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darbepoetin

✓ Approved

PanPharmaceuticals USA · EPOR · 重组蛋白

什么是 darbepoetin？

darbepoetin 是一种重组蛋白，由PanPharmaceuticals USA研发。该药已获批，用于治疗相关适应症，给药途径：Injectable (Others)。

药物档案

公司PanPharmaceuticals USA
药物类别重组蛋白
分子靶点EPOR
给药途径Injectable (Others)
状态Approved
来源： ClinicalTrials.gov, PanPharmaceuticals USA

作用机制

分子靶点

darbepoetin 作用于 1 个分子靶点：

EPORerythropoietin receptor (EPO-R)
需要更深入的分析？Noah AI 可解释复杂机制并与同类药物比较。

治疗适应症

darbepoetin 针对 2 个适应症，涉及 1 个治疗领域。

治疗领域疾病/病症分期
Blood and lymphatic system disordersAnaemia✓ Approved
Blood and lymphatic system disordersNephrogenic anaemia✓ Approved

相关研究文献

PubMedDrug testing and analysis2026-10-22

Doping Control Analysis of Darbepoetin Alfa Biosimilars in Human Urine, Serum, Plasma, and Dried Blood Spots.

Akiyama Kentaro K, Sakurai Hikaru H, Sato Mitsuhiko M, Momobayashi Atsushi A et al.

Following the patent expiration of the originator darbepoetin alfa, three biosimilar products have been marketed in Japan; however, their detectability by current anti-doping methods has not yet been verified. The present study assessed whether these biosimilars can be detected in human urine, serum, plasma, and dried blood spots (DBS) using the established initial testing procedure and confirmation analysis for erythropoietin-receptor agonists. The originator product and three biosimilars (5 μg, i.v.) were administered to healthy male volunteers. Samples collected up to 72 h postdose were subjected to immunopurification followed by sodium N-lauroyl sarcosinate polyacrylamide-gel electrophoresis (SAR-PAGE) as the initial testing procedure. Confirmation was performed by SAR-PAGE with double blotting for serum and plasma. DBS and urine samples were confirmed by SAR-PAGE using an alternative antibody, and urine samples were further examined by liquid chromatography-tandem mass spectrometry (LC-MS/MS). SAR-PAGE analysis of the pharmaceutical preparations revealed product-specific electrophoretic profiles: two biosimilars migrated slightly above one originator product as diffused smears, whereas the third produced a sharp band comparable to that of another originator product. Similar profiles were observed in postdose samples from all biological matrices, and all biosimilars remained detectable in urine, serum, plasma, and DBS for at least 72 h. Although some biosimilars showed distinct SAR-PAGE banding patterns, product attribution remained limited. LC-MS/MS confirmed administered darbepoetin alfa in the 24 h urine samples but did not detect analyte in lower concentration samples, indicating that its performance was concentration-dependent. Accordingly, SAR-PAGE should incorporate reference standards beyond the originator product, particularly those with different band morphologies.

PMID 42902912
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PubMedPharmacoepidemiology and drug safety2026-10-18

Evaluating Darbepoetin Treatment Strategies for Managing Anaemia in Haemodialysis Patients: Effects on All-Cause Mortality From a Target Trial Emulation Using Electronic Health Record Data.

Birnie Kate K, Caskey Fergus J FJ, Ben-Shlomo Yoav Y, Nitsch Dorothea D et al.

