OTULFI
OTULFI (ustekinumab-aauz) is a human interleukin-12 and -23 antagonist indicated for the treatment of several chronic inflammatory conditions in both adult and pediatric populations. It is approved for adults with moderate to severe plaque psoriasis, active psoriatic arthritis, and moderately to severely active Crohn's disease or ulcerative colitis. Additionally, the medication is indicated for pediatric patients aged six years and older with moderate to severe plaque psoriasis or active psoriatic arthritis. For patients with plaque psoriasis, the therapy is specifically intended for those who are candidates for phototherapy or systemic therapy.
How OTULFI Works
OTULFI is a monoclonal antibody that binds specifically to the p40 protein subunit shared by the IL-12 and IL-23 cytokines. By targeting this subunit, the drug prevents these cytokines from interacting with the IL-12Rβ1 receptor found on the surface of immune cells. This disruption inhibits the signaling cascades and immune responses—such as T-cell activation and differentiation—that contribute to chronic inflammation. Blocking these pathways helps manage the inflammatory processes underlying conditions like Crohn's disease, ulcerative colitis, and psoriasis.
Details
- Status
- Prescription
- First Approved
- 2024-09-27
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
OTULFI Approval History
What OTULFI Treats
4 indicationsOTULFI is approved for 4 conditions since its original approval in 2024. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Plaque Psoriasis
- Psoriatic Arthritis
- Crohn's Disease
- Ulcerative Colitis
OTULFI Target & Pathway
ProTarget
A cytokine that promotes Th17 cell development and maintenance. IL-23 is upstream of IL-17 in the inflammatory cascade driving psoriasis and inflammatory bowel disease. Blocking IL-23 provides sustained control of these conditions.
Pharmacists can substitute OTULFI for Stelara without calling the prescriber. This is a lower-cost alternative with no clinically meaningful differences.
OTULFI Competitors
Pro6 other drugs also target IL-12. Compare mechanisms, indications, and trial activity.
Competitors share the same molecular target (IL-12). Earlier expiry dates signal biosimilar/generic opportunities.
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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.
OTULFI FDA Label Details
ProIndications & Usage
FDA Label (PDF)OTULFI 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 , who are candidates for phototherapy or systemic therapy. • active psoriatic arthritis (PsA) . 1.1 Plaque Psoriasis (PsO) OTULFI is indicated for the treatment of adult...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.