Jesduvroq (daprodustat) / GSK, Kyowa Kirin - LARVOL DELTA

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

EFFICACY OF HIF-PHD INHIBITORS FOR RENAL ANEMIA IN PERITONEAL DIALYSIS PATIENTS: A SINGLE-CENTER RETROSPECTIVE STUDY (ISN-WCN 2026) - "Among 49 PD patients treated with HIF-PHD inhibitors daprodustat or vadadustat, 15 patients met the inclusion criteria:(1) switched from ESA therapy (patients with prior HIF-PHD inhibitor or without prior ESA use were excluded) and (2) baseline Hb < 11 g/dL. The improvement was particularly evident among those with baseline Hb < 10 g/dL. These findings support the clinical utility of HIF-PHD inhibitors as an effective alternative to ESA therapy in PD populations though larger prospective studies are warranted."

Retrospective data • Anemia • Hematological Disorders

OUTCOME OF DAPRODUSTAT IN BANGLADESHI NON DIALYSIS CKD PATIENTS (ISN-WCN 2026) - "Treatment with Daprodustat was cost effective as Darbepoetin costs 8000 to 16000 BDT per month ( USD 65 to 130 USD ) and Daprodustat costs only 2700 to 4200 BDT ( USD 22 to 34) per month in Bangladesh.Conclusion Daprodustat can be a cost effective treatment of non dialysis CKD patients in Bangladesh. Larger studies needed to evaluate its efficacy and side effects in non dialysis CKD patients on Bangladeshi Population."

Clinical • Cardiovascular • Chronic Kidney Disease • Coronary Artery Disease • Diabetic Retinopathy • Heart Failure • Retinal Disorders

HEPCIDIN AND CARDIOVASCULAR EVENTS IN CHRONIC KIDNEY DISEASE WITH AND WITHOUT DIALYSIS: POST HOC ANALYSIS OF THE ASCEND-ND AND ASCEND-D TRIALS (ACC 2026) - " This is a post-hoc analysis of the Anemia Studies in Chronic Kidney Disease: Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor Daprodustat-Non-Dialysis (ASCEND-ND) trial, and the Anemia Studies in Chronic Kidney Disease: Erythropoiesis via a Novel Prolyl Hydroxylase Inhibitor Daprodustat-Dialysis (ASCEND-D) trial; 2 randomized, open-label, phase 3 trials to test the efficacy and safety of daprodustat compared with conventional erythropoiesis-stimulating agents... In patients with CKD not undergoing dialysis, a U-shaped relationship was observed between baseline hepcidin levels and MACE, while no association between hepcidin levels and MACE was observed in patients with CKD undergoing dialysis."

Retrospective data • Cardiovascular • Chronic Kidney Disease • Hematological Disorders • Myocardial Infarction • Nephrology • Renal Disease • CRP

Prolyl hydroxylase inhibitors, roxadustat and daprodustat, inhibit platelet activation and thrombosis through the PI3K/AKT/HIF-1α pathway. (PubMed, Biochem Pharmacol) - "Our study revealed the pharmacological effects of roxadustat and daprodustat in inhibiting platelet activation and thrombosis. The effects may provide some insights into the physiological activity of HIF and clinical medication safety."

Journal • Cardiovascular • Chronic Kidney Disease • Hematological Disorders • Nephrology • Pulmonary Embolism • Renal Disease • Respiratory Diseases • Thrombosis • HIF1A

Efficacy and safety of prolyl hydroxylase inhibitors for anemia in chronic kidney disease: a network meta-analysis. (PubMed, Ren Fail) - "Roxadustat improved serum iron in D-CKD (MD = 6.19 μg/dL, 95% CI: 2.81-9.58), and vadadustat and roxadustat reduced hepcidin in ND-CKD. Regarding safety, ESA had the lowest AE risk in ND-CKD (OR = 0.85, 95% CI: 0.74-0.98), while roxadustat ranked lowest (SUCRA = 18.4%). Roxadustat demonstrated the strongest efficacy in hemoglobin improvement but higher AE incidence in ND-CKD, whereas ESA and daprodustat showed safety and iron metabolism benefits, supporting individualized therapy for renal anemia.Registration number: PROSPERO (CRD420251066181)."

