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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

PubMedNature medicine2026-07-17

Englumafusp alfa plus glofitamab in B cell non-Hodgkin lymphoma: a phase 1 trial.

Hutchings Martin M, Dickinson Michael M, Gritti Giuseppe G, Carlo-Stella Carmelo C et al.

There is an unmet need for effective, off-the-shelf therapies for relapsed or refractory aggressive B cell non-Hodgkin lymphoma (B-NHL). Part 2 of the current study was an open-label, nonrandomized, phase 1 study of escalating doses of the CD19-4-1BBL co-stimulatory molecule, englumafusp alfa, in combination with glofitamab in patients with relapsed or refractory B-NHL. Obinutuzumab pretreatment was administered 7 days before the first glofitamab dose. Glofitamab step-up dosing in cycle 1 was followed by 11 cycles of glofitamab plus englumafusp alfa. Englumafusp alfa was administered at escalating doses, with the initial dose on cycle 2 day 8 (C2D8) or cycle 1 day 10 (C1D10). Primary objectives were to establish the maximum tolerated dose, and safety and tolerability. A total of 134 patients were enrolled, including 109 with aggressive B-NHL and 25 with indolent B-NHL. The maximum tolerated dose of englumafusp alfa was not reached; one dose-limiting toxicity occurred (grade 5 Pneumocystis jirovecii pneumonia). Adverse events were reported in 98.5% of all patients, with grade 3/4 adverse events in 59.0%. Grade 5 adverse events occurred in ten patients. In the subgroup of C2D8 patients with aggressive B-NHL (n = 83), overall response and complete metabolic response rates were 68.7% and 56.6%, respectively; among those without previous exposure to chimeric antigen receptor T cell therapy (n = 41), the corresponding rates were 73.2% and 65.9%. Pharmacodynamic changes following englumafusp alfa administration supported its co-stimulatory mode of action. These data demonstrate that the addition of englumafusp alfa to glofitamab is associated with encouraging efficacy and robust pharmacodynamic modulation, as well as a safety profile consistent with glofitamab monotherapy, in patients with relapsed or refractory B-NHL. CTIS identifier: 2022-502616-37-00 ; ClinicalTrials.gov identifier: NCT04077723 .

PMID 42463852
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PubMedCanadian journal of kidney health and disease2026-07-17

Evaluation of Anemia Management in a Contemporary Population of Patients With Chronic Kidney Disease in Canada Since the Publication of Target Hemoglobin Trials: A Retrospective Observational Cohort Study.

Birks Peter P, Canney Mark M, Djurdjev Ognjenka O, Induruwage Dilshani D et al.

Guidelines for anemia management in chronic kidney disease (CKD) adopted a conservative approach in response to landmark clinical trials demonstrating lack of benefit and potential harm associated with higher hemoglobin targets. Although the findings have been applied to all CKD populations, the concordance between trial populations and those being treated in clinical practice has not been well described. We sought to evaluate trends in hemoglobin distribution and erythropoiesis stimulating agent (ESA) use among adult patients with CKD, and compare their characteristics to those of participants from landmark hemoglobin target trials. Retrospective observational cohort study. A provincial clinical information system was used to identify patients with CKD under the care of a nephrologist in British Columbia between April 1, 2007 and March 31, 2018. Adult patients (over 18 years) with estimated glomerular filtration rate (eGFR) less than 45 mL/min/1.73m2 and a minimum of three hemoglobin values during follow-up. Patients were censored if they left the province, died, or started kidney replacement therapy. Hemoglobin was measured in grams per litre (g/L) and treated as both a continuous and categorical variable. ESA use was defined as the proportion of patients who received at least one prescription for ESA therapy. The dose of ESA was quantified as an average monthly dose of epoetin alfa or darbepoetin alfa. Descriptive statistics were used to compare characteristics of patients in the study population to those of trial participants including Trial to Reduce Cardiovascular Events with Aranesp Therapy (TREAT), Correction of Hemoglobin and Outcomes in Renal Insufficiency (CHOIR), and Cardiovascular Risk Reduction by Early Anemia Treatment with Epoetin Beta trial (CREATE). Polytomous logistic regression was used to estimate odds ratios (OR) of different hemoglobin levels across cohort years. The model was adjusted for age, sex, race, comorbid conditions, eGFR, proteinuria, etiology of CKD and iron parameters. A total of 29,033 patients were included in the analysis (mean age 71 years, 45% female, median eGFR 29 mL/min/1.73m2). Average hemoglobin declined from 122 g/L in 2007 to 112.9 g/L in 2017 with a reduction in ESA use from 35% to 18%. The likelihood of patients having a hemoglobin below 90 g/L (versus 110-124 g/L) increased progressively over time (OR 5.3 in 2008; OR 16.2 in 2017). The proportion of patients meeting inclusion criteria for landmark trials ranged from 9% (TREAT) to 27% (CHOIR). Compared to trial participants, the study population had less comorbidities and received lower doses of ESA therapy. Measurement of hemoglobin may have been subject to confounding by indication, for example due to a bleeding episode. Physicians may have elected not to treat certain patients with ESA therapy, introducing selection bias. Data regarding blood transfusions were not available. Despite a minority of patients meeting criteria for prior hemoglobin target trials, the universal adoption of guidelines favoring a conservative approach to anemia has culminated in a higher likelihood of patients experiencing severe anemia. The implications of this, particularly patient-reported outcomes, warrant further investigation.

