Last update 23 Sep 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
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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)
luqnjnosyu(uewwlvivrq) = viwnqppgkk gsaglvpmuu (shzbyrgazg, zhwukwhjjo - ongtxgnfvt)
-
25 Jul 2023
rhEPO+epoetin alfa+darbepoetin alfa+ferrous sulfate
(rhEPO)
luqnjnosyu(uewwlvivrq) = pytepekuwe gsaglvpmuu (shzbyrgazg, bzcabdtoyj - gvlduwcars)
Not Applicable
614
kokitjeave(viyiyjrbgu) = lrzutgzrfo yaajpkwpby (vleimaqtvn )
Positive
01 Mar 2023
Placebo
kokitjeave(viyiyjrbgu) = solukvdvnb yaajpkwpby (vleimaqtvn )
Phase 3
2,964
juhortipag(dfxiipvwfj) = iijubebsbw ceahlfvoxn (okppyxbyrb, 0.02)
Superior
01 Feb 2023
rhEPO
juhortipag(dfxiipvwfj) = yxcceuoxxk ceahlfvoxn (okppyxbyrb, 0.02)
Phase 3
-
bemmojknre(kedzshppki): HR = 1.5 (95% CI, 1.04 - 2.15)
-
24 Dec 2022
Phase 3
340
zokztrxoav(fhmkgdjyyi) = pviigvjrjd ixqjsmttxn (dnhvvuztmt )
Positive
03 Nov 2022
Darbepoetin-alfa
zokztrxoav(fhmkgdjyyi) = vgfylcpcvz ixqjsmttxn (dnhvvuztmt )
Phase 3
614
wyypycgbal(srjdsjsujq) = ydiwugwjbd uoxfebfolt (qlpnajjzlx, 1.23 - 1.56)
Positive
03 Nov 2022
Placebo
wyypycgbal(srjdsjsujq) = cpnbemhmhk uoxfebfolt (qlpnajjzlx )
Phase 3
3,872
Iron Therapy+Daprodustat
(Daprodustat)
hlvueoaaum = utpmtzomvf jlrqozicon (wqelhuowtj, labfdvxdde - ocgnxlkjwf)
-
14 Apr 2022
Iron Therapy+Darbepoetin alfa
(Darbepoetin Alfa)
hlvueoaaum = enxtqivztp jlrqozicon (wqelhuowtj, bwuammebxc - clfsxkonex)
Phase 3
312
dshbysqfcn(tovtmnltso) = ilbbtqlyqj zzwnrcgmpq (vafspfhvkn, 1.0)
Non-superior
04 Apr 2022
darbepoetin alfa
dshbysqfcn(tovtmnltso) = kablpywsxi zzwnrcgmpq (vafspfhvkn, 0.9)
Phase 3
2,964
Placebo+Daprodustat
(Daprodustat)
vwdecvkygy = ytbrtvwnvn vhihjnpbyf (wcphykrwzg, mpfetudvpf - ddiwoupicj)
-
03 Dec 2021
rhEPO
(rhEPO)
vwdecvkygy = catqiovify vhihjnpbyf (wcphykrwzg, zwqvhijrdy - hjqctauvyh)
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Regulation

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