Evrenzo

(Roxadustat)

Phase 3Small molecule

Roxadustat is used to treat anemia (low red blood cell count) in patients with chronic kidney disease, particularly those who may not respond well to other treatments or cannot use certain other medications.[1] Evrenzo is currently being investigated across 6 indications[3], with its most advanced program in Phase 3.[1]

Evrenzo is one of 145 small molecule programs targeting Anemia (phenotype). It is currently in Phase 3.

Indications

Total Trials

Active Trials

144

Competitors

Pipeline

Status by Indication[3][1]

Indication

Anemia (phenotype)Unknown

Myelodysplastic SyndromesNot yet recruiting

Chronic Kidney DiseaseCompleted

SarcopeniaNot yet recruiting

Dialysis PatientsRecruiting

ElectiveActive, not recruiting

Anemia (phenotype)Preclinical

Unknown

Myelodysplastic SyndromesPhase 3

Not yet recruiting

Chronic Kidney DiseasePhase 3

Completed

SarcopeniaPhase 3

Not yet recruiting

Dialysis PatientsPhase 2

Recruiting

ElectivePhase 3

Active, not recruiting

Competition

Competitive Landscape

172 competitors in Chronic Kidney Disease

#DrugCompanyPhaseTrials

Evrenzo

Astellas

Phase 3

20 2

Uloric

Takeda

Preclinical

2 3

Sovaldi

Gilead

Preclinical

1 4

Glucotrol

Pfizer

Preclinical

1 5

Vemlidy

Gilead

Preclinical

1 6

Lorelco

Sanofi

Preclinical

1 7

Flomax

Activase

Januvia

ZZydus Therapeutics Inc.

Preclinical

1 10

Baraclude

KKaruna Therapeutics, Inc., a Bristol Myers Squibb company

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Post-ApprovalNot yet recruiting

Sarcopenia

NCT07162090

Q2 2027

Phase 3Active, not recruiting

Elective

NCT06772272

Q4 2027

Phase 3Recruiting

Chronic Kidney Disease

NCT05970172

Phase 2Not yet recruiting

Nephropathy

NCT05810311

Q4 2032

Phase 3Not yet recruiting

Myelodysplastic Syndromes

NCT07722988

Clinical

Trials by Indication[1]

Chronic Kidney Disease20 trials

Safety and Efficacy Study of Roxadustat to Treat Anemia in Patients With Chronic Kidney Disease (CKD), Not on Dialysis

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT02174627·2,781 enrolled

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

Unknown status·—·Phase 4·NCT05691257·300 enrolled

A Study of Intermittent Oral Dosing of ASP1517 in ESA-untreated Chronic Kidney Disease Patients With Anemia

Completed· Astellas logo

Astellas·Phase 3·NCT02964936·100 enrolled

Show 17 more trials

Roxadustat in the Treatment of Anemia in Chronic Kidney Disease Patients Not Requiring Dialysis

Completed· Astellas logo

Astellas·Phase 3·NCT01887600·594 enrolled

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)

Completed· AstraZeneca logo

AstraZeneca·Phase 4·NCT04655027·25 enrolled

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

Completed· Astellas logo

Astellas·Phase 3·NCT02779764·164 enrolled

Effect of Roxadustat on Heart Failure Patients With Anaemia and Moderate-to-Severe Chronic Kidney Disease

Not yet recruiting·ZZhongda Hospital··NCT07268807·200 enrolled

Evaluate the Efficacy and Safety of Multiple Roxadustat Dosing Regimens for the Treatment of Anemia in Dialysis Participants With Chronic Kidney Disease

Completed·KKyntra Bio·Phase 4·NCT04059913·318 enrolled

Phase 2 Study of Roxadustat in Participants With Anemia and Chronic Kidney Disease Not Requiring Dialysis

Completed·KKyntra Bio·Phase 2·NCT00761657·117 enrolled

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

Completed·KKyntra Bio·Phase 2·NCT01630889·15 enrolled

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

Completed· Astellas logo

Astellas·Phase 3·NCT02780141·75 enrolled

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

Completed·KKyntra Bio·Phase 3·NCT01750190·922 enrolled

Roxadustat in the Treatment of Anemia in Chronic Kidney Disease (CKD) Patients, Not on Dialysis, in Comparison to Darbepoetin Alfa

Completed· Astellas logo

Astellas·Phase 3·NCT02021318·616 enrolled

Safety and Efficacy Study of Roxadustat to Treat Anemia in Patients With Chronic Kidney Disease, on Dialysis.

