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Skyrizi (RISANKIZUMAB)
Skyrizi works by blocking the interleukin-23 protein, which plays a key role in inflammation and immune response.
Skyrizi (risankizumab) is a biologic medication developed by AbbVie INC, targeting interleukin-23 subunit alpha to treat various inflammatory conditions. It is an interleukin-23 antagonist, approved by the FDA in 2019 for indications such as Crohn's disease, psoriasis, and psoriatic arthritis. Skyrizi is a patented medication with a half-life of 28 days, and its safety profile includes potential risks of infections and allergic reactions. As a biologic medication, Skyrizi is not a small molecule, contrary to the initial statement. It is currently owned and marketed by AbbVie INC.
At a glance
| Generic name | RISANKIZUMAB |
|---|---|
| Sponsor | AbbVie |
| Drug class | Interleukin-23 Antagonist [EPC] |
| Target | Interleukin-23 subunit alpha |
| Modality | Monoclonal antibody |
| Therapeutic area | Immunology |
| Phase | FDA-approved |
| First approval | 2019 |
| Annual revenue | 8600 |
Mechanism of action
Risankizumab-rzaa is humanized IgG1 monoclonal antibody that selectively binds to the p19 subunit of human IL-23 cytokine and inhibits its interaction with the IL-23 receptor. IL-23 is naturally occurring cytokine that is involved in inflammatory and immune responses. Risankizumab-rzaa inhibits the release of pro-inflammatory cytokines and chemokines.
Approved indications
- Crohn's disease
- Erythrodermic psoriasis
- Plaque psoriasis
- Psoriasis
- Psoriatic arthritis
- Pustular psoriasis
Common side effects
- Infections
- Headache
- Fatigue
- Injection site reactions
- Folliculitis
- Urticaria
- Hepatic events
- ALT increased
- AST increased
- GGT increased
- Hypersensitivity reactions
- Rash
Key clinical trials
- BI 655066 / ABBV-066 (Risankizumab) in Moderate to Severe Plaque Psoriasis With Randomized Withdrawal and Re-treatment (PHASE3)
- Study to Assess Change in Disease Activity of Risankizumab Treatment in Japanese Participants With Moderate to Severe Ulcerative Colitis
- Evaluation of Sonelokimab in Patients With Active Psoriatic Arthritis and Anti-TNFα Inadequate Response (PHASE3)
- A Study of Guselkumab Versus Risankizumab in Participants With Moderately to Severely Active Crohn's Disease (PHASE3)
- A Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Study Participants With Active Psoriatic Arthritis (PHASE3)
- An Observational Study to Validate the Cumulative Life Course Impairment (CLCI) Instrument (DermCLCI-p) in Adult Participants With Moderate to Severe Chronic Plaque Psoriasis (PsO)
- Study to Assess Change in Quality of Life of Risankizumab Treatment in Adult Participants With Moderate-to-Severe Plaque Psoriasis
- A Study to Assess Adverse Events, Change in Disease Activity, and How Intravenous and Subcutaneous Risankizumab Moves Through the Body of Pediatric Participants With Moderately to Severely Active Crohn's Disease (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| SEC EDGAR | Revenue + earnings |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Skyrizi CI brief — competitive landscape report
- Skyrizi updates RSS · CI watch RSS
- AbbVie portfolio CI