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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

PubMedJournal of clinical medicine2026-08-27

Darbepoetin and Infantile Hemangioma in Premature Infants.

Shoris Irit I, Riskin Arieh A, Sharkansky Livnat L, Zoabi-Safadi Rasha R et al.

Objectives: An association between erythropoietin (Epo) administration and infantile hemangiomas (IH) in preterm infants was previously described; however, scarce data exists on a newer drug, darbepoetin (Darbe) and IH. We aimed to determine whether Darbe treatment was associated with IH in our preterm population. Methods: Retrospective observational cohort study including a consecutive sample of premature babies born < 32 weeks at a single tertiary center between the years 2012-2023. We compared the rate of IH with Epo exposure, Darbe exposure and no exposure. Results: The cohort comprised 390 infants: 262 infants with no exposure, 36 infants with Epo exposure, and 92 infants with Darbe exposure. Exposed infants had significantly lower birth weight and gestational age compared to non-exposed infants. No differences were found in gestational age or birth weight between the two drug exposure groups. The rate of IH was 6.8%, 8.3% and 18.4% in the no exposure, Epo exposure and Darbe exposure groups, respectively. The rate of IH in the Darbe group was significantly higher compared to the non-exposed group (p = 0.003), and Darbe exposure was found to be significantly correlated with IH in a multiple logistic regression model (OR 3.07, 95% CI 1.5-6.2; p = 0.002). However, after adjusting for gestational age or birth weight, this correlation was no longer significant. Conclusions: Darbe exposure was associated with a higher rate of IH than no exposure in this cohort, but the association did not persist after adjustment for maturity, and the design does not allow us to distinguish the effect of Darbe from the effect of prematurity itself. Further prospective studies are needed to ascertain these findings.

PMID 42652848
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PubMedMolecular biotechnology2026-08-25

UCOE-Mediated Transcriptional Stabilization Combined with EGFP-Based FACS Screening Enables Efficient Selection of High-Producing CHO Cells.

Lohrasbi Reyhane R, Daneshipour Abbas A, Jazayeri Seyede Hoda SH, Halfinezhad Zahra Z et al.

Position effects and transgene silencing remain major obstacles to the generation of stable high-producing CHO cell lines. Applying genetic regulatory elements, such as a ubiquitous chromatin-opening element (UCOE), can mitigate these limitations by maintaining a transcriptionally permissive chromatin environment and supporting sustained transgene expression. In parallel, EGFP-based fluorescence-activated cell sorting (FACS) enables a rapid and efficient platform for the identification and enrichment of high-producing cell populations. Here, we have used the combined strategy of FACS-based screening and UCOE to accelerate the clonal selection and enhance recombinant Darbepoetin alfa (DPO) productivity in Chinese Hamster Ovary (CHO) cells. Accordingly, two plasmids were designed: pOptiVEC™ (non-UCOE) and CET1019HD (containing a UCOE). Both contained a codon-optimized Darbepoetin alfa-LoxP-IRES-EGFP-LoxP-IRES-DHFR fragment. To achieve a stable cell line, the cassettes were linearized and transfected into CHO DG44 cells. Then, EGFP was used as a selection marker in FACS to enrich cells with the brightest green fluorescence intensity. Subsequently, DPO and EGFP expression were assessed at the transcriptional and protein levels using qRT-PCR, Flow cytometry, western blotting, and ELISA. Expression analysis revealed that all UCOE-containing cell pools exhibited higher DPO yield compared with non-UCOE populations. Indeed, FACS sorting and enrichment of UCOE-containing cells led to a clone with more than an eightfold increase in productivity. Moreover, isolating high-producing cells via FACS with a simple gate yielded a 1.5-fold increase in target protein concentration compared with unsorted cells. This study demonstrated that UCOE-mediated transcriptional stabilization establishes a robust expression framework while EGFP-based FACS screening enables efficient enrichment of high-producing cells. Combining them enhances protein yield with potential for further optimization in larger-scale applications.

PMID 42640421
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PubMedCase reports in oncology2026-08-21

Weekly Metronomic Venetoclax and Decitabine/Cedazuridine in Acute Myeloid Leukemia Patient Declining Blood Transfusion.

Aldapt Mahmood M, Badar Talha T, Saliba Antoine N AN, Foran James J et al.