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT02174731·2,133 enrolled

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

Completed· Astellas logo

Astellas·Phase 3·NCT02988973·334 enrolled

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

Completed· Astellas logo

Astellas·Phase 3·NCT02952092·303 enrolled

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

Completed· Astellas logo

Astellas·Phase 3·NCT02780726·56 enrolled

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

Completed·KKyntra Bio·Phase 2·NCT01244763·145 enrolled

A Study to Investigate the Effect of ASP1517 After Intermittent Oral Dosing in Dialysis Chronic Kidney Disease Patients With Anemia Compared With Darbepoetin as a Reference Drug

Completed· Astellas logo

Astellas·Phase 2·NCT01888445·130 enrolled

A Phase 3, Open-label, Uncontrolled Study to Evaluate the Activity, Safety, Pharmacokinetics and Pharmacodynamics of Roxadustat for the Treatment of Anemia in Pediatric Participants With Chronic Kidney Disease

Recruiting· Astellas logo

Astellas·Phase 3·NCT05970172·100 enrolled

Anemia16 trials

Investigating the Efficacy and Safety of Roxadustat (FG-4592) for Treatment of Anemia in Pediatric Patients With CKD

Unknown status·MMao Jianhua·Phase 3·NCT04925011·30 enrolled

Different Doses of Roxadustat Treatment for Anemia in Peritoneal Dialysis Patients

Completed·PPeking University First Hospital·Phase 4·NCT04454879·100 enrolled

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

Completed·KKyntra Bio·Phase 3·NCT02273726·741 enrolled

Show 13 more trials

Study of Roxadustat Conversion in Participants Receiving Stable ESA or as Initial Anemia Treatment in Hemodialysis Participants

Completed·KKyntra Bio·Phase 3·NCT04484857·283 enrolled

Evaluation of Efficacy and Safety of Roxadustat for the Treatment of Chemotherapy Induced Anemia

Completed·KKyntra Bio·Phase 2·NCT04076943·92 enrolled

Investigating the Efficacy, Safety and PK of Roxadustat (FG-4592) for Treatment of Anemia in Pediatric Patients With CKD

Withdrawn·KKyntra Bio·Phase 3·NCT04621331

Study of Roxadustat Conversion in Participants Receiving Stable Erythropoiesis-Stimulating Agent (ESA) or as Initial Anemia Treatment in Chronic Dialysis Participants

Completed·KKyntra Bio·Phase 3·NCT04410198·203 enrolled

Roxadustat for Anemia in Patients With CKD

Unknown status·SShenzhen Second People's Hospital··NCT04502537·200 enrolled

ASP1517 Pharmacokinetics Study in Anemia Patients on Hemodialysis

Completed· Astellas logo

Astellas·Phase 1·NCT01083888·12 enrolled

HEC53856 Phase Ib Study in Patients With Non-dialysis Renal Anemia

Completed· Sunshine Lake Pharma Co., Ltd. logo

Sunshine Lake Pharma Co., Ltd.·Phase 1·NCT04925661·40 enrolled

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

Completed· Astellas logo

Astellas·Phase 3·NCT02278341·838 enrolled

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

Completed·KKyntra Bio·Phase 3·NCT05301517·159 enrolled

Safety and Efficacy Study of Roxadustat (FG-4592) for the Treatment of Anemia in End-Stage Renal Disease (ESRD) Newly Initiated Dialysis Participants

Completed·KKyntra Bio·Phase 3·NCT02052310·1,043 enrolled

Post-marketing Surveillance of EVRENZO® Tablets (Roxadustat) in Patients With Renal Anemia

