Enaroy (enarodustat) / Japan Tobacco, JW Pharma, Shenzhen Salubris - LARVOL DELTA

Rapid Hemoglobin Recovery with Enarodustat in Newly Diagnosed Multiple Myeloma Patients with Anemia: A Single-Center Single-Arm Study with Historical Comparison (IMS 2026) - "In this single-center single-arm study, Enarodustat was associated with rapid and sustained Hb recovery in newly diagnosed MM patients with anemia, including those with renal dysfunction. Exploratory comparison with matched historical controls suggested clinically meaningful hematologic benefit without an apparent increase in thrombotic risk. A prospective randomized double-blind placebo-controlled study is underway to further validate these findings."

Clinical • Anemia • Hematological Disorders • Hematological Malignancies • Multiple Myeloma • Nephrology • Renal Disease

Detection and confirmation of hypoxia-inducible factor activating agents in equine plasma and urine by liquid chromatography coupled to mass spectrometry. (PubMed, J Chromatogr A) - "LOC was 50 to 200 pg/mL for all analytes in plasma, except daprodustat and IOX 3 at 500 pg/mL, and 20 to 500 pg/mL in urine, except daprodustat and IOX 3 at 1000 pg/mL. The developed LC-MS method was successfully applied to the analysis of plasma and urine samples from a research horse following oral administration of JNJ 42041935."

Journal • EPO

Real-World Study of Enarodustat for Anemia in Non-Dialysis CKD Patients (clinicaltrials.gov) - P=N/A | N=90 | Recruiting | Sponsor: Huashan Hospital

New trial • Real-world evidence • Anemia • Chronic Kidney Disease • Hematological Disorders • Nephrology • Renal Disease

The Clinical Significance of Enarodustat,Roxadustat and Erythropoiesis Stimulatig Agents in Non-Dialysis Patients with Renal Anemia (ChiCTR) - P=N/A | N=150 | Not yet recruiting | Sponsor: The Affiliated Hospital of Xuzhou Medical University; The Affiliated Hospital of Xuzhou Medical University

New trial • Anemia • Chronic Kidney Disease • Hematological Disorders • Nephrology • Renal Disease

Enarodustat for Renal Anemia in Patients on Dialysis (ChiCTR) - P=N/A | N=100 | Completed | Sponsor: 363 Hospital; 363 Hospital

New trial • Anemia • Chronic Kidney Disease • Hematological Disorders • Nephrology • Renal Disease

SAL-0951 in the Treatment of Chemotherapy-induced Anemia in Patients With Non-myeloid Malignancies (clinicaltrials.gov) - P2 | N=140 | Sponsor: Shenzhen Salubris Pharmaceuticals Co., Ltd. | N=60 ➔ 140

Enrollment change • Anemia • Chemotherapy-Induced Anemia • Oncology • Solid Tumor

Enarodustat Improves Iron Handling and Limits Organ Iron Deposition in CKD Anemia with Iron Overload via Hepato–Spleno–Intestinal Axis Regulation (ERA 2026) - "Method A rat model of CKD anemia with graded iron overload was established via 5/6 nephrectomy and iron dextran injection...Changes in the proportion of iron deposition-positive areas in the intestine, liver, spleen, kidney, femur, and heart tissues of chronic kidney disease (CKD) rats after intervention with enarodustat, roxadustat, and recombinant human erythropoietin (rHuEPO) under different degrees of iron overload . Note : A two-tailed test was used. *P<0.05 indicates a statistically significant difference, **P<0.01 indicates a strongly statistically significant difference, ***P<0.001 indicates a very strongly statistically significant difference, and ****P<0.0001 indicates an extremely significant statistically difference."

Anemia • Chronic Kidney Disease • Hematological Disorders • Hepatology • Inflammation • Liver Failure • Nephrology • BMP6 • DMRT1 • EPAS1 • NCOA4

Enarodustat+CsA vs CsA in the Treatment of Newly-diagnosed TD-NSAA (clinicaltrials.gov) - P3 | N=0 | Withdrawn | Sponsor: Peking Union Medical College Hospital | N=90 ➔ 0 | Not yet recruiting ➔ Withdrawn

Enrollment change • Monotherapy • Trial withdrawal • Anemia • Aplastic Anemia • Hematological Disorders

Enarodustat + CsA vs CsA in Newly Diagnosed TD-NSAA (clinicaltrials.gov) - P3 | N=90 | Not yet recruiting | Sponsor: Peking Union Medical College Hospital

Monotherapy • New P3 trial • Anemia • Aplastic Anemia • Hematological Disorders

Enarodustat+CsA vs CsA in the Treatment of Newly-diagnosed TD-NSAA (clinicaltrials.gov) - P3 | N=90 | Not yet recruiting | Sponsor: Peking Union Medical College Hospital

Monotherapy • New P3 trial • Anemia • Aplastic Anemia • Hematological Disorders

Enarodustat combined with oral iron supplementation for iron-deficient non-dialysis-dependent chronic kidney disease anemia patients: Synergistic effects and safety. (PubMed, Medicine (Baltimore)) - "This study indicates that enarodustat combined with oral iron supplementation may have a certain synergistic effect on iron-deficient NDD-CKD anemia compared with oral iron alone, potentially helping to improve hematological indicators and promote erythropoiesis, with an acceptable safety profile. This combined regimen may provide a preliminary reference for the management of NDD-CKD anemia."

