Ustekinumab: clinical trials recruiting now
FDA drug label
- FDA-approved
- Yes. Ustekinumab appears in the FDA drug-label database. Marketed as ustekinumab.
- Drug class
- Interleukin-12 Antagonist; Interleukin-23 Antagonist (FDA established pharmacologic class)
- Mechanism of action
- Interleukin-12 Antagonists; Interleukin-23 Antagonists (as stated on the FDA label)
FDA-approved use
Ustekinumab is a human interleukin-12 and -23 antagonist indicated for the treatment of: Moderate to severe plaque psoriasis in adult and pediatric patients 6 years of age and older who are candidates for phototherapy or systemic therapy. ( 1.1 ) Active psoriatic arthritis in adults and pediatric patients 6 years of age and older. ( 1.2 ) Moderately to severely active Crohn's disease in adult and pediatric patients 2 years of age and older. ( 1.3 ) Moderately to severely active ulcerative colitis in adult patients. ( 1.4 ) 1.1 Plaque Psoriasis (PsO) Ustekinumab is indicated for the treatment of adults and pediatric patients 6 years of age and older with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy. 1.2 Psoriatic Arthritis (PsA) Ustekinumab is indicated for the treatment of adults and pediatric patients 6 years of age and older with active psoriatic arthritis. 1.3 Crohn's Disease (CD) Ustekinumab is indicated for the treatment of adults and pediatric patients 2 years of age and older with moderately to severely active Crohn's disease. 1.4 Ulcerative Colitis (UC) Ustekinumab is indicated for the treatment of adult patients with moderatel…
FDA recalls / enforcement
| Reason (FDA) | Classification | Status | Initiated |
|---|---|---|---|
| Lack of assurance of Sterility: — ACCORD BIOPHARMA INC | Class II (FDA: may cause temporary or reversible harm) | Ongoing | 2026-06-10 |
Phase breakdown
Conditions being studied
Recruiting trials involving Ustekinumab
- A Study of Vedolizumab Intravenous (IV) and Adalimumab or Vedolizumab and Ustekinumab in Adults With Crohn's Disease
- A Study to Assess the Long-Term Safety of Ustekinumab Versus Other Biologics in Patients With Crohn's Disease and Ulcerative Colitis
- An Open-Label, Proof of Consent Study of Vorinostat for the Treatment of Mdoerate-to-Severe Crohn s Disease and Maintenance Therapy With Ustekinumab
- Comparison of Ustekinumab, Infliximab and Combination Therapy in Moderately to Severely Active Ulcerative Colitis
- Development of Predictive Psoriasis Response Endotypes Using Single Cell Transcriptomics
- Efficacy and Safety of Dual-targeted Therapy With Upadacitinib and Ustekinumab Versus Intensified Ustekinumab Therapy in Crohn's Disease
- Efficacy of Ustekinumab Therapy in Patients With Symptomatic Stricturing Crohn's Disease
- Immunosuppressant Management in Rheumatology Patients Undergoing Elective Total Shoulder Arthroplasty
- Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)
- Quantitative Fluorescence Molecular Imaging of Ustekinumab-800CW to Elucidate the Drug Distribution Throughout Inflamed Tissue in Crohn's Disease and Psoriasis.
- Stelara and Tremfya Pregnancy Exposure Registry OTIS Autoimmune Diseases in Pregnancy Project
- Swiss Dermatology Network of Targeted Therapies (SDNTT)
Common questions
Is Ustekinumab FDA-approved?
Yes, marketed as ustekinumab.
How many recruiting trials involve Ustekinumab?
12 recruiting trials across 14 conditions.
Is this list of trials complete?
No. For the full record, search ClinicalTrials.gov.