CDEK
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canakinumab

Trade name: ilaris

mAbapprovedCOVID-19Orphan Drug FDA

Approved

Jun 17, 2009

Canakinumab, sold under the brand name Ilaris, is a medication for the treatment of systemic juvenile idiopathic arthritis, active Still's disease, including adult-onset Still's disease, gout flares. It is a human monoclonal antibody targeted at interleukin-1 beta. It has no cross-reactivity with other members of the interleukin-1 family, including interleukin-1 alpha. — Wikipedia

Clinical trial activity

106 trials · 51 clinical orgs · 1 marketing orgs

Phase 1
17
Phase 2
91
Phase 3
35
Phase 4
1

Earliest trial started Dec 1, 2003 (NCT00619905)

Timeline

2000s

  1. Jan 1, 2003

    Novartis — Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 2005

    Novartis — Earliest Phase 2 Sponsor(trial)

  3. Jan 1, 2007

    Novartis — Earliest Phase 3 Sponsor(trial)

  4. Dec 18, 2007

    Orphan Drug Designation

  5. Jun 17, 2009

    Novartis — Earliest FDA Approval

  6. Jun 17, 2009

    Novartis — Marketing Organization

  7. Jun 17, 2009

    Novartis — NDA Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedJun 17, 2009

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

  • acz885
  • acz885
  • acz885
  • acz885
  • acz-885
  • acz-885
  • acz-885
  • canakinumab
  • canakinumab
  • canakinumab
  • canakinumab
  • canakinumab
  • canakinumab
  • canakinumab
  • canakinumab
  • canakinumab
  • canakinumab
  • ilaris
  • ilaris
  • ilaris
  • ilaris
  • ilaris
  • immunoglobulin g1, anti-(human interleukin 1beta) (human clone acz885 heavy chain v region)

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07138898Phase 2Sep 30, 2025New York University
NCT06691217Phase 2Apr 1, 2025Broad Institute, Harvard University, National Institutes of Health (NIH), Yale University
NCT06497491Phase 3Dec 12, 2023AO GENERIUM
NCT06038526Phase 2Sep 30, 2023Ohio State University
NCT05984602Phase 1Jul 14, 2023New York University
NCT05401578Phase 3Feb 1, 2023University of Basel
NCT05641831Phase 2Jan 1, 2023Ohio State University
NCT05535738Phase 2/Phase 3 (Phase 3)Sep 15, 2022University of Massachusetts
NCT06481189Phase 1Sep 6, 2022AO GENERIUM
NCT05467800Phase 2Jul 31, 2022Icahn School of Medicine at Mount Sinai, Mount Sinai Hospital, Canada
NCT05237713Phase 2Apr 26, 2022Novartis, University of Leipzig
NCT05725343Phase 3Feb 3, 2022Mario Negri Institute, Novartis
NCT05080218Phase 4Oct 31, 2021AbbVie, Bristol-Myers Squibb, Eli Lilly, Foundation for Advancing Science Technology Education and Research, Illumination Health, Novartis, Pfizer, University of Alabama, Birmingham, University of Nebraska, University of Pennsylvania
NCT04795466Phase 2Oct 28, 2021Novartis
NCT04814368Phase 2Aug 27, 2021Novartis
NCT04789681Phase 2Jul 20, 2021University of Texas at Houston
NCT04810611Phase 1Jun 18, 2021Novartis
NCT04905316Phase 2May 21, 2021Memorial Sloan-Kettering Cancer Center, Novartis
NCT04717635Phase 3Mar 30, 2021Novartis
NCT04798339Phase 1/Phase 2 (Phase 2)Mar 30, 2021Novartis, University of South Florida
Showing 20 of 106 trials
Page 1 / 6

Organizations

Research & Development (51)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
NovartisFor profit847052003
Humboldt UniversityAcademic/Hospital3312010
University of BaselAcademic/Hospital3222013
AO GENERIUMFor profit2222022
New York UniversityAcademic/Hospital2222023
Ohio State UniversityAcademic/Hospital2212023
University of Texas at HoustonAcademic/Hospital2212020
University of ZurichAcademic/Hospital2212011
AbbVieFor profit1012021
Bilim UniversityAcademic/Hospital1012016
Bristol-Myers SquibbFor profit1012021
Broad InstituteAcademic/Hospital1012025
Children's National Medical CenterAcademic/Hospital1112019
Columbia UniversityAcademic/Hospital1112019
Eli LillyFor profit1012021
Foundation for Advancing Science Technology Education and ResearchAcademic/Hospital1112021
Foundation to Eradicate DuchenneAcademic/Hospital1012019
French National Agency for Research on AIDS and Viral HepatitisGovernment1112013
Government of the United KingdomGovernment1012006
Harvard UniversityAcademic/Hospital1112025
51 organizations
Page 1 / 3

Marketing (2)

OrganizationOrg typeRelationshipDate
NovartisFor profitMKTGJun 17, 2009
NovartisFor profitNDAJun 17, 2009