Anaemia is a common complication of chronic kidney disease, often treated with erythropoiesis-stimulating agents (ESAs), but the optimal haemoglobin (Hb) target remains uncertain. Using electronic health records, we emulated a target trial comparing different Hb targets in haemodialysis patients to estimate their effects on mortality. We used electronic health records from UK kidney centres reporting to the UK Renal Registry. Adults aged ≥ 18 years, receiving haemodialysis for ≥ 3 months, and without marked ESA resistance were eligible. Using the clone-censor-weight method, we emulated trials comparing Hb targets: (1) 105-125 versus 95-115 g/L and (2) 125-145 versus 95-115 g/L. Darbepoetin dosing followed a standardised protocol with predefined dose adjustments and a maximum dose of 150 μg/week. The outcome was all-cause mortality over 8 months. The study included 8628 patients from 10 centres between 2004 and 2016; 62% male, median age 66 years (IQR 52-76). At baseline, mean Hb was 97.7 g/L (SD 15.1), and 79% of patients were receiving darbepoetin. The hazard ratio for mortality was 0.92 (95% CI 0.75-1.12) for the 105-125 versus 95-115 g/L comparison, and 1.20 (95% CI 0.94-1.54) for the 125-145 versus 95-115 g/L comparison. Adherence to the highest Hb target was lower, limiting precision. Targeting an Hb range of 105-125 g/L under controlled ESA dosing was not associated with increased mortality compared with 95-115 g/L. Targeting Hb levels above 125 g/L may increase mortality risk, consistent with previous trial findings.

PMID 42893801
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PubMedFrontiers in pharmacology2026-10-17

Health technology assessment of long-acting erythropoiesis-stimulating agents for the treatment of renal anemia in China.

Wang Xinwen X, Li Huiling H, Zhang Yazhuo Y, Duan Yinyin Y

Renal anemia is a common complication of chronic kidney disease (CKD) and is associated with increased cardiovascular morbidity and mortality and reduced quality of life. Long-acting erythropoiesis-stimulating agents (ESAs) offer advantages in dosing convenience and adherence, but a comprehensive multidimensional evaluation comparing these agents within the Chinese healthcare context is lacking. The aim of this study was to conduct a multidimensional quantitative evaluation of long-acting ESAs and provide a reference for drug selection and rational clinical use in medical institutions. Based on the method recommended in the Rapid Guideline for Drug Evaluation and Selection in Chinese Medical Institutions (Third Edition), three long-acting ESAs were evaluated in five dimensions, namely, efficacy (28 points), safety (27 points), pharmaceutical properties (27 points), economy (10 points), and other attributes (8 points). The final assessment scores were 80.39 points for the continuous erythropoietin receptor activator (CERA), 73.04 points for pegmolesatide, and 71.70 points for darbepoetin alfa, in descending order. CERA achieved the highest scores in safety and other attributes, darbepoetin alfa ranked first in economy, and pegmolesatide performed best in pharmaceutical properties. According to the scoring results, CERA, pegmolesatide, and darbepoetin alfa all exceeded the guideline-defined threshold for strong recommendation (>70 points) and can be included in the list of strongly recommended drugs for medical institutions. This study provides a scientific, reasonable, and safe basis for medical institutions to select long-acting ESAs.

PMID 42890961
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PubMedCase reports in nephrology2026-10-11

Recurrent Invasive Staphylococcus aureus Infections in a Non-Neutropenic Hemodialysis Patient With Myelodysplastic Syndrome: A Case Report.

Ono Keisuke K, Ayuzawa Nobuhiro N, Kawakami Takahisa T, Taniwaki Koichi K et al.

Myelodysplastic syndromes (MDS) may be overlooked in patients undergoing hemodialysis (HD) because anemia is commonly attributed to renal anemia and treated with erythropoiesis-stimulating agents. MDS is also associated with an increased risk of bacterial infections due to neutropenia and qualitative immune dysfunction. We report recurrent invasive methicillin-susceptible Staphylococcus aureus (MSSA) infections in a patient undergoing HD with concomitant MDS. The patient was a 76-year-old man undergoing HD for end-stage kidney disease due to nephrosclerosis who was referred to our hospital because of persistent anemia despite high-dose darbepoetin alfa therapy. He had a history of CHOP therapy for diffuse large B-cell lymphoma, and his MDS was considered possibly therapy related. Bone marrow aspiration revealed trilineage dysplasia and 3.4% blasts without chromosomal abnormalities, leading to a diagnosis of MDS with multilineage dysplasia. Approximately 1 year later, he developed persistent fever. Blood cultures yielded MSSA, and imaging studies revealed septic pulmonary embolism and multiple cerebral infarctions. He improved after intravenous cefepime therapy. Twenty-two months later, he developed fever and left shoulder pain. Contrast-enhanced computed tomography revealed an abscess in the left subscapularis muscle, and MSSA was isolated from the drainage fluid after CT-guided drainage. He improved with drainage and antibiotic therapy. In both episodes, the neutrophil count was preserved. This case illustrates recurrent invasive MSSA infections in a non-neutropenic HD patient with possibly therapy-related MDS. HD-related factors should be carefully evaluated as common causes of recurrent S. aureus infection, and MDS may represent an additional, unproven host factor. MDS should be considered in ESA-resistant anemia in HD patients, particularly in those with a history of cytotoxic chemotherapy.

