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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

Mechanism of Action

Molecular Targets

darbepoetin acts on 1 molecular target:

EPORerythropoietin receptor (EPO-R)
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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

PubMedCanadian journal of kidney health and disease2026-07-17

Evaluation of Anemia Management in a Contemporary Population of Patients With Chronic Kidney Disease in Canada Since the Publication of Target Hemoglobin Trials: A Retrospective Observational Cohort Study.

Birks Peter P, Canney Mark M, Djurdjev Ognjenka O, Induruwage Dilshani D et al.

Guidelines for anemia management in chronic kidney disease (CKD) adopted a conservative approach in response to landmark clinical trials demonstrating lack of benefit and potential harm associated with higher hemoglobin targets. Although the findings have been applied to all CKD populations, the concordance between trial populations and those being treated in clinical practice has not been well described. We sought to evaluate trends in hemoglobin distribution and erythropoiesis stimulating agent (ESA) use among adult patients with CKD, and compare their characteristics to those of participants from landmark hemoglobin target trials. Retrospective observational cohort study. A provincial clinical information system was used to identify patients with CKD under the care of a nephrologist in British Columbia between April 1, 2007 and March 31, 2018. Adult patients (over 18 years) with estimated glomerular filtration rate (eGFR) less than 45 mL/min/1.73m2 and a minimum of three hemoglobin values during follow-up. Patients were censored if they left the province, died, or started kidney replacement therapy. Hemoglobin was measured in grams per litre (g/L) and treated as both a continuous and categorical variable. ESA use was defined as the proportion of patients who received at least one prescription for ESA therapy. The dose of ESA was quantified as an average monthly dose of epoetin alfa or darbepoetin alfa. Descriptive statistics were used to compare characteristics of patients in the study population to those of trial participants including Trial to Reduce Cardiovascular Events with Aranesp Therapy (TREAT), Correction of Hemoglobin and Outcomes in Renal Insufficiency (CHOIR), and Cardiovascular Risk Reduction by Early Anemia Treatment with Epoetin Beta trial (CREATE). Polytomous logistic regression was used to estimate odds ratios (OR) of different hemoglobin levels across cohort years. The model was adjusted for age, sex, race, comorbid conditions, eGFR, proteinuria, etiology of CKD and iron parameters. A total of 29,033 patients were included in the analysis (mean age 71 years, 45% female, median eGFR 29 mL/min/1.73m2). Average hemoglobin declined from 122 g/L in 2007 to 112.9 g/L in 2017 with a reduction in ESA use from 35% to 18%. The likelihood of patients having a hemoglobin below 90 g/L (versus 110-124 g/L) increased progressively over time (OR 5.3 in 2008; OR 16.2 in 2017). The proportion of patients meeting inclusion criteria for landmark trials ranged from 9% (TREAT) to 27% (CHOIR). Compared to trial participants, the study population had less comorbidities and received lower doses of ESA therapy. Measurement of hemoglobin may have been subject to confounding by indication, for example due to a bleeding episode. Physicians may have elected not to treat certain patients with ESA therapy, introducing selection bias. Data regarding blood transfusions were not available. Despite a minority of patients meeting criteria for prior hemoglobin target trials, the universal adoption of guidelines favoring a conservative approach to anemia has culminated in a higher likelihood of patients experiencing severe anemia. The implications of this, particularly patient-reported outcomes, warrant further investigation.

PubMedThe Journal of veterinary medical science2026-07-13

Negative correlation between serial changes in the reticulocyte number and C-reactive protein level in dogs with delayed reticulocytosis.

Kim Yubin Y, Hong Seung Bin SB, Song Woo-Jin WJ, Yun Youngmin Y et al.

Inflammation suppresses erythropoiesis, leading to non-regenerative anemia in dogs. Currently, clinical evidence of this inhibitory effect remains limited. This study provides important clinical insight by demonstrating a negative correlation between C-reactive protein (CRP) concentration and reticulocyte count over time in dogs with inflammatory anemia. This study aimed to leverage inflammatory anemia as a model to examine the longitudinal relationship between CRP levels and reticulocyte counts in dogs. Medical records of 23 dogs diagnosed with various inflammatory conditions and persistently non-regenerative erythropoiesis were retrospectively reviewed. Serial results of hematological and serological parameters were analyzed using linear mixed-effects models to account for intra- and inter-individual variation. Reticulocyte counts in anemic dogs with resolving underlying inflammatory conditions were significantly negatively correlated with CRP levels (standardized β = -0.53, 95% confidence interval (CI) -0.68 to -0.37; P<0.001). Moreover, cross-sectional analysis revealed that higher CRP levels were significantly associated with lower reticulocyte counts, suggesting that the severity of inflammation may be linked to reduced reticulocyte counts (Pearson's r = -0.5; P=0.01). Similarly, erythropoietic responses to darbepoetin alfa appeared to be attenuated in dogs with elevated CRP concentrations. In these dogs, whose mean CRP concentration was 6.15 mg/dL, the onset of reticulocytosis was delayed approximately twofold, and the increase in peak reticulocyte count was approximately 38% lower than that in dogs with normal CRP concentrations. This study provides clinical evidence supporting an association between systemic inflammation and reduced or delayed reticulocytosis in dogs, highlighting the clinical utility of concurrently monitoring CRP and reticulocyte levels to assess disease progression and inflammatory recovery.