Journal • Observational data • Retrospective data • Anemia • Chronic Kidney Disease • Hematological Disorders • Nephrology • Renal Disease

REAL-WORLD ANEMIA MANAGEMENT BEFORE HEMODIALYSIS INITIATION IN JAPAN: A RETROSPECTIVE MULTICENTER COHORT STUDY (ISN-WCN 2026) - "ESA was used in 60%, HIF-PHIs in 30%, and no erythropoietic agents in 10%, with the following distribution: darbepoetin alfa 34%, epoetin beta pegol 26%, daprodustat 25%, roxadustat 3%, vadadustat 1%, and enarodustat 1%. In a multivariate logistic regression model adjusted for sex, age, and transferrin saturation, lower Hb 6 months prior was independently associated with Hb < 9 g/dL at HD initiation (p < 0.001), without significant differences between ESA and HIF-PHI groups.Conclusion Despite contemporary anemia therapy, 60% of patients presented with Hb < 10 g/dL and one-third with Hb < 9 g/dL at HD initiation. Lower baseline Hb strongly predicted suboptimal Hb control, suggesting that earlier dose adjustment and closer monitoring are warranted during progression to end-stage kidney disease."

Real-world • Real-world evidence • Retrospective data • Acute Kidney Injury • Anemia • Cardiovascular • Chronic Kidney Disease • Congestive Heart Failure • Diabetic Nephropathy • Glomerulonephritis • Heart Failure • Hematological Disorders • Lupus Nephritis • Nephrology • Renal Disease • STAT3

The Efficacy and Safety of Enarodustat for the Treatment of Anemia in Hemodialysis Dependent Chronic Kidney Disease Patients: A Phase 3, Multicenter, Randomized, Active-Comparator (recombinant human erythropoietin), Open-Label Study：the ENARODIAL study. (PubMed, Am J Nephrol) - "Enarodustat was noninferior to rHuEPO for the treatment of anemia in HD-CKD patients , with good safety and tolerability over 24 weeks."

Journal • P3 data • Anemia • Chronic Kidney Disease • Hematological Disorders • Nephrology • Renal Disease

Prospective, Multicenter, Randomized, Controlled, Double-Blind Study: Analysis of the Efficacy of Enarodustat in Treating Anemia in Patients with Renal Insufficiency due to Multiple Myeloma (ChiCTR) - P=N/A | N=154 | Not yet recruiting | Sponsor: The FIrst Affiliated Hospital, College of Medicine, Zhejiang University; The FIrst Affiliated Hospital, College of Medicine, Zhejiang University

New trial • Anemia • Hematological Disorders • Hematological Malignancies • Multiple Myeloma • Nephrology • Oncology • Renal Disease

A Multicenter, Randomized, Positive Controlled Exploratory Study of Enadurestat in the Treatment of Renal Anemia in Diabetes Nephropathy (ChiCTR) - P4 | N=150 | Not yet recruiting | Sponsor: The Second Affiliated Hospital Zhejiang University School of Medicine; The Second Affiliated Hospital Zhejiang University School of Medicine

New P4 trial • Anemia • Diabetes • Diabetic Nephropathy • Hematological Disorders • Metabolic Disorders • Nephrology • Renal Disease

A Phase 3 Study of Enarodustat in Chinese Patients Undergoing Peritoneal Dialysis for Treatment of Anemia: The ENAROPERA Study. (PubMed, Kidney Dis (Basel)) - "Enarodustat effectively maintained target Hb levels in PD patients with anemia, demonstrating favorable safety and tolerability. Its convenient once-daily oral dosing regimen may enhance patient adherence, highlighting its potential as a promising therapeutic option for anemia management in PD patients."

Journal • P3 data • Anemia • Cardiovascular • Chronic Kidney Disease • Hematological Disorders • Nephrology • Renal Disease

Prospective, Multicenter, Randomized, Controlled, Double-Blind Study: Analysis of the Efficacy and Safety of Enarodustat in Treating Anemia in Patients with Multiple Myeloma (ChiCTR) - P4 | N=82 | Not yet recruiting | Sponsor: The FIrst Affiliated Hospital, College of Medicine, Zhejiang University; The FIrst Affiliated Hospital, College of Medicine, Zhejiang University

New P4 trial • Anemia • Hematological Disorders • Hematological Malignancies • Multiple Myeloma • Oncology

Enarodustat suppresses thymic stromal lymphopoietin expression via hypoxia-inducible factor-mediated c-Jun N-terminal kinases dephosphorylation. (PubMed, PLoS One) - "Collectively, our findings identify a previously uncharacterized HIF-DUSP-JNK axis that negatively regulates TSLP expression. This study provides mechanistic insight into how HIF activation shapes epithelial cytokine responses, offering a basis for understanding the pathogenesis of TSLP-associated diseases such as atopic dermatitis."

