DeepMed Research

Roxadustat

Generic Name: Roxadustat

Brand Names: Evrenzo

Drug Type: Small Molecule

Chemical Formula: C_₁₉H_₁₆N_₂O_₅

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

A Drug Interaction Study to Evaluate the Pharmacokinetics of ASP1517 and Lanthanum Carbonate Hydrate

Phase 1

Completed

Conditions: Healthy Subjects

Interventions: Drug: ASP1517
Drug: Lanthanum carbonate hydrate

First Posted Date: 2016-11-02

Last Posted Date: 2017-01-25

Lead Sponsor: Astellas Pharma Inc

Target Recruit Count: 18

Registration Number: NCT02952040

Locations: 🇯🇵
Site JP00001, Tokyo, Japan

A Food Effect Study to Evaluate the Pharmacokinetics of ASP1517

Phase 1

Completed

Conditions: Healthy Subjects

Interventions: Drug: ASP1517

First Posted Date: 2016-06-20

Last Posted Date: 2016-08-24

Lead Sponsor: Astellas Pharma Inc

Target Recruit Count: 16

Registration Number: NCT02805374

Locations: 🇯🇵
Site JP00001, Tokyo, Japan

A Study of Intermittent Oral Dosing of ASP1517 in Erythropoieses Stimulating Agent (ESA)-Naive Hemodialysis Chronic Kidney Disease Patients With Anemia

Phase 3

Completed

Conditions: ESA-naive Hemodialysis Chronic Kidney Disease Patients With Anemia

Interventions: Drug: roxadustat

First Posted Date: 2016-05-23

Last Posted Date: 2024-10-30

Lead Sponsor: Astellas Pharma Inc

Target Recruit Count: 75

Registration Number: NCT02780141

Locations: 🇯🇵
Site JP00003, Aichi, Japan
🇯🇵
Site JP00005, Aichi, Japan
🇯🇵
Site JP00002, Niigata, Japan

and more 44 locations

A Study of Intermittent Oral Dosing of ASP1517 in Peritoneal Dialysis Chronic Kidney Disease Patients With Anemia

Phase 3

Completed

Conditions: Peritoneal Dialysis Chronic Kidney Disease Patients With Anemia

Interventions: Drug: roxadustat

First Posted Date: 2016-05-23

Last Posted Date: 2024-10-30

Lead Sponsor: Astellas Pharma Inc

Target Recruit Count: 56

Registration Number: NCT02780726

Locations: 🇯🇵
Site JP00005, Fukuoka, Japan
🇯🇵
Site JP00004, Aichi, Japan
🇯🇵
Site JP00003, Nagano, Japan

and more 12 locations

A Long Term Study of Intermittent Oral Dosing of ASP1517 in Hemodialysis Chronic Kidney Disease Patients With Anemia Converted From Erythropoieses Stimulating Agent (ESA) Treatment

Phase 3

Completed

Conditions: Hemodialysis Patients With Renal Anemia

Interventions: Drug: roxadustat

First Posted Date: 2016-05-20

Last Posted Date: 2024-10-31

Lead Sponsor: Astellas Pharma Inc

Target Recruit Count: 164

Registration Number: NCT02779764

Locations: 🇯🇵
Site JP00001, Yamaguchi, Japan
🇯🇵
Site JP00004, Gunma, Japan
🇯🇵
Site JP00021, Hokkaido, Japan

and more 22 locations

Pharmacokinetic Study of ASP1517 With Kremezin®

Phase 1

Completed

Conditions: Healthy Volunteers

Interventions: Drug: ASP1517
Drug: Kremezin®

First Posted Date: 2016-02-29

Last Posted Date: 2016-06-21

Lead Sponsor: Astellas Pharma Inc

Target Recruit Count: 34

Registration Number: NCT02693613

Locations: 🇯🇵
Site JP00001, Tokyo, Japan

FG-4592 for Treatment of Anemia in Subjects With Chronic Kidney Disease

Phase 3

Completed

Conditions: Anemia

Interventions: Drug: FG-4592
Drug: Epoetin Alfa

First Posted Date: 2016-01-12

Last Posted Date: 2017-08-24

Lead Sponsor: FibroGen

Target Recruit Count: 305

Registration Number: NCT02652806

Locations: 🇨🇳
The First Affiliated hospital of Guangxi Medical University, Nanning, Guangxi, China
🇨🇳
The First Affiliated Hospital of Dalian Medical University, Dalian, Liaoning, China
🇨🇳
Jiangsu Province Hospital, Nanjing, Jiangsu, China

and more 28 locations

FG-4592 for Treatment of Anemia in Subjects With Chronic Kidney Disease Not on Dialysis

Phase 3

Completed

Conditions: Anemia

Interventions: Drug: FG-4592
Drug: Placebo

First Posted Date: 2016-01-12

Last Posted Date: 2017-08-24

Lead Sponsor: FibroGen

Target Recruit Count: 154

Registration Number: NCT02652819

Locations: 🇨🇳
Ningbo No.2 Hospital, Ningbo, Zhejiang, China
🇨🇳
The Second Hospital of Anhui Medical University, Hefei, Anhui, China
🇨🇳
301 Hospital, Beijing, Beijing, China

and more 27 locations

Roxadustat in the Treatment of Anemia in End Stage Renal Disease (ESRD) Patients on Stable Dialysis

Phase 3

Completed

Conditions: Anemia
End Stage Renal Disease (ESRD)

Interventions: Drug: Epoetin alfa
Drug: Roxadustat
Drug: Iron
Drug: Darbepoetin alfa

First Posted Date: 2014-10-30

Last Posted Date: 2024-11-27

Lead Sponsor: Astellas Pharma Europe B.V.

Target Recruit Count: 838

Registration Number: NCT02278341

Locations: 🇵🇱
Site PL48002, Katowice, Poland
🇭🇷
Site HR38509, Zagreb, Grad Zagreb, Croatia
🇭🇷
Site HR38505, Karlovac, Croatia

and more 140 locations

Study to Evaluate the Efficacy and Safety of Roxadustat in the Treatment of Anemia in Participants With ESRD on Stable Dialysis

Phase 3

Completed

Conditions: CKD Anemia in Stable Dialysis Patients

Interventions: Drug: Epoetin Alfa
Drug: Roxadustat

First Posted Date: 2014-10-24

Last Posted Date: 2021-10-29

Lead Sponsor: FibroGen

Target Recruit Count: 741

Registration Number: NCT02273726

Locations: 🇵🇷
Research Center, San Juan, Puerto Rico

Drug Development Updates

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