Oxemia (desidustat) / Zydus Lifesciences - LARVOL DELTA

COMPARATIVE EVALUATION OF DESIDUSTAT VERSUS ERYTHROPOIETIN ON HEMOGLOBIN CORRECTION, IRON UTILISATION AND COST IN DIALYSIS-DEPENDENT CKD PATIENTS: A 12-MONTH RANDOMIZED CONTROLLED STUDY (ISN-WCN 2026) - "In the health-economic analysis across all dialysis schedules and dialyser types, the annual medication cost was ₹ 76,024 for the Desidustat group versus ₹ 84,840 for the EPO group, yielding an 11.6 % cost reduction though this difference did not reach statistical significance.Download: Download high-res image (203KB)Download: Download full-size imageConclusion Desidustat demonstrated superior hemoglobin correction, better iron utilisation and lower annual treatment cost compared to Erythropoietin, with comparable safety in DD-CKD. The oral HIF-PHD inhibitor thus represents an effective, patient-convenient, and economically favourable alternative to injectable ESA therapy for renal anemia management in real-world Indian settings."

Clinical • Cardiovascular • Chronic Kidney Disease • Hypertension • Mental Retardation • Musculoskeletal Pain • Nephrology

REDEFINING ANEMIA TREATMENT IN CKD: A DUAL-MODALITY STRATEGY WITH ESA AND HIF-PHIS (ISN-WCN 2026) - "No serious adverse events or treatment-related discontinuations; except in 2 patients where dose of anti-hypertensives was scrolled up.Download: Download high-res image (64KB)Download: Download full-size imageConclusion Desidustat add-on therapy produced a statistically significant and sustained rise in Hb among CKD patients inadequately responding to ESAs, with corresponding improvement in iron utilization. The therapy was well tolerated and effective across dialysis and non-dialysis groups, underscoring Desidustat's role as a valuable adjunct and potential maintenance option in CKD-related anemia."

Anemia • Cardiovascular • Chronic Kidney Disease • Diabetes • Diabetic Nephropathy • Hematological Disorders • Hypertension • Metabolic Disorders • Nephrology

A RANDOMIZED PROSPECTIVE STUDY COMPARING DESIDUSTAT AND ERYTHROPOIETIN FOR THE TREATMENT OF ANEMIA IN CHRONIC KIDNEY DISEASE PATIENTS ON PERITONEAL DIALYSIS(CAPD). (ISN-WCN 2026) - "Its oral route, favorable biomarker profile, and renal safety position Desidustat as a promising, next-generation alternative for anemia management in dialysis-dependent CKD. Further multicenter validation is warranted."

Clinical • Anemia • Chronic Kidney Disease • Hematological Disorders • Inflammation • Nephrology • Renal Disease • CRP

A PHASE-4, 52-WEEK, SINGLE ARM, POST-MARKETING SURVEILLANCE TO EVALUATE SAFETY OF DESIDUSTAT FOR TREATMENT OF ANEMIA IN SUBJECTS WITH CHRONIC KIDNEY DISEASE (ISN-WCN 2026) - "In terms of efficacy, treatment with Desidustat led to an increase in hemoglobin level, a reduction in serum hepcidin, and no significant change in VEGF and e-GFR levels.Conclusion This ongoing, phase 4 study demonstrated a favorable safety profile and sustained efficacy over 24 weeks in the treatment of anemia in patients with chronic kidney disease, irrespective of dialysis status. These interim findings support long-term use of Desidustat as a safe and effective oral HIF-PHI for managing anemia in CKD patients."

