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darbepoetin alfa (Darbatitor)

✓ Approved

Torrent Pharmaceuticals Limited · EPOR · Recombinant Proteins

What is darbepoetin alfa?

darbepoetin alfa is a recombinant proteins developed by Torrent Pharmaceuticals Limited. It is approved for therapeutic indications.

Drug Profile

Brand NamesDarbatitor
CompanyTorrent Pharmaceuticals Limited
Drug ClassRecombinant Proteins
Molecular TargetEPOR
StatusApproved
Sources: ClinicalTrials.gov, Torrent Pharmaceuticals 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 1 unique indication across 1 therapeutic area.

Therapeutic AreaConditionPhase
Blood and lymphatic system disordersNephrogenic anaemia✓ Approved

Related Research Articles

PubMedNeonatology2026-11-13

Relationship between Darbepoetin and Intermittent Hypoxemia in Preterm Infants.

Di Fiore Juliann M JM, Hibbs Anna Maria AM, Minich Nori Mercuri NM, Ambalavanan Namasivayam N et al.

In the Darbepoetin to Improve Red Cell Mass and Neuroprotection in Preterm Infants Trial (Darbe; NCT03169881), infants <29wks gestation receiving darbepoetin were less likely to develop bronchopulmonary dysplasia (BPD) and had higher hematocrit and red blood cell counts (RBC) suggesting that darbepoetin may augment tissue oxygen delivery and thereby improve respiratory outcomes. Intermittent hypoxemia (IH) is associated with an increased risk of BPD, and it is possible that darbepoetin reduces BPD by attenuating IH. A subcohort of 94 infants enrolled in Darbe were retrospectively analyzed. Number, duration, nadir and total time with IH <90% and <80% were identified through 42 days of age on continuous oxygen saturation recordings. Hematocrit and RBC counts were documented at days 14 and 42. Darbepoetin infants had a higher hematocrit at day 42 and there were fewer IH events <80% with a higher hematocrit (β=-1.51, 95% CI (-2.67, -0.36), p=0.03). However, the effect of darbepoetin supplementation on patterns of IH was limited to a significantly higher nadir (less severe) for IH <80% (β=-0.02, 95% CI (-0.04, 0), p=0.04). Darbepoetin increases hematocrit but only modestly improves oxygen stability in preterm infants.

PMID 43023688
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PubMedJournal of community genetics2026-11-13

Rare diseases and orphan therapies in India: burden and pharmacopeial considerations.

Joy Jessica J, Suresh Jaishree J, Chhakra Uday U, Shukla Shatrunajay S et al.

Rare diseases are a heterogeneous group of disorders that collectively impose a substantial health burden despite their low individual prevalence. India is estimated to have 70-80 million individuals affected by rare diseases and has implemented the National Policy for Rare Diseases (2021) to improve diagnosis and treatment access. However, information on the pharmacopeial status of therapies used in rare disease management remains limited. A structured review was conducted using official Indian government resources, rare-disease registries, established rare-disease organisations, and published literature retrieved from PubMed/MEDLINE, Embase, Cochrane Library, and Google Scholar. Searches were conducted up to 24 June 2026. Search concepts included rare diseases, India, prevalence, epidemiology, treatment, pharmacotherapy, orphan drugs, and individual disease names combined with terms such as "India", "prevalence", "treatment", "management", "therapy", and "pharmacotherapy". The pharmacopoeial status of medicines was assessed using Indian Pharmacopoeia 2026 (IP 2026), the USP-NF Online resource, and the 12th Edition of the European Pharmacopoeia (Ph. Eur.). Approximately 450 rare diseases are currently registered in India, predominantly genetic, metabolic, and immunological disorders. Evaluation of the most prevalent rare diseases revealed that many symptomatic therapies are included in IP, USP, and Ph. Eur. However, several orphan drugs, enzyme replacement therapies, and disease-specific treatments, including agalsidase alfa, asfotase alfa, ivacaftor, carglumic acid, and alglucosidase alfa, lack monographs in one or more major pharmacopoeias. Rare diseases remain a significant public health challenge in India. Strengthening rare disease registries, expanding pharmacopeial coverage of orphan therapies, and enhancing regulatory harmonization are essential to improve access to quality-assured treatments and support long-term patient care.

