WEZLANA (ustekinumab-auub) · Amgen
Wezlana is a human interleukin-12 and -23 antagonist indicated for the treatment of several chronic inflammatory conditions in both adult and pediatric populations. In adults, it is used to treat moderate to severe plaque psoriasis, active psoriatic arthritis, and moderately to severely active Crohn's disease or ulcerative colitis. Pediatric patients aged 6 years and older may receive the treatment for moderate to severe plaque psoriasis and active psoriatic arthritis. It is specifically indicated for psoriasis patients who are candidates for phototherapy or systemic therapy.
How WEZLANA Works
Wezlana is a monoclonal antibody that binds 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 on the surface of cells. This disruption inhibits signaling cascades that lead to natural killer cell activation and T-cell differentiation. This mechanism addresses the chronic inflammation that characterizes immune-mediated diseases like Crohn's disease and ulcerative colitis.
Details
- Status
- Prescription
- First Approved
- 2023-10-31
- Patent Cliff
- 2025
- Revenue
- $44M (Q4-2025)
- Routes
- INTRAVENOUS, SUBCUTANEOUS
- Dosage Forms
- INJECTABLE
WEZLANA Approval History
What WEZLANA Treats
4 indicationsWEZLANA is approved for 4 conditions since its original approval in 2023. These indications span multiple therapeutic areas including oncology, immunology, and more.
WEZLANA Target & Pathway
ProTarget
Pharmacists can substitute WEZLANA for Stelara without calling the prescriber. This is a lower-cost alternative with no clinically meaningful differences.
WEZLANA 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 WEZLANA's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications WEZLANA treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to WEZLANA
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Amgen's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
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.
WEZLANA FDA Label Details
Indications & Usage
FDA Label (PDF)WEZLANA 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) WEZLANA is indicated for the treatment of adults a...
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Deep insights for WEZLANA
Revenue Insights
- • Q4-2025: $44M
- • Historical trend analysis
Patent Timeline
- • Cliff: 2025
- • Generic/biosimilar risk
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.