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darbepoetin alfa (Darberel)

✓ Approved

Reliance Life Sciences Private Limited · EPOR · Recombinant Proteins

What is darbepoetin alfa?

darbepoetin alfa is a recombinant proteins developed by Reliance Life Sciences Private Limited. It is approved for therapeutic indications via injectable (others) or subcutaneous injection.

Drug Profile

Brand NamesDarberel
CompanyReliance Life Sciences Private Limited
Drug ClassRecombinant Proteins
Molecular TargetEPOR
RouteInjectable (Others), Subcutaneous Injection
StatusApproved
Sources: ClinicalTrials.gov, Reliance Life Sciences Private Limited

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 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

PubMedClinical drug investigation2026-10-15

The Economic Burden of HDV in Italy: Evaluating the Potential Impact and Effects of Bulevirtide for Chronic HDV Infection.

Paoletti Martina M, Cazzato Daniela D, Marcellusi Andrea A, Kondili Loreta A LA et al.

Chronic hepatitis D is associated with substantial clinical and economic burden due to its progressive course and risk of severe liver-related complications. The aim of this study was to quantify the economic burden of chronic hepatitis D (HDV) in Italy from societal perspectives, and to estimate the clinical and economic consequences associated with bulevirtide, peginterferon alfa (PEG-IFN-α), and best supportive care (BSC) in HDV-RNA-positive adults with compensated liver disease. The economic impact of HDV infection was estimated using a cost-of-illness (COI) analysis, while the costs and effects of introducing bulevirtide were estimated using a cost-and-outcomes analysis (COA). The COA compared two scenarios: a clinical practice scenario that includes PEG-IFN-α and BSC, and a scenario that introduces bulevirtide. The analyses were conducted from the societal perspective; therefore, direct and indirect estimated costs were included. The most relevant outcomes were quality adjusted life years (QALYs) and the number of deaths. Both analyses were carried out on a standardised hypothetical cohort of 1000 HDV-RNA-positive adult patients with compensated liver disease, over 10 years. A deterministic sensitivity analysis (DSA) was conducted to assess parameter uncertainty. The COI estimated a 10-year economic burden of €34,939,429.41 for the management and treatment of patients with HDV infection in Italy. The COA estimated a total 10-year reduction in disease-related costs of €2,152,752.76 after the introduction of bulevirtide, an increase of 8.26% (+ 366.12) in the number of QALYs gained, and a 12.39% reduction (- 73.67) in the number of deaths. Our study suggests that the introduction of bulevirtide may alleviate the clinical and economic burden associated with HDV in Italy, while improving quality of life.

PMID 42875707
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PubMedFrontiers in medicine2026-10-15

Season-adjusted longitudinal changes in serum 25-hydroxyvitamin D during pegylated interferon add-on to ongoing tenofovir alafenamide therapy in chronic hepatitis B: a real-world cohort study.

