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darbepoetin alfa

Trade name: aranesp

Recombinant proteinapproved

Approved

Sep 17, 2001

Darbepoetin alfa (INN) is a re-engineered form of erythropoietin containing 5 amino acid changes resulting in the creation of 2 new sites for N-linked carbohydrate addition. It has a 3-fold longer serum half-life compared to epoetin alpha and epoetin beta. It stimulates erythropoiesis by the same mechanism as rHuEpo and is used to treat anemia, commonly associated with chronic kidney failure and cancer chemotherapy. Darbepoetin is marketed by Amgen under the trade name Aranesp. — Wikipedia

Clinical trial activity

194 trials · 124 clinical orgs · 1 marketing orgs

Phase 1
19
Phase 2
141
Phase 3
88
Phase 4
22

Earliest trial started Jul 1, 1999 (NCT00540384)

Timeline

1990s

  1. Jan 1, 1999

    Amgen — Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 1999

    Amgen — Earliest Phase 3 Sponsor(trial)

2000s

  1. Jan 1, 2000

    Amgen — Earliest Phase 2 Sponsor(trial)

  2. Sep 17, 2001

    Amgen — Earliest FDA Approval

  3. Sep 17, 2001

    Amgen — Marketing Organization

  4. Sep 17, 2001

    Amgen — NDA Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedSep 17, 2001

Chemistry & pharmacology

Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Parenteral
Availability
Prescription Only
Multi-specific
No

Oral

No

Parenteral

Yes

Topical

No

Black box warning

Sources

Also known as

  • aranesp
  • aranesp
  • aranesp
  • aranesp
  • aranesp sureclick
  • cj-40001
  • darbepoetin
  • darbepoetin
  • darbepoetin alfa
  • darbepoetin alfa
  • darbepoetin alfa
  • darbepoetin alfa
  • darbepoetin alfa
  • darbepoetin alfa
  • darbepoetin alfa
  • darbepoetin alfa
  • darbepoetin alfa
  • darbepoetin alfa,recombinant
  • darbepoietin
  • darbepoietin alpha
  • darbopoetin
  • krn321
  • mk2578
  • nesp
  • nesp
  • pegylated darbepoetin beta

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07300111Phase 3Dec 31, 2025Qilu Pharmaceutical Co., Ltd.
NCT07096297Phase 2Nov 30, 2025Bristol-Myers Squibb, Yale University
NCT07169643Phase 3Nov 25, 2025Institut d'Investigacions Biomèdiques August Pi i Sunyer, University of Barcelona
NCT07002827N/AMay 30, 2025Institute of Liver and Biliary Sciences, India
NCT06636877Phase 1Oct 23, 2024Boryung Pharmaceutical Company
NCT06220773Phase 3May 21, 2024Boryung Pharmaceutical Company
NCT06226727Phase 1Feb 14, 2024Boryung Pharmaceutical Company
NCT06466785Phase 3Jan 25, 2024Genexine, Inc.
NCT05810311Phase 2Jan 1, 2024County of Stockholm
NCT05864261Phase 4May 15, 2023Peking University
NCT05875259Phase 1May 13, 2023Boryung Pharmaceutical Company
NCT05768997Phase 3Mar 1, 2023Hallym University
NCT05340465Phase 2Oct 10, 2022National Institutes of Health (NIH), University of Washington
NCT04798339Phase 1/Phase 2 (Phase 2)Mar 30, 2021Novartis, University of South Florida
NCT04680143Phase 1/Phase 2 (Phase 2)Sep 1, 2020Alexandria University
NCT04432662Phase 2Sep 1, 2020Imperial College London
NCT04313153Phase 3Apr 30, 2020Akebia Therapeutics, Otsuka
NCT04343170N/AApr 4, 2020Tanta University
NCT07025460Phase 4Dec 19, 2019Yonsei University
NCT04012957Phase 3Jul 20, 2019Cadila Healthcare
Showing 20 of 194 trials
Page 1 / 10

Organizations

Research & Development (124)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
AmgenFor profit766451999
RocheFor profit121132004
Akebia TherapeuticsFor profit7722015
National Cancer Institute (NCI)Government6132003
Seoul National UniversityAcademic/Hospital6332007
BayerFor profit5522014
AstellasFor profit4422013
BiocadFor profit4422013
Boryung Pharmaceutical CompanyFor profit4422023
Chong Kun Dang PharmaceuticalFor profit4422012
GlaxoSmithKlineFor profit4422016
FibroGenFor profit3012014
Kyowa Hakko KirinFor profit3322006
University of New MexicoAcademic/Hospital3222006
University of TorontoAcademic/Hospital3132005
AffymaxFor profit2212007
Barts & The London NHS TrustAcademic/Hospital2212004
Bristol-Myers SquibbFor profit2022002
Genexine, Inc.For profit2222014
Harvard UniversityAcademic/Hospital2222003
124 organizations
Page 1 / 7

Marketing (2)

OrganizationOrg typeRelationshipDate
AmgenFor profitMKTGSep 17, 2001
AmgenFor profitNDASep 17, 2001