Clinical • P4 data • Anemia • Cardiovascular • Chronic Kidney Disease • Hematological Disorders • Nephrology • Renal Disease • Thrombocytopenia

EFFICACY OF DESIDUSTAT IN ERYTHROPOIETIN-HYPORESPONSIVE CKD PATIENTS: A REAL-WORLD EVALUATION AS PER KDIGO GUIDELINES (ISN-WCN 2026) - "Statistical comparisons were performed using paired t-tests.Results At baseline, mean Hb was 7.07 ± 0.52 g/dL.Following switch to Desidustat:Hb at 1 month: 7.83 ± 0.63 g/dL (Δ = +0.76 g/dL; +10.7%, p = 0.00023)Hb at 3 months: 8.55 ± 0.71 g/dL (Δ = +1.48 g/dL; +20.9%, p = 0.00052)Despite previous high-dose EPO exposure with suboptimal response, patients demonstrated a clinically and statistically significant rise in Hb within 3 months of Desidustat therapy.Download: Download high-res image (69KB)Download: Download full-size imageMetabolic parameters remained stable throughout follow-up:Creatinine: 3.25 ± 1.00 mg/dLCalcium: 8.92 ± 0.36 mg/dLPhosphate: 4.62 ± 0.60 mg/dLALP: 118.8 ± 33.97 U/LNa/K: 138.5 ± 2.88 / 4.57 ± 0.39 mmol/LTransferrin Saturation: 27.47 ± 6.83%Ferritin: 288.8 ± 99.24 ng/mLNo significant derangements or safety concerns were observed, suggesting a favorable tolerability profile.Conclusion Desidustat..."

Clinical • HEOR • Real-world • Real-world evidence • Chronic Kidney Disease • Hematological Disorders • Nephrology

Real World Evidence with Desidustat: India's Contribution to the Global HIF Story (ISN-WCN 2026) - "Organized By: Zydus LifeSciences"

Clinical • HEOR • Real-world • Real-world evidence • Anemia • Chronic Kidney Disease • Hematological Disorders

Industry Symposium 43: Reimagining Anemia Management in CKD: Evolution with HIF-PHIsTheme: Preserving Kidney Health (ISN-WCN 2026) - "Newer evidence also suggests a possible role of this new class of drugs beyond anemiaThis symposium reviews the evolving role of CKD anemia management in the era of HIF PHIs with Real-World Experience from India. Learning Objectives:Understand how HIF-PHIs work and why treatment is shifting from ESAs to HIF-PHIs.Review key clinical and real-world evidence for Desidustat and other HIF-PHIs.Apply practical guidance on patient selection, initiation, and monitoring for Desidustat/HIF-PHIs"

Anemia • Chronic Kidney Disease • Hematological Disorders

CMS(867.HK/8A8.SG): New Drug for Renal Anaemia Desidustat Tablets Approved in China (The Manila Times) - "The Product is a novel, oral HypoxiaInducible Factor-Prolyl Hydroxylase Inhibitor (HIF-PHI) for treating anaemia in non-dialysis adult, Chronic Kidney Disease (CKD) patients...Its China Phase III clinical trial has demonstrated positive results."

China approval • Anemia • Chronic Kidney Disease • Renal Disease

A Phase III Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating Desidustat's Efficacy and Safety in Non-Dialysis Chronic Kidney Disease Patients with Anemia. (PubMed, Am J Nephrol) - "Desidustat significantly improved Hb levels and accelerated anemia correction in NDD-CKD patients versus placebo, with comparable safety."

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

Zydus secures Orphan drug designation for sickle cell therapy in US (The Economic Times) - "Desidustat, marketed under the brand name ‘Oxemia’, helps in boosting red blood cell production."

Orphan drug • Sickle Cell Disease

Silent saboteur: parvovirus B19 (B19V) and its impact on refractory post-transplant anemia. (PubMed, Front Med (Lausanne)) - "Routine surveillance is not warranted, but targeted testing should be considered in refractory anemia cases, particularly in resource-limited settings. Further studies are needed to optimize therapeutic strategies and validate novel treatments such as Desidustat."

Journal • Anemia • Fatigue • Hematological Disorders • Infectious Disease • Leukopenia • Thrombocytopenia • Transplantation • Urology

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