Wednesday, July 8, 2026

Drug profile · INN

darbepoetin alfa

darbepoetin alfa (ARANESP) is a erythropoietin receptor agonist. Associated with Amgen. Route of administration: subcutaneous. Current US regulatory status: approved.

FDA: approved EMA: approved TGA: approved Blood and blood forming organs (B03) B03XA02
US status approved
Patents linked 0
Pipeline programs 4
News articles 0
Drug details — darbepoetin alfa
US status
approved
Class
Blood and blood forming organs (B03)
Route
SUBCUTANEOUS
Patents
0
Programs
4
Data quality
0.84

Quick answer

darbepoetin alfa (ARANESP) is a erythropoietin receptor agonist. Associated with Amgen. Route of administration: subcutaneous. Current US regulatory status: approved.

Key facts

INN darbepoetin alfa
Brand ARANESP
Mechanism Erythropoietin receptor agonist
Target Erythropoietin receptor
Therapeutic class Blood and blood forming organs (B03)
Route SUBCUTANEOUS
Formulation VIAL
ATC code B03XA02
Originator Amgen

Mechanism of action

Erythropoietin receptor agonist

Primary target: Erythropoietin receptor

Approval history

Authority Status Date
FDA approved
EMA approved
TGA approved

Pipeline programs

  1. Darbepoetin alfa Phase 3 · Amgen · Non-Small Cell Lung Cancer
  2. Epoetin Phase 3 · Takeda · Chronic Kidney Disease
  3. 16-739 Phase 2 · Disc Medicine · Perinatal Arterial Ischemic Stroke (PAIS)
  4. DARBEPOETIN ALFA Approved · George Institute for · hepatic trasplant

Related & competitor drugs

  1. apixaban Blood and blood forming organs (B01)
  2. berotralstat Blood and blood forming organs (B06)
  3. bivalirudin Blood and blood forming organs (B01)
  4. c1 inhibitor (human) Blood and blood forming organs (B06)
  5. clopidogrel Blood and blood forming organs (B01)
  6. dabigatran etexilate Blood and blood forming organs (B01)

Frequently asked questions

What is darbepoetin alfa?

darbepoetin alfa (ARANESP) is a erythropoietin receptor agonist. Associated with Amgen. Route of administration: subcutaneous. Current US regulatory status: approved.

What is the brand name for darbepoetin alfa?

ARANESP is a marketed brand name for darbepoetin alfa. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of darbepoetin alfa?

darbepoetin alfa has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.