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Ustekinumab IV
Ustekinumab is a monoclonal antibody that blocks the IL-12 and IL-23 cytokines, which are key drivers of immune-mediated inflammatory responses.
Ustekinumab is a monoclonal antibody that blocks the IL-12 and IL-23 cytokines, which are key drivers of immune-mediated inflammatory responses. Used for Moderate to severe plaque psoriasis, Psoriatic arthritis, Crohn's disease.
At a glance
| Generic name | Ustekinumab IV |
|---|---|
| Also known as | STELARA |
| Sponsor | Janssen Research & Development, LLC |
| Drug class | IL-12/IL-23 inhibitor (monoclonal antibody) |
| Target | IL-12 p40 subunit / IL-23 p40 subunit |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | Phase 3 |
Mechanism of action
Ustekinumab binds to the p40 subunit shared by IL-12 and IL-23, preventing these cytokines from activating T cells and other immune cells that drive inflammation. By inhibiting these pathways, it reduces pathogenic Th1 and Th17 cell responses implicated in autoimmune and inflammatory diseases. This mechanism has proven effective in conditions like psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis.
Approved indications
- Moderate to severe plaque psoriasis
- Psoriatic arthritis
- Crohn's disease
- Ulcerative colitis
Common side effects
- Nasopharyngitis
- Upper respiratory tract infection
- Headache
- Fatigue
- Injection site reactions
Key clinical trials
- A Study of Vedolizumab Intravenous (IV) and Adalimumab or Vedolizumab and Ustekinumab in Adults With Crohn's Disease (PHASE4)
- A Study to Evaluate the Efficacy of Guselkumab in Chinese Participants With Crohn's Disease (CD) (PHASE4)
- A Study of the Efficacy and Safety of Guselkumab in Participants With Moderately to Severely Active Crohn's Disease (PHASE2, PHASE3)
- Guselkumab Vs Ustekinumab in Stricturing Crohn's Disease
- Efficacy of Ustekinumab Therapy in Patients With Symptomatic Stricturing Crohn's Disease
- Ustekinumab for the Prevention of Acute Graft-versus-Host Disease After Unrelated Donor Hematopoietic Cell Transplant (PHASE2)
- A Long-term Extension Study of Mirikizumab (LY3074828) in Participants With Crohn's Disease (PHASE3)
- A Study of Ustekinumab in Pediatric Participants With Moderately to Severely Active Crohn's Disease (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |