Treats moderate to severe plaque psoriasis. Sold as Stelara. Every FDA application for this active ingredient.
As of Nov 15, 2026, FDA lists 2 applications for Ustekinumab (sold as Stelara), first approved Sep 25, 2009, with 10 new uses approved and 0 published complete response letters.
| Stelara | Part D | $3.23B | -4% | 24,947 |
| Stelara (J3357) | Part B | $10.5M | -14% | 230 |
| Stelara (J3358) | Part B | $5.9M | -43% | 1,032 |
| Ustekinumab | Part D | $1.3M | New | 117 |
| Immune Aging and Advanced Therapy Outcomes in Older Adults With IBDInflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis), Frailty · First Affiliated Hospital, Sun Yat-Sen University | — | Not yet recruiting | Sep 18, 2026 |
| A Study of Guselkumab Given After Ustekinumab in Participants With Moderate to Severe Psoriasis in Routine Clinical PracticePsoriasis · Janssen-Cilag Kft. | — | Recruiting | Aug 5, 2026 |
| Comparison of the Efficacy of Different Biologic Agents in Preventing Postoperative Endoscopic Recurrence of Crohn's DiseaseInflamatory Bowel Disease, Crohn Disease (CD) · Shanghai 10th People's Hospital | — | Recruiting | Jul 10, 2026 |
| FirST Lines of Biologics in pAtients With ulceRaTivE Colitis: a Randomised Controlled TrialUlcerative Colitis (UC) · University Hospital, Clermont-Ferrand | Phase 4 | Not yet recruiting | May 8, 2026 |
| Digestive Evolution of Children With Crohn's Disease or Ulcerative Colitis Whose Anti-TNFα Treatment Was Switched to Ustekinumab Due to Paradoxical Psoriasis,Chronic Inflammatory Bowel Diseases · Centre Hospitalier Universitaire de Nice | Not applicable | Recruiting | Apr 14, 2026 |
| Efficacy of Different Biological Treatments in Patients With Inflammatory Bowel Disease After One Year of Treatment in Upper EgyptInflamatory Bowel Disease (Crohn's and Ulcerative Colitis) · Assiut University | — | Not yet recruiting | Mar 27, 2026 |
| A Prospective Observational Study on the Efficacy and Safety of Guselkumab in the Treatment of Crohn's Disease Patients Previously Treated With UstekinumabInflamatory Bowel Disease, Inflamatory Bowel Disease (Crohn's and Ulcerative Colitis) · Second Affiliated Hospital, Zhejiang University, School of Medicine | — | Recruiting | Mar 23, 2026 |
| Guselkumab Vs Ustekinumab in Stricturing Crohn's DiseaseCD - Crohn's Disease, Stricture; Bowel · Second Affiliated Hospital, Zhejiang University, School of Medicine | — | Recruiting | Mar 2, 2026 |
| Sep 25, 2009 | StelaraBLA 125261 · New molecular entity | Centocor Ortho Biotech Inc | 31 | Marketed |
| Sep 23, 2016 | StelaraBLA 761044 · New dosage form | Janssen Biotech | 15 | Marketed |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA
