OTULFI (ustekinumab-aauz)
OTULFI is indicated for the treatment of Plaque Psoriasis; Psoriatic Arthritis; Crohn's Disease; Ulcerative Colitis.
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
Pharmacists can substitute OTULFI for Stelara without calling the prescriber. This is a lower-cost alternative with no clinically meaningful differences.
OTULFI Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in OTULFI's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications OTULFI treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to OTULFI
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
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
Indications & Usage
FDA Label (PDF)OTULFI is indicated for the treatment of Plaque Psoriasis; Psoriatic Arthritis; Crohn's Disease; Ulcerative Colitis.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.