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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

PubMedPediatric allergy, immunology, and pulmonology2026-11-11

Successful Reintroduction of Olipudase Alfa Following Anaphylaxis Using a 12-Step Desensitization Protocol in a Child With Chronic Neurovisceral Acid Sphingomyelinase Deficiency.

Cimi Burcu Sarigul BS, Akyüzlüer Güneş Merve Setenay MS, Ozturk Gokcan G, Gurlek Erkut E et al.

Background:Olipudase alfa is the first disease-specific enzyme replacement therapy (ERT) approved for the treatment of noncentral nervous system manifestations of acid sphingomyelinase deficiency (ASMD); however, experience with the management of olipudase alfa-induced anaphylaxis remains limited.Case Presentation:We report a 13-year-old girl with chronic neurovisceral ASMD who developed anaphylaxis during an olipudase alfa infusion, presenting with periorbital edema, generalized urticaria, and hypotension. Following successful treatment with intramuscular adrenaline, olipudase alfa was reintroduced using a 12-step desensitization protocol. After two successful infusions at 2 mg/kg, the dose was re-escalated to the full therapeutic dose of 3 mg/kg, which has since been maintained every 2 weeks without recurrence of hypersensitivity reactions.Conclusion:In contrast to the previously reported real-world pediatric case, in which recurrent anaphylactic reactions ultimately necessitated omalizumab therapy, our patient successfully achieved and maintained the full therapeutic dose with desensitization alone. This case suggests that individualized desensitization may enable the safe continuation of olipudase alfa following anaphylaxis, thereby avoiding permanent discontinuation of ERT.

PMID 43010577
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PubMedAnalytical chemistry2026-11-11

Single-Step Sample-Activated Alternating Sequential Flow Enables Autonomous Multistep Electrochemical Lateral Flow Detection of Mpox Virus DNA.

Lapee-E Vasita V, Phimdee Piyathida P, Jung Hyo-Il HI, Pasomsub Ekawat E et al.

The 2022 multinational mpox virus (MPXV) outbreak and continued cross-border transmission have highlighted limitations of laboratory-confined PCR diagnostics. Here, we report an alternating lateral flow architecture (ALFA) that transforms traditional single-pass lateral flow into a programmable platform for autonomous multistep electrochemical nucleic acid detection following a single prepared-sample introduction. By regulating passive fluid delivery, ALFA enables sequential molecular processing and in situ signal generation without external intervention. Coupled with Ag(I)-mediated mismatch DNA nanocomplexes (MDNs), the system provides electrochemical signal amplification without nucleic acid amplification. ALFA detected MPXV DNA with a limit of detection (LOD) of 1.55 pM and a linear range of 101-105 pM. In urine and saliva spiked with structurally intact viral particles, the lowest statistically distinguishable concentration was 10 copies mL-1. Clinical evaluation of 50 PCR-characterized lesion swab samples yielded 92.11% sensitivity, 100% specificity, and 94.0% accuracy. The platform also maintained stable performance over an estimated 112 days. ALFA therefore provides a programmable lateral flow framework for rapid, amplification-free, decentralized nucleic acid diagnostics.

PMID 43010552
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PubMedReproductive biomedicine online2026-11-10

The one-shot protocol: a novel single-injection strategy for ovarian stimulation. A prospective pilot study.

Donno Valeria V, Grau Silvia S, García-Martinez Sandra S, Rodriguez Ignacio I et al.

What stimulation outcomes and endocrine profile are associated with a novel ovarian stimulation protocol using a single corifollitropin alfa injection plus daily oral clomiphene citrate? Single-centre prospective pilot study including 20 women undergoing ovarian stimulation for IVF with an elective freeze-all strategy. Eligible participants were aged 40 years or younger, had anti-Müllerian hormone (AMH) 1.2-3.5 ng/ml or antral follicle count (AFC) 7-20 and body mass index (BMI) 18-30 kg/m². Ovarian stimulation began on cycle day 1-3 with a single 150 μg corifollitropin alfa injection, followed by oral clomiphene citrate 100 mg daily until trigger day. Monitoring included transvaginal ultrasound and blood tests on stimulation days 1, 6, 8 and 10, then as clinically indicated. Final oocyte maturation was triggered with 0.2 mg triptorelin; oocytes were retrieved 36 h later. Primary outcome was hormonal profile. Of the 23 women screened, 20 completed ovarian stimulation and were included in the analysis. Mean age was 35.55 ± 2.11 years, mean BMI 24.07 ± 3.43 kg/m² and mean AMH 1.88 ± 0.58 ng/ml. Mean oocyte yield was 13.60 ± 6.31, including 10.35 ± 5.07 mature oocytes. No cases of ovarian hyperstimulation syndrome were observed. One patient experienced spontaneous ovulation before oocyte retrieval. FSH concentrations declined from day 6 to trigger day; LH remained broadly stable during stimulation. Single-injection protocol combining corifollitropin alfa with daily oral clomiphene citrate is feasible and can effectively support follicular development. Larger controlled studies are warranted to confirm efficacy and safety.

PMID 43008356
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PubMedFrontiers in medicine2026-11-10

Longitudinal hematologic decline during peginterferon alfa-2b therapy in chronic hepatitis B: clinical safety and exploratory whole-blood transcriptomics.