PMID 42857200
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PubMedAmerican journal of translational research2026-09-22

Darbepoetin alfa is more effective than epoetin-β in suppressing hepcidin and improving iron utilization in maintenance hemodialysis patients.

Tan Jinfeng J, Yan Huimin H, Li Xin X, Chen Yong Y

This study aimed to compare the dynamics of serum hepcidin and iron metabolism markers in maintenance hemodialysis patients treated with reconstituted human Erythropoietin-β (EPO-β) and darbepoetin alfa (DA). This retrospective observational study included 105 patients on maintenance hemodialysis. Of these, 64 were in the EPO-β group (administered 2-3 times weekly) and 41 in the DA group (administered once every two weeks). Serum hepcidin, ferritin, transferrin saturation (TSAT), high-sensitivity C-reactive protein (hs-CRP), serum iron and hemoglobin (Hb) were measured at baseline, at week 8 and at week 12. A correlation analysis was performed. For the repeated measures analysis of variance comparing multiple time points (baseline, week 8 and week 12) between the two groups, Bonferroni post-hoc tests were used to perform pairwise comparisons. Serum hepcidin decreased continuously in both groups during the 12-week treatment duration. At week 12, the DA group exhibited significantly lower hepcidin levels compared with EPO-β group. The Δhepcidin from baseline to week 12 was significantly greater in the DA group. The DA group also showed significant improvements in iron metabolism markers, with a greater decrease in TSAT, and a greater increase in serum iron compared to the EPO-β group. The erythropoiesis-stimulating agents resistance index (ERI) was significantly lower in the DA group than in the EPO-β group. LnΔhepcidin showed a positive correlation with LnΔFerritin, LnΔTSAT, LnΔSerum iron, and LnΔHb. The rates of adverse events were comparable between the two groups. Compared to EPO-β, DA more effectively suppresses hepcidin, improves iron metabolism markers, and achieves higher erythropoietic efficiency, with comparable Hb response rates and safety profiles between the two groups.

PMID 42769333
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PubMedJournal of perinatology : official journal of the California Perinatal Association2026-09-04

Assessment of iron sufficiency in premature infants treated with darbepoetin using conventional and novel erythrocyte metrics.

Bishara Natalie N, Bahr Timothy M TM, Woodbury Anne A, Christensen Robert D RD et al.

Randomized trials demonstrate that administering darbepoetin to extremely low birth weight (ELBW) neonates increases hematocrits and reduces or eliminates transfusions. However, further studies are needed regarding maintaining adequate iron during darbepoetin therapy. We analyzed datasets from the Neonatal Research Network Darbe Trial and Intermountain Health to assess iron sufficiency during darbepoetin treatment. We tracked traditional markers of erythropoiesis (reticulocytes and RET-He), and novel markers of iron-limited erythropoiesis (Micro-R and HYPO-He). Among the placebo recipients, RET-He fell over the first week (33.6 ± 0.5 pg to 27.4 ± 0.2 pg, p < 0.001). Darbepoetin recipients fell further (p < 0.0001). We identified a reciprocal relationship between rising reticulocytes and falling RET-He. The majority (83%) of darbepoetin recipients with a RET-He <25 pg had Micro-R and HYPO-He measurements indicating iron-sufficiency. Traditional and novel red cell markers together may better inform iron sufficiency during accelerated erythropoiesis.

PMID 42693254
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