PubMedKidney research and clinical practice2026-07-08

Efficacy, safety, and dose selection of efepoetin alfa in anemic patients on maintenance dialysis: a phase 2, randomized, multicenter, active-controlled trial.

Ko Eun Jeong EJ, Byun Mi-Sun MS, Yang Chul Woo CW, Shin Sug Kyun SK et al.

Efepoetin alfa (GC1113, GX-E2) is a long-acting recombinant human erythropoietin fused to a hybrid fragment crystallizable (hyFc) that prolongs systemic exposure via neonatal Fc receptor-mediated recycling. This active-controlled phase 2 trial evaluated efepoetin alfa and informed phase 3 starting dose selection for chronic kidney disease-related anemia in dialysis patients. In this multicenter, open-label, active-controlled trial, adults on hemodialysis (HD) or peritoneal dialysis (PD) with hemoglobin (Hb) levels <10 g/dL were randomized after erythropoiesis-stimulating agent discontinuation. Over 12 weeks, HD patients received intravenous efepoetin alfa (5 or 8 µg/kg once weekly [Q1W], 8 µg/kg every 2 weeks [Q2W]) or darbepoetin alfa (30 µg Q1W). PD patients received subcutaneous efepoetin alfa (5 or 8 µg/kg Q2W) or methoxy polyethylene glycol-epoetin beta (0.6 µg/kg Q2W). The primary endpoint was the mean Hb change from baseline after 12 weeks of treatment, and an exploratory dose-conversion ratio (DCR) analysis was performed in the PD cohort to inform phase 3 dosing. Efepoetin alfa showed dose-dependent Hb increases. In the HD cohort, mean Hb increases were 3.19 g/dL for efepoetin alfa 5 and 8 µg/kg Q1W and 2.52 g/dL for darbepoetin alfa. In the PD cohort, mean Hb increases were 2.69 g/dL and 3.48 g/dL for efepoetin alfa 5 and 8 µg/kg Q2W, respectively, and 2.01 g/dL for the control group. Exploratory DCR analysis supported 4 µg/kg Q2W efepoetin alfa as the phase 3 starting dose. Efepoetin alfa demonstrated dose-dependent erythropoietic efficacy and an acceptable safety profile in dialysis patients, supporting dose-range characterization and phase 3 starting dose selection.

PubMed3 Biotech2026-06-11

A comparative study of PiggyBac-mediated gene insertion and ubiquitous chromatin opening element incorporation to enhance Darbepoetin alfa expression.

Khoshnood Zeynab Z, Lohrasbi Reyhane R, Hasheminejad Fateme F, Halfinezhad Zahra Z et al.

Stable and robust production of recombinant therapeutic proteins in mammalian cells remains challenging due to position effects and transcriptional silencing of the transgene following random integration. We investigated whether semi-targeted integration and UCOE-incorporation could enhance Darbepoetin alfa (DPO) transgene expression. A PiggyBac-mediated Darbepoetin alfa-secreting cell pool (PB-DPO) was established by semi-targeted insertion of a DPO-containing expression cassette using pB513B-1, a PiggyBac transposon-derived vector, into CHO DG44 host cells. A UCOE-incorporated Darbepoetin alfa-secreting cell pool (UCOE-DPO) was also used to compare DPO production rates between the two groups and the control (pOptiVEC-DPO) cell pool. DPO expression at both transcript and protein levels was compared across DPO-producing cell pools using real-time quantitative PCR, Western blotting, and ELISA. The PB-DPO showed ~ 1.96- and ~ 1.79-fold increases in mRNA and protein levels, respectively, whereas the UCOE-DPO exhibited even stronger enhancement, with ~ 2.94- and ~ 4.53-fold increases compared with the control. In conclusion, PiggyBac-mediated transgene transposition generated a cell population with increased transgene expression, likely through multiple insertions and preferential integration near transcriptionally active regions. Although both modified pools demonstrated increased DPO transcript and protein yields, UCOE-DPO was more effective at overcoming integration-associated silencing. Compared with the semi-targeted transposition method, UCOE incorporation further increased Darbepoetin alfa production by ~ 2.5-fold. The online version contains supplementary material available at 10.1007/s13205-026-04828-6.

