SKYRIZI (risankizumab-rzaa)
SKYRIZI is indicated for the treatment of Moderate-to-severe plaque psoriasis; Active psoriatic arthritis; Moderately to severely active Crohn's disease; 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.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2019-04-23
- Patent Cliff
- 2035
- Revenue
- $4.5B (Q1-2026)
- 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 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 SKYRIZI's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications SKYRIZI treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to SKYRIZI
3 of 6FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
2 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07258745 | A148_01PK2408 2025-522345-21-00 | Ph 1 | recruiting | Pharmacokinetic, Safety, Tolerability, and Immunogenicity Comparison of CKD-704 (Risankizumab Biosimilar), With EU-approved Skyrizi®, and US-licensed Skyrizi® in Healthy Adult Participants |
| NCT04630652 | JKI-1011 K23AR080043 | Ph 4 | active not recruiting | Risankizumab Long-term Remission Study |
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
Indications & Usage
FDA Label (PDF)SKYRIZI is indicated for the treatment of Moderate-to-severe plaque psoriasis; Active psoriatic arthritis; Moderately to severely active Crohn's disease; Moderately to severely active ulcerative colitis.
Pro Intelligence Preview
Deep insights for SKYRIZI
Revenue Insights
- • Q1-2026: $4.5B
- • Historical trend analysis
Patent Timeline
- • Cliff: 2035
- • Generic/biosimilar risk
Trial Analysis
- • 3 total trials
- • Stage: Growth
Competitive Landscape
- • 6 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Related Intelligence
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment