Drug Database
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erythropoietin

✓ Approved

Helvetic Biopharma · EPOR · Recombinant Proteins

What is erythropoietin?

erythropoietin is a recombinant proteins developed by Helvetic Biopharma. It is approved for therapeutic indications via injectable (others).

Drug Profile

CompanyHelvetic Biopharma
Drug ClassRecombinant Proteins
Molecular TargetEPOR
RouteInjectable (Others)
StatusApproved
Sources: ClinicalTrials.gov, Helvetic Biopharma

Mechanism of Action

Molecular Targets

erythropoietin 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

erythropoietin is developed for 1 unique indication across 1 therapeutic area.

Therapeutic AreaConditionPhase
Vascular disordersThrombosis✓ Approved

Related Research Articles

PubMedRenal failure2026-11-11

Longitudinal trajectory characteristics of the erythropoietin resistance index and their association with all-cause mortality in maintenance hemodialysis patients.

Yang Yun Y, He Wang W, Shi Junbo J, Wang Xiaoyun X et al.

Anemia is common in kidney failure, and most patients depend on erythropoiesis-stimulating agents (ESAs). We grouped maintenance hemodialysis (MHD) patients by how their erythropoietin resistance index (ERI) changed over time, and asked whether these patterns predicted death. We reviewed records of MHD patients treated at our center between 2021 and 2025. K-means clustering was applied to repeated ERI measurements to define trajectories. Logistic regression tested whether trajectory group, continuous ERI, and ERI quartile were related to all-cause mortality, the primary outcome. We also used spline models, subgroup and sensitivity analyses, and examined whether ERI improved prediction. A total of 150 patients were included, and 110 had enough repeated ERI data for trajectory analysis; 26 of them died (23.6%). Baseline ERI quartiles differed in dialysis vintage, dry weight, hemoglobin, and sex. In adjusted models, none of the ERI measures-continuous, quartile, or trajectory-predicted mortality. Dialysis vintage, sex, and hemoglobin were stronger predictors, and adding ERI barely changed discrimination. ERI varied widely between patients and tracked the severity of anemia and overall clinical state. It did not, however, show an independent association with death that we could detect. With a retrospective design and limited precision, our results are inconclusive about prognostic value rather than evidence that none exists.

PMID 43009750
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PubMedBMC public health2026-11-11

Geographical disparities and temporal trends of end stage kidney disease incidence: a systematic review.

Tesfaw Lijalem M LM, Dalugoda Yohani Y, Tiong Mark K MK, Osborne Nicholas J NJ et al.

While individual studies address the geographical and temporal variations contributing to end-stage kidney disease (ESKD) incidence, there is a notable lack of comprehensive research consolidating these findings. This study systematically reviewed and analyzed original articles reporting the incidence of ESKD across different geographical locations and time over two decades worldwide. The study focused on individuals with ESKD, aged 18 and older, regardless of whether they received kidney replacement therapy. Original studies published between 01 Jan 2003 and 23 March 2026 focusing on ESKD incidence and reporting geographical variations and/or temporal trends were included. Literature screening and data extraction were performed using Covidence. Geographical variations in ESKD incidence were assessed across countries, major sub-divisions, and small areas, while temporal trends were evaluated both annually and seasonally. Among forty-one papers reviewed, 18 (43.9%) reported geographical variation, 17 (41.5%) reported temporal trends, and 6(14.6%) reported both. Of those examining geographical variations, 16.7% assessed ESKD incidence across countries, 33.3% across major sub-divisions, and 50.0% across small areas. ESKD incidence varies widely across regions, ranging from 100 per million population in Nepal to over 450 in Taiwan, with higher rates in high-income settings and notable within-country disparities in areas such as the southern United States, southern Taiwan, and parts of Japan. Incidence has increased over time, though some regions remain stable, with higher rates observed in winter than summer. Geographical variation in ESKD incidence was observed across countries, regions, and small areas, with notable increases over time. Factors impacting geographical variations include angiotensin converting enzyme inhibitor use, income, erythropoietin use, obesity, and paraquat exposure, while race, country of residence, diabetes type, hypertension, cardiovascular disease, and calendar year affect temporal variations. Both age and gender contribute to geographical and temporal variations.

