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CKD-11101(Darbepoetin alfa)
CKD-11101(Darbepoetin alfa) is a Erythropoiesis-stimulating agent (ESA) Biologic drug developed by Chong Kun Dang Pharmaceutical. It is currently in Phase 3 development for Anemia associated with chronic kidney disease, Chemotherapy-induced anemia in cancer patients.
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.
At a glance
| Generic name | CKD-11101(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 with a longer half-life than epoetin alfa due to additional carbohydrate chains. It binds to erythropoietin receptors on erythroid progenitor cells in the bone marrow, activating JAK2 signaling and promoting proliferation, differentiation, and maturation of red blood cells. This 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
Common side effects
- Hypertension
- Headache
- Thrombotic events (DVT, PE, stroke)
- Injection site pain
- Fatigue
- Fever
Key clinical trials
- CKD-11101 Phase 3 SC Study (PHASE3)
- CKD-11101 Phase 3 IV Study in Patients Who Had Renal Anemia Receiving Hemodialysis (PHASE3)
- Pharmacokinetics Study of CKD-11101 and NESP After SC Administration in Health Male Volunteers (PHASE1)
- Pharmacokinetics Study of CKD-11101 and NESP After IV Administration in Health Male Volunteers (PHASE1)
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:
- CKD-11101(Darbepoetin alfa) CI brief — competitive landscape report
- CKD-11101(Darbepoetin alfa) updates RSS · CI watch RSS
- Chong Kun Dang Pharmaceutical portfolio CI
Frequently asked questions about CKD-11101(Darbepoetin alfa)
What is CKD-11101(Darbepoetin alfa)?
How does CKD-11101(Darbepoetin alfa) work?
What is CKD-11101(Darbepoetin alfa) used for?
Who makes CKD-11101(Darbepoetin alfa)?
What drug class is CKD-11101(Darbepoetin alfa) in?
What development phase is CKD-11101(Darbepoetin alfa) in?
What are the side effects of CKD-11101(Darbepoetin alfa)?
What does CKD-11101(Darbepoetin alfa) target?
Related
- Drug class: All Erythropoiesis-stimulating agent (ESA) drugs
- Target: All drugs targeting Erythropoietin receptor (EPOR)
- Manufacturer: Chong Kun Dang Pharmaceutical — full pipeline
- Therapeutic area: All drugs in Hematology/Oncology
- Indication: Drugs for Anemia associated with chronic kidney disease
- Indication: Drugs for Chemotherapy-induced anemia in cancer patients
- Compare: CKD-11101(Darbepoetin alfa) vs similar drugs
- Pricing: CKD-11101(Darbepoetin alfa) cost, discount & access