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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 reviews. Urology2026-10-16

Combination therapy for BCG-unresponsive non-muscle-invasive bladder cancer: biological rationale and ongoing clinical strategies.

Daneshmand Siamak S, Boorjian Stephen A SA, Meeks Joshua J JJ, Lotan Yair Y et al.

Radical cystectomy is the current first-line treatment for patients with BCG-unresponsive non-muscle-invasive bladder cancer; however, this surgical procedure is associated with considerable morbidity and mortality. Bladder-preserving treatments, including single agents - such as nadofaragene firadenovec, a nonreplicating adenoviral-vector-based gene therapy; pembrolizumab, an immune checkpoint inhibitor immunotherapy; and single-agent intravesical chemotherapy using valrubicin or controlled-release gemcitabine - and combination therapies, including nogapendekin alfa inbakicept-pmln (an IL-15 receptor agonist immunotherapy) plus BCG - and multiagent intravesical chemotherapy (for example, gemcitabine plus docetaxel) are also recommended by current guidelines. Single-agent therapies can lead to development of acquired immune resistance; thus, combination therapies are a key area of interest for improving patient outcomes. Options for this approach include combinations of intravesical chemotherapy, BCG, immunotherapy, gene therapy and radiotherapy. These bladder-preserving combination therapies have the potential to change the treatment paradigm for patients with BCG-unresponsive non-muscle-invasive bladder cancer by improving clinical efficacy and avoiding the need for cystectomy. Future studies must evaluate the benefits and risks associated with combination treatment, considering patient convenience, toxicity, efficacy, the risk of progression and treatment cost.

PMID 42881230
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PubMedDiagnostics (Basel, Switzerland)2026-10-16

Beyond Tuberculosis: Late Diagnosis of Cystic Fibrosis in an Adolescent with Bronchiectasis and Recurrent Pseudomonas aeruginosa Isolation: A Case Report.

Mihailov Oana Mariana OM, Luțenco Valerii V, Țocu Lavinia L, Mihailov Raul R et al.

Background and Clinical Significance: Cystic fibrosis may remain undiagnosed until adolescence, when recurrent respiratory infections and bronchiectasis are attributed to a previous severe infection. Case Presentation: We report the case of a male adolescent in whom approximately five years elapsed between microbiologically confirmed pulmonary tuberculosis in July 2021 and recognition of cystic fibrosis in August 2026. Archived records documented two sputum specimens that were acid-fast bacilli smear-positive (1+) and culture-positive (1+) for Mycobacterium tuberculosis complex. During adolescence, persistent bronchiectasis, recurrent Gram-negative respiratory infections, digital clubbing, and repeated Pseudomonas aeruginosa isolation prompted etiologic reassessment. A single documented sweat chloride concentration was 114 mmol/L. CFTR analysis of blood collected on 18 August 2026, reported on 16 September 2026, identified homozygous c.1521_1523delCTT (p.Phe508del; F508del), providing molecular confirmation. Spirometry showed FEV1 2.69 L (79.6% predicted), FVC 3.73 L (91.56% predicted), and FEV1/FVC 72.01% (z-score -2.58), consistent with airflow obstruction; without total lung capacity measurements, restriction or a mixed ventilatory defect could not be confirmed. The previously recorded azithromycin regimen was 500 mg orally three times weekly. Tobramycin inhalation solution 300 mg/5 mL was prescribed as one ampoule twice daily for 28 days, followed by 28 days off, with three planned cycles and salbutamol 15 min before administration. Management of cystic fibrosis also included airway-clearance therapy, dornase alfa 2.5 mg once daily, a high-calorie diet, pancreatic enzyme replacement, and vitamin supplementation. Longitudinal post-treatment spirometry, anthropometry, and validated quality-of-life measurements were not available. Conclusions: Previous pulmonary tuberculosis should not terminate etiologic investigation when bronchiectasis, repeated Pseudomonas aeruginosa isolation, digital clubbing, or progressive structural lung disease persists. Earlier recognition may permit earlier coordinated cystic fibrosis care and genotype-appropriate CFTR-modulator assessment.

PMID 42882257
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PubMedNutrients2026-10-16

Assessment of Vitamin D Status and Calcium-Phosphate Metabolism in Patients with Hypophosphatasia-A Single-Center Cohort Study.

Michałus Izabela I, Pejska Marta M, Jóźwiak-Markiewicz Aleksandra A, Konopka Agnieszka A et al.

Background: Hypophosphatasia (HPP) is a rare genetic disorder caused by a loss-of-function mutation in the ALPL gene, which encodes tissue-nonspecific alkaline phosphatase (TNSALP). Reduced TNSALP activity in HPP primarily leads to bone mineralization disorders. Given the complex and challenging nature of issues related to vitamin D and HPP, it is essential to evaluate each patient individually and adjust the appropriate dose of vitamin D according to their specific needs in order to maintain calcium phosphate homeostasis and normal vitamin D levels. Maintaining proper vitamin D homeostasis in patients with hypophosphatasia is one of the greatest challenges. Objective: The objective of this study was to conduct a retrospective, comprehensive assessment of calcium-phosphate metabolism, with particular emphasis on vitamin D status in patients with genetically confirmed hypophosphatasia (HPP), and to identify potential correlations between 25(OH)D concentrations and other parameters of calcium-phosphate in this group of patients. Methods: A single-center, retrospective pilot study was conducted in a small cohort (n = 36) of patients suffering from an ultra-rare genetic disorder, hypophosphatasia. The small sample size reflects the ultra-rare nature of the disease; so far, HPP has been diagnosed in approximately 50 patients in Poland (prevalence 1:300,000). The analysis included medical records of patients. Results: Vitamin D deficiency was not observed in the majority of patients with hypophosphatasia in the study group. The initiation of long-term enzyme replacement therapy (with asfotase alfa) did not significantly affect the annual change in mean serum vitamin D concentration. As established in the literature, growth disorders are an inherent feature of the clinical picture of hypophosphatasia. This was reflected in our study group, where nearly half of the pediatric patients achieved a height below the 10th percentile. Conclusions: Within this limited sample, these growth issues did not appear to be associated with disturbances in calcium and phosphate metabolism or vitamin D deficiency.