PMID 42466097
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PubMedBlood advances2026-07-17

Long-term experience with emicizumab in people with hemophilia A in the Canadian Bleeding Disorders Registry.

Iorio Alfonso A, Germini Federico F, Ibrahim Quazi Q, Keepanasseril Arun A et al.

Emicizumab prophylaxis has been approved in Canada for the prevention or reduction of bleeding episodes in people with congenital hemophilia A (PwHA). Using routinely collected health data from the Canadian Bleeding Disorders Registry (CBDR), this observational cohort study aimed to evaluate the long-term safety and effectiveness of emicizumab in PwHA. De-identified data from the CBDR were collected for PwHA who had received ≥1 dose of emicizumab from 2018 up to December 31, 2023. Intra-patient comparisons of annualized bleeding rates (ABRs) for all reported bleeds pre- and post-emicizumab were performed using a negative binomial regression model. Overall, 710 PwHA received ≥1 emicizumab dose and 539 (75.9%) had >1 year of emicizumab exposure. During the observational period, the safety profile was in keeping with previous reports; 34 adverse events were observed, including two thrombotic events (one unlikely related to emicizumab; one probably related to previous use of eptacog alfa and/or possibly related to previous emicizumab, and associated with a central venous access device). Over a median (Q1-Q3) follow-up time of 549 (374-690) days, 439 (61.8%) PwHA had no recorded bleeds. Mean ABR (95% confidence interval [CI]) decreased from 1.00 (0.87-1.14) pre-emicizumab to 0.47 (0.40-0.55) post-emicizumab (rate ratio [95% CI], 0.47 [0.41-0.55]; P < .001). A notable decrease in bleeds and sustained bleed control were observed in this population for up to a 5-year follow-up period. Continued follow-up will allow for greater quantification of this impact over time, providing valuable information to healthcare practitioners and regulatory authorities.

PMID 42466987
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PubMedJournal of Alzheimer's disease : JAD2026-07-17

Bilingualism and cognition: The impact of age of acquisition, language use, and proficiency in cognitively unimpaired older adults.

Grueso Sergio S, Sánchez-Benavides Gonzalo G, Santos-Santos Miguel M, Subirats Laia L et al.

BackgroundThe positive effect of bilingualism as a cognitive reserve factor in aging remains inconclusive, with inconsistencies often stemming from treating bilingualism as a dichotomous variable rather than a dynamic, multidimensional experience.ObjectiveTo investigate the impact of bilingualism on cognition in cognitively unimpaired older adults, focusing on age of language acquisition (AoA), proficiency, and usage throughout life.MethodsData from 2415 participants (aged 45-74) from the Alzheimer's and Families (ALFA) study were analyzed. Cognitive assessments included the Mini-Mental State Examination to assess global cognition, semantic verbal fluency for semantic lexical retrieval, Memory Binding Test for verbal episodic memory, and WAIS-IV subtests for processing speed (Coding), visual-spatial reasoning (Visual Puzzles), non-verbal abstract reasoning (Matrix Reasoning), verbal short-term memory and attention (Digit Span Forward) and working memory (Digit Span Backward and Sequencing). We defined three groups based on AoA (Early/Late) and proficiency (High/Low) of Catalan: 1) Early High-Proficiency bilinguals (n = 1559); 2) Late High-Proficiency bilinguals (n = 537) and 3) Late Low-Proficiency bilinguals, primarily Spanish-dominant (n = 319).ResultsEarly and Late High-Proficiency bilingual groups outperformed Late Low-Proficiency bilinguals in verbal semantic fluency and processing speed. Additionally, Early High-Proficiency bilinguals scored significantly higher in verbal short-term memory than both Late AoA groups.ConclusionsThe effects of bilingualism are domain-specific and primarily driven by high proficiency and active language use rather than AoA alone. These findings suggest that maintaining high L2 proficiency throughout the lifespan contributes to cognitive reserve, enhancing attentional control and processing speed in healthy aging.