PMID 43009887
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PubMedDrug testing and analysis2026-11-10

Mutant Human Erythropoietin from Insect Cells as Novel Low Molecular-Weight Internal Standards for ERAs Analysis.

Niu Chengshuai C, Mao Junhan J, He Sen S, Liu Xinchao X et al.

Doping analysis of erythropoietin receptor agonists (ERAs) is frequently hindered by the "no band" phenomenon, in which endogenous erythropoietin (EPO) becomes undetectable owing to a variety of pre-analytical factors. The absence of an internal standard (ISTD) poses the risk of an undetected sample preparation failure. Furthermore, the EPO gene variant c.577del presents a substantial analytical challenge. Specifically, the failure to identify variant-encoded EPO (VAR-EPO) during reverse immunopurification (RI) may cause false-positive results for recombinant EPO (rEPO), highlighting the necessity of an ISTD for RI process monitoring. Nevertheless, the degradation of high molecular weight PEG-modified ISTDs could interfere with ERAs detection. To address these technical limitations, low molecular weight ISTDs represent a superior alternative for methodological development. This study reports the strategic development of two novel low molecular weight ISTDs: a wild-type EPO-based designed mutant (INS1) and a mutant EPO encoded by the c.557del variant (INS2). Both mutant proteins were expressed in the H5 insect cell line via the baculovirus expression vector system. The two engineered EPO mutants possess simplified paucimannose-type N-glycans, conferring a distinctly lower molecular weight profile than endogenous EPO and mammalian cell-expressed rEPO. Functionally, INS1 is designed to monitor the integrity of the initial testing procedure (ITP), whereas INS2 is engineered for process monitoring of RI to enable accurate rEPO confirmation. The results demonstrate that the developed low molecular weight ISTDs can effectively monitor procedural integrity and improve the detection performance of ERAs analytical assays.

PMID 43004537
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PubMedAdvanced pharmaceutical bulletin2026-11-10

Comparative Analysis of MAR and Terminator Elements in Controlling Stable EPO Expression in CHO-K1 Cells.

Jalali Fatemeh F, Abdoli Shahriyar S, Shamsabadi Fatemeh F, Yamchi Ahad A et al.

Chromosome remodeling, mRNA 3' end extension diversity, mRNA maturation, and the utilization of upstream and downstream DNA elements have been shown to significantly impact the production of recombinant proteins. In this study, we employed the human beta-globin Matrix Attachment Region (β-MAR) as an upstream element and the human beta-globin terminator (β-TERM) as a downstream section to augment erythropoietin (EPO) production. Four plasmids expressing the EPO transgene, after optimization for codon bias and secondary structure of the EPO mRNA, were transfected into CHO-K1 cells. Two weeks after antibiotic selection, pooled stable clones were evaluated for gene copy number (GCN), mRNA quantification, and EPO expression level. Our results revealed a significant increase in the amount of EPO secreted by stable CHO cells in the presence of β-MAR. At the same time, β-TERM had no noticeable impact on EPO production. As expected, the presence of the β-MAR sequence resulted in a higher gene copy number with 15 gene copy per cell (GCN/cell) and mRNA quantity with 5.3 fold change, leading to a much greater secretion of EPO with 28.3 mIU/ml compared to the β-TERM sequence with 3 GCN/cell, 2.8 mRNA fold change and 8.2 mIU/ml of EPO quantity. In the other construct incorporating both β-MAR and β-TERM elements, a gene copy number (GCN) of 7.0 per cell was detected, accompanied by a 4.58-fold elevation in mRNA expression and a secreted erythropoietin (EPO) concentration of 22.45 mIU/ml. In contrast, the construct devoid of both β-MAR and β-TERM (used as the calibrator) elements demonstrated a GCN of 1.0 per cell, an mRNA expression fold change of 1.0, and an EPO concentration of 8.35 mIU/ml. This experiment further supports previous studies, demonstrating the significant impact of the β-MAR element on recombinant protein production in stable CHO-K1 cells.