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

REDCURE Registry for Chronic Kidney Disease (CKD) Anemia (clinicaltrials.gov) - P4 | N=384 | Not yet recruiting | Sponsor: Nabiqasim Industries (Pvt) Ltd

HEOR • New P4 trial • Real-world evidence • Anemia • Chronic Kidney Disease • Hematological Disorders • Nephrology • Renal Disease

Daprodustat vs Recombinant Human Erythropoietin for Anemia and Cardiovascular Safety in Dialysis-Dependent and Non-Dialysis-Dependent CKD Patients - A Systematic Review and Meta-analysis. (PubMed, Curr Rev Clin Exp Pharmacol) - "Daprodustat offers a promising alternative to traditional anemia treatments in CKD, with efficacy comparable to rhEPO and a favorable cardiovascular safety profile, which marks its potential as a valuable therapeutic option."

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

A Study to Evaluate Efficacy and Safety of QLG1218(Daprodustat) in Chinese Hemodialysis (HD)-Dependent Subjects With Anemia Associated With Chronic Kidney Disease (CKD) (clinicaltrials.gov) - P3 | N=100 | Not yet recruiting | Sponsor: Qilu Pharmaceutical Co., Ltd.

New P3 trial • Anemia • Chronic Kidney Disease • Hematological Disorders • Nephrology • Renal Disease

30 years of classical hematology drugs in the US: Approvals, costs, and sales (ASH 2025) - "Six drugs have been discontinued (year approved/year discontinued/reason): betrixaban(2017/2020/business), daprodustat (2023/2024/business), fidanacogene elaparvovec(2024/2025/business), oprelvekin (1997/2011/business), peginesatide (2012/2013/safety), and voxelotor(2019/2024/safety).There are limitations to our study. Some drugs have non-classical hematology indications (anticoagulantsin atrial fibrillation; luspatercept in myelodysplastic neoplasm) and/or may also be prescribed by non-classical hematologists (erythropoiesis stimulating agents by nephrologists and medical oncologists)...Classical hematology drugs contribute substantially to US prescription drug spending, with over $70billion in annual sales and medications for thromboembolism accounting for over half of the costs.Approvals have accelerated over the past three decades, doubling each decade. Biologics and biosimilarsnow represent two-thirds of approvals. Continuous-duration treatments, particularly for..."

Anemia • Atrial Fibrillation • Beta-Thalassemia • Cardiovascular • Chemotherapy-Induced Neutropenia • Chronic Kidney Disease • Complement-mediated Rare Disorders • Gene Therapies • Genetic Disorders • Hematological Malignancies • Hemophagocytic lymphohistiocytosis • Hemophilia • Immune Thrombocytopenic Purpura • Immunology • Myelodysplastic Syndrome • Nephrology • Neutropenia • Paroxysmal Nocturnal Hemoglobinuria • Rare Diseases • Renal Disease • Sickle Cell Disease • Thrombocytopenia • Thrombocytopenic Purpura

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

Comparative effectiveness of darbepoetin vs other agents in chronic kidney disease-related anemia: a systematic review and network meta-analysis. (PubMed, BMC Nephrol) - "Daprodustat and roxadustat indicated equivalent or higher efficacy when compared to darbepoetin in elevating hemoglobin levels in CKD-related anemia, with daprodustat demonstrating a good safety profile. While conventional ESAs remain beneficial, HIF-PHIs offer promising oral alternatives with possible benefits in cardiovascular safety and decreased hypertension risk. Further head-to-head trials are necessary to confirm these findings and guide individualized treatment strategies."

Clinical • HEOR • Journal • Retrospective data • Review • Anemia • Cardiovascular • Chronic Kidney Disease • Diabetes • Hematological Disorders • Hypertension • Metabolic Disorders • Nephrology • Renal Disease

A computer-aided drug repurposing: the antibacterial agents targeting GroEL. (PubMed, Br J Pharmacol) - "This study validated our computational workflow for repurposing non-antibacterial drugs as antibacterial agents, demonstrating that cost-effective, computer-aided drug repurposing is a feasible strategy for identifying new therapeutic approaches to diseases, such as cancer, diabetes and COVID-19. Furthermore, the synergistic effect of daprodustat combined with an efflux pump inhibitor (e.g. PAβN) represents a promising therapeutic approach against both Gram-positive and Gram-negative bacterial pathogens."

Journal • Diabetes • Infectious Disease • Metabolic Disorders • Novel Coronavirus Disease • Oncology

Daprodustat in heart failure and renal Anemia: Still early, but promising. (PubMed, J Cardiol) - No abstract available

Journal • Anemia • Cardiovascular • Congestive Heart Failure • Heart Failure • Hematological Disorders • Renal Disease

Daprodustat, a Hypoxia-Inducible Factor-Prolyl Hydroxylase Inhibitor, Improves Hematological Insufficiency without Progression of Myelodysplastic Syndrome with Chronic Kidney Disease (ASH 2023) - "ConclusionHIF-PHi administration did not lead to MDS progression. Notably, in MDS patients with CKD, low TSAT was a predictor for achieving HI by HIF-PHi."