IO biomarker • Journal • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Inflammation • EPAS1 • HIF1A • MAPK8 • TLR2 • TSLP

Prolyl-hydroxylase domain inhibition enhances collagen levels in oral mucosa-derived fibroblasts. (PubMed, Biochim Biophys Acta Mol Basis Dis) - "We examined three PHD inhibitors, IOX4, Enarodustat, and Daprodustat, for their effect on collagen levels in keratinized OMDFs. The mechanism involves HIF-1α-mediated upregulation of collagen-modifying enzymes. These findings highlight the potential of repurposing clinically approved PHD inhibitors as therapeutic agents for promoting the healing and regeneration of damaged gingiva and additional tissues."

Journal • HIF1A

Characterization of Novel Enarodustat Metabolites Using Liquid Chromatography-High Resolution Mass Spectrometry for Doping Control Purposes. (PubMed, Drug Test Anal) - "The study elucidates enarodustat's metabolic pathways and provides a foundation for developing sensitive detection methods. Future work should focus on synthesizing reference materials to identify metabolite structures."

Journal

Erythropoietin-Mimetic Peptide Pegmolesatide Therapy for Pure Red Cell Aplasia in a Patient with Nondialysis-Dependent Type 1 Diabetic Nephropathy: A Case Report (KIDNEY WEEK 2025) - "Enarodustat and roxadustat were administered successively after discontinuation of EPO, but anemia did not improve, and the patient was maintained with weekly blood transfusions...Discussion The new EPO-mimetic peptide pegmolesatide, which consists of 44 amino acids and has a completely different peptide chain structure from peginesatide and EPO (Fig 4), was independently developed in China...Thus, there is no cross-immune response between pegmolesatide and EPO. In addition, pegmolesatide rarely produces drug antibodies, attributed to the low immunogenicity.Based on these findings, we speculate that pegmolesatide can provide a safe, effective, and convenient therapeutic strategy for PRCA in Chinese patients with chronic kidney disease."

Case report • Clinical • Anemia • Chronic Kidney Disease • Diabetes • Diabetic Nephropathy • Hematological Disorders • Nephrology • Renal Disease • Type 1 Diabetes Mellitus

Effect and Mechanism of Enarodustat on Delaying Renal Interstitial Fibrosis by Mediating Aerobic Glycolysis (KIDNEY WEEK 2025) - "After interfering with HIF expression in HK-2 cells using shRNA, supplementation with JTZ-951 did not significantly improve the above phenomena. Conclusion JTZ-951 can inhibit the excessive activation of FOXK1 and the abnormally activated glycolysis, thereby delaying the progression of renal fibrosis."

Anemia • Cardiovascular • Chronic Kidney Disease • Fibrosis • Hematological Disorders • Immunology • Nephrology • Renal Disease • Reperfusion Injury • TGFB1

Profiling Inhibitor Scaffolds for the Cancer Target Jumonji-C Domain-Containing Protein 6. (PubMed, ChemMedChem) - "By contrast, some, but not all, clinically used inhibitors of the human hypoxia-inducible factor-α prolyl hydroxylase domain-containing proteins (PHDs) efficiently inhibit isolated JMJD6, in particular Enarodustat and Desidustat. The results identify attractive scaffolds for the development of selective, cell permeable JMJD6 inhibitors and suggest that JMJD6 inhibition is a potential off-target effect of PHD inhibitors in clinical use."

Journal • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Discovery of enarodustat: A HIF prolyl hydroxylase inhibitor for the treatment of renal anemia (ACS-Fall 2025) - "As a result, we succeeded in identifying compound A bearing an [1,2,4]triazolo[4,3-a]pyridine core as a lead compound. Lead optimization to improve the efficacy of EPO release in cells and in vivo by improving cell permeability led to the discovery of enarodustat, with a 5-phenethyl substituent on the triazolopyridine group, which increased hemoglobin levels with daily oral dosing in rats."

Anemia • Chronic Kidney Disease • Hematological Disorders • Nephrology • Renal Disease

CANNON: Correction of Anemia With Enarodustat in Non-dialysis Dependent Chronic Kidney Disease (clinicaltrials.gov) - P4 | N=1670 | Recruiting | Sponsor: Shanghai Zhongshan Hospital | Not yet recruiting ➔ Recruiting | Initiation date: Dec 2024 ➔ Mar 2025

Enrollment open • Trial initiation date • Anemia • Chronic Kidney Disease • Congestive Heart Failure • Hematological Disorders • Nephrology • Renal Disease