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...
- Indication
Roxadustat is indicated for the treatment of adult patients with symptomatic anemia associated with chronic kidney disease (CKD).
- Associated Conditions
- Anemia
- Associated Therapies
- -
A Study to Investigate the Effect of Roxadustat Versus Recombinant Human Erythropoietin (rHuEPO) on Oral Iron Absorption in Chinese Patients With Anemia of Chronic Kidney Disease (CKD)
- First Posted Date
- 2020-12-04
- Last Posted Date
- 2024-04-22
- Lead Sponsor
- AstraZeneca
- Target Recruit Count
- 25
- Registration Number
- NCT04655027
- Locations
- 🇨🇳
Research Site, Wuhan, China
Investigating the Efficacy, Safety and PK of Roxadustat (FG-4592) for Treatment of Anemia in Pediatric Patients With CKD
- Conditions
- Interventions
- First Posted Date
- 2020-11-09
- Last Posted Date
- 2022-07-05
- Lead Sponsor
- FibroGen
- Registration Number
- NCT04621331
- Locations
- 🇺🇸
University of Nebraska Medical Center, Omaha, Nebraska, United States
🇺🇸Ann and Robert H. Lurie Children's Hospital of Chicago, Chicago, Illinois, United States
🇺🇸Icahn School of Medicine at Mount Sinai (ISMMS) - The Mount Sinai Hospital (MSH), New York, New York, United States
Roxadustat for Anemia in Patients With CKD
- Conditions
- Interventions
- First Posted Date
- 2020-08-06
- Last Posted Date
- 2021-01-22
- Lead Sponsor
- Shenzhen Second People's Hospital
- Target Recruit Count
- 200
- Registration Number
- NCT04502537
- Locations
- 🇨🇳
Shenzhen Second People's Hospital, Shenzhen, China
Study of Roxadustat Conversion in Participants Receiving Stable ESA or as Initial Anemia Treatment in Hemodialysis Participants
- Conditions
- Interventions
- First Posted Date
- 2020-07-24
- Last Posted Date
- 2022-07-26
- Lead Sponsor
- FibroGen
- Target Recruit Count
- 283
- Registration Number
- NCT04484857
- Locations
- 🇺🇸
Investigational Site, Norfolk, Virginia, United States
🇺🇸Investigator Site, San Antonio, Texas, United States
🇺🇸Investigator Sites, San Antonio, Texas, United States
Different Doses of Roxadustat Treatment for Anemia in Peritoneal Dialysis Patients
- First Posted Date
- 2020-07-02
- Last Posted Date
- 2021-11-26
- Lead Sponsor
- Peking University First Hospital
- Target Recruit Count
- 100
- Registration Number
- NCT04454879
- Locations
- 🇨🇳
Peking University First Hospital, Beijing, China
Study of Roxadustat Conversion in Participants Receiving Stable Erythropoiesis-Stimulating Agent (ESA) or as Initial Anemia Treatment in Chronic Dialysis Participants
- Conditions
- Interventions
- First Posted Date
- 2020-06-01
- Last Posted Date
- 2022-09-13
- Lead Sponsor
- FibroGen
- Target Recruit Count
- 203
- Registration Number
- NCT04410198
- Locations
- 🇺🇸
Investigational Site, Saint George, Utah, United States
Post-marketing Surveillance of EVRENZO® Tablets (Roxadustat) in Patients With Renal Anemia
- First Posted Date
- 2020-05-29
- Last Posted Date
- 2024-12-16
- Lead Sponsor
- Astellas Pharma Inc
- Target Recruit Count
- 2104
- Registration Number
- NCT04408820
- Locations
- 🇯🇵
Site JP00023, Aichi, Japan
🇯🇵Site JP00018, Fukui, Japan
🇯🇵Site JP00021, Gifu, Japan
Evaluation of Efficacy and Safety of Roxadustat for the Treatment of Chemotherapy Induced Anemia
- First Posted Date
- 2019-09-04
- Last Posted Date
- 2022-06-03
- Lead Sponsor
- FibroGen
- Target Recruit Count
- 92
- Registration Number
- NCT04076943
- Locations
- 🇺🇸
Research Center, Philadelphia, Pennsylvania, United States
Evaluate the Efficacy and Safety of Multiple Roxadustat Dosing Regimens for the Treatment of Anemia in Dialysis Participants With Chronic Kidney Disease
- First Posted Date
- 2019-08-16
- Last Posted Date
- 2022-05-06
- Lead Sponsor
- FibroGen
- Target Recruit Count
- 318
- Registration Number
- NCT04059913
- Locations
- 🇨🇳
Investigational Site, Tianjin, China
A Study to Assess the Relative Bioavailability of Roxadustat Following a Single Dose of Pediatric Azo Dye-free Tablet Formulation and Pediatric Azo Dye-free Mini-tablet Formulation Compared to a Single Dose of Azo Dye-containing Tablet Formulation in Healthy Adult Subjects
- First Posted Date
- 2019-05-23
- Last Posted Date
- 2024-10-31
- Lead Sponsor
- Astellas Pharma Global Development, Inc.
- Target Recruit Count
- 24
- Registration Number
- NCT03960489
- Locations
- 🇩🇪
Site DE49001, Berlin, Germany
Drug Development Updates
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