Anemia • Bone Marrow Transplantation • Cardiovascular • Chronic Kidney Disease • Dermatology • Eosinophilia • Hematological Disorders • Hematological Malignancies • Infectious Disease • Leukemia • Musculoskeletal Diseases • Myelodysplastic Syndrome • Myocardial Infarction • Nephrology • Oncology • Orthopedics • Pneumonia • Renal Disease • Respiratory Diseases • Solid Tumor • Transplantation • Wilms Tumor • HIF1A • WT1

Haematologic Effects of Long-Term Daprodustat in Patients on Maintenance Hemodialysis: A Three-Year Evaluation (KIDNEY WEEK 2025) - "Changes in MCV, MCH, and MCHC and a reduction in RDW-CV suggest favorable modulation of erythrocyte indices. Additionally, increased serum iron and TSAT without a rise in ferritin indicate enhanced iron utilization without iron overload."

Clinical • Hematological Disorders • Renal Disease

Darbepoetin vs. Other Agents in CKD Anemia: A Meta-Analysis (KIDNEY WEEK 2025) - "Results Molidustat showed the best cardiovascular and thrombotic safety despite lower efficacy, while methyl polyethylene glycol-epoetin beta showed the largest Hb increase in this network meta-analysis of 12 randomized trials involving over 4,000 CKD patients with anemia...Conclusion Daprodustat and roxadustat indicated equivalent or higher efficacy when compared to darbepoetin in elevating hemoglobin levels in CKD-related anemia, with daprodustat demonstrating a good safety profile...Comparitive efficacy of ESAs + Lower rank number = greater hgb-raising efficacy. * Comparison only, not an exact quantitative ranking."

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

Pharmacological Evaluation of a First-in-Class Hemoglobin Elevating Agent (HbEA) AND017 in a Rat 5/6 Nephrectomy Model (ASH 2024) - "BackgroundTwo hypoxia-inducible factor prolyl hydroxylase inhibitors (HIF-PHI), daprodustat and vadadustat, have been approved by FDA to treat dialysis dependent (DD) chronic kidney disease (CKD) anemia patients in US while all HIF-PHIs failed in getting approval by FDA in treating non-dialysis dependent (NDD) CKD anemia in US due to safety concerns. The hematocrits (%) for 5 groups were between 38.2±1.5 and 39.4±2.0 on day 1, were 41.6±1.6**, 36.3±1.9, 36.3±1.4, 37.2±1.2, and 36.3±1.7 respectively on day 35, were 41.8±1.3**, 36.8±2.4, 39.4±1.9*, 43.9±1.4**, and 51.4±2.8** respectively on day 49, and were 41.0±1.2**, 35.2±2.3, 39.0±3.6*, 45.7±3.1**, and 59.1±3.7** respectively on day 63. (Significance analysis was compared to group 2,* p<0.05,** p < 0.01)ConclusionThe rat 5/6 nephrectomy CKD anemia model was successfully established; on day 63, RBC, HGB, and HCT for rats in three..."

Preclinical • Anemia • Beta-Thalassemia • Chronic Kidney Disease • Genetic Disorders • Hematological Disorders • Nephrology • Renal Disease • Sickle Cell Disease • MYC

Pharmacological Evaluation of a First-in-Class Hemoglobin Elevating Agent (HbEA) AND017 in Sprague Dawley Rats (ASH 2024) - "BackgroundInhibiting hypoxia-inducible factor prolyl hydroxylase (HIF-PH) by oral small molecules has been intensively pursued in treating chronic kidney disease (CKD) anemia during the past 20 years, leading to approval of daprodustat and vadadustat by FDA in treating dialysis-dependent (DD) CKD anemia in US while both plus roxadustat failed in getting approval by FDA in treating non-dialysis dependent (NDD) CKD anemia in US due to safety concerns. The hematocrits (%) for group 1 to 4 were between 38.7 and 39.1 on day 1, were 41.7±1.5, 44.0±2.0, 48.6±2.5**, and 57.9±2.7** respectively on day 28, and were 42.5±1.4, 41.7±1.5, 43.6±1.5, and 41.9±0.9 respectively on day 56. (Significance analysis was compared to group 1,* p<0.05,** p<0.01)ConclusionRBC, HGB, and HCT in normal SD male rats were significantly increased after dosing AND017 at 2.5 and 5 mg/kg PO QD for 4 weeks and gradually recovered to background levels after..."

