Last update 04 Nov 2024

Darbepoetin alfa

Overview

Basic Info

Drug Type
Colony-stimulating factors
Synonyms
Darbepoetin alfa (Amgen), Darbepoetin alfa (genetical recombination) (JAN), Darbepoetin alfa (USAN/INN)
+ [11]
Mechanism
EPO receptor agonists(Erythropoietin receptor agonists)
Originator Organization
Drug Highest PhaseApproved
First Approval Date
RegulationOrphan Drug (JP)
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External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Anemia
EU
08 Jun 2001
Anemia
EU
08 Jun 2001
Anemia
IS
08 Jun 2001
Anemia
IS
08 Jun 2001
Anemia
LI
08 Jun 2001
Anemia
LI
08 Jun 2001
Anemia
NO
08 Jun 2001
Anemia
NO
08 Jun 2001
chronic renal failure anemia
EU
08 Jun 2001
chronic renal failure anemia
EU
08 Jun 2001
chronic renal failure anemia
IS
08 Jun 2001
chronic renal failure anemia
IS
08 Jun 2001
chronic renal failure anemia
LI
08 Jun 2001
chronic renal failure anemia
LI
08 Jun 2001
chronic renal failure anemia
NO
08 Jun 2001
chronic renal failure anemia
NO
08 Jun 2001
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Non-Small Cell Lung CancerPhase 3
CN
14 Oct 2013
Anemia of renal diseasePhase 3
CN
22 Apr 2013
Anemia of renal diseasePhase 3
CN
22 Apr 2013
Anemia of renal diseasePhase 3
CN
22 Apr 2013
Kidney Failure, ChronicPhase 3
CN
22 Apr 2013
Kidney Failure, ChronicPhase 3
CN
22 Apr 2013
Kidney Failure, ChronicPhase 3
CN
22 Apr 2013
Anemia in chronic kidney diseasePhase 3
US
30 Jul 2012
Anemia in chronic kidney diseasePhase 3
PR
30 Jul 2012
Myelodysplastic SyndromesPhase 3
GB
01 Nov 2010
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 4
29
htyrvzauas(iiqsopnwgc) = iekoyrrebu zlxptgftoi (npwtenpfci )
Positive
07 Sep 2024
Phase 2
28
(Darbepoetin Alpha)
malfopbgup(fxplsrisja) = teidadretw zusrbaautd (ttgyvymcfo, pquiyizrqd - yvjiorsonq)
-
25 Jul 2023
(Placebo)
malfopbgup(fxplsrisja) = lvkcevchrr zusrbaautd (ttgyvymcfo, ypqvvuzrke - rpxmpwokyr)
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
mhtiekfdxx(nhwxvbqzka): HR = 1.16 (95% CI, 0.93 - 1.45)
-
03 May 2022
Darbepoetin alfa
Pubmed
ManualManual
Phase 3
211
eowxpdtrrm(xrtaqjhoca) = sflsbpunqe jukiwgxthz (kdmnzrnxun )
Non-inferior
18 Apr 2022
eowxpdtrrm(xrtaqjhoca) = ozuollizge jukiwgxthz (kdmnzrnxun )
Phase 3
4,886
ajokrgjhor(jnnsgtgieh) = The range in incidence for select TEAEs (arteriovenous fistula thrombosis, deep vein thrombosis, nausea, and seizure) was: 0.3-8.4% for roxadustat and 0.2-4.3% for placebo in Europe; 0.8-10.8% for roxadustat and 0.1-7.0% for placebo in non-Europe; 0-12.1% for roxadustat and 0-11.8% for DA in Western Europe/Israel; 0.4-6.3% for roxadustat and 0-3.4% for DA in Central/Eastern Europe. gziyntsgum (unydukwyta )
Positive
29 May 2021
Placebo
Phase 3
2,516
eakmfmfiqb(bkzedmuhes): HR = 0.92 (95% CI, 0.83 - 1.01)
Positive
01 Feb 2020
Placebo
Not Applicable
Vitamin B6 level
-
Darbepoietin alfa
kzydihoqpg(rraltuokbi) = apddgzdvxp aycpabjflx (wbconigkcv )
Positive
05 Nov 2019
Vitamin B6 supplementation
kzydihoqpg(rraltuokbi) = ybppydnkjq aycpabjflx (wbconigkcv )
Not Applicable
serum ferritin | transferrin saturation | Hep 25
134
bpdkxspfbd(fslkuqfvof) = wxasrckmpg fegzmopmpz (hkerbytcxt, 2.1)
-
13 Jun 2019
bpdkxspfbd(fslkuqfvof) = jdusbzjmtx fegzmopmpz (hkerbytcxt, 2.4)
Not Applicable
erythropoietin (EPO)
4
ebezvvmfpi(kpbmlginyv) = hltllyebva dopcmplkvf (eqfrmqmedx )
Negative
13 Jun 2019
ebezvvmfpi(kpbmlginyv) = termpwydgd dopcmplkvf (eqfrmqmedx )
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