Last reviewed 2026-05-15 · How we verify

Darbepoetin (DP)

Fundacion Clinic per a la Recerca Biomédica · Phase 3 active Small molecule

Darbepoetin (DP) is a Erythropoiesis-stimulating agent (ESA) Small molecule drug developed by Fundacion Clinic per a la Recerca Biomédica. It is currently in Phase 3 development for Anemia associated with chronic kidney disease, Chemotherapy-induced anemia in cancer patients, Anemia in patients with non-myeloid malignancies.

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.

Likelihood of approval

61.3% vs 58.3% industry baseline

If approved by FDA: likely 2028–2030

Steps remaining: NDA/BLA submission

Confidence: High

Why this estimate

Baseline phase 3 → approval rate +58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
Oncology Phase 3 boost +3.0pp
Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway.

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2028–2030	—
EMA	EU	2029–2031	+0.7 yr
MHRA	GB	2029–2031	+0.7 yr
Health Canada	CA	2029–2032	+0.9 yr
TGA	AU	2029–2032	+1.2 yr
PMDA	JP	2029–2032	+1.5 yr
NMPA	CN	2030–2033	+2.3 yr
MFDS	KR	2029–2032	+1.4 yr
CDSCO	IN	2029–2033	+1.8 yr
ANVISA	BR	2030–2033	+2.3 yr

Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).

Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.

At a glance

Generic name	Darbepoetin (DP)
Sponsor	Fundacion Clinic per a la Recerca Biomédica
Drug class	Erythropoiesis-stimulating agent (ESA)
Target	Erythropoietin receptor (EPOR)
Modality	Small molecule
Therapeutic area	Hematology/Oncology
Phase	Phase 3

Mechanism of action

Darbepoetin is a hyperglycosylated analog of erythropoietin (EPO) with a longer half-life than recombinant human EPO. It activates the erythropoietin receptor on erythroid progenitor cells in the bone marrow, promoting proliferation, differentiation, and maturation of red blood cells. This mechanism is used to treat anemia associated with chronic kidney disease, cancer chemotherapy, and other conditions.

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
Thrombotic events (DVT, PE, stroke)
Headache
Injection site pain
Flu-like symptoms

Key clinical trials

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:

Darbepoetin (DP) CI brief — competitive landscape report
Darbepoetin (DP) updates RSS · CI watch RSS
Fundacion Clinic per a la Recerca Biomédica portfolio CI

Frequently asked questions about Darbepoetin (DP)

What is Darbepoetin (DP)?

Darbepoetin (DP) is a Erythropoiesis-stimulating agent (ESA) drug developed by Fundacion Clinic per a la Recerca Biomédica, indicated for Anemia associated with chronic kidney disease, Chemotherapy-induced anemia in cancer patients, Anemia in patients with non-myeloid malignancies.

How does Darbepoetin (DP) work?

Darbepoetin alfa is an erythropoiesis-stimulating agent that binds to the erythropoietin receptor to stimulate red blood cell production.

What is Darbepoetin (DP) used for?

Darbepoetin (DP) is indicated for Anemia associated with chronic kidney disease, Chemotherapy-induced anemia in cancer patients, Anemia in patients with non-myeloid malignancies.

Who makes Darbepoetin (DP)?

Darbepoetin (DP) is developed by Fundacion Clinic per a la Recerca Biomédica (see full Fundacion Clinic per a la Recerca Biomédica pipeline at /company/fundacion-clinic-per-a-la-recerca-biom-dica).

What drug class is Darbepoetin (DP) in?

Darbepoetin (DP) belongs to the Erythropoiesis-stimulating agent (ESA) class. See all Erythropoiesis-stimulating agent (ESA) drugs at /class/erythropoiesis-stimulating-agent-esa.

What development phase is Darbepoetin (DP) in?

Darbepoetin (DP) is in Phase 3.

What are the side effects of Darbepoetin (DP)?

Common side effects of Darbepoetin (DP) include Hypertension, Thrombotic events (DVT, PE, stroke), Headache, Injection site pain, Flu-like symptoms.

What does Darbepoetin (DP) target?

Darbepoetin (DP) targets Erythropoietin receptor (EPOR) and is a Erythropoiesis-stimulating agent (ESA).

Drug class: All Erythropoiesis-stimulating agent (ESA) drugs
Target: All drugs targeting Erythropoietin receptor (EPOR)
Manufacturer: Fundacion Clinic per a la Recerca Biomédica — 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
Indication: Drugs for Anemia in patients with non-myeloid malignancies

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing