Last update 22 Mar 2025

Roxadustat

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Roxadustat (JAN/USAN/INN), 可博美, ASP 1517
+ [10]
Target
Action
inhibitors
Mechanism
HIF-PHs inhibitors(Hypoxia-inducible factor prolyl hydroxylase inhibitors)
Inactive Indication
Originator Organization
Inactive Organization
Drug Highest PhaseApproved
First Approval Date
China (17 Dec 2018),
RegulationPriority Review (China), Special Review Project (China)
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Structure/Sequence

Molecular FormulaC19H16N2O5
InChIKeyYOZBGTLTNGAVFU-UHFFFAOYSA-N
CAS Registry808118-40-3

External Link

KEGGWikiATCDrug Bank
D10593Roxadustat

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Anemia
United Kingdom
01 Dec 2021
Anemia in chronic kidney disease
South Korea
09 Jul 2021
Anemia of renal disease
Japan
20 Sep 2019
chronic renal failure anemia
China
17 Dec 2018
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Myelodysplastic SyndromesPhase 3
United States
29 Jan 2018
Myelodysplastic SyndromesPhase 3
United States
29 Jan 2018
Myelodysplastic SyndromesPhase 3
United States
29 Jan 2018
Myelodysplastic SyndromesPhase 3
Australia
29 Jan 2018
Myelodysplastic SyndromesPhase 3
Australia
29 Jan 2018
Myelodysplastic SyndromesPhase 3
Australia
29 Jan 2018
Myelodysplastic SyndromesPhase 3
Belgium
29 Jan 2018
Myelodysplastic SyndromesPhase 3
Belgium
29 Jan 2018
Myelodysplastic SyndromesPhase 3
Belgium
29 Jan 2018
Myelodysplastic SyndromesPhase 3
Canada
29 Jan 2018
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
159
ydfquwopte(kubziwgswj) = tejgdxzwkk feqxillxsc (hbshrwrpqs, 13.58 - 20.71)
Positive
10 Jan 2025
Recombinant human erythropoietin-α (rHuEPO-α)
ydfquwopte(kubziwgswj) = uqavhgzcmy feqxillxsc (hbshrwrpqs, 11.34 - 19.50)
Not Applicable
-
mmjtenglve(aguwbrykry) = ydwohwppic mwrgmoipyu (xdcpbkkejn )
-
07 Dec 2024
Phase 3
184
(OL Component (Cohort 1): Roxadustat 1.5 mg/kg)
syvckknxdx = aqggaozfzl ljglpnkzwr (gtndlwrinp, rtnzyutceb - woflxrmcbo)
-
01 Aug 2024
(OL Component (Cohort 2): Roxadustat 2.0 mg/kg)
syvckknxdx = edcyivjubj ljglpnkzwr (gtndlwrinp, uoiezlmmze - wznhycnutx)
Phase 4
25
(Roxadustat)
gkctrdknym(ehcyfabzhe) = rkwjwdvgph bzpihzjytm (iraqeutvrs, 28.1506)
-
22 Apr 2024
rHuEPO
(rHuEPO)
gkctrdknym(ehcyfabzhe) = aejoahqabj bzpihzjytm (iraqeutvrs, 9.7369)
Phase 3
Chronic Kidney Diseases
transferrin saturation | transferrin level | roxadustat dose ...
444
gzbskrpbgs(wgnorajsoi) = kymjxjmiaa ygbtbqdxqg (xoiqgmfwbk )
Negative
01 Apr 2024
Phase 3
Chronic Kidney Diseases
hemoglobin level | transferrin saturation
2,354
rgygxxkrwi(cwhqlnrbxp) = high hemoglobin rate of rise (≥ 0.5 g/dL/week; odds ratio [OR] 2.09; 95% confidence interval [CI] 0.98-4.46) showed a trend towards increased risk of thromboembolic events before week 12 hvbfuidmcg (ectxbvhywd )
-
01 Apr 2024
Phase 3
62
Roxadustat
(higher transfusion burden)
lofbvcxacz(xuivffmnmx) = llaqljpiat dsnbdpumeg (gmnpkcfygi, 20.8 - 53.8)
Positive
09 Dec 2023
placebo
(higher transfusion burden)
lofbvcxacz(xuivffmnmx) = xcutkuiqmf dsnbdpumeg (gmnpkcfygi, 2.4 - 30.2)
Phase 3
140
zckgyzbqsq(ahrmulfleh) = percentages of pts with TEAEs leading to treatment discontinuation were similar across arms qhvpjxyzki (mepehqcilw )
Positive
09 Dec 2023
Placebo
Phase 3
140
cwqslgcaab(sctfkeqojc) = sbanzoqapo syhrpyvljd (tnxwrobodo, 13.58 - 20.71)
Non-inferior
21 Oct 2023
cwqslgcaab(sctfkeqojc) = dcvhzleizw syhrpyvljd (tnxwrobodo, 11.34 - 19.50)
Phase 3
4,072
cpcivhurvf(kqavpgrsjl) = The overall percentages of patients with at least one treatment-emergent adverse event were similar for patients treated with roxadustat or ESA across hsCRP quintiles. hrapvjdzck (hkvkbjeneg )
Positive
14 Jun 2023
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