PMID 42884569
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PubMedAdvances in therapy2026-10-15

Safety, Efficacy, and Pharmacokinetics of Agalsidase Alfa in Treatment-Naive Chinese Patients with Fabry Disease: 52-Week Phase 3, Open-Label, Single-Arm Study.

Ren Hong H, Mao Jianhua J, Wang Rong R, Chen Yucheng Y et al.

Clinical data on the efficacy, tolerability, and pharmacokinetics of agalsidase alfa in Chinese patients with Fabry disease are limited. We evaluated the safety, efficacy, and pharmacokinetics of agalsidase alfa in Chinese patients who are treatment-naive over 52 weeks. This was an open-label, non-randomized, single-arm, multicenter (six centers in China) phase 3 study. Patients with Fabry disease (aged 7-65 years; either sex) received agalsidase alfa 0.2 mg/kg intravenously (every other week for up to 52 weeks). The primary endpoint was the incidence of serious treatment-emergent adverse events (TEAEs). Secondary endpoints included the incidence of TEAEs, changes from baseline in estimated glomerular filtration rate (eGFR), left ventricular mass index (LVMI), left ventricular ejection fraction (LVEF), and agalsidase alfa pharmacokinetics. Overall, 20 patients were enrolled (May 2022 to January 2024) and received ≥ 1 dose of agalsidase alfa. The median number of infusions was 27; median exposure duration was 12.0 months. Agalsidase alfa was generally well tolerated. Two patients (10.0%) reported one serious TEAE each (sepsis, ectopic pregnancy). All patients reported ≥ 1 TEAE, most of which were mild or moderate (98.2%); nine patients (45.0%) had ≥ 1 TEAE assessed as related to treatment. Baseline eGFR, LVMI, and LVEF were 118.8 (21.4) mL/min/1.73 m2, 38.0 (11.2) g/m2.7, and 66.8% (4.9), respectively. Renal function and cardiac structure and function remained relatively stable over 52 weeks; mean (SD) changes in eGFR, LVMI, and LVEF from baseline were 4.1 (12.5) mL/min/1.73 m2, 0.56 (8.71) g/m2.7, and 0.8% (3.3%), respectively. Agalsidase alfa exposure (area under the concentration-time curve and maximum serum concentration) was generally similar at week 0 and at week 28. Data from this 52-week study support the use of agalsidase alfa as a long-term treatment option for Chinese patients with Fabry disease. Safety, efficacy, and pharmacokinetic profiles were consistent with studies in other populations. Graphical Abstract available for this article. NCT04974749.

PMID 42879111
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PubMedFrontiers in reproductive health2026-10-15

Comparative outcomes of conventional follitropin delta 15 µg/day versus follitropin alfa 225 IU/day for ovarian stimulation: results from an exploratory post hoc analysis of Spanish participants from the ADAPT-1 randomized controlled trial.

García Sánchez Marta M, Bernabeu Andrea A, Hernández Cesteros Ana A, Blasco Gastón Laura L et al.

Can follitropin delta be used in a conventional regimen (15 µg/day starting dose) without compromising efficacy and safety in patients seeking fertility treatment in Spain? This was an exploratory post hoc analysis of the ADAPT-1 randomized controlled trial. Participants, 18-40 years, enrolled at specialist reproductive centers in Spain in this accessor-blinded, multicenter trial assessing efficacy and safety of conventional follitropin delta 15 μg/day and follitropin alfa 225 IU/day for ovarian stimulation. The primary endpoint was the number of oocytes retrieved. During the follow-up period, clinical pregnancies from the first fresh or frozen transfer within 3 months of the start of stimulation, and ovarian hyperstimulation syndrome (OHSS) rates were assessed. All cycles used a gonadotropin-releasing hormone (GnRH) antagonist protocol. A total of 132 patients were randomized (10-AUG-2022 to 11-MAR-2024): follitropin delta group, n = 85; follitropin alfa group, n = 47. The adjusted mean number of oocytes retrieved was 10.6 and 11.0 for each group, respectively [difference: -0.3 (95% CI: -2.4; 1.7)]. Adjusted clinical pregnancy rates per started cycle were 34.8% and 32.0%, respectively [difference: 2.8% (95% CI: -14.3; 20.0)]. Adverse events were reported for 28.2% and 42.6% of participants, respectively, with the most common adverse events being headache [10.6% (n = 9) and 8.5% (n = 4)], pelvic discomfort [4.7% (n = 4) and 4.3% (n = 2)], dysmenorrhea [0% and 6.4% (n = 3)], and early OHSS [1.2% (n = 1) and 4.3% (n = 2)]. Our exploratory analysis shows that a higher starting dose of follitropin delta 15 µg/day in a conventional regimen can be successfully used in appropriately selected infertile patients, resulting in a good average oocyte yield without compromising first-transfer clinical pregnancy rates and while maintaining a low incidence of early OHSS.

PMID 42877143
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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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