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darbepoetin

✓ Approved

PanPharmaceuticals USA · EPOR · Recombinant Proteins

What is darbepoetin?

darbepoetin is a recombinant proteins developed by PanPharmaceuticals USA. It is approved for therapeutic indications via injectable (others).

Drug Profile

CompanyPanPharmaceuticals USA
Drug ClassRecombinant Proteins
Molecular TargetEPOR
RouteInjectable (Others)
StatusApproved
Sources: ClinicalTrials.gov, PanPharmaceuticals USA

Mechanism of Action

Molecular Targets

darbepoetin acts on 1 molecular target:

EPORerythropoietin receptor (EPO-R)
Want deeper analysis?Noah AI can explain complex mechanisms and compare to similar drugs.

Therapeutic Indications

darbepoetin is developed for 2 unique indications across 1 therapeutic area.

Therapeutic AreaConditionPhase
Blood and lymphatic system disordersAnaemia✓ Approved
Blood and lymphatic system disordersNephrogenic anaemia✓ Approved

Related Research Articles

PubMedNature communications2026-10-29

A human erythropoietin-albumin fusion protein tailored for enhanced plasma half-life and delivery across mucosal surfaces.

Anthi Aina Karen AK, Bejan Daniela D, Mester Simone S, Bethur Nijaguna N et al.

Erythropoietin (EPO) products stimulate production of erythrocytes in patients with anemia. The drugs are delivered intravenously or subcutaneously up to several times per week due to short plasma half-life. Improving the pharmacokinetic properties of EPO will allow less frequent administration, and thus impact therapeutic utility and patient compliance. In this study, we took advantage of an albumin variant (QMP) engineered for improved engagement of FcRn, a key regulator of the plasma half-life of albumin. After genetic coupling of EPO to QMP, the fusion protein shows favorable neonatal Fc receptor (FcRn) binding, and 5.2-fold prolonged plasma half-life in human FcRn expressing mice upon intravenous administration, when comparing with EPO fused to WT albumin, with a similar half-life obtained following subcutaneous administration. Importantly, both fusions bind the EPO receptor with binding kinetics equal to that of the product darbepoetin alfa. After intravenous administration, mice receiving darbepoetin alfa experiences a faster drop in EPO levels compared to those given EPO-QMP, and moreover, we measure a prolonged increase in erythrocytes with EPO-QMP. Furthermore, intranasal administration results in 5-fold higher circulating amounts of EPO-QMP and a prolonged increase in erythrocytes compared to darbepoetin alfa. Thus, long-acting EPO-QMP could be an attractive design to explore for both invasive and non-invasive delivery to patients with anemia.

PMID 42951888
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PubMedVeterinary sciences2026-10-27

Hematologic Responses to Molidustat in Cats with Anemia of Heterogeneous Etiology: A Retrospective Descriptive Study.

Lee Gippeum G, Lee Jeongmin J, Song Kun-Ho KH

Molidustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor, is approved for nonregenerative anemia associated with chronic kidney disease (CKD) in cats but is also used for anemia of other causes. This retrospective, single-center study described the hematologic response to molidustat in 39 cats with anemia of heterogeneous etiology and identified factors that complicate attribution of improvement to the drug. Response was defined as a hematocrit (HCT) increase of ≥4 percentage points from baseline at the complete blood count closest to day 28 (days 14-45), without transfusion to treat anemia. Molidustat was used outside the approved indication in 33 cats (84.6%). Seventeen cats (43.6%) had a response-window measurement; they had a longer treatment span and differed in etiology and concurrent treatment from non-evaluable cats. Among these 17 cats, 12 (70.6%; 95% CI 46.9-86.7%) met the response criterion; sensitivity analyses specified before formal analysis gave 70.6-75.0% and post hoc attribution analyses 29.4-50.0%. In 7 of the 12 responders, darbepoetin or transfusion preceded the qualifying measurement, or it was obtained more than 7 days after the last dose. These data describe clinical use but do not establish effectiveness outside CKD-associated anemia.

PMID 42944170
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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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