PubMedEuropean journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V2026-06-10

Site-specific enrichment of highly sialylated N-glycans in an erythropoietin-hybrid Fc fusion protein.

Park Juhee J, Eom Daeun D, Park Chi Soo CS, Moon Chulmin C et al.

Erythropoietin-hybrid Fc fusion protein (EPO-hyFc), comprising an EPO domain fused to a hybrid IgD-IgG4 Fc, is a next-generation erythropoiesis-stimulating agent with an approximately two-fold longer serum half-life than darbepoetin alfa, a clinically established long-acting EPO formulation. Although sialylation at Asn-38 and Asn-83 is known to modulate serum stability and half-life, the site-specific N-glycosylation of EPO-hyFc has not been characterized. Here, we performed comprehensive N-glycan profiling using LC-MS/MS glycomics combined with nano-LC-MS/MS glycoproteomic analysis of Glu-C-digested peptides. In total, 23 N-glycans (15 sialylated and 8 neutral) were identified. Site-normalized quantification revealed that Asn-24 was mainly occupied by mono- and di-sialylated glycans (64.9%), whereas Asn-38 (76.9%) and Asn-83 (87.7%) were enriched in tri- and tetra-sialylated structures. The Fc site (Asn-261) contained mainly non-sialylated glycans (94.4%). The average number of sialic acids per N-glycan was 2.2, and the sialic acid-capping ratio was 90.9%, indicating extensive terminal sialylation across the EPO sites. These results provide the first site-specific characterization of N-glycosylation in EPO-hyFc and offer structural and quantitative insights for optimizing its stability, pharmacokinetics, and therapeutic efficacy.

PubMedJournal of the National Comprehensive Cancer Network : JNCCN2026-06-10

Feasibility and Efficacy of Reiki Versus Massage for Cancer-Related Fatigue in Patients With Breast and Prostate Cancer Receiving Hormone Therapy.

McGuire Jeremy J, Roscoe Joseph J, Reschke Jennifer J, Lin Po-Ju PJ et al.

Cancer-related fatigue (CRF) is a common, distressing symptom in patients undergoing hormone therapy for breast and prostate cancer. Although exercise is recommended, it is not suitable for all patients. Passive therapies such as massage and Reiki may offer accessible alternatives. This study evaluated the feasibility and preliminary efficacy of Reiki and massage therapy in reducing CRF, with Reiki also assessed for potential dose-response effects. Adults (age ≥21 years) with breast cancer receiving aromatase inhibitors or with prostate cancer receiving androgen deprivation therapy (ADT) for at least 8 weeks, who reported moderate CRF (score ≥4/10), were enrolled if they had completed other cancer treatments at least 2 months prior. Exclusion criteria included planned nonhormonal cancer treatments, use of erythropoietin or darbepoetin, recent professional massage or energy therapy, or contraindications to massage. CRF was assessed using the Brief Fatigue Inventory (BFI). ANCOVA, adjusted for baseline values, was used to evaluate between-group differences in BFI total score at week 6. Cohen d was used to estimate within-group effect sizes. Feasibility was assessed based on recruitment, retention, and adherence. A total of 87 participants (breast cancer, n=57; prostate cancer, n=30) were randomized to 2 sessions of massage therapy, 2 sessions of Reiki, or 4 sessions of Reiki. All interventions significantly reduced CRF from baseline (P<.001). Reiki produced greater within-group effect sizes (Cohen d=0.81-1.49 for 2 sessions; 0.99-1.49 for 4 sessions) than massage (d=0.50-0.60). The 4-session Reiki group had the largest reductions in total CRF (d=1.16), worst CRF (d=1.49), and CRF interference (d=0.99). Feasibility was high, with 51% recruitment, 94% retention, and 85% adherence. Reiki and massage are safe, feasible, and promising interventions for managing CRF in patients receiving hormone therapy. Reiki showed the largest improvements, supporting its clinical relevance. Larger trials are needed to confirm these findings and inform CRF management guidelines. gov Identifier: NCT02758756.

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