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Ustekinumab Injection
Ustekinumab Injection is a IL-12/IL-23 inhibitor (monoclonal antibody) Small molecule drug developed by National Medical Research Center for Children's Health, Russian Federation. It is currently FDA-approved for Plaque psoriasis, Psoriatic arthritis, Ankylosing spondylitis.
Ustekinumab is a monoclonal antibody that blocks the IL-12 and IL-23 cytokines, reducing inflammatory immune responses.
Ustekinumab is an interleukin-12 inhibitor, classified as an antibody inhibitor, used to treat various conditions including Crohn's disease, arthritis, and ulcerative colitis. It is marketed under the brand name Stelara and is administered via injection.
At a glance
| Generic name | Ustekinumab Injection |
|---|---|
| Sponsor | National Medical Research Center for Children's Health, Russian Federation |
| Drug class | IL-12/IL-23 inhibitor (monoclonal antibody) |
| Target | IL-12/IL-23 p40 subunit |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | FDA-approved |
Mechanism of action
Ustekinumab binds to the p40 subunit shared by IL-12 and IL-23, preventing these interleukins from activating T cells and other immune cells that drive chronic inflammatory diseases. By inhibiting these key cytokines, it suppresses the Th1 and Th17 pathways involved in autoimmune and inflammatory conditions.
Approved indications
- Plaque psoriasis
- Psoriatic arthritis
- Ankylosing spondylitis
- Crohn's disease
- Ulcerative colitis
Common side effects
- Nasopharyngitis
- Upper respiratory tract infection
- Headache
- Fatigue
- Injection site reactions
Key clinical trials
- A Long-term Extension Study of Ustekinumab in Pediatric Participants (PHASE3)
- 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)
- A Study of Ustekinumab or Guselkumab in Pediatric Participants With Active Juvenile Psoriatic Arthritis (PHASE3)
- A Study to Evaluate the Efficacy and Safety of Bimekizumab Compared to Ustekinumab in Children and Adolescents From 6 Years to Less Than 18 Years of Age With Moderate to Severe Plaque Psoriasis (PHASE3)
- A Study of Ustekinumab in Pediatric Participants With Moderately to Severely Active Crohn's Disease (PHASE3)
- A Study of Ustekinumab (STELARA) in Chinese Participants With Moderately to Severely Active Crohn's Disease (PHASE4)
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 Injection CI brief — competitive landscape report
- Ustekinumab Injection updates RSS · CI watch RSS
- National Medical Research Center for Children's Health, Russian Federation portfolio CI
Frequently asked questions about Ustekinumab Injection
What is Ustekinumab Injection?
How does Ustekinumab Injection work?
What is Ustekinumab Injection used for?
Who makes Ustekinumab Injection?
What drug class is Ustekinumab Injection in?
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What are the side effects of Ustekinumab Injection?
What does Ustekinumab Injection target?
Related
- Drug class: All IL-12/IL-23 inhibitor (monoclonal antibody) drugs
- Target: All drugs targeting IL-12/IL-23 p40 subunit
- Manufacturer: National Medical Research Center for Children's Health, Russian Federation — full pipeline
- Therapeutic area: All drugs in Immunology
- Indication: Drugs for Plaque psoriasis
- Indication: Drugs for Psoriatic arthritis
- Indication: Drugs for Ankylosing spondylitis
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing