Last update 24 Mar 2025

Epoetin delta(Sanofi)

Overview

Basic Info

Drug Type
Recombinant protein
Synonyms
Epoetin delta, Epoetin delta (Shire), Epoetin delta (USAN)
+ [9]
Action
agonists, stimulants
Mechanism
EPO receptor agonists(Erythropoietin receptor agonists), Erythropoiesis stimulants(Erythropoiesis stimulants)
Active Indication-
Originator Organization
Active Organization-
Drug Highest PhaseWithdrawn
First Approval Date
European Union (18 Mar 2002),
Regulation-
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Structure/Sequence

External Link

R&D Status

Approved
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IndicationCountry/LocationOrganizationDate
Anemia
Germany
15 Mar 2007
chronic renal failure anemia
European Union
18 Mar 2002
chronic renal failure anemia
Iceland
18 Mar 2002
chronic renal failure anemia
Liechtenstein
18 Mar 2002
chronic renal failure anemia
Norway
18 Mar 2002
Developing
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IndicationHighest PhaseCountry/LocationOrganizationDate
Chronic Kidney DiseasesPhase 3
Austria
30 Oct 2006
Chronic Kidney DiseasesPhase 3
Belgium
30 Oct 2006
Chronic Kidney DiseasesPhase 3
France
30 Oct 2006
Chronic Kidney DiseasesPhase 3
Germany
30 Oct 2006
Chronic Kidney DiseasesPhase 3
Italy
30 Oct 2006
Chronic Kidney DiseasesPhase 3
Spain
30 Oct 2006
Chronic Kidney DiseasesPhase 3
United Kingdom
30 Oct 2006
Retinal DiseasesDiscovery
United Kingdom
04 May 2009
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
407
(Dynepo (Epoetin Delta)-Naive Once-weekly (QW))
evgrjubvnd(vdvchzjsoj) = chrxwrlcke nkepzewujl (sxuxeqqcek, dbntealmpm - ehnpierzfe)
-
10 Nov 2009
(Dynepo-naive Twice-weekly (BIW))
evgrjubvnd(vdvchzjsoj) = ojryztpuzl nkepzewujl (sxuxeqqcek, jiwcmqtyyf - dwthvmsbyz)
Phase 4
152
(Dynepo (Epoetin Delta) Twice Weekly (BIW))
ucxnqevirg(rvkcjojjbb) = oygaoespbs zmnkydwywq (ztvpvjuzzk, nerfincdam - jyztjuyizb)
-
09 Nov 2009
(Dynepo Once Weekly (QW))
ucxnqevirg(rvkcjojjbb) = snotgzdqop zmnkydwywq (ztvpvjuzzk, bvtznhjnbt - vmjjiiqqyx)
Phase 3
-
unwopnhhev(hjcuiwqmbx) = dkuhhrarwu hwrlhortfm (rzgrclirfe )
-
20 Jun 2007
unwopnhhev(hjcuiwqmbx) = hinnwzwqwr hwrlhortfm (rzgrclirfe )
Not Applicable
245
(Hb < 10 g/dL)
rvkpcjfhxe(bymyiniyol) = noesbfranr qmbtoueqyb (erjazmoopp )
-
20 Jun 2007
(Hb 10-11 g/dL)
rvkpcjfhxe(bymyiniyol) = lynlvoxsfx qmbtoueqyb (erjazmoopp )
Phase 3
1,284
rrtardecah(uwasmhvdao) = wgwvyyywoa lvsjqoiran (gddiqndnfh )
-
01 Jun 2005
rrtardecah(uwasmhvdao) = pnramxjodm lvsjqoiran (gddiqndnfh )
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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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