ustekinumab

Trade name: stelara

mAbapproved

Approved

Sep 25, 2009

Ustekinumab, sold under the brand name Stelara among others, is a monoclonal antibody medication used for the treatment of Crohn's disease, ulcerative colitis, plaque psoriasis and psoriatic arthritis, targeting both IL-12 and IL-23. It is administered either by intravenous infusion or subcutaneous injection. The antibody targets a subunit of human interleukin 12 and interleukin 23, which are naturally occurring proteins that regulate the immune system and immune-mediated inflammatory disorders. Ustekinumab is a fully human IgG1κ monoclonal antibody that binds to the p40 subunit of interleukin 12 and 23, thereby preventing them from binding to the IL 12Rβ1 receptor expressed on the surface of immune cells. By doing so, ustekinumab prevents the activation of the Th1 and Th17 cytokine pathways, which are central to the pathology of plaque psoriasis, psoriatic arthritis and Crohn's disease. Ustekinumab was developed by Centocor Ortho Biotech. — Wikipedia

Clinical trial activity

155 trials · 89 clinical orgs · 8 marketing orgs

Phase 1
26
Phase 2
106
Phase 3
69
Phase 4
19

Earliest trial started Nov 1, 2003 (NCT00320216)

Timeline

2000s

  1. Jan 1, 2003

    Earliest Phase 2 Sponsor(trial)

  2. Jan 1, 2005

    Earliest Phase 3 Sponsor(trial)

  3. Jan 1, 2009

    Earliest Phase 1 Sponsor(trial)

  4. Sep 25, 2009

    Johnson and Johnson — Earliest FDA Approval

  5. Sep 25, 2009

    Johnson and Johnson — Marketing Organization

  6. Sep 25, 2009

    Johnson and Johnson — NDA Organization

2020s

  1. Apr 16, 2024

    Alvotech — Marketing Organization

  2. Jun 28, 2024

    Samsung — Marketing Organization

  3. Sep 27, 2024

    Fresenius — Marketing Organization

  4. Oct 10, 2024

    Accord Research — Marketing Organization

  5. Nov 29, 2024

    Biocon Limited — Marketing Organization

  6. Dec 17, 2024

    Celltrion — Marketing Organization

  7. May 22, 2025

    Biothera — Marketing Organization

Indications

Mechanism of action

Approval history

  • approvedSep 25, 2009

Chemistry & pharmacology

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

Oral

No

Parenteral

Yes

Topical

No

First in class

Sources

Also known as

  • cnto 1275
  • cnto 1275
  • cnto-1275
  • cnto-1275
  • jnj-26113100
  • stelara
  • stelara
  • stelara
  • stelara
  • stelara
  • stelera
  • stelera
  • tt-20
  • ustekinumab
  • ustekinumab
  • ustekinumab
  • ustekinumab
  • ustekinumab
  • ustekinumab
  • ustekinumab
  • ustekinumab
  • ustekinumab
  • ustekinumab
  • ustekinumab

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07268534Phase 2Apr 1, 2026Assistance Publique - Hôpitaux de Paris
NCT07177118Phase 3Oct 20, 2025Wenzhou Medical University
NCT07303686Phase 4Oct 8, 2025Janssen Pharmaceutica NV, McGill University
NCT07138898Phase 2Sep 30, 2025New York University
NCT07116967Phase 3Sep 22, 2025Bristol-Myers Squibb
NCT07149467Phase 3Sep 10, 2025Sun Yat-Sen University
NCT06788340Phase 4Sep 1, 2025University of Southern Denmark
NCT06807593N/AJun 30, 2025University of Texas at Houston
NCT06951828Phase 1May 30, 2025Celltrion
NCT06934226Phase 3Apr 15, 2025
NCT06878404Phase 3Feb 21, 2025
NCT06742606Early Phase 1 (Phase 1)Jan 15, 2025Ain Shams University
NCT06738277Phase 1Jan 14, 2025Biocon Limited
NCT06912815N/AAug 1, 2024Sun Yat-Sen University
NCT06453317Phase 2Jul 31, 2024Government of Poland, K. Marcinkowski University of Medical Sciences, Medical University of Lodz, Poznan University
NCT06520397Phase 4Jul 15, 2024Sun Yat-Sen University
NCT06425549Phase 3Jun 25, 2024UCB
NCT06290934Phase 2Mar 27, 2024Gilead Sciences
NCT06045754Phase 4Jan 16, 2024Takeda
NCT05928039Phase 4Oct 25, 2023Robarts Clinical Trials, University of Calgary
Showing 20 of 155 trials
Page 1 / 8

Organizations

Research & Development (89)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Johnson and JohnsonFor profit312942007
Janssen Pharmaceutica NVFor profit261352008
CentocorFor profit131242003
AbbVieFor profit4412016
AmgenFor profit4412012
Boehringer IngelheimFor profit4222014
Bristol-Myers SquibbFor profit3332016
CelltrionFor profit3322020
National Institute of Allergy and Infectious Diseases (NIAID)Government3312014
NovartisFor profit3312014
Sun Yat-Sen UniversityAcademic/Hospital3332024
AlvotechFor profit2222021
AO GENERIUMFor profit2222022
Assistance Publique - Hôpitaux de ParisAcademic/Hospital2212018
Belgian Inflammatory Bowel Disease Research and Development (BIRD) VZWAcademic/Hospital2212020
Biocon LimitedFor profit2222022
BiotheraFor profit2222020
Eli LillyFor profit2212015
Juvenile Diabetes Research FoundationAcademic/Hospital2022015
Katholieke Universiteit LeuvenAcademic/Hospital2222018
89 organizations
Page 1 / 5

Marketing (10)

OrganizationOrg typeRelationshipDate
Accord ResearchFor profitMKTGOct 10, 2024
AlvotechFor profitMKTGApr 16, 2024
Biocon LimitedFor profitMKTGNov 29, 2024
BiotheraFor profitMKTGMay 22, 2025
CelltrionFor profitMKTGDec 17, 2024
FreseniusFor profitMKTGSep 27, 2024
Johnson and JohnsonFor profitMKTGSep 25, 2009
Johnson and JohnsonFor profitSYNSep 23, 2016
Johnson and JohnsonFor profitNDASep 25, 2009
SamsungFor profitMKTGJun 28, 2024