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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)
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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

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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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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