Oxemia (desidustat) / Zydus Lifesci - LARVOL DELTA

Phase 4, 52-Week, Single-Arm, Post-Marketing Surveillance to Evaluate Safety of Desidustat for Treatment of Anemia in Patients with CKD (KIDNEY WEEK 2025) - "Treatment with Desidustat led to an increase in hemoglobin, a reduction in serum hepcidin, and no significant change in VEGF. Conclusion This, phase-4 study showed favourable safety and efficacy of desidustat over 24-weeks for anemia in CKD patients."

Clinical • Late-breaking abstract • P4 data • Anemia • Chronic Kidney Disease • Cough • Hematological Disorders • Nephrology • Respiratory Diseases • Thrombocytopenia

Efficacy of Desidustat in Patients with Dialysis-Dependent CKD with Functional Iron Deficiency and High Ferritin (KIDNEY WEEK 2025) - "(Fig 1) Patients maintained good compliance with the therapy. Conclusion Desidustat effectively reduced hepcidin levels in DD-CKD patients with high-ferritin, suggesting its potential to improve iron utilization and manage anemia in this challenging patient population."

Clinical • Anemia • Chronic Kidney Disease • Hematological Disorders

Desidustat Is Effective in Treating Pure Red Cell Aplasia Due to Recombinant Human Erythropoietin in Patients with Chronic Kidney Disease (ASH 2024) - "Four patients had failed prior immunosuppression therapy for PRCA (wysolone -2, wysolone followed by cyclosporine -1, Wysolone followed by cyclophosphamide 1). Desidustat is useful in this setting with better tolerability. This study warrants further randomised control trial in these patients to assess optimal dose or schedule."

Clinical • Anemia • Chronic Kidney Disease • CNS Disorders • Depression • Hematological Disorders • Infectious Disease • Nephrology • Psychiatry • Renal Disease • Respiratory Diseases • Septic Shock • Solid Tumor • Thymoma • Thymus Cancer • Tuberculosis

Zydus Lifesciences receives USFDA Orphan Drug Designation for Desidustat to treat beta-thalassemia (Business Upturn)

Orphan drug • Beta-Thalassemia

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

Desidustat for the Treatment of Anaemia in Adult End-Stage Kidney Disease Patients on Maintenance Haemodialysis: A Prospective Observational Study. (PubMed, Int J Nephrol) - "Desidustat demonstrated efficacy and safety in ESKD patients on haemodialysis, offering effective haemoglobin management and a favourable safety profile. These findings support desidustat as a viable treatment option for patients with anaemia, providing a valuable alternative to existing therapies."

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

Tumor vascularization of NSCLC depending on nighttime hypoxemic stress (DGT 2025) - "There was no significant difference in central and peripheral vascularization depending on the carcinoma subtype (p=0.607 and p=0.689, respectively) or depending on the oxemia subtype (p=0.272 and p=0.689, respectively). PD-L1 status was also not significantly influenced by the oxemia subtype (IPC: p=0.447 and IC: p=0.173, respectively). The ratio of the determined vessel count by examiner no."

Chronic Obstructive Pulmonary Disease • Immunology • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Respiratory Diseases • Solid Tumor • Squamous Cell Carcinoma • CD34 • PD-L1

ISS2.4 New ERA for Managing CKD Anemia: Focus on HIF-PHIs (ERA 2025) - "The pathophysiological mechanisms involved in the anemia of CKD are diverse however a relative decrease in erythropoietin (EPO) production and absolute and/or functional iron deficiency are most commonly implicated in the disease...In recent times, the optimal CKD management has evolved with the advent of HIF-PHIs.In India, currently, Desidustat is the only HIF-PHI marketed and available for clinical usage...Several real-world studies have been published highlighting the utility of HIF Stabilizers for anemia of CKD and identifying the most suitable patient profiles. Newer evidence also suggests a possible role of this new class of drugs beyond anemia of CKDThis symposium reviews the evolving role of CKD anemia management in the era of HIF PHIs with Real-World Experience from India."

