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anakinra

Trade name: Kineret

Recombinant proteinapproved

Approved

Nov 14, 2001

Anakinra, sold under the brand name Kineret, is a biopharmaceutical medication used to treat rheumatoid arthritis, cryopyrin-associated periodic syndromes, familial Mediterranean fever, and Still's disease. It is a slightly modified recombinant version of the human interleukin 1 receptor antagonist protein. It is marketed by Swedish Orphan Biovitrum. Anakinra is administered by subcutaneous injection. — Wikipedia

Clinical trial activity

162 trials · 150 clinical orgs · 3 marketing orgs

Phase 1
43
Phase 2
103
Phase 3
36
Phase 4
8

Earliest trial started Jul 1, 2000 (NCT00037648)

Timeline

2000s

  1. Jan 1, 2000

    Amgen — Earliest Phase 2 Sponsor(trial)

  2. Nov 14, 2001

    Amgen — Earliest FDA Approval

  3. Nov 14, 2001

    Amgen — NDA Organization

  4. Nov 14, 2001

    Biovitrum AB — Marketing Organization

  5. Nov 14, 2001

    Swedish Orphan Biovitrum — NDA Secondary Org

  6. Jan 1, 2003

    Earliest Phase 1 Sponsor(trial)

  7. Jan 1, 2005

    Amgen — Earliest Phase 3 Sponsor(trial)

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedNov 14, 2001

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

  • anakinra
  • anakinra
  • anakinra
  • anakinra
  • anakinra
  • anakinra
  • anakinra
  • anakinra
  • anakinra
  • anakinra
  • antril
  • hl2351
  • icil-1ra
  • il1 inhibitor
  • il-1ra
  • il-1ra
  • il-1rn
  • interleukin-1 receptor antagonist protein precursor
  • irap
  • kineret
  • kineret
  • kineret

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07281027Phase 3Mar 1, 2026Patient-Centered Outcomes Research Institute, Yale University
NCT07138898Phase 2Sep 30, 2025New York University
NCT07254000Phase 2Jun 27, 2025Hudson Institute of Medical Research, Monash University
NCT06697431Phase 4Apr 1, 2025Meyer Children's Hospital IRCCS, University of Trieste
NCT06703216Phase 1/Phase 2 (Phase 2)Dec 1, 2024National Center for Advancing Translational Science (NCATS), Northwestern University
NCT06710197Phase 2Nov 30, 2024University of Toronto
NCT06624436Phase 4Oct 31, 2024Radboud University
NCT06666335Phase 4Oct 30, 2024Swedish Orphan Biovitrum, Tigermed Consulting Co., Ltd
NCT06336733Phase 3Mar 31, 2024Assistance Publique - Hôpitaux de Paris
NCT06062966Phase 1Jan 15, 2024Virginia Commonwealth University
NCT05926505Phase 2/Phase 3 (Phase 3)Sep 6, 2023Hellenic Institute for the Study of Sepsis
NCT05854251Phase 2Jun 15, 2023University of Basel
NCT05805930Phase 3Jun 1, 2023University of Genoa
NCT05914454Phase 2May 19, 2023University of Udine
NCT05785442Phase 2Mar 6, 2023Hellenic Institute for the Study of Sepsis
NCT05611710Phase 2Dec 31, 2022Tropical Diseases Hospital, Ho Chi Minh City, University of Oxford
NCT05498467Phase 3Sep 1, 2022University of Copenhagen
NCT05814159Phase 3Aug 24, 2022CMIC Co, Ltd. Japan, Swedish Orphan Biovitrum
NCT05174507Phase 2Jun 24, 2022University of Basel
NCT05267821Phase 2/Phase 3 (Phase 3)Jun 14, 2022National Institutes of Health (NIH), Ohio State University
Showing 20 of 162 trials
Page 1 / 9

Organizations

Research & Development (150)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Virginia Commonwealth UniversityAcademic/Hospital151542008
Swedish Orphan BiovitrumFor profit13542015
Radboud UniversityAcademic/Hospital8842009
University of BaselAcademic/Hospital8542011
AmgenFor profit7732000
Hellenic Institute for the Study of SepsisAcademic/Hospital7722017
National Heart, Lung, and Blood Institute (NHLBI)Government7032014
Assistance Publique - Hôpitaux de ParisAcademic/Hospital5522018
National Cancer Institute (NCI)Government5222002
American Heart AssociationAcademic/Hospital4032010
Baylor UniversityAcademic/Hospital4422012
Harvard UniversityAcademic/Hospital4312008
National Institutes of Health (NIH)Government4032003
University of AthensAcademic/Hospital4222011
University of California, San DiegoAcademic/Hospital4432014
University of North Carolina at Chapel HillAcademic/Hospital4422011
University of ParisAcademic/Hospital4322006
National Institute for Health Research, United KingdomGovernment3022016
National Institute of Neurological Disorders and Stroke (NINDS)Government3222015
Northwell HealthAcademic/Hospital3312011
150 organizations
Page 1 / 8

Marketing (3)

OrganizationOrg typeRelationshipDate
AmgenFor profitNDANov 14, 2001
Biovitrum ABFor profitMKTGNov 14, 2001
Swedish Orphan BiovitrumFor profitNDA2Nov 14, 2001