Han Ning N, Liu Huan H, Zhu Xia X

To characterize serum 25-hydroxyvitamin D [25(OH)D] trajectories during peginterferon alfa-2b (Peg-IFN) add-on to ongoing tenofovir alafenamide (TAF) therapy in chronic hepatitis B and explore associations with hepatitis B surface antigen (HBsAg). This retrospective cohort identified 203 consecutive patients, of whom 190 contributed longitudinal data through week 48. The primary random-intercept mixed-effects model used categorical visit time and adjusted for seasonality, age, and sex. Continuous-time, random-slope, visit-timing, and HBsAg-censoring analyses assessed sensitivity. The primary adjusted week-48 25(OH)D difference was -7.9 nmol/L (95% CI, -9.8 to -6.0) (P < 0.001); the secondary continuous-time estimate was -8.3 nmol/L over 48 weeks. Observed concentrations declined through week 36 and partially rebounded at week 48. The proportion below 47.7 nmol/L increased from 21.1% to 34.7%. The adjusted total serum calcium trend was -0.061 mmol/L (95% CI, -0.074 to -0.049). Triglycerides increased while cholesterol fractions decreased. At week 48, 104/190 patients (54.7%) had an HBsAg decline of at least 1 log10 and 50/190 (26.3%) had visit-specific HBsAg loss. The concurrent 48-week change correlation was weak (ρ = 0.150; FDR-adjusted P = 0.117), and the magnitude of 25(OH)D decline was not independently associated with either binary endpoint. Within patients, each 10 nmol/L increase in 25(OH)D was associated with a 0.068-log10 IU/mL increase in concurrent HBsAg (95% CI, 0.020 to 0.116; P = 0.006). Serum 25(OH)D showed a non-linear decline during 48 weeks of follow-up, and the week-48 difference remained evident after adjustment for seasonality. However, without a concurrent comparator, the observed change cannot be attributed specifically to Peg-IFN, TAF, or their combination. Exploratory analyses suggested only a weak concurrent relationship between 25(OH)D and HBsAg, without evidence of prediction or causality. The clinical relevance of the observed changes in 25(OH)D and total serum calcium warrants further prospective investigation.

PMID 42876729
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PubMedClinical pharmacokinetics2026-10-14

Efsubaglutide Alfa: A Comprehensive Pharmacological Review.

Zheng Haolin H, Yan Run R, Jiang Fan F, Li Yi Y et al.

Efsubaglutide alfa (also known as supaglutide) is a long-acting glucagon-like peptide-1 receptor agonist (GLP-1RA) engineered as a GLP-1 analogue fused to a human immunoglobulin G2 (IgG2) fragment crystallisable (Fc) domain. This narrative review summarises published and publicly available evidence on efsubaglutide alfa pharmacology, pharmacokinetics/pharmacodynamics, dose-exposure-response relationships, drug-drug interaction potential, and clinical efficacy and safety in type 2 diabetes (T2D) and overweight/obesity. Efsubaglutide alfa has prolonged exposure (terminal half-life approximately 182-215 h) and low steady-state fluctuation, but dosing-interval selection should not be inferred from half-life alone. Available population pharmacokinetic and exposure-response analyses indicate that steady-state trough concentration is most informative for glycaemic response, whereas average and peak concentrations contribute to interpretation of weight response and gastrointestinal tolerability. Across available studies, predominantly conducted in Chinese populations, efsubaglutide alfa shows class-consistent improvements in glycaemic control and body weight, with gastrointestinal adverse events as the main tolerability limitation. Exploratory every 2-week dosing and post-discontinuation glycaemic durability findings remain hypothesis-generating. No head-to-head comparative trials dedicated cardiovascular or renal outcome trials, or large globally diverse datasets are yet available; therefore, the current evidence should be interpreted as a clinical pharmacology synthesis rather than a comparative positioning claim.

PMID 42870102
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PubMedFrontiers in endocrinology2026-10-14

Case Report: Atypical femoral fractures in adult-onset hypophosphatasia treated with low-dose asfotase alfa and adjunctive teriparatide therapy.

Chung Yoon-Sok YS, Kim Kwang-Kyoun KK, S Gokul B GB, Park Ji-Seong JS

Hypophosphatasia is a rare inherited metabolic bone disease caused by low activity of tissue-nonspecific alkaline phosphatase. Adult-onset hypophosphatasia is increasingly recognized, but fracture patterns and optimal management remain unclear. We report a 52-year-old woman who presented with progressive pain and bilateral atypical femoral fractures. She was diagnosed with hypophosphatasia based on low alkaline phosphatase, markedly elevated pyridoxal 5'-phosphate, a history of metatarsal fracture, premature tooth loss, and pathogenic ALPL variants. Low-dose asfotase alfa was started because standard-dose therapy was not feasible. After 6 months, callus formation was observed, and pain improved. However, 6 months later, the pain recurred, and radiographs showed a progressive fracture, suggesting insufficient fracture healing. Staged intramedullary fixation was performed for both femurs. Two perioperative femoral fractures occurred during the course of surgical management. Therefore, adjunctive teriparatide (20 µg daily for six months) was initiated while continuing low-dose asfotase alfa. At 5-year follow-up, radiographic union of all femoral fractures was achieved, and the patient remained ambulatory without assistance and had no fracture-related pain. This case shows that adult-onset hypophosphatasia can cause severe skeletal fragility and may require individualized multidisciplinary management, including biochemical diagnosis, long-term radiographic surveillance, cautious surgical planning, and selective use of medication.