Preclinical • Anemia • Beta-Thalassemia • Cardiovascular • Chronic Kidney Disease • Genetic Disorders • Hematological Disorders • Nephrology • Renal Disease • Sickle Cell Disease • MYC

Daprodustat Induces Fetal Hemoglobin and Erythropoietic Drive in an in Vitro and In Vivo Model of Sickle Cell Disease (ASH 2024) - "The current standard of care therapy, hydroxyurea (HU), inhibits polymerization of abnormal hemoglobin S (HbS) by inducing fetal hemoglobin (HbF) expression, preventing vaso-occlusive complications...In addition, the HIF-PHI roxadustat (roxa) has been shown to induce HbF expression in CD34+ hematopoietic stem and progenitor cells (HPSCs) in vitro, suggesting multiple therapeutic benefits in SCD...Finally, we saw a decrease in all three cell lines (WBC, RBC, and platelets) in the vehicle group at D21, concerning for bone marrow toxicity from the vehicle, suggesting that the erythropoietic effect of dapro treatment may have been even greater without this confounding effect. In summary, daprodustat proves to be a promising candidate for treatment of anemia in SCD, and the long-term effects of daprodustat on erythropoiesis, HbF induction, and iron metabolism in SCD should be further evaluated."

Preclinical • Anemia • Cardiovascular • Chronic Kidney Disease • Genetic Disorders • Hematological Disorders • Nephrology • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases • Sickle Cell Disease • CD34 • EPO • HIF1A

The cocrystal advantage: overcoming polymorph patent barriers in generic drug development. (PubMed, Mol Divers) - "Through case studies of recently developed cocrystals for APIs like Daprodustat, Roxadustat, and Vadadustat, we illustrate the practical application and commercial potential of this strategy. Ultimately, pharmaceutical cocrystals represent a critical convergence of materials science, regulatory law, and drug delivery, offering an innovative and effective route for accelerating patient access to affordable and improved medicines."

Journal • Review

Erythropoiesis-Stimulating Agents (ESAs) in Chronic Kidney Disease and Cancer-Related Anemia: A Narrative Review of Literature. (PubMed, Cureus) - "Anemia associated with chronic kidney disease (CKD) and cancer is conventionally managed with packed red blood cell (PRBC) transfusions or erythropoietin-stimulating agents (ESAs) like epoetin alfa; however, transfusions are limited by complications such as alloimmunization and infection risk, which has led to ESAs becoming the preferred standard of care...The emerging alternative of HIF-PHIs shows promise in mitigating these adverse risks with a similar treatment efficacy to ESAs. However, there is still a lack of long-term safety data on these treatment options, and future research should focus on determining this risk profile as well as potential dosing strategies to potentially guide the use of HIF-PHIs in future clinical practice as a novel therapeutic alternative for anemia of CKD and cancer-related anemia."

Journal • Review • Anemia • Cardiovascular • Chronic Kidney Disease • Hematological Disorders • Infectious Disease • Nephrology • Oncology • Renal Disease

Model-Informed Drug Development for Daprodustat Supports the Design of Individualized Dosing Regimens in Chronic Kidney Disease Patients With Anemia. (PubMed, Clin Pharmacol Ther) - "This tutorial illustrates how integrated quantitative approaches, including longitudinal hemoglobin response modeling, population pharmacokinetics (PopPK), and clinical trial simulations, were applied to guide phase III dose selection, inform trial design, and support regulatory interactions. We highlight the evolution and application of these models, emphasizing key development decisions, challenges encountered, and insights gained."

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

Nardilysin in adipocyte regulates insulin sensitivity via HIF1α and PPARγ. (PubMed, Sci Rep) - "The augmented Akt phosphorylation by NRDC knockdown was reversed by daprodustat, which stabilizes HIF1α, suggesting that the effect of NRDC on insulin sensitivity is mediated by HIF1α...We also confirmed the complex formation of NRDC and PPARγ. In conclusion, NRDC in adipocyte regulates insulin sensitivity through HIF1α and PPARγ."

Journal • Diabetes • Genetic Disorders • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus • HIF1A • PPARG

Structure-Based Optimization of HIF-2α Agonists That Synergistically Enhance Erythropoietin Production with PHD Inhibitors. (PubMed, J Med Chem) - "Notably, SD-10 exhibited remarkable synergy with Daprodustat, an approved PHD inhibitor, in stimulating erythropoietin (EPO) secretion both in cellular models and animal studies. These findings not only provide insights into HIF-2α activation mechanism, but also offer a promising lead compound for developing innovative treatments for renal anemia."

Journal • Hematological Disorders • Targeted Protein Degradation • EPAS1