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Ustekinumab SC
Ustekinumab SC is a IL-12/IL-23 inhibitor monoclonal antibody Small molecule drug developed by Janssen Research & Development, LLC. It is currently in Phase 3 development for Plaque psoriasis, Psoriatic arthritis, Crohn's disease.
Ustekinumab is a monoclonal antibody that blocks the IL-12 and IL-23 cytokines, which are key drivers of immune-mediated inflammatory responses.
Ustekinumab SC is an interleukin-12 inhibitor, a type of antibody that belongs to the drug class of inhibitors. It is used to treat various conditions, including Crohn's disease, ulcerative colitis, moderate to severe plaque psoriasis, and systemic lupus erythematosus, among others.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Immunology slight uplift
+1.0pp
Mature endpoint landscape (ACR, DAS28, PASI) makes immunology approvals slightly more predictable. -
Big-pharma sponsor
+3.0pp
Janssen Research & Development, LLC is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Ustekinumab SC |
|---|---|
| Sponsor | Janssen Research & Development, LLC |
| Drug class | IL-12/IL-23 inhibitor monoclonal antibody |
| Target | IL-12/IL-23 p40 subunit |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | Phase 3 |
Mechanism of action
Ustekinumab binds to the p40 subunit shared by both IL-12 and IL-23, preventing these cytokines from activating T cells and other immune cells that drive chronic inflammation. By inhibiting these pathways, it reduces pathogenic Th1 and Th17 cell responses implicated in autoimmune and inflammatory diseases. This dual IL-12/IL-23 inhibition provides broad immunomodulatory effects across multiple inflammatory conditions.
Approved indications
- Plaque psoriasis
- Psoriatic arthritis
- Crohn's disease
- Ulcerative colitis
Common side effects
- Nasopharyngitis
- Upper respiratory tract infection
- Headache
- Injection site reactions
- Fatigue
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)
- 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)
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 SC CI brief — competitive landscape report
- Ustekinumab SC updates RSS · CI watch RSS
- Janssen Research & Development, LLC portfolio CI
Frequently asked questions about Ustekinumab SC
What is Ustekinumab SC?
How does Ustekinumab SC work?
What is Ustekinumab SC used for?
Who makes Ustekinumab SC?
What drug class is Ustekinumab SC in?
What development phase is Ustekinumab SC in?
What are the side effects of Ustekinumab SC?
What does Ustekinumab SC target?
Related
- Drug class: All IL-12/IL-23 inhibitor monoclonal antibody drugs
- Target: All drugs targeting IL-12/IL-23 p40 subunit
- Manufacturer: Janssen Research & Development, LLC — full pipeline
- Therapeutic area: All drugs in Immunology
- Indication: Drugs for Plaque psoriasis
- Indication: Drugs for Psoriatic arthritis
- Indication: Drugs for Crohn's disease
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing