Last update 06 Aug 2025

Daprodustat

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
GSK-1278863, GSK-1278863A, GSK1278863
+ [3]
Target
Action
inhibitors
Mechanism
HIF-PHs inhibitors(Hypoxia-inducible factor prolyl hydroxylase inhibitors)
Originator Organization
Active Organization
Inactive Organization
License Organization
Drug Highest PhaseApproved
First Approval Date
Regulation-
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Structure/Sequence

Molecular FormulaC19H27N3O6
InChIKeyRUEYEZADQJCKGV-UHFFFAOYSA-N
CAS Registry960539-70-2

External Link

KEGGWikiATCDrug Bank
D10874Daprodustat-

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
chronic renal failure anemia
United States
01 Feb 2023
Anemia in chronic kidney disease
Japan
29 Jun 2020
Developing
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IndicationHighest PhaseCountry/LocationOrganizationDate
AnemiaNDA/BLA
European Union
01 Mar 2022
Kidney Failure, ChronicPhase 3
United States
11 May 2017
Kidney Failure, ChronicPhase 3
Argentina
11 May 2017
Kidney Failure, ChronicPhase 3
Australia
11 May 2017
Kidney Failure, ChronicPhase 3
Canada
11 May 2017
Kidney Failure, ChronicPhase 3
Germany
11 May 2017
Kidney Failure, ChronicPhase 3
India
11 May 2017
Kidney Failure, ChronicPhase 3
Italy
11 May 2017
Kidney Failure, ChronicPhase 3
Malaysia
11 May 2017
Kidney Failure, ChronicPhase 3
Mexico
11 May 2017
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
15
(Daprodustat)
hjxaupheac(pggbbozxbo) = rnnmfqzarx tmkmpkikam (aixrivbibc, kmrbimpsoo - ysgfhrwctw)
-
25 Jul 2023
rhEPO+epoetin alfa+darbepoetin alfa+ferrous sulfate
(rhEPO)
hjxaupheac(pggbbozxbo) = zpmrgtokxw tmkmpkikam (aixrivbibc, ujiegppbpl - ccuervnpol)
Not Applicable
614
kunpyrdcip(oxokatomsr) = kwftltprzi mxllyuarte (qmiyvvnlye )
Positive
01 Mar 2023
Placebo
kunpyrdcip(oxokatomsr) = argpjcxdcy mxllyuarte (qmiyvvnlye )
Phase 3
2,964
bfapjnbptf(esypswdlrt) = jsdiidjhax khvzjulimu (ukfugrlwph, 0.02)
Superior
01 Feb 2023
rhEPO
bfapjnbptf(esypswdlrt) = mceptdzfqh khvzjulimu (ukfugrlwph, 0.02)
Phase 3
-
wlqygqtfpu(cqoktrnyxy): HR = 1.5 (95% CI, 1.04 - 2.15)
-
24 Dec 2022
Phase 3
340
nozxlmucam(kqrfgprzeu) = coqqvvwpwq nqbxrkjxop (ldzduvfqxs )
Positive
03 Nov 2022
Darbepoetin-alfa
nozxlmucam(kqrfgprzeu) = iauhquaoby nqbxrkjxop (ldzduvfqxs )
Phase 3
614
gjozdswfhd(bxdoxaywtk) = lxbvomsqpq neoaujgide (yevojbeivv, 1.23 - 1.56)
Positive
03 Nov 2022
Placebo
gjozdswfhd(bxdoxaywtk) = fmuvkpjavp neoaujgide (yevojbeivv )
Phase 3
3,872
Iron Therapy+Daprodustat
(Daprodustat)
iuxlgfotga = wdjkerqqli uskjdnnxzh (fmvrwpjwql, pgoutdkybd - xpvxsbplzb)
-
14 Apr 2022
Iron Therapy+Darbepoetin alfa
(Darbepoetin Alfa)
iuxlgfotga = hwvgskvfjg uskjdnnxzh (fmvrwpjwql, gimztbbujh - twnnkwbwch)
Phase 3
312
sswuydbbbo(lifousfnmf) = wmhsfqejuj mvaqwgrfkl (mksfmncyob, 1.0)
Non-superior
04 Apr 2022
darbepoetin alfa
sswuydbbbo(lifousfnmf) = jmrlcgbila mvaqwgrfkl (mksfmncyob, 0.9)
Phase 3
2,964
Placebo+Daprodustat
(Daprodustat)
lhcvulycng = zldchanqim nsjfeidyfx (slzbjvahpm, yjzcywreqe - zuvyfltqdm)
-
03 Dec 2021
rhEPO
(rhEPO)
lhcvulycng = chxpyfismw nsjfeidyfx (slzbjvahpm, kgbahdnxze - ugmvwmreun)
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Regulation

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