PMID 42466724
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PubMedReproductive biomedicine online2026-07-16

Corifollitropin alfa N02 versus recombinant FSH for ovarian stimulation: a phase 3 trial and safety study in Chinese women.

Li Tingting T, Chen Xiujuan X, Sun Yingpu Y, Jin Lei L et al.

What is the efficacy and safety of corifollitropin alfa N02, a long-acting FSH analogue, in comparison with daily recombinant FSH (rFSH) for ovarian stimulation in Chinese women? In this double-blind, multicentre trial (NCT06091436), 474 women aged 20-39 years with a normal ovarian reserve were randomized 1:1 to a single subcutaneous dose of corifollitropin alfa N02 (100/150 μg; n = 238) or daily rFSH (150/225 IU; n = 236) for the first week of stimulation, followed by individualized daily rFSH from day 8. The primary objective was non-inferiority in the number of oocytes retrieved (margin -3). The corifollitropin alfa N02 group demonstrated non-inferiority, with a mean of 12.1 oocytes retrieved versus 10.9 in the daily rFSH group (estimated difference 1.2, 95% CI 0.23-2.12). The clinical pregnancy rate was 46.3% in the corifollitropin alfa N02 group and 51.1% in the daily rFSH group, and the ongoing pregnancy rate was 38.8% and 44.3%, respectively. Safety profiles were similar: ovarian hyperstimulation syndrome occurred in 3.8% of women in the corifollitropin alfa N02 group and 2.5% of women in the daily rFSH group, and treatment-related adverse events occurred in 15.2% and 11.0% of women, respectively. Pooled data from phase 2 and 3 trials reported neonatal outcomes at 12 months, with a birth defect rate of 7.6% for the corifollitropin alfa N02 group and 12.0% the daily rFSH group. Anti-drug antibodies were detected in 3.0% of women in the corifollitropin alfa N02 group without clinical impact. A single dose of corifollitropin alfa N02 was non-inferior to daily rFSH in terms of oocyte yield, with similar safety, offering a simplified ovarian stimulation alternative for Chinese women with a normal ovarian reserve.

PMID 42462332
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PubMedEuropean journal of neurology2026-07-16

Real-Life Effectiveness After Switching to Avalglucosidase Alfa in Late-Onset Pompe Disease Patients Worsening on Alglucosidase Alfa Therapy: A French Cohort Study.

Tard Céline C, Sacconi Sabrina S, Taouagh Nadjib N, Bouhour Françoise F et al.

Late-onset Pompe disease (LOPD) is a progressive myopathy. Enzyme replacement therapy is effective, but long-term outcomes vary. Avalglucosidase alfa, shown to be non-inferior to alglucosidase alfa in a phase 3 trial, became available in France through compassionate use for patients with insufficient response to alglucosidase alfa. Data from the French Pompe registry were analyzed for patients who switched to avalglucosidase alfa with at least 1 year of follow-up. Respiratory function (forced vital capacity, FVC) and motor function evaluated with gait performance (Six-Minute Walk Test, 6MWT) were assessed before the switch, and one and 2 years after. Individual changes were compared using paired-sample tests. Forty-seven adult patients were included. A stabilization of motor decline was observed: prior to switching, the 6MWT decreased by -27 m/year, whereas an improvement of +17 m/year was seen during the first year after the switch (p = 0.001), followed by overall stability in the second year (-10 m/year, p = 0.280). Respiratory changes were not statistically significant: a decline of 60 mL/year before the switch versus 10 mL/year after 1 year (p = 0.161), and 20 mL/year during the second year (p = 0.346). Three patients died during follow-up, with causes unrelated to the disease or treatment. Gait deterioration halted during the first year after transitioning to avalglucosidase, with sustained stabilization thereafter, while respiratory parameters showed minimal change. For patients experiencing significant walking decline under alglucosidase alfa therapy, switching to avalglucosidase alfa resulted in disease stabilization, beginning with mild improvement in the first year and a return to pre-switch baseline thereafter.

PMID 42462098
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