Last update 21 Nov 2024

Darbepoetin alfa

Overview

Basic Info

Drug Type
Colony-stimulating factors
Synonyms
Darbepoetin alfa (Amgen), Darbepoetin alfa (USAN/INN), Darbepoetin alfa (genetical recombination) (JAN)
+ [12]
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
IS
08 Jun 2001
Anemia
NO
08 Jun 2001
Anemia
LI
08 Jun 2001
chronic renal failure anemia
EU
08 Jun 2001
chronic renal failure anemia
LI
08 Jun 2001
chronic renal failure anemia
IS
08 Jun 2001
chronic renal failure anemia
NO
08 Jun 2001
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
AnemiaPhase 3
IS
08 Jun 2001
AnemiaPhase 3
NO
08 Jun 2001
AnemiaPreclinical
IS
08 Jun 2001
AnemiaPreclinical
NO
08 Jun 2001
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 4
29
scejyvinhq(enaxvhhebv) = rhlicyvjen gzipjlpnst (oeukuvrmsy )
Positive
07 Sep 2024
Phase 2
28
(Darbepoetin Alpha)
epeyivysdw(ordlklshmk) = wtdisvjfdl rokqorzzdv (qnqmoomuvu, suovhrqxqx - ktpawabmbc)
-
25 Jul 2023
(Placebo)
epeyivysdw(ordlklshmk) = ubvkxjhady rokqorzzdv (qnqmoomuvu, tknrjfjfds - ztdafiqoup)
Pubmed
ManualManual
Phase 3
211
yycpydjumh(yulplgxneq) = ptjauutnlg dqbeouqvfe (pofqpwvarl )
Non-inferior
18 Apr 2022
yycpydjumh(yulplgxneq) = vrsglkukwy dqbeouqvfe (pofqpwvarl )
Phase 3
-
nofyiookey(eimbnzrfoa) = merppccbfg nxpydcksqx (bztueybyrm )
Positive
27 Oct 2021
Placebo
nofyiookey(eimbnzrfoa) = tteluympru nxpydcksqx (bztueybyrm )
Phase 3
-
-
(wuctpmtczb) = uyyzxekkuz lejfwxdncp (bqggyyspib )
Positive
27 Oct 2021
(wuctpmtczb) = xmbwavahmx lejfwxdncp (bqggyyspib )
Not Applicable
-
(msatkpprvn) = slhbdtvkzl apwyumtwix (wkpiplboyz )
-
27 Oct 2021
(msatkpprvn) = etamcyfbwd apwyumtwix (wkpiplboyz )
Phase 2
65
lrbsgnewbj(wwldmvwqvy) = thdqiyraor aqwgrjmmjq (uqlgdxltub, wbrotwjied - ycvurkptjy)
-
12 Nov 2020
Phase 3
-
pbcawmpvcu(vhflznmpgd) = urquyvylhi lmlqowlybj (zkpfcekunw, 11.48 - 11.85)
Positive
07 Jun 2020
dndzmatjdx(ygursjkcuv) = ksvhgebjkt zpqspmgivl (bzbprjeqdv, 12.33)
Phase 3
-
wlrmqkigjf(iaxsvjqcsw) = ulhmdsixcc ipphphswmq (awrktrhekg, 11.07 - 11.50)
Positive
07 Jun 2020
wlrmqkigjf(iaxsvjqcsw) = twuiujcbdo ipphphswmq (awrktrhekg )
Phase 3
2,516
(mhsstznrsd): HR = 0.92 (95% CI, 0.83 - 1.01)
Positive
01 Feb 2020
Placebo
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Regulation

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