STEQEYMA (ustekinumab-stba)
STEQEYMA is a human interleukin-12 and -23 antagonist indicated for the treatment of: Adult patients with: moderate to severe plaque psoriasis (PsO) who are candidates for phototherapy or systemic therapy. active psoriatic arthritis (PsA) . moderately to severely active Crohn's disease (CD) . moderately to severely active ulcerative colitis. Pediatric patients 6 years and older with: moderate to severe plaque psoriasis (PsO), who are candidates for phototherapy or systemic therapy.
Details
- Status
- Prescription
- First Approved
- 2024-12-17
- Routes
- SUBCUTANEOUS, INTRAVENOUS
- Dosage Forms
- INJECTABLE
STEQEYMA Approval History
What STEQEYMA Treats
2 FDA approvalsOriginally approved for its first indication in 2024 . Covers 2 distinct patient populations.
- Other (2)
STEQEYMA Target & Pathway
ProTarget
Pharmacists can substitute STEQEYMA for Stelara without calling the prescriber. This is a lower-cost alternative with no clinically meaningful differences.
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
STEQEYMA FDA Label Details
Indications & Usage
FDA Label (PDF)STEQEYMA is a human interleukin-12 and -23 antagonist indicated for the treatment of: Adult patients with: moderate to severe plaque psoriasis (PsO) who are candidates for phototherapy or systemic therapy. active psoriatic arthritis (PsA) . moderately to severely active Crohn's disease (CD) . moderately to severely active ulcerative colitis. Pediatric patients 6 years and older with: moderate to severe plaque psoriasis (PsO), who are candidates for phototherapy or systemic therapy. active psoriatic arthritis (PsA) . 1.1. Plaque Psoriasis (PsO) STEQEYMA is indicated for the treatment of adults ...
Explore on TheraRadar
Crohn's Disease Drug Landscape 2026
Approved therapies, pipeline drugs, and clinical trial intelligence
Related Intelligence
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.