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Ustekinumab - Standard Dosage
Ustekinumab is a monoclonal antibody that targets and binds to the p40 subunit of interleukin-12 (IL-12) and interleukin-23 (IL-23), thereby inhibiting their activity and reducing inflammation.
Ustekinumab is a monoclonal antibody that targets and binds to the p40 subunit of interleukin-12 (IL-12) and interleukin-23 (IL-23), thereby inhibiting their activity and reducing inflammation. Used for Moderate to severe plaque psoriasis, Moderate to severe Crohn's disease, Active psoriatic arthritis.
At a glance
| Generic name | Ustekinumab - Standard Dosage |
|---|---|
| Sponsor | Humanitas Clinical and Research Center |
| Drug class | IL-12/23 inhibitor |
| Target | p40 subunit of IL-12 and IL-23 |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | Phase 3 |
Mechanism of action
By binding to the p40 subunit, ustekinumab prevents the formation of the IL-12 and IL-23 heterodimers, which are essential for the activation of T helper 1 (Th1) and Th17 cells. This leads to a decrease in the production of pro-inflammatory cytokines, such as interferon-gamma (IFN-γ) and interleukin-17 (IL-17), which are involved in the pathogenesis of various inflammatory and autoimmune diseases.
Approved indications
- Moderate to severe plaque psoriasis
- Moderate to severe Crohn's disease
- Active psoriatic arthritis
Common side effects
- Injection site reactions
- Headache
- Fatigue
- Nausea
- Diarrhea
Key clinical trials
- Guselkumab Vs Ustekinumab in Stricturing Crohn's Disease
- Efficacy and Safety of Dual-targeted Therapy With Upadacitinib and Ustekinumab Versus Intensified Ustekinumab Therapy in Crohn's Disease (PHASE4)
- Determination of the Optimal Treatment Target in Ulcerative Colitis (PHASE4)
- The Association Between TNFSF4 Polymorphism and CD
- A Study to Test Whether BI 706321 Combined With Ustekinumab Helps People With Crohn's Disease (PHASE2)
- Immunosuppressant Management in Rheumatology Patients Undergoing Elective Total Shoulder Arthroplasty (PHASE2)
- NAZA - Nottingham/Astra ZenecA Prospective IBD Cohort Study
- A Study to Evaluate Efficacy and Safety of Ustekinumab Re-induction Therapy in 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 |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Ustekinumab - Standard Dosage CI brief — competitive landscape report
- Ustekinumab - Standard Dosage updates RSS · CI watch RSS
- Humanitas Clinical and Research Center portfolio CI