PMID 43005228
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PubMedAAPS PharmSciTech2026-11-10

Scalable Workflow for Extracellular Vesicle Isolation, Purification and Storage Guided by Subtype-Specific Features.

Erana-Perez Zuriñe Z, Rossello-Gelabert Maria M, Hernandez Rosa Maria RM, Santos-Vizcaino Edorta E

Extracellular vesicles (EV) are promising drug delivery platforms; however, clinical translation is limited by challenges in scalable production and storage. This study evaluates how isolation, purification, and preservation strategies influence the physicochemical properties, yield, surface composition, and functional cargo of large EV (lEV) and small EV (sEV), using erythropoietin (EPO) as a model therapeutic cargo. EV were isolated by ultracentrifugation (UC) alone or combined with tangential flow filtration (TFF), and stored under - 80°C (reference condition), refrigerated, or lyophilized using a standard (Std Lyo) or a proprietary optimized cycle (Opt Lyo) designed to minimize structural damage without lyoprotectants. Refrigeration reduced particle recovery and altered surface charge in both EV subtypes, indicating decreased stability. Std Lyo induced structural alterations and fragmentation, particularly in sEV, only partially mitigated by trehalose addition. In contrast, Opt Lyo better preserved size distribution and physicochemical stability across subtypes. Both lyophilization cycles altered surface marker detectability, reflecting membrane reorganization. TFF markedly enhanced yield and purity, especially in sEV, but also modified EV composition and their response to Opt Lyo, influencing downstream stability. EPO cargo in lEV showed no significant differences across conditions, with lower mean values after lyophilization, whereas sEV were more sensitive. Uptake assays revealed subtype- and process-dependent differences in cellular internalization, with limited involvement of heparin-sensitive pathways under the tested conditions. Collectively, these findings support a scalable workflow in which TFF-based purification followed by UC and Opt Lyo maximize overall performance, while revealing subtype-specific vulnerabilities that define the final EV product and inform tailored optimization.

PMID 43004075
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PubMedAnnals of African medicine2026-11-08

Clinical Spectrum of Young-onset Hypertension: Diverse Etiologies, Target-organ Damage, and Diagnostic Challenges - A Seven-case Series.

Ravichandran A Saipradeep AS, Ravichandran Preethi Yazhini PY, Narayanan Ashwin R AR

Young-onset hypertension - defined as sustained blood pressure elevation presenting before the age of 40 years - is increasingly encountered in tertiary care settings in India. Unlike hypertension in older adults, it frequently harbors secondary etiologies, presents with severe target-organ damage, and poses considerable diagnostic challenges. This case series illustrates the clinical heterogeneity of the condition and highlights the importance of systematic evaluation in this population. We report seven cases (age range 19-38 years; six males, one female) presenting to a tertiary care teaching hospital. Secondary etiologies included biopsy-proven focal segmental glomerulosclerosis with nephrotic-range proteinuria (Case 1), bilateral ostial renal artery stenosis complicated by heart failure with reduced ejection fraction (Case 2), and hypertension associated with erythrocytosis under evaluation (Case 6). Hypertensive emergency with acute ischemic stroke and hemorrhagic transformation, complicated by hypertensive dilated cardiomyopathy, occurred in Case 7. Essential hypertension was established in Cases 3-5, with end-organ manifestations including hypomagnesemia-induced ventricular premature complexes (Case 4) and hypertensive retinopathy (Case 5). Diagnostic investigations included renal biopsy, renal Doppler ultrasonography, renal angiography, 24-h Holter monitoring, serum erythropoietin assay, and brain magnetic resonance imaging. Individualized antihypertensive regimens were supplemented by disease-specific interventions. Outcomes ranged from clinical stabilization to partial neurological recovery, reflecting the variable prognosis associated with delayed diagnosis and inadequate treatment. Young-onset hypertension is not a uniformly benign or essential condition. Systematic evaluation for secondary causes and comprehensive assessment of target-organ damage are critical, particularly in resource-limited settings where these steps are frequently deferred.

PMID 42995434
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