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

A Retrospective, Multicenter Study on the Efficacy and Safety of Desidustat in Chronic Kidney Disease-Induced Anemia (ERA 2025) - "Desidustat is a safe and effective oral therapy for CKD-induced anemia, demonstrating consistent Hb increases in both dialysis and pre-dialysis patients. Its oral administration route enhances usability, particularly in tropical conditions."

Retrospective data • Anemia • Cardiovascular • Chronic Kidney Disease • Constipation • Diabetes • Diabetic Nephropathy • Gastroenterology • Gastrointestinal Disorder • Hematological Disorders • Hypertension • Metabolic Disorders • Nephrology • Pain • Renal Disease

Correction of Functional Iron Deficiency & Iron Sequestration in Patients with Chronic Kidney Disease with Desidustat: A Retrospective Study (ERA 2025) - "This retrospective cohort study demonstrate that Desidustat achieves desired hemoglobin levels with significantly less iron sequestration in comparison to EPO group in patients of CKD 5-D with anemia. Patient receiving Desidustat may be switched to I/V iron given in a reactive fashion as it will be more cost effective as well as avoid long term oxidative stress of iron sequestration while also avoiding the ill effects of supraphysiological exogenous erythropoietin."

Retrospective data • Anemia • Cardiovascular • Chronic Kidney Disease • Hematological Disorders • Infectious Disease • Inflammation • Nephrology • Renal Disease

Desidustat in CKD Anemia: A single center experience (ERA 2025) - "This study demonstrates that Desidustat is an effective and safe alternative to traditional erythropoietin analogues for treating CKD-induced anemia. The significant increase in hemoglobin levels, along with stable renal function and serum potassium levels, highlights its efficacy and safety. Patients showed good compliance with the therapy, and adverse events were self-limiting."

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

Retrospective single center analysis of Desidustat in CKD Anemia (ERA 2025) - "The study demonstrates significant improvements in hemoglobin levels across all patient groups, with the most notable increases observed in pre-dialysis patients. Serum potassium levels remained stable throughout the follow-up period. These findings suggest that Desidustat therapy is effective in managing anemia in CKD patients, providing a viable alternative to traditional erythropoietin therapy."

Retrospective data • Anemia • Cardiovascular • Chronic Kidney Disease • Hematological Disorders • Nephrology • Pancreatitis • Thrombosis

Desidustat in Chronic Kidney Disease Anaemia: Real-World Experience and Outcomes (ERA 2025) - "Desidustat significantly improved haemoglobin levels in the majority of patients, with a response profile that was consistent across various stages of CKD without causing severe adverse drug reactions. The treatment was associated with minimal side effects suggesting that Desidustat may offer a safer alternative to traditional ESA therapy, particularly for patients at risk for cardiovascular events or those who prefer oral medication over injections. Further randomised controlled trials are warranted to validate these findings and assess the long-term benefits of Desidustat in CKD-related anaemia."

Clinical • Real-world • Real-world evidence • Anemia • Cardiovascular • Chronic Kidney Disease • Fatigue • Hematological Disorders • Nephrology • Pain • Renal Disease

Derivatives of the Clinically Used HIF Prolyl Hydroxylase Inhibitor Desidustat Are Efficient Inhibitors of Human γ-Butyrobetaine Hydroxylase. (PubMed, J Med Chem) - "We report that the clinically used hypoxia-inducible factor-α prolyl residue hydroxylase (PHD) inhibitors Desidustat, Enarodustat, and Vadadustat efficiently inhibit isolated recombinant BBOX, suggesting that BBOX inhibition by clinically used PHD inhibitors should be considered as a possible off-target effect. Structure-activity relationship studies on the Desidustat scaffold enabled development of potent BBOX inhibitors that manifest high levels of selectivity for BBOX inhibition over representative human 2OG oxygenases, including PHD2. The Desidustat derivatives will help to enable investigations into the biological roles of l-carnitine and the therapeutic potential of BBOX inhibition."