Acute myeloid leukemia (AML) treatment typically involves intensive chemotherapy associated with prolonged cytopenias and frequent transfusion requirements. Patients who decline blood products, such as Jehovah's Witnesses (JW), present a therapeutic challenge, as transfusion support is integral to standard care. Emerging low-intensity regimens combining venetoclax (VEN) with hypomethylating agents offer a potential alternative with reduced myelosuppression. A 77-year-old male JW with AML with myelodysplastic syndrome-related changes and mutations in DDX41, ASXL1, and PPM1D presented with pancytopenia. Due to refusal of transfusions, he was treated with a metronomic, all-oral regimen of VEN 400 mg weekly and decitabine/cedazuridine (DEC-C) 35/100 mg weekly, supported by erythropoiesis-stimulating agent (darbepoetin alfa) and thrombopoietin agonist (romiplostim) as needed. After 4 weeks, bone marrow blasts decreased from 20-25% to 10%, with clearance of ASXL1 and PPM1D mutations and reduction of DDX41 variant allele frequency (VAF) to 2.9% from 9.7%. At 26 weeks, marrow blasts further decreased to 5%, DDX41 VAF remained low (2.6%), and counts normalized (ANC 1.73 × 103/µL, hemoglobin 13.1 g/dL, PLT 256 × 103/µL) without any transfusions. This case demonstrates that a metronomic, all-oral VEN and DEC-C regimen can achieve hematologic improvement and molecular response in AML while maintaining transfusion independence. It highlights a feasible and safe therapeutic option for patients declining blood products, achieving disease control with minimal toxicity.

PMID 42626761
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PubMedClinics in perinatology2026-08-06

Drugs and Cell-Based Therapies for the Prevention and Treatment of Neonatal Brain Injury.

McNally Melanie A MA, Soul Janet S JS

The international burden of neonatal brain injury (NBI) remains significant with enormous potential for therapeutic intervention. Recent large trials have demonstrated no neuroprotection with either erythropoietin or darbepoetin for term or pre-term brain injury. Neuroprotective strategies with strong evidence are currently limited to antenatal steroids, antenatal magnesium, and supportive care for pre-term NBI and therapeutic hypothermia for term hypoxic-ischemic encephalopathy. Of the pharmacologic strategies currently being investigated clinically, the agents with the highest likelihood of success and closest to clinical implementation include melatonin, topiramate, and stem cell-based therapies. More therapies to prevent or treat NBI are urgently needed.

PMID 42556987
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PubMedJournal of artificial organs : the official journal of the Japanese Society for Artificial Organs2026-07-28

Adsorption characteristics of erythropoietin in two β2-microglobulin absorption systems: a preliminary in vitro study using FILTOR® and Lixelle®.

Hara Shoichiro S, Hirose Masakazu M, Goto Taisuke T, Imamura Katsuro K

To compare the erythropoietin adsorption characteristics of two adsorption devices, Lixelle® and FILTOR®, used for the treatment of dialysis-related amyloidosis, using bovine serum. Three recirculating perfusion studies were performed using bovine serum containing recombinant human erythropoietin (epoetin beta; EPO), darbepoetin alfa (DA), or epoetin beta pegol (C.E.R.A.). Because direct quantitative assays for DA and C.E.R.A. were unavailable, and it was difficult to obtain suitable measurement systems for these agents, they were evaluated using an erythropoietin immunoassay based on assay cross-reactivity. In the EPO perfusion test (n = 3), the 4-h EPO removal rate was 18.7 ± 3.2% in the Lixelle® group and 53.0 ± 3.1% in the FILTOR® group (p < 0.05). In the DA perfusion test (n = 3), the 4-h removal rate based on erythropoietin immunoassay measurements was 3.3 ± 1.5% in the Lixelle® group and 31.0 ± 6.1% in the FILTOR® group (p < 0.05). In the C.E.R.A. perfusion test (n = 3), the corresponding removal rates were 0.3 ± 0.6% and 1.3 ± 2.3%, respectively, with no significant difference (p = 0.5351). The FILTOR® adsorption device showed greater reductions in erythropoietin concentration than the Lixelle® device in experiments using EPO. A similar trend was observed for DA, whereas no apparent difference was observed for C.E.R.A. Because DA and C.E.R.A. were evaluated using assay cross-reactivity, and quantitative assessment was limited by the sampling strategy, these findings should be interpreted with caution.

PMID 42509492
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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.

PMID 42466097
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