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Roxadustat

Generic Name
Roxadustat
Brand Names
Evrenzo
Drug Type
Small Molecule
Chemical Formula
C19H16N2O5
CAS Number
808118-40-3
Unique Ingredient Identifier
X3O30D9YMX
Background

Roxadustat is a first-in-class hypoxia-inducible factor prolyl hydroxylase inhibitor used to treat anemia associated with chronic kidney disease. It works by reducing the breakdown of the hypoxia-inducible factor (HIF), which is a transcription factor that stimulates red blood cell production in response to low oxygen levels. Roxadustat was first approved by the European Commission in August 2021.

Indication

Roxadustat is indicated for the treatment of adult patients with symptomatic anemia associated with chronic kidney disease (CKD).

Associated Conditions
Anemia
Clinical Trials
Related News

A Study of Roxadustat for the Treatment of Anemia in Participants With Chronic Kidney Disease and Not Receiving Dialysis

Phase 3
Completed
Conditions
CKD Anemia
Interventions
Drug: Placebo
First Posted Date
2012-12-17
Last Posted Date
2021-10-01
Lead Sponsor
FibroGen
Target Recruit Count
922
Registration Number
NCT01750190
Locations
🇦🇷

Investigational Product, Villa Domínico, Provincia De Buenos Aires, Argentina

🇹🇭

Investigational Site, Chiang Mai, Thailand

🇵🇭

Investigational site, Pasig, Philippines

Open-Label Extension Study for the Long-Term Efficacy and Safety of Roxadustat in Participants With Dialysis and Non-Dialysis Chronic Kidney Disease

Phase 2
Completed
Conditions
Chronic Kidney Disease
End Stage Renal Disease
Anemia
Interventions
First Posted Date
2012-06-28
Last Posted Date
2021-10-01
Lead Sponsor
FibroGen
Target Recruit Count
15
Registration Number
NCT01630889
Locations
🇵🇷

CAIMED School of Medicine, Ponce, Puerto Rico

🇵🇷

Consolidated Medical Plaza, Caguas, Puerto Rico

🇺🇸

Mountain Kidney & HTN Associates, PA, Asheville, North Carolina, United States

and more 2 locations

Study of FG-4592 in Subjects With Chronic Kidney Disease in China

Phase 2
Completed
Conditions
Anemia in Chronic Kidney Disease
Interventions
Drug: Placebo
First Posted Date
2012-05-16
Last Posted Date
2014-03-03
Lead Sponsor
FibroGen
Target Recruit Count
91
Registration Number
NCT01599507
Locations
🇨🇳

First Affiliated Hospital, Sun Yat-Sen University, Guangzhou, China

🇨🇳

West China Hospital, Chengdu, China

🇨🇳

First affiliated hospital of Dalian medical university, DaLian, China

and more 10 locations

Study of FG-4592 in Subjects With End-Stage Renal Disease Receiving Maintenance Hemodialysis in China

Phase 2
Completed
Conditions
Anemia in End Stage Renal Disease
Interventions
First Posted Date
2012-05-11
Last Posted Date
2013-02-04
Lead Sponsor
FibroGen
Target Recruit Count
96
Registration Number
NCT01596855
Locations
🇨🇳

Peking Union Medical College Hospital, Beijing, China

🇨🇳

Chang Zheng Hospital, Shanghai, China

🇨🇳

RuiJin Hospital, Shanghai, China

and more 6 locations

Study of Roxadustat (FG-4592) to Correct Anemia in Newly Initiated Dialysis Participants Not on Erythropoiesis-Stimulating Agent Treatment

Phase 2
Completed
Conditions
Dialysis
Anemia
Interventions
First Posted Date
2011-08-11
Last Posted Date
2021-10-01
Lead Sponsor
FibroGen
Target Recruit Count
60
Registration Number
NCT01414075

Study to Investigate the Interaction Between FG-4592 and Rosiglitazone in Healthy Adult Subjects

Phase 1
Completed
Conditions
Healthy Adult Subjects
Interventions
First Posted Date
2011-06-20
Last Posted Date
2011-06-20
Lead Sponsor
FibroGen
Target Recruit Count
20
Registration Number
NCT01376063

Study of Roxadustat in Non-Dialysis Chronic Kidney Disease Participants With Anemia

Phase 2
Completed
Conditions
Chronic Kidney Disease
Anemia
Interventions
First Posted Date
2010-11-19
Last Posted Date
2022-02-10
Lead Sponsor
FibroGen
Target Recruit Count
145
Registration Number
NCT01244763

Study of Roxadustat (FG-4592) in Participants With End-Stage Renal Disease Receiving Maintenance Hemodialysis

Phase 2
Completed
Conditions
Anemia
End Stage Renal Disease
Interventions
Other: Placebo
First Posted Date
2010-06-22
Last Posted Date
2022-01-11
Lead Sponsor
FibroGen
Target Recruit Count
161
Registration Number
NCT01147666

ASP1517 Pharmacokinetics Study in Anemia Patients on Hemodialysis

Phase 1
Completed
Conditions
Anemia
Hemodialysis
Renal Impairment
Interventions
First Posted Date
2010-03-10
Last Posted Date
2024-10-30
Lead Sponsor
Astellas Pharma Inc
Target Recruit Count
12
Registration Number
NCT01083888

Safety, Tolerability and Pharmacokinetic Study of ASP1517 in Healthy Non-elderly Male Volunteers

Phase 1
Completed
Conditions
Healthy Volunteers
Interventions
Drug: Placebo
First Posted Date
2009-09-16
Last Posted Date
2010-06-22
Lead Sponsor
Astellas Pharma Inc
Target Recruit Count
100
Registration Number
NCT00978198
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