Journal • Cardiovascular

HIF-Prolyl Hydroxylase Inhibitor Desidustat Increases Pyruvate Kinase Activity and Reduces Oxidative Stress in Red Blood Cells, Causes Erythrocytosis in Thalassaemic Mice, and Reduces Sickling in Sickle Cell Patient's Blood. (PubMed, Drug Dev Res) - "Bone marrow transplants or blood transfusion are frequently employed as treatment for these diseases, and erythropoietin analogues are sometimes used to boost erythropoiesis to compensate the destruction of RBCs. Desidustat treatment increased pyruvate kinase activity in RBCs of human, mice, and rats in a dose-dependent manner, and reduced sickling in SCD patients' RBCs. These data indicate that desidustat stimulates pyruvate kinase and attenuates oxidative stress in red blood cells, causes erythrocytosis in thalassemic mice, and reduces sickling in sickle cell patient's blood."

Journal • Preclinical • Beta-Thalassemia • Bone Marrow Transplantation • Genetic Disorders • Hematological Disorders • Pain • Sickle Cell Disease • Transplantation

Hypoxia-Inducible Factor Prolyl Hydroxylase Inhibitors for Anemia in Non-Dialysis Dependent Chronic Kidney Disease: Systematic Review and Meta-Analysis of Randomized Controlled Trials. (PubMed, Indian J Nephrol) - "The studies included roxadustat (n = 2), daprodustat (n = 3), molidustat (n = 3), vadadustat (n = 2), enarodustat (n = 1), and desidustat (n = 1). Broadly, HIF-PHI molecules exhibited little difference when compared to other alternatives like erythropoietin stimulating agents (ESAs), but the evidence is not of high certainty. Our meta-analysis provides evidence on the use of HIF-PHIs as an alternative to ESAs for anemia in NDD-CKDs."

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

Hypoxia-Inducible Factor Prolyl Hydroxylase Inhibitors for Anemia in Dialysis-Dependent Chronic Kidney Disease: Systematic Review and Meta-Analysis of Randomized Controlled Trials. (PubMed, Indian J Nephrol) - "The studies included roxadustat (n = 9), daprodustat (n = 5), vadadustat (n = 2), molidustat (n = 2), enarodustat (n = 1), and desidustat (n = 1). Roxadustat increased treatment-emergent adverse events up to 6-52 weeks as compared to ESAs [OR: 1.45 (95% CI 1.08-1.96); p = 0.01; six studies; 1715 participants; moderate certainty evidence]. The study provided evidence on the use of HIF-PHIs for treating renal anemia in DD-CKD patients as an alternative to ESAs."

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

A Real-World Experience of Desidustat in Maintenance Hemodialysis Patients-A 1-Year Retrospective Database Analysis From a Single Center: Desidustat-A Real World Experience in Hemodialysis Patients From a Single Center. (PubMed, Semin Dial) - "Desidustat is effective and safe in management of anemia in hemodialysis patients over a period of 1 year. It helps in achieving target hemoglobin in majority of patients within 6 months."

Journal • Real-world evidence • Retrospective data • Hematological Disorders • Hepatology • Human Immunodeficiency Virus • Infectious Disease • Inflammation • Renal Disease • Transplantation

Balancing Efficacy, Health Status, and Cost-Effectiveness: A Comparative Study of Desidustat and Erythropoietin in Chronic Kidney Disease Patients on Hemodialysis. (PubMed, G Ital Nefrol) - "Serum albumin and iPTH were significant predictors of hemoglobin response. To validate these results larger multicentric studies are necessary."

HEOR • Journal • Chronic Kidney Disease • Hematological Disorders • Infectious Disease • Nephrology • Renal Disease

Prolyl Hydroxylase Inhibitor Desidustat Improves Stroke Outcomes by Enhancing Microglial Efferocytosis in Mice with Chronic Kidney Disease (ISC 2025) - "Desidustat treatment significantly reduced cerebral inflammation and enhanced microglial efferocytosis (72 h post-stroke) and improved neurological recovery and sensorimotor function for up to 4 weeks. In vitro mechanistic studies revealed that desidustat directly enhanced efferocytosis in a human microglial-neuronal co-culture assay.Conclusion : Our results demonstrated that desidustat treatment enhances microglial efferocytosis and improves neurological outcomes and sensorimotor deficits following ischemic stroke in mice."