Completed· Astellas logo

Astellas··NCT04408820·2,104 enrolled

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

Completed·KKyntra Bio·Phase 2·NCT01414075·60 enrolled

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

Completed·AAlexandria University·Approved·NCT06115421·72 enrolled

Dialysis Patients2 trials

Roxadustat for Bone and Neuropsychiatric Aspects in Hemodialysis Patients

Recruiting·MMansoura University·Phase 1/2·NCT06917950·46 enrolled

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

Recruiting·MMansoura University·Phase 1/2·NCT06903559·46 enrolled

Myelodysplastic Syndromes2 trials

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Investigating the Efficacy and Safety of Roxadustat (FG-4592) for Treatment of Anemia Due to IPSS-R Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS) in Participants With High Red Blood Cell Transfusion Burden

Not yet recruiting·KKyntra Bio·Phase 3·NCT07722988·201 enrolled

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

Withdrawn·PPeking Union Medical College Hospital·Preclinical·NCT06020833

Kidney Disease1 trial

Study of Roxadustat's Effect on Anemia in Patients With Diabetic Kidney Disease

Completed·SSecond Xiangya Hospital of Central South University·Phase 4·NCT07359027·124 enrolled

11 more indications

Coronary Artery Bypass1 trial

Study of Roxadustat for Reducing the Incidence of Acute Kidney Injury After Coronary Artery Bypass Grafting

Terminated·PPeking Union Medical College Hospital·Phase 2·NCT05010460·98 enrolled

Adult Subject1 trial

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

Completed· Astellas logo

Astellas·Phase 1·NCT03960489·24 enrolled

Nephropathy1 trial

The Effect of Roxadustat on Renal Oxygenation in Diabetes Nephropathy

Not yet recruiting·RRegion Stockholm·Phase 2·NCT05810311·30 enrolled

Monotherapy1 trial

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

Unknown status·PPeking Union Medical College Hospital·Phase 4·NCT06006949·62 enrolled

Sarcopenia1 trial

Hypoxia-inducible Factor Prolyl Hydroxylase Inhibitors on Sarcopenia in Hemodialysis Patients

Not yet recruiting·TTianjin Medical University General Hospital·Phase 4·NCT07162090·60 enrolled

Elective1 trial

Effect of Perioperative Roxadustat in Elective Lumbar Interbody Fusion Surgery.

Active, not recruiting·SSecond Affiliated Hospital, School of Medicine, Zhejiang University·Phase 3·NCT06772272·158 enrolled

End-Stage Renal Disease1 trial

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

Completed·KKyntra Bio·Phase 2·NCT01147666·161 enrolled

Myelodysplastic Syndrome1 trial

Efficacy and Safety of Roxadustat for Treatment of Anemia in Participants With Lower Risk Myelodysplastic Syndrome With Low Red Blood Cell Transfusion Burden

Terminated·KKyntra Bio·Phase 3·NCT03263091·184 enrolled

Acute Myocardial Infarction1 trial

Study of Roxadustat in the Treatment of Acute Myocardial Infarction

Unknown status·RRuijin Hospital·Phase 2·NCT04803864·158 enrolled

Function1 trial

A Phase 1 Study of Roxadustat in Subjects With Different Degrees of Renal Function

Completed· Astellas logo

Astellas·Phase 1·NCT02965040·34 enrolled

Diabetic Nephropathy1 trial

Roxadustat Versus Erythropoietin for Anaemia Treatment in Diabetic Nephropathy

Completed·HHanzla Arshad·Preclinical·NCT07786168·64 enrolled

Sources

References

[1]
ClinicalTrials.gov — 52 trial records for Roxadustat. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Roxadustat compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Roxadustat. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Astellas company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Hypoxia-Inducible Factor Prolyl Hydroxylase Inhibitor[2]
Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: Astellas

Evrenzo

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q2 2027

Q4 2027

Q4 2032

Trials by Indication[1]

Chronic Kidney Disease20 trials

Anemia16 trials

Dialysis Patients2 trials

Myelodysplastic Syndromes2 trials

Kidney Disease1 trial

Coronary Artery Bypass1 trial

Adult Subject1 trial

Nephropathy1 trial

Monotherapy1 trial

Sarcopenia1 trial

Elective1 trial

End-Stage Renal Disease1 trial

Myelodysplastic Syndrome1 trial

Acute Myocardial Infarction1 trial

Function1 trial

Diabetic Nephropathy1 trial

References

Drug Info

Quick Facts

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