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Stelara (ustekinumab) — Competitive Intelligence Brief
phase 3
IL-12/IL-23 inhibitor (monoclonal antibody)
IL-12 p40 subunit / IL-23 p40 subunit
Immunology
Biologic
Live · refreshed every 30 min
Target snapshot
Stelara (ustekinumab) (Stelara (ustekinumab)) — National Institute of Allergy and Infectious Diseases (NIAID). Ustekinumab is a monoclonal antibody that blocks the IL-12 and IL-23 cytokines, which are key drivers of inflammatory and autoimmune responses.
Comparator set (3 drugs)
| Drug | Generic | Sponsor | Phase | Class | Target | Approval / PDUFA |
|---|---|---|---|---|---|---|
| Stelara (ustekinumab) TARGET | Stelara (ustekinumab) | National Institute of Allergy and Infectious Diseases (NIAID) | phase 3 | IL-12/IL-23 inhibitor (monoclonal antibody) | IL-12 p40 subunit / IL-23 p40 subunit | |
| Stelara (EU-sourced) | Stelara (EU-sourced) | Bio-Thera Solutions | phase 3 | IL-12/IL-23 inhibitor (monoclonal antibody) | IL-12 p40 subunit / IL-23 p40 subunit | |
| Ustekinumab IV | Ustekinumab IV | Janssen Research & Development, LLC | phase 3 | IL-12/IL-23 inhibitor (monoclonal antibody) | IL-12 p40 subunit / IL-23 p40 subunit | |
| Ustekinumab Injection | Ustekinumab Injection | National Medical Research Center for Children's Health, Russian Federation | marketed | IL-12/IL-23 inhibitor (monoclonal antibody) | IL-12/IL-23 p40 subunit |
Recent regulatory actions (last 90 days)
Upcoming PDUFA dates (next 180 days)
Patent timeline (forward window)
Sponsor landscape (IL-12/IL-23 inhibitor (monoclonal antibody) class)
- Bio-Thera Solutions · 1 drug in this class
- Janssen Research & Development, LLC · 1 drug in this class
- National Institute of Allergy and Infectious Diseases (NIAID) · 1 drug in this class
- National Medical Research Center for Children's Health, Russian Federation · 1 drug in this class
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Cite this brief
Drug Landscape (2026). Stelara (ustekinumab) — Competitive Intelligence Brief. https://druglandscape.com/ci/stelara-ustekinumab. Accessed 2026-05-14.
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