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

Roxadustat for Bone and Neuropsychiatric Aspects in Hemodialysis Patients

Phase 1

Recruiting

Conditions: Kidney Failure,Chronic
Anemia in End Stage Renal Disease
Depression Anxiety Disorder

Interventions: Drug: Roxadustat
Drug: Conventional Anemia Management

First Posted Date: 2025-04-09

Last Posted Date: 2025-05-11

Lead Sponsor: Mansoura University

Target Recruit Count: 46

Registration Number: NCT06917950

Locations: 🇪🇬
Urology and Nephrology Center, Mansoura University, Mansoura, Dakahliya, Egypt

Roxadustat's Effect on Heart, Nutrition, and Inflammation in Hemodialysis Patients

Phase 1

Recruiting

Conditions: Kidney Failure, Chronic
Malnutrition-Inflammation Syndrome
Anemia in End Stage Renal Disease
Cardiovascular Diseases (CVD)

Interventions: Drug: Roxadustat
Drug: Conventional Anemia Management

First Posted Date: 2025-03-30

Last Posted Date: 2025-05-13

Lead Sponsor: Mansoura University

Target Recruit Count: 46

Registration Number: NCT06903559

Locations: 🇪🇬
Urology and Nephrology Center, Mansoura University, Mansoura, Dakahliya, Egypt

Effect of Perioperative Roxadustat in Elective Lumbar Interbody Fusion Surgery.

Phase 3

Active, not recruiting

Conditions: Perioperative Anemia

Interventions: Drug: Roxadustat

First Posted Date: 2025-01-13

Last Posted Date: 2025-01-13

Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Target Recruit Count: 158

Registration Number: NCT06772272

Locations: 🇨🇳
Second Affiliated Hospital of Zhejiang University, School of Medicine, Hangzhou, Zhejiang, China

Effect of Low Doses of Hypoxia-inducible Factor- Prolyl Hydroxylase Enzyme Inhibitor Plus Iron in the Treatment of Anemia in Dialysis-dependent Chronic Kidney Disease Patients

Phase 4

Recruiting

Conditions: Anemia in Dialysis-dependent CKD Patients

Interventions: Drug: Roxadustat

First Posted Date: 2023-11-03

Last Posted Date: 2024-02-01

Lead Sponsor: Alexandria University

Target Recruit Count: 72

Registration Number: NCT06115421

Locations: 🇪🇬
Alexandria University, Alexandria, Egypt

A Single-arm Trial of Roxadustat Combined With Retinoic Acid in the Treatment of Refractory Low-risk MDS

Phase 1

Not yet recruiting

Conditions: Myelodysplastic Syndromes

Interventions: Drug: Roxadustat in combination with retinoic acid

First Posted Date: 2023-09-01

Last Posted Date: 2023-09-01

Lead Sponsor: Peking Union Medical College Hospital

Target Recruit Count: 25

Registration Number: NCT06020833

Roxadustat Combined With Luspatercept Versus Luspatercept Monotherapy in the Treatment of Refractory MDS-RS

Phase 4

Not yet recruiting

Conditions: Myelodysplastic Syndromes

Interventions: Drug: Roxadustat
Drug: Luspatercept

First Posted Date: 2023-08-23

Last Posted Date: 2023-08-23

Lead Sponsor: Peking Union Medical College Hospital

Target Recruit Count: 62

Registration Number: NCT06006949

Locations: 🇨🇳
Peking union medical college hospital, Beijing, China

A Study of Roxadustat to Treat Anemia in Children and Teenagers With Chronic Kidney Disease

Phase 3

Recruiting

Conditions: Chronic Kidney Disease
Renal Anemia

Interventions: Drug: Roxadustat

First Posted Date: 2023-08-01

Last Posted Date: 2025-05-18

Lead Sponsor: Astellas Pharma Global Development, Inc.

Target Recruit Count: 100

Registration Number: NCT05970172

Locations: 🇸🇪
Site SE46003, Mölnlycke, Sweden
🇸🇰
Site SK42101, Bratislava, Slovakia
🇪🇸
Site SP34001, Madrid, Spain

and more 39 locations

The Effect of Roxadustat on Renal Oxygenation in Diabetes Nephropathy

Phase 2

Not yet recruiting

Conditions: Diabetes Complications
Diabetes; Nephropathy (Manifestation)

Interventions: Drug: Darbepoietin Alfa
Drug: Roxadustat

First Posted Date: 2023-04-12

Last Posted Date: 2024-11-19

Lead Sponsor: Region Stockholm

Target Recruit Count: 30

Registration Number: NCT05810311

Locations: 🇸🇪
Centre for diabetes, Stockholm, Sweden

Study of the Safety and Efficacy of Roxadustat in the Treatment of Heart Failure With Chronic Kidney Disease and Anemia

Phase 4

Not yet recruiting

Conditions: Heart Failure
Chronic Kidney Diseases
Anemia

Interventions: Drug: Roxadustat
Drug: Recombinant human eythropoietin and/or Iron agents

First Posted Date: 2023-01-19

Last Posted Date: 2023-01-20

Lead Sponsor: China-Japan Friendship Hospital

Target Recruit Count: 300

Registration Number: NCT05691257

A Study to Evaluate the Efficacy and Safety of Roxadustat for the Treatment of Anemia in Participants Receiving Chemotherapy Treatment for Non-Myeloid Malignancies

Phase 3

Completed

Conditions: Chemotherapy Induced Anemia

Interventions: Drug: SEPO®
Drug: Roxadustat

First Posted Date: 2022-03-29

Last Posted Date: 2023-06-06

Lead Sponsor: FibroGen

Target Recruit Count: 159

Registration Number: NCT05301517

Locations: 🇨🇳
Shandong First Medical University Cancer Hospital, Jinan, China
🇨🇳
The Second Hospital of Lanzhou University, Lanzhou, China
🇨🇳
Neijiang Second People's Hospital, Neijiang, China

and more 42 locations

Drug Development Updates

Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.

Home Terms & Conditions Privacy Policy