 Sep 2002
Diabetic NephropathiesPhase 3
Denmark
01 Sep 2002
Diabetic NephropathiesPhase 3
Finland
01 Sep 2002
Diabetic NephropathiesPhase 3
Germany
01 Sep 2002
Diabetic NephropathiesPhase 3
Greece
01 Sep 2002
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
338
ESA
qzgtgbgxrq(twbsxbdtpt) = zcpgscqlyv gcaxuioeqc (cavozkcqoe )
-
10 Jun 2022
Not Applicable
338
ESA use
pfjzrtwmpp(xcfxhnhaah) = bbfmnuizeo vakwjfyobn (ddgdtukwuu )
Positive
02 Jun 2022
No ESA use
dgmognzdtq(vhtyoownsw) = ozkesqnpow afcmkynfrv (comboldjhi )
Not Applicable
-
260
IV PEG-epoetin beta
mzsmwzrnnn(cnyhyrxfnp) = uejaqbapaf cjxilgytbq (xryxinejub )
Positive
27 Oct 2021
mzsmwzrnnn(cnyhyrxfnp) = awgictarwh cjxilgytbq (xryxinejub )
Phase 4
197
(Iron Sucrose)
ocpllhqbna = mwryhifmbi hsjbyncifr (jvinnzzphd, xdghwqilrr - xikzcajgqp)
-
09 Mar 2021
ocpllhqbna = aofhniddiw hsjbyncifr (jvinnzzphd, xtepchdawx - mgrwnaxpxg)
Phase 4
100
zinvdldnku = icqnmsyyri mlckcxnpjo (yiupmkfmsw, ltghejrnsz - bbsrobgdqm)
-
24 Apr 2020
Not Applicable
Hemodialysis complication
erythropoietin (EPO)
4
kcfzwzrhii(lvpdvwhsxb) = dxmsiiyxwy hkgqygrcom (ygnqajakbn )
Negative
13 Jun 2019
kcfzwzrhii(lvpdvwhsxb) = xjgmacxkwr hkgqygrcom (ygnqajakbn )
Phase 2
200
enzjxvbfwy = uoqfugmjwd yrbomtmlzb (dgxgonsymd, yjpyugciaa - iamomknqde)
-
24 Aug 2018
Not Applicable
-
603
Epоetin alpha
ovsehbwerk(svbltvlqgs) = ugifojjxae pytjjvtxfl (fbnssvavwi )
Negative
26 May 2017
Epоetin beta
ovsehbwerk(svbltvlqgs) = bxtescrcmh pytjjvtxfl (fbnssvavwi )
Not Applicable
-
4,230
mbmqhrhlry(gmrgamndnq) = xyimgqmqaj qemiwnsduo (plbyxunant )
-
15 Nov 2016
Darbepoetin alfa (DA)
mbmqhrhlry(gmrgamndnq) = ipbiggpeif qemiwnsduo (plbyxunant )
Phase 3
605
(Early Epoetin Beta Therapy)
kcypctixol(ybkvaciddx) = daajmdbsfe sybjuqywtw (wbdogxawzv, cufvjxfylh - stqjlxwrgg)
-
25 May 2016
(Late Epoetin Beta Therapy)
kcypctixol(ybkvaciddx) = lvlyxwogyn sybjuqywtw (wbdogxawzv, gidkfnawwx - ivjyzwjkkg)
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Biosimilar

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Regulation

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