PMID 42871899
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PubMedAlzheimer's & dementia : the journal of the Alzheimer's Association2026-10-14

Air pollution is associated with sex-specific longitudinal changes in astrocytic and neuroinflammatory processes linked to cognitive decline in Alzheimer's disease at-risk individuals.

Vilor-Tejedor Natalia N, Rodríguez-Fernández Blanca B, Genius Patricia P, Fernández-Bonet Alba A et al.

Air pollution is associated with dementia risk, but its role during preclinical Alzheimer's disease (AD) remains unclear. We examined long-term residential exposure to traffic-related air pollution in 226 cognitively unimpaired middle-aged individuals at increased risk of AD from the ALzheimer's and FAmilies ALFA+ cohort (a nested longitudinal cohort within the ALzheimer's and Families parent cohort). Participants underwent baseline and 3-year follow-up cerebrospinal fluid (CSF) assessment of AD, neurodegeneration, astrocytic, microglial, and inflammatory biomarkers. Exposure to nitrogen dioxide (NO2), particulate matter (PM)10, PM2.5, and PM2.5 absorbance was estimated using land-use regression models. Sex-interaction and stratified analyses were performed. Mediation analyses evaluated cognitive and brain-age outcomes. Sex-dependent associations were observed between air pollution exposure and CSF inflammatory and astrocytic biomarkers. Higher exposure was associated with longitudinal increases in glial fibrillary acidic protein (GFAP) and interleukin (IL) -6, primarily in women. GFAP partially mediated associations between air pollution exposure and worsening executive and attentional performance. Findings support sex-specific astroglial and neuroinflammatory susceptibility to traffic-related air pollution in preclinical AD. The ALFA+ study has been registered at ClinicalTrials.gov (10-06-2015, identifier: NCT02485730).

PMID 42872554
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PubMedBMC ophthalmology2026-10-13

Pediatric conjunctival papilloma managed with staged multimodal therapy: a case report.

Sedaghat Mohammadreza M, Sadeghi Javad J, Khazaei Sahel S

Conjunctival papilloma is a rare benign ocular surface tumor in children, most commonly associated with low-risk human papillomavirus types 6 and 11. Management can be challenging because of multifocal disease, persistence, recurrence, and the need to preserve healthy conjunctival tissue in young patients. We report a pediatric case of multifocal conjunctival papilloma successfully managed with a staged multimodal approach combining preoperative medical therapy with limited surgical excision. A 4-year-old boy presented with multifocal conjunctival papillomatous lesions. Following clinical evaluation and diagnosis of conjunctival papilloma, preoperative topical and intralesional interferon alfa-2b were administered to reduce the lesion size. Residual lesions were subsequently treated with limited surgical excision following preoperative interferon-mediated debulking and intraoperative application of mitomycin C. The patient had a favorable clinical course, with preservation and progressive restoration of the conjunctival architecture. At 2 years of follow-up, there was no evidence of recurrence. This case highlights the potential value of a staged multimodal strategy for managing multifocal conjunctival papilloma in children. Preoperative medical debulking followed by targeted surgical excision may help reduce the extent of surgery, preserve healthy conjunctival tissue, and achieve durable disease control. This approach may be particularly useful in pediatric ocular surface disease, where tissue preservation is an important consideration.

PMID 42864620
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