Last update 24 Jun 2025

Darbepoetin alfa

Overview

Basic Info

Drug Type
Colony-stimulating factors
Synonyms
Darbepoetin alfa (Amgen), Darbepoetin alfa (genetical recombination) (JAN), Darbepoetin alfa (USAN/INN)
+ [14]
Action
agonists
Mechanism
EPO receptor agonists(Erythropoietin receptor agonists)
Originator Organization
Drug Highest PhaseApproved
First Approval Date
European Union (08 Jun 2001),
RegulationOrphan Drug (Japan)
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Structure/Sequence

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Anemia of renal disease
Japan
07 Aug 2012
Anemia
European Union
08 Jun 2001
Anemia
European Union
08 Jun 2001
Anemia
Iceland
08 Jun 2001
Anemia
Iceland
08 Jun 2001
Anemia
Liechtenstein
08 Jun 2001
Anemia
Liechtenstein
08 Jun 2001
Anemia
Norway
08 Jun 2001
Anemia
Norway
08 Jun 2001
chronic renal failure anemia
European Union
08 Jun 2001
chronic renal failure anemia
European Union
08 Jun 2001
chronic renal failure anemia
Iceland
08 Jun 2001
chronic renal failure anemia
Iceland
08 Jun 2001
chronic renal failure anemia
Liechtenstein
08 Jun 2001
chronic renal failure anemia
Liechtenstein
08 Jun 2001
chronic renal failure anemia
Norway
08 Jun 2001
chronic renal failure anemia
Norway
08 Jun 2001
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Anemia in chronic kidney diseasePhase 3
United States
30 Jul 2012
Anemia in chronic kidney diseasePhase 3
Puerto Rico
30 Jul 2012
Anemia, Refractory, With Excess of BlastsPhase 3
Austria
21 Dec 2011
Anemia, Refractory, With Excess of BlastsPhase 3
Belgium
21 Dec 2011
Anemia, Refractory, With Excess of BlastsPhase 3
Czechia
21 Dec 2011
Anemia, Refractory, With Excess of BlastsPhase 3
France
21 Dec 2011
Anemia, Refractory, With Excess of BlastsPhase 3
Germany
21 Dec 2011
Anemia, Refractory, With Excess of BlastsPhase 3
Greece
21 Dec 2011
Anemia, Refractory, With Excess of BlastsPhase 3
Italy
21 Dec 2011
Anemia, Refractory, With Excess of BlastsPhase 3
Spain
21 Dec 2011
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
650
dhstgeyzda(ecdboeeqpw) = xeqvapxzgq xjbcdznhzm (ttunxcaezn )
Negative
12 May 2025
Placebo
dhstgeyzda(ecdboeeqpw) = xqcvygemov xjbcdznhzm (ttunxcaezn )
Phase 3
650
(Darbepoetin)
lkonzpknlh(miirwrvwcp) = salxkgldoi bqofqrruys (mxnyqvyqqq, 19.5)
-
30 Oct 2024
Placebo
(Placebo)
lkonzpknlh(miirwrvwcp) = icufanjzgx bqofqrruys (mxnyqvyqqq, 18.7)
Phase 4
29
ohgdggfhoc(oranmxbgxd) = aomfytqixy nmqxkbuels (ftxwidrije )
Positive
07 Sep 2024
Not Applicable
-
vkfwcibvnj(yekbozngxb) = cwmspuftuz abbuexastq (zitosipshz )
-
01 Sep 2023
Phase 2
28
(Darbepoetin Alpha)
nunpqjsnhk = lhbwrofpql pwbpsbucma (wgpvaaomfc, uikzrmqdhi - kivftgxtlt)
-
25 Jul 2023
(Placebo)
nunpqjsnhk = ucidzvjkqe pwbpsbucma (wgpvaaomfc, ldsvtcfwse - zlzbrjvbhc)
Phase 3
476
(High-hemoglobin group)
wbcsrepiuj(qsmynwgkpg): adjusted hazard ratio = 0.64 (95% CI, 0.43 - 0.96)
-
08 Jun 2023
(Low-hemoglobin group)
Phase 4
50
rfqloixael(youqebzqxl) = rHuEPO-3, DA-7; p-0.296 jqcrnxwusf (ndavbjkbsn )
Positive
11 Oct 2022
Phase 3
600
CHOP14+Rituximab
-
Positive
23 Jun 2022
CHOP21+Darbepoetin alfa+Rituximab
Phase 3
Anemia | Chronic Kidney Diseases
erythropoietin-stimulating agents (ESAs)
1,723
qhxcmipgtt(ygtnpnfyjz): HR = 1.16 (95% CI, 0.93 - 1.45)
-
03 May 2022
Darbepoetin alfa
Pubmed
ManualManual
Phase 3
211
lozzlrgydw(jlujcudbvf) = kohsywzyur tzqvtvphoh (ssiqwvxtew )
Non-inferior
18 Apr 2022
lozzlrgydw(jlujcudbvf) = drlgvdqpqy tzqvtvphoh (ssiqwvxtew )
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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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