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NESP(Darbepoetin alfa)
Darbepoetin alfa is an erythropoiesis-stimulating agent that binds to the erythropoietin receptor to stimulate red blood cell production.
Darbepoetin alfa is an erythropoiesis-stimulating agent that binds to the erythropoietin receptor to stimulate red blood cell production. Used for Anemia associated with chronic kidney disease, Chemotherapy-induced anemia in cancer patients, Anemia in patients with non-myeloid malignancies.
At a glance
| Generic name | NESP(Darbepoetin alfa) |
|---|---|
| Sponsor | Chong Kun Dang Pharmaceutical |
| Drug class | Erythropoiesis-stimulating agent (ESA) |
| Target | Erythropoietin receptor (EPOR) |
| Modality | Biologic |
| Therapeutic area | Hematology/Oncology |
| Phase | Phase 3 |
Mechanism of action
Darbepoetin alfa is a recombinant human erythropoietin analog engineered with two additional N-linked carbohydrate chains, which extends its half-life compared to epoetin alfa. It activates the erythropoietin receptor on erythroid progenitor cells in the bone marrow, promoting their proliferation, differentiation, and maturation into mature red blood cells. This mechanism increases hemoglobin levels and reduces the need for blood transfusions in patients with anemia.
Approved indications
- Anemia associated with chronic kidney disease
- Chemotherapy-induced anemia in cancer patients
- Anemia in patients with non-myeloid malignancies
Common side effects
- Hypertension
- Thrombovascular events (stroke, myocardial infarction, venous thromboembolism)
- Headache
- Injection site reactions
- Fatigue
- Pure red cell aplasia (rare)
Key clinical trials
- Luspatercept + Darbepoetin in MDS (PHASE2)
- Vafseo Outcomes In-Center Experience (PHASE3)
- Choices About Genetic Testing And Learning Your Risk With Smart Technology (NA)
- Darbe Plus IV Iron to Decrease Transfusions While Maintaining Iron Sufficiency in Preterm Infants (PHASE2)
- Efficacy and Safety Study to Evaluate MT-6548 in Non-dialysis Subjects With Anemia Associated With Chronic Kidney Disease in Japan (PHASE3)
- Efficacy and Safety Study to Evaluate MT-6548 in Hemodialysis Subjects Currently Receiving ESAs With Anemia Associated With Chronic Kidney Disease in Japan (PHASE3)
- A Study to Evaluate Efficacy and Safety of QLG1218(Daprodustat) in Chinese Hemodialysis (HD)-Dependent Subjects With Anemia Associated With Chronic Kidney Disease (CKD) (PHASE3)
- Darbepoetin in Patients Candidates for Liver Transplant. (EPO-LT Trial) (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- NESP(Darbepoetin alfa) CI brief — competitive landscape report
- NESP(Darbepoetin alfa) updates RSS · CI watch RSS
- Chong Kun Dang Pharmaceutical portfolio CI