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darbepoetin alfa (Actorise)

✓ Approved

Cipla Inc · EPOR · Recombinant Proteins

What is darbepoetin alfa?

darbepoetin alfa is a recombinant proteins developed by Cipla Inc. It is approved for therapeutic indications via injectable (others) or intravenous (iv) or subcutaneous injection.

Drug Profile

Brand NamesActorise
CompanyCipla Inc
Drug ClassRecombinant Proteins
Molecular TargetEPOR
RouteInjectable (Others), Intravenous (IV), Subcutaneous Injection
StatusApproved
Sources: ClinicalTrials.gov, Cipla Inc

Mechanism of Action

Molecular Targets

darbepoetin alfa 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 alfa is developed for 1 unique indication across 1 therapeutic area.

Therapeutic AreaConditionPhase
Blood and lymphatic system disordersNephrogenic anaemia✓ Approved

Related Research Articles

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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PubMedGeneral thoracic and cardiovascular surgery cases2026-10-21

Perioperative management of acute type A aortic dissection using extended half-life factor IX (Alprolix) in a patient with severe hemophilia B: a case report.

Kitamura Tessho T, Ryu Yutaro Y, Nakaji Shun S, Taniguchi Shinichiro S

Emergency surgery for acute type A aortic dissection (ATAAD) in patients with severe hemophilia B is extremely rare, and perioperative coagulation management is a major challenge. A 63-year-old man with severe hemophilia B (factor IX activity < 1%) was diagnosed with ATAAD and underwent emergency surgery. Replacement therapy with an extended half-life factor IX product (eftrenonacog alfa; Alprolix) was administered targeting a factor IX activity of 80-100%, and total arch replacement was performed. Cardiopulmonary bypass was performed under standard heparinization conditions. Since rapid measurement of factor IX activity was not possible, postoperative replacement therapy was based primarily on the clinical assessment of hemostasis, with serial activated partial thromboplastin time measurements providing supportive information, whereas intraoperative anticoagulation was managed using standard activated clotting time monitoring. Intra- and postoperative bleeding volumes were within ranges comparable to those observed in standard complex aortic surgery, and the postoperative course was uneventful. The use of an extended half-life factor IX product may be a practical option for perioperative coagulation management during emergency aortic surgery in patients with severe hemophilia B.

PMID 42902440
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PubMedClinical therapeutics2026-10-19

Evaluation of Inpatient Epoetin Alfa Dosing in Patients With Anemia of Chronic Kidney Disease: A Retrospective Cohort Study.

Elhamra Rita R, Streck Timothy T, Iso Tomona T, Hong Lisa T LT

Epoetin alfa labeling and clinical guidelines recommend weight-based dosing for the management of patients with anemia and chronic kidney disease (CKD). However, fixed dosing continues to be used in inpatient practice, and comparative data in hospitalized populations are limited. This study aimed to compare fixed versus weight-based dosing in hospitalized patients with CKD. This retrospective cohort study included hospitalized adult patients with anemia of CKD who were initiated on epoetin alfa at a large academic medical center between January 2014 and August 2024. The primary outcome was hemoglobin exceeding targets (>10 g/dL for non-dialysis-dependent CKD and >11 g/dL for dialysis-dependent CKD). Secondary outcomes included 90-day all-cause mortality, rehospitalization, major adverse cardiovascular events, packed red blood cell transfusion, new or worsening hypertension, and iron deficiency. Among 100 patients (50 in the fixed-dose group and 50 in the weight-based dose group), hemoglobin exceeded targets in 8% and 4% of patients, respectively (P = 0.678). Ninety-day all-cause mortality occurred in 18% and 4% of patients, respectively (P = 0.160); no statistically significant differences were observed in other secondary outcomes. Fixed-dose regimens resulted in higher weight-normalized epoetin alfa doses than weight-based dosing (119.8 vs 67.1 units/kg; P < 0.001). Among hospitalized patients with CKD, fixed-dose epoetin alfa was associated with substantially higher weight-normalized doses and numerically higher rates of hemoglobin exceeding targets and mortality, though differences in clinical outcomes were not statistically significant. These findings suggest that adherence to guideline-recommended weight-based dosing may minimize excessive epoetin alfa dosing. Larger prospective studies are needed to clarify optimal inpatient erythropoiesis-stimulating agent dosing.

PMID 42897033
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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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PubMedArchivos de la Sociedad Espanola de Oftalmologia2026-10-18

Conjunctival involvement with corneal extension in pediatric mycosis fungoides. Surgical and immunomodulatory management.

Montoya Alicia Cárceles AC, Tarazona Jaimes Claudia P CP, Valero Daniel Romero DR

A 13-year-old boy with mycosis fungoides (MF) presented with uncommon ophthalmic involvement. Clinical examination revealed a vascularized conjunctival nodule with corneal extension involving the visual axis and causing severe visual impairment. Initial treatment with topical corticosteroids and tacrolimus showed poor response. Complete surgical excision was performed for diagnostic and therapeutic purposes. Histopathological analysis confirmed progression to T-cell lymphoma. Adjuvant treatment with topical interferon alfa-2b was initiated. After two years of follow-up, no recurrence was observed, with partial visual improvement. This case highlights a rare pediatric presentation and central corneal involvement, both infrequently described. Combined surgical and immunomodulatory treatment achieved adequate local control, although residual sequelae limiting visual acuity persisted.

PMID 42892324
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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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