Preclinical • Anemia • Cardiovascular • Chronic Kidney Disease • Fibrosis • Hematological Disorders • Immunology • Inflammation • Ischemic stroke • Nephrology • Renal Disease

Prolyl hydroxylase inhibitor desidustat improves stroke outcomes via enhancing efferocytosis in mice with chronic kidney disease. (PubMed, Exp Neurol) - "In vitro studies using human-induced microglia-like cells further confirmed the ability of desidustat to enhance efferocytosis of apoptotic neurons by reducing the cleavage of MerTK. These findings suggest that desidustat may serve as a novel therapeutic strategy for improving stroke outcomes in patients with CKD, a population at high risk for stroke and poor functional recovery."

Journal • Preclinical • Cardiovascular • Chronic Kidney Disease • Hematological Disorders • Inflammation • Ischemic stroke • Nephrology • Renal Disease • ADAM17 • MERTK

A CASE SERIES OF POST TRANSPLANT - PARVOVIRUS B19 INDUCED ANAEMIA TREATED WITH NOVEL HIF-PHI: DESIDUSTAT (ISN-WCN 2025) - "Results Case 1: A 38-year-old female who underwent a live-related renal transplant with no induction, wherein the post-operative course was complicated by acute ABMR and ACMR for which she received plasma exchange, low dose IV Ig and rituximab in the immediate post-transplant period...He tolerated the gradual reintroduction of mycophenolate mofetil, and Desidustat was stopped after 45 days with stable Hb and graft function thereafter...However, long term outcomes of desidustat use and duration of therapy is uncertain as literature is unavailable with respect to use of the drug in parvo related anaemia. Large scale studies are required to definitely establish the role of Desidustat in Parvovirus B19 induced anaemia, especially when the response to standard therapy and erythropoietin is suboptimal."

Clinical • Post-transplantation • Anemia • Chronic Kidney Disease • Hematological Disorders • Infectious Disease • Transplantation • Urology

A RETROSPECTIVE STUDY ON THE OUTCOMES OF DESIDUSTAT IN CHRONIC KIDNEY DISEASE PATIENTS WITH ANEMIA: A SINGLE CENTRE EXPERIENCE (ISN-WCN 2025) - "Good compliance of the drug was observed, attributed to its oral administration. Long- term prospective studies with larger population and prospective comparative studies with use of other erythropoietin stimulating agents are recommended to further assess the safety and efficacy outcomes of Desidustat in CKD-anemia patients."

Retrospective data • Anemia • Atrial Fibrillation • Cardiovascular • Chronic Kidney Disease • Diabetic Retinopathy • Hematological Disorders • Nephrology • Renal Disease • Retinal Disorders

ROLE OF DESIDUSTAT IN ANEMIC CKD-EASTERN INDIA EXPERIENCE (ISN-WCN 2025) - "Conclusions Desidustat significantly increase the Hb in CKD Anemia without causing severe adverse drug reaction. More studies are required to assess the long term efficacy and safety of Desidustat in DD- CKD patients."

Anemia • Autosomal Dominant Polycystic Kidney Disease • Cardiovascular • Chronic Kidney Disease • Constipation • Diabetic Nephropathy • Diabetic Retinopathy • Focal Segmental Glomerulosclerosis • Gastroenterology • Gastrointestinal Disorder • Glomerulonephritis • Hematological Disorders • Hypertension • Nephrology • Pain • Polycystic Kidney Disease • Retinal Disorders

A COMPARATIVE STUDY OF DESIDUSTAT AND ERYTHROPOIETIN STIMULATING AGENTS IN CKD-RELATED ANEMIA (ISN-WCN 2025) - "A total of 60 patients with CKD-related anemia were enrolled, with 30 patients receiving Desidustat and 30 receiving ESA therapy (epoetin alfa). Adverse events were minimal and comparable in both groups. Download: Download high-res image (167KB) Download: Download full-size image Conclusions Desidustat offers a comparable rise in hemoglobin levels to ESAs in CKD-related anemia, with additional benefits of reduced cost, ease of administration, and ease of storage."

Anemia • Chronic Kidney Disease • Hematological Disorders • Nephrology