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etanercept

Trade name: enbrel

Recombinant proteinapprovedOrphan Drug FDA

Approved

Nov 2, 1998

Etanercept, sold under the brand name Enbrel among others, is a biologic medical product that is used to treat autoimmune diseases by interfering with tumor necrosis factor (TNF), a soluble inflammatory cytokine, by acting as a TNF inhibitor. It has US Food and Drug Administration (FDA) approval to treat rheumatoid arthritis, juvenile idiopathic arthritis and psoriatic arthritis, plaque psoriasis and ankylosing spondylitis. Tumor necrosis factor alpha (TNFα) is the "master regulator" of the inflammatory (immune) response in many organ systems. Autoimmune diseases are caused by an overactive immune response. Etanercept has the potential to treat these diseases by inhibiting TNF-alpha. — Wikipedia

Clinical trial activity

341 trials · 265 clinical orgs · 4 marketing orgs

Phase 1
51
Phase 2
155
Phase 3
97
Phase 4
114

Earliest trial started Apr 1, 1997 (NCT00357903)

Timeline

1990s

  1. Jan 1, 1997

    Earliest Phase 2 Sponsor(trial)

  2. Jan 1, 1997

    Earliest Phase 3 Sponsor(trial)

  3. Oct 27, 1998

    Orphan Drug Designation

  4. Nov 2, 1998

    Immunex — Earliest FDA Approval

  5. Nov 2, 1998

    Immunex — Marketing Organization

  6. Nov 2, 1998

    Immunex — NDA Organization

2000s

  1. Jan 1, 2000

    Earliest Phase 1 Sponsor(trial)

2010s

  1. Aug 30, 2016

    Sandoz — Marketing Organization

  2. Aug 30, 2016

    Novartis — NDA Secondary Org

  3. Apr 25, 2019

    Samsung — Marketing Organization

  4. Apr 25, 2019

    Samsung — NDA Secondary Org

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedNov 2, 1998

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

  • benepali
  • cd120b
  • enbrel
  • enbrel
  • enbrel
  • enbrel
  • entanercept
  • erelzi
  • etanercept
  • etanercept
  • etanercept
  • etanercept
  • etanercept
  • etanercept
  • etanercept
  • etanercept
  • etanercept (genetical recombination)
  • etanercept-szzs
  • etanercept-szzs
  • etanercept-szzs
  • etanercept-szzs
  • etanercept-szzs
  • etanercept-szzs
  • hitanercept
  • l04ab01
  • p75
  • p75
  • p80 tnf-alpha receptor
  • rhu tnfr:fc
  • tnf-r2
  • tnfr:fc
  • tnfr-immunoadhesin
  • tnr 001
  • tnr-001
  • tumor necrosis factor receptor 2
  • tumor necrosis factor receptor superfamily member 1b precursor
  • tumor necrosis factor receptor type ii

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07138898Phase 2Sep 30, 2025New York University
NCT07184853N/ASep 25, 2025Huazhong University of Science and Technology, Jiao Tong University, Zhejiang University, Zhengzhou University
NCT06585384Phase 1Mar 31, 2025Adolphe Rothschild Ophtalmologic Foundation
NCT06707194Phase 4Mar 1, 2025Southern Medical University
NCT06596772Phase 3Sep 11, 2024Insud Pharma
NCT06392074Phase 1Mar 7, 2024Insud Pharma
NCT06011889Phase 2/Phase 3 (Phase 3)Dec 13, 2023Government of Poland
NCT05950724Early Phase 1 (Phase 1)Sep 17, 2023Northwestern University
NCT05925166N/ASep 1, 2023Jiangxi Provincial People's Hospital
NCT04585711Phase 1Jul 31, 2023Duke University, National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
NCT05305066N/AJan 31, 2023McGill University, Technion University
NCT05281614Early Phase 1 (Phase 1)Aug 1, 2022University of California, San Diego, Virginia Mason Medical Center
NCT05164198Phase 4Jan 15, 2022Hanyang University, Linical Co., Ltd.
NCT05115903Phase 4Nov 1, 2021University of Toronto
NCT04973566Phase 1Aug 31, 2021Janssen Pharmaceutica NV
NCT05135312Phase 4Aug 9, 2021Amgen, OptiSkin Medical
NCT04559412Phase 1Dec 31, 2020Sorrento Therapeutics, Inc.
NCT04610476Phase 3Oct 31, 2020University of Erlangen-Nuremberg
NCT04254627Phase 1Feb 28, 2020Nova Southeastern University, RTI International, University of Rochester
NCT04485325Phase 4Nov 4, 2019Fraunhofer, J. W. Goethe University, Pfizer
Showing 20 of 341 trials
Page 1 / 18

Organizations

Research & Development (265)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
AmgenFor profit724451997
PfizerFor profit585352000
WyethFor profit47052000
ImmunexFor profit14051997
Harvard UniversityAcademic/Hospital11952004
National Institute of Allergy and Infectious Diseases (NIAID)Government9941999
National Cancer Institute (NCI)Government8121999
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)Government8351999
University of MichiganAcademic/Hospital8632001
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Government6132004
Sun Yat-Sen UniversityAcademic/Hospital6522007
University of WashingtonAcademic/Hospital6621999
SamsungFor profit5442013
Seoul National UniversityAcademic/Hospital5012010
United States ArmyGovernment5032006
University of California, San FranciscoAcademic/Hospital5131999
University of LeedsAcademic/Hospital5522006
Department of Veteran AffairsGovernment4242007
Han Wha Pharma Co., Ltd.For profit4422010
InnovadermFor profit4422006
265 organizations
Page 1 / 14

Marketing (6)

OrganizationOrg typeRelationshipDate
ImmunexFor profitMKTGNov 2, 1998
ImmunexFor profitNDANov 2, 1998
NovartisFor profitNDA2Aug 30, 2016
SamsungFor profitMKTGApr 25, 2019
SamsungFor profitNDA2Apr 25, 2019
SandozFor profitMKTGAug 30, 2016