SKYRIZI
Skyrizi (risankizumab-rzaa) is an interleukin-23 antagonist indicated for the treatment of several chronic immune-mediated inflammatory conditions in adults. It is approved for patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy, as well as those with active psoriatic arthritis. Additionally, the medication is used to treat adults with moderately to severely active Crohn's disease and moderately to severely active ulcerative colitis.
How SKYRIZI Works
Risankizumab-rzaa is a humanized IgG1 monoclonal antibody that selectively binds to the p19 subunit of the human IL-23 cytokine. This binding action prevents the IL-23 cytokine from interacting with its receptor. Because IL-23 is a naturally occurring cytokine involved in inflammatory and immune responses, blocking this interaction inhibits the release of pro-inflammatory cytokines and chemokines. This targeted mechanism helps manage the inflammation associated with the drug's indicated conditions.
Details
- Status
- Prescription
- First Approved
- 2019-04-23
- Routes
- INTRAVENOUS, INJECTION
- Dosage Forms
- INJECTABLE
SKYRIZI Approval History
What SKYRIZI Treats
4 indicationsSKYRIZI is approved for 4 conditions since its original approval in 2019. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Moderate-to-severe plaque psoriasis
- Active psoriatic arthritis
- Moderately to severely active Crohn's disease
- Moderately to severely active ulcerative colitis
SKYRIZI 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.
SKYRIZI Competitors
Pro10 other drugs also target IL-23. Compare mechanisms, indications, and trial activity.
Competitors share the same molecular target (IL-23). 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.
SKYRIZI FDA Label Details
ProIndications & Usage
FDA Label (PDF)SKYRIZI is an interleukin-23 antagonist indicated for the treatment of: moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. active psoriatic arthritis in adults. moderately to severely active Crohn's disease in adults. moderately to severely active ulcerative colitis in adults. 1.1 Plaque Psoriasis SKYRIZI ® is indicated for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. 1.2 Psoriatic Arthritis SKYRIZI is indicated for the treatment of active psoriatic arthritis in adults...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.