Li Jie J, Chen Weilai W, Chen Jinggu J, Xing Jiayi J et al.

Peginterferon-based therapy for chronic hepatitis B is known to cause leukopenia, neutropenia, and thrombocytopenia, but the relationship of early hematologic trajectories to serological response, supportive management, and whole-blood molecular signals remains uncertain. We conducted an exploratory hematologic safety-focused secondary analysis of a prospective, single-center cohort of 21 patients receiving peginterferon alfa-2b-based therapy (13 responders and 8 non-responders). WBC, ANC, and platelet counts were assessed at visits corresponding approximately to baseline, Week 5, and Week 10. Non-parametric comparisons were supplemented with effect sizes and 95% confidence intervals, and supportive-treatment timing was examined in locked sensitivity analyses. All paired Visit-1-to-Visit-3 changes were negative in both response groups, whereas responder-versus-non-responder estimates were imprecise and did not establish a response-group-specific toxicity pattern. Visit-2 WBC <4.0 × 109/L occurred in 19/21 patients (90.5%; exact 95% CI: 69.6%-98.8%) and was treated as a pragmatic clinical-management context threshold rather than a discriminating transcriptomic endpoint. A post-documented oral-support-date indicator did not materially alter the fitted WBC or ANC pattern, but this non-randomized sensitivity analysis cannot estimate treatment efficacy. In the manuscript-consistent DESeq2 variance-stabilizing-transformation workflow, no unadjusted primary Hallmark or candidate-gene family met the prespecified exploratory BH-FDR q < 0.10 threshold. A reviewer-directed xCell2 sensitivity analysis showed longitudinal internal concordance between the prespecified neutrophil enrichment score and measured ANC; composition adjustment changed several pathway estimates, but no paired W0-W10 family reached q < 0.10 and unstable baseline-adjusted platelet signals did not support a specific pathway or mechanism. These small-cohort findings are exploratory, are not evidence of equivalence or mechanism, and require confirmation in larger independent cohorts.

PMID 43005640
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PubMedACS nano2026-11-10

NanoBlocks: Creating Genetically Encoded Protein Switches Using Competitive Binding.

Denis Silke S, Van Deuren Vincent V, Frecot Desiree I DI, Rothbauer Ulrich U et al.

Many regulatory mechanisms function by changing a molecule's conformation such that it is switched between active and inactive states. Engineering macromolecules such as proteins to show robust conformational changes in response to arbitrary, well-defined molecular stimuli is of great interest in fields such as synthetic biology and nanoscale engineering, because it allows the development of "smart" molecular tools. We present a strategy that can convert "simple" affinity binders such as nanobodies into protein switches that undergo clear structural rearrangements in response to their innate targets, by introducing a peptide that competes for the binding site. We demonstrate proof-of-concept implementations of this "NanoBlock" design by developing genetically encoded fluorescent biosensors based on two entirely different binder frameworks, the ALFA nanobody and the PDZ domain of Erbin. We show that our design allows the construction of well-performing protein switches that can reliably detect their targets in vitro, in mammalian cells, as part of fluorescence-activated cell sorting (FACS) experiments, and that also generalizes to the creation of stimulus-responsive enzymes via the integration of a bioluminescent readout. We furthermore develop a theoretical model that rationalizes the observations and provides insight into the underlying molecular mechanisms. Overall, our strategy expands the possibilities to create "smart" protein-based molecules and effectors.

PMID 43007788
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PubMedCureus2026-11-10

The Blind Spot of Bone Disease: Adult Hypophosphatasia in a Middle-Aged Man With Prolonged Fracture Healing.

Busbaih Albatool A AA, Busbaih Alkawthar A AA, Hussein Salma S, Alfaraj Abdullah A

Hypophosphatasia (HPP) is a rare inherited disorder caused by pathogenic variants in the ALPL gene, which encodes tissue-nonspecific alkaline phosphatase. In adults, it presents with nonspecific musculoskeletal features and is often mistaken for osteoporosis. We describe a 47-year-old man referred to endocrinology with a previous diagnosis of osteoporosis and recurrent femoral fractures with markedly delayed healing, at ages 30 and 39 years. He also had chronic musculoskeletal pain and atraumatic loss of teeth early in childhood, at age four; a bone scan showed multiple metatarsal fractures, and nephrocalcinosis was present. Serum alkaline phosphatase was persistently low and pyridoxal 5'-phosphate was elevated at 494 mcg/L (reference range: 5-50 mcg/L), while thyroid, parathyroid, cortisol, pituitary, renal, hepatic, and vitamin D evaluations were unremarkable. Several relatives had related manifestations. Adult HPP was diagnosed clinically in 2017, and genetic testing later identified an apparently homozygous, likely pathogenic ALPL variant (c.214A>G, p.Ile72Val). Treatment with asfotase alfa was associated with marked improvement, and he regained the ability to walk without a cane. This case shows that persistently low alkaline phosphatase in an adult with recurrent fractures and poor fracture healing should prompt evaluation for HPP before osteoporosis is assumed and that the diagnosis need not wait for genetic confirmation. Greater clinical awareness may shorten diagnostic delay.

PMID 43005820
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