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epoetin

Trade name: Epogen

Recombinant proteinapprovedOrphan Drug FDA

Approved

Jun 1, 1989

Erythropoietin, also known as erythropoetin, haematopoietin, or haemopoietin, is a glycoprotein cytokine secreted mainly by the kidneys in response to cellular hypoxia; it stimulates red blood cell production (erythropoiesis) in the bone marrow. Low levels of EPO are constantly secreted in sufficient quantities to compensate for normal red blood cell turnover. Common causes of cellular hypoxia resulting in elevated levels of EPO include any anemia, and hypoxemia due to chronic lung disease. — Wikipedia

Clinical trial activity

483 trials · 386 clinical orgs · 3 marketing orgs

Phase 1
66
Phase 2
304
Phase 3
166
Phase 4
67

Earliest trial started Jul 1, 1988 (NCT00270283)

Timeline

1980s

  1. Apr 10, 1986

    Orphan Drug Designation

  2. Jan 1, 1988

    Earliest Phase 2 Sponsor(trial)

  3. Jan 1, 1989

    Earliest Phase 3 Sponsor(trial)

  4. Jun 1, 1989

    Amgen — Earliest FDA Approval

  5. Jun 1, 1989

    Amgen — Marketing Organization

  6. Jun 1, 1989

    Amgen — NDA Secondary Org

  7. Jun 1, 1989

    Amgen — NDA Organization

1990s

  1. Jan 1, 1999

    Earliest Phase 1 Sponsor(trial)

2010s

  1. May 15, 2018

    Hospira — Marketing Organization

  2. May 15, 2018

    Pfizer — NDA Secondary Org

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedJun 1, 1989

Chemistry & pharmacology

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

Oral

No

Parenteral

Yes

Topical

No

Sources

Also known as

  • aphoelinebrake
  • binocrit
  • dynepo
  • dynepo (pending)
  • epiao
  • epo
  • epo
  • epo
  • e.p.o.
  • epo90
  • epoetin
  • epoetin
  • epoetina dseta
  • epoetin alfa
  • epoetin alfa
  • epoetin alfa
  • epoetin alfa
  • epoetin alfa
  • epoetin alfa
  • epoetin alfa
  • epoetin alfa
  • epoetin alfa
  • epoetin alfa-epbx
  • epoetin alfa (genetical recombination)
  • epoetin alfa rdna
  • epoetin alfa, recombinant
  • epoetin alpha
  • epoetin delta
  • epoetin delta
  • epoetin delta
  • epoetin epsilon
  • epoétine zêta
  • epoetin gamma
  • epoetin gamma rdna
  • epoetin kappa
  • epoetin omega
  • epoetin theta
  • epoetin theta
  • epoetin theta
  • epoetin theta
  • epoetinum zeta
  • epoetin zeta
  • epoetin zeta
  • epoetin zeta
  • epoetin zeta
  • epoetin zeta
  • epogen
  • epogen
  • epogen
  • epogen
  • epoietin
  • epoietin alpha
  • epoietin zeta
  • eporatio
  • eporatio
  • eprex
  • eprex
  • eprex
  • eptotermin alfa
  • eptotermin alfa
  • eptotermin alfa
  • eptotermin alfa
  • erythopoietin
  • erythropoetin
  • erythropoiesis stimulating factor
  • erythropoietin
  • erythropoietin
  • erythropoietin
  • erythropoietin
  • erythropoietin
  • erythropoietin
  • erythropoietin alfa
  • erythropoietin (human, recombinant)
  • erythropoietin (recombinant human)
  • erythropoietin zeta
  • esf
  • esf
  • ga-epo
  • gc1113
  • gx-e2
  • hmr-4396
  • human recombinant bone morphogenetic protein 7
  • osigraft
  • pegylated rhepo
  • procrit
  • procrit
  • procrit
  • recombinant erythropoietin alpha
  • recombinant erythropoietin stimulating protein
  • retacrit
  • rhbmp-7
  • rhepo
  • rhepo
  • sh-polypeptide-72
  • silapo
  • silapo
  • silapo
  • ub-851

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07296146Phase 3Dec 15, 2025Badr University
NCT07178678Phase 2Nov 30, 2025Centro Inmunologia Molecular (CIM), University of Saskatchewan
NCT07162090Phase 4Sep 10, 2025Tianjin Medical University
NCT06352138Phase 3Jul 31, 2025Megalabs
NCT06919861Phase 1Jun 30, 2025Epoch Biosciences
NCT06832189Phase 1Jun 1, 2025Icahn School of Medicine at Mount Sinai, National Institute of Allergy and Infectious Diseases (NIAID), University of California, San Francisco
NCT07150858N/AMay 25, 2025Alexandria University
NCT06968936N/AMay 15, 2025Chongqing Medical University, Nanjing Medical University, Wenzhou Medical University, Zhejiang University
NCT07025681Phase 3Apr 24, 2025Incepta Vaccine Limited, Institute for Developing Science and Health Initiatives, Bangladesh
NCT06854276Phase 2Mar 1, 2025Sunshine Lake Pharma Co., Ltd.
NCT06670963Phase 4Nov 30, 2024Silesian University of Medicine
NCT06665451N/ANov 30, 2024Al Azhar University
NCT06590155Early Phase 1 (Phase 1)Nov 24, 2024Assiut University
NCT06601400N/ASep 14, 2024Cairo University
NCT06490939Phase 1Aug 1, 2024Genexine, Inc.
NCT06923605Phase 4Jul 1, 2024Future University in Egypt
NCT06542393Phase 2Jun 1, 2024Federal University of Sao Paulo, Fundação de Amparo à Pesquisa do Estado de São Paulo
NCT06466785Phase 3Jan 25, 2024Genexine, Inc.
NCT06513039Phase 4Jan 1, 2024Ain Shams University
NCT06135259Phase 3Dec 20, 2023Ain Shams University
Showing 20 of 483 trials
Page 1 / 25

Organizations

Research & Development (386)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Johnson and JohnsonFor profit727051988
Ortho Biotech, Inc.For profit561251988
National Cancer Institute (NCI)Government19351997
RocheFor profit171432003
AmgenFor profit141451999
Janssen Pharmaceutica NVFor profit9031996
University of CopenhagenAcademic/Hospital9932008
FibroGenFor profit8622010
Zhejiang UniversityAcademic/Hospital8432011
GlaxoSmithKlineFor profit7722012
Ortho PharmaceuticalsFor profit7621999
SandozFor profit7722004
Seoul National UniversityAcademic/Hospital7432008
AzidusFor profit6622012
National Institutes of Health (NIH)Government6132001
Shahid Beheshti University of Medical SciencesAcademic/Hospital6442008
Sunshine Lake Pharma Co., Ltd.For profit6642014
Ain Shams UniversityAcademic/Hospital5532010
Cha Medical UniversityAcademic/Hospital5432010
Genexine, Inc.For profit5532014
386 organizations
Page 1 / 20

Marketing (5)

OrganizationOrg typeRelationshipDate
AmgenFor profitMKTGJun 1, 1989
AmgenFor profitNDA2Jun 1, 1989
AmgenFor profitNDAJun 1, 1989
HospiraFor profitMKTGMay 15, 2018
PfizerFor profitNDA2May 15, 2018