Roxadustat

Overview

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

Title	Posted	Study ID	Phase	Status	Sponsor
Roxadustat for Bone and Neuropsychiatric Aspects in Hemodialysis Patients	2025/04/09	NCT06917950	Phase 1	Recruiting	Mansoura University
Roxadustat's Effect on Heart, Nutrition, and Inflammation in Hemodialysis Patients	2025/03/30	NCT06903559	Phase 1	Recruiting	Mansoura University
Effect of Perioperative Roxadustat in Elective Lumbar Interbody Fusion Surgery.	2025/01/13	NCT06772272	Phase 3	Active, not recruiting	Second Affiliated Hospital, School of Medicine, Zhejiang University
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	2023/11/03	NCT06115421	Phase 4	Recruiting	Alexandria University
A Single-arm Trial of Roxadustat Combined With Retinoic Acid in the Treatment of Refractory Low-risk MDS	2023/09/01	NCT06020833	Phase 1	Not yet recruiting	Peking Union Medical College Hospital
Roxadustat Combined With Luspatercept Versus Luspatercept Monotherapy in the Treatment of Refractory MDS-RS	2023/08/23	NCT06006949	Phase 4	Not yet recruiting	Peking Union Medical College Hospital
A Study of Roxadustat to Treat Anemia in Children and Teenagers With Chronic Kidney Disease	2023/08/01	NCT05970172	Phase 3	Recruiting	Astellas Pharma Global Development, Inc.
The Effect of Roxadustat on Renal Oxygenation in Diabetes Nephropathy	2023/04/12	NCT05810311	Phase 2	Not yet recruiting	Region Stockholm
Study of the Safety and Efficacy of Roxadustat in the Treatment of Heart Failure With Chronic Kidney Disease and Anemia	2023/01/19	NCT05691257	Phase 4	Not yet recruiting	China-Japan Friendship Hospital
A Study to Evaluate the Efficacy and Safety of Roxadustat for the Treatment of Anemia in Participants Receiving Chemotherapy Treatment for Non-Myeloid Malignancies	2022/03/29	NCT05301517	Phase 3	Completed	FibroGen

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
Evrenzo	Astellas Pharma Europe B.V.,Sylviusweg 62,2333 BE Leiden,The Netherlands	Authorised	8/18/2021

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
♐♇ EVRENZO CAPSULES 50MG	N/A	FIBROGEN INTERNATIONAL (HONG KONG) LIMITED	N/A	N/A	11/8/2024
♐♇ EVRENZO CAPSULES 20MG	N/A	FIBROGEN INTERNATIONAL (HONG KONG) LIMITED	N/A	N/A	11/8/2024

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
No Health Canada approvals found for this drug.

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
EVRENZO 70 MG COMPRIMIDOS RECUBIERTOS CON PELICULA	Astellas Pharma Europe B.V.	1211574003	COMPRIMIDO RECUBIERTO CON PELÍCULA	Diagnóstico Hospitalario	Commercialized
EVRENZO 20 MG COMPRIMIDOS RECUBIERTOS CON PELICULA	Astellas Pharma Europe B.V.	1211574001	COMPRIMIDO RECUBIERTO CON PELÍCULA	Diagnóstico Hospitalario	Commercialized
EVRENZO 150 MG COMPRIMIDOS RECUBIERTOS CON PELICULA	Astellas Pharma Europe B.V.	1211574005	COMPRIMIDO RECUBIERTO CON PELÍCULA	Diagnóstico Hospitalario	Commercialized
EVRENZO 100 MG COMPRIMIDOS RECUBIERTOS CON PELICULA	Astellas Pharma Europe B.V.	1211574004	COMPRIMIDO RECUBIERTO CON PELÍCULA	Diagnóstico Hospitalario	Commercialized
EVRENZO 50 MG COMPRIMIDOS RECUBIERTOS CON PELICULA	Astellas Pharma Europe B.V.	1211574002	COMPRIMIDO RECUBIERTO CON PELÍCULA	Diagnóstico Hospitalario	Commercialized

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

Related News

FibroGen Receives FDA Approval for Phase 3 Trial of Roxadustat in Lower-Risk MDS Patients with High Transfusion Burden

14 days ago

FibroGen has reached agreement with the FDA on key design elements for a pivotal Phase 3 trial of roxadustat in lower-risk myelodysplastic syndrome patients with high transfusion burden.

AstraZeneca Acquires FibroGen China for $160 Million, Strengthening Roxadustat Position

6 months ago

FibroGen has agreed to sell its China subsidiary to AstraZeneca for approximately $160 million, comprising $85 million in enterprise value plus an estimated $75 million in net cash holdings.

FibroGen Terminates Pamrevlumab Development After Failed Pancreatic Cancer Trials, Announces Major Workforce Reduction

a year ago

• FibroGen's lead drug pamrevlumab fails to demonstrate survival benefits in two pivotal pancreatic cancer trials, leading to complete termination of the program. • The company announces plans to reduce its workforce by 75% following the drug's failure, marking a significant setback after previous unsuccessful trials in Duchenne muscular dystrophy. • Despite setbacks, FibroGen maintains a $215 million cash reserve and continues development of other pipeline candidates, including promising ADC therapy FG-3246 for prostate cancer.

FibroGen Highlights Pamrevlumab's Potential in Pancreatic Cancer and Roxadustat's Growth in Q1 2024 Earnings Call

a year ago

FibroGen anticipates top-line data from Phase 3 trials of pamrevlumab in metastatic and locally-advanced pancreatic cancer, addressing a significant unmet need.

GSK's Jesduvroq Receives FDA Approval for Anemia in Dialysis-Dependent CKD Patients

3 years ago

The FDA has approved GSK's Jesduvroq (roxadustat) for anemia treatment in adults with chronic kidney disease (CKD) who are on dialysis.

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