PMID 43020952
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PubMedStroke2026-11-13

Predictors of Thrombotic Events and Mortality in Patients Treated With Andexanet: A Pooled Analysis.

Sharma Mukul M, Xu Lizhen L, Eikelboom John W JW, Cohen Alexander T AT et al.

Andexanet reduces hematoma expansion compared with usual care for acute FXa (factor Xa) inhibitor-associated intracerebral hemorrhage but is associated with a risk of thrombotic events (TE). We pooled data from andexanet-treated trial participants to determine baseline predictors of TE. Secondary analyses of andexanet-treated participants in ANNEXA-I (Andexanet Alfa, a Novel Antidote to the Anticoagulant Effects of Factor Xa Inhibitors in ICH) and ANNEXA-4 (Andexanet Alfa, a Novel Antidote to the Anticoagulation Effects of Factor Xa Inhibitors), which included adults with acute life-threatening hemorrhage on FXa inhibitors. Stratified Cox proportional hazards models were used to examine associations between baseline variables and arterial or all TE and mortality. A stratified Cox regression model with arterial events as time-dependent covariates was used to examine associations of arterial events with mortality, adjusted for clinical covariates. Of 741 participants (mean age, 78.5 years; 54.5% male), 593 (80.0%) had intracranial hemorrhage and 109 (14.7%) had gastrointestinal hemorrhage. Seventy-seven (10.4%) participants had ≥1 TE, and 147 (19.8%) died. Arterial and venous thromboembolism events occurred a median of 3.5 days (interquartile range, 2.0-12.0) and 14.0 days (interquartile range, 10.0-20.0), respectively, after randomization. No baseline factors were associated with all TE. Arterial TE were associated with prior myocardial infarction (hazard ratio [HR], 2.64 [95% CI, 1.33-5.26]), high-dose eligibility (HR, 2.44 [95% CI, 1.33-4.48]), female sex (HR, 1.78 [95% CI, 1.00-3.16]), and age (HR per year, 1.04 [95% CI, 1.00-1.08]). Mortality was associated with arterial TE (HR, 2.68 [95% CI, 1.64-4.36]), prior congestive heart failure (HR, 2.53 [95% CI, 1.76-3.63]), intracerebral hemorrhage or intraventricular hemorrhage (HR, 1.90 [95% CI, 1.20-3.01]), and age (HR per year, 1.06 [95% CI, 1.03-1.08]). The initiation of anticoagulation after randomization was associated with a reduction in TE. In FXa inhibitor-associated hemorrhage treated with andexanet, baseline factors are associated with arterial TE and can be used to inform treatment decisions. Initiation of anticoagulation reduces the occurrence of TE. URL: https://www.clinicaltrials.gov; Unique identifier: NCT02313909. URL: https://www.clinicaltrials.gov; Unique identifier: NCT02329327.

PMID 43023572
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PubMedAnnual review of medicine2026-11-12

Rapidly Evolving Insulin Landscape: Ultrashort Acting and Ultralong Acting.

Sohi Navneet N, Gupta Rishi B RB, Arora Suhani K SK, Bajaj Harpreet S HS

Since the discovery of insulin in 1921, there has been remarkable evolution in insulin treatment for diabetes, with modern insulin analogues utilizing highly engineered recombinant technology. The purpose of this review is to focus on two revolutionary developments in contemporary insulin therapy: once-weekly ultralong-acting basal insulins and ultrashort-acting bolus insulins. Insulin icodec and insulin efsitora alfa represent a unique shift in basal insulin delivery, offering the convenience of once-weekly administration, flat pharmacokinetic profiles, and glycemic efficacy and safety comparable to those of daily basal analogues while reducing injection burden and improving patient satisfaction. With regard to bolus therapy, faster-acting aspart and ultrarapid lispro achieve accelerated absorption through novel excipient engineering, enabling more flexible mealtime dosing and improved postprandial glucose control compared to their traditional counterparts. Looking ahead, there are promising innovations on the horizon, including glucose-responsive insulins, artificial intelligence-driven automated insulin delivery, and the continued pursuit of oral insulin. Together, these advances represent an accelerating trajectory toward more physiological, convenient, and, most importantly, safe insulin therapy.

PMID 43019456
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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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