BLAINJECTIONINJECTABLE
Approved
Sep 2009
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
4/8 — Partial
STELARA (ustekinumab) by Johnson & Johnson is interleukin-12 antagonists [moa]. First approved in 2009.
Drug data last refreshed 13h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
STELARA (ustekinumab) is a monoclonal antibody that antagonizes interleukin-12, a key cytokine driving immune-mediated inflammatory responses. It is administered via injection and treats multiple immune-mediated conditions by suppressing Th1 and Th17 cell differentiation. The drug represents a foundational biologic therapy in the immunology space with broad clinical applications.
LOE Approaching
As STELARA approaches loss of exclusivity with moderate competitive pressure (30/100), commercial teams are shifting focus to lifecycle extensions, line extensions, and biosimilar mitigation strategies rather than growth initiatives.
Mechanism of Action
Interleukin-12 Antagonists
Pharmacologic Class:
Interleukin-12 Antagonist
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
A Study of Guselkumab Given After Ustekinumab in Participants With Moderate to Severe Psoriasis in Routine Clinical Practice
Started Sep 2026
100 enrolled
Psoriasis
Treatment of Immune Checkpoint Inhibitor-related Diarrhea and/ or Colitis With Ustekinumab in Cancer Patients
Started Feb 2026
10 enrolled
Cancer
A Study of Guselkumab After Switching From Ustekinumab in Participants With Moderate to Severe Psoriasis
Started Feb 2026
9 enrolled
Psoriasis
Switching to the IL-23 Inhibitor Guselkumab for People With Active IBD Who Previously Used Ustekinumab (SHIFT-IBD)
Started Jan 2026
200 enrolled
Inflammatory Bowel Disease (IBD)Crohn Disease (CD)Ulcerative Colitis (UC)+1 more
De-escalation of Ustekinumab Therapy in Patients With Crohn's Disease and Ulcerative Colitis
Started Oct 2025
115 enrolled
Crohn Disease (CD)Ulcerative Colitis (UC)
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.