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risankizumab SC
risankizumab SC is a IL-23 inhibitor (monoclonal antibody) Small molecule drug developed by AbbVie. It is currently in Phase 3 development for Moderate to severe plaque psoriasis, Crohn's disease, Ulcerative colitis. Also known as: ABBV-066 BI 655066, SKYRIZI, BI 655066, ABBV-066.
Risankizumab is a monoclonal antibody that selectively blocks the IL-23 cytokine pathway by binding to the p19 subunit of IL-23.
Risankizumab is a monoclonal antibody that selectively blocks the IL-23 cytokine pathway by binding to the p19 subunit of IL-23. Used for Moderate to severe plaque psoriasis, Crohn's disease, Ulcerative colitis.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Immunology slight uplift
+1.0pp
Mature endpoint landscape (ACR, DAS28, PASI) makes immunology approvals slightly more predictable. -
Big-pharma sponsor
+3.0pp
AbbVie is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | risankizumab SC |
|---|---|
| Also known as | ABBV-066 BI 655066, SKYRIZI, BI 655066, ABBV-066 |
| Sponsor | AbbVie |
| Drug class | IL-23 inhibitor (monoclonal antibody) |
| Target | IL-23 p19 subunit |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | Phase 3 |
Mechanism of action
IL-23 is a key driver of inflammatory responses in immune-mediated diseases. By inhibiting IL-23 signaling, risankizumab reduces the differentiation and activation of pathogenic T cells and innate lymphoid cells, thereby suppressing chronic inflammation. This mechanism is particularly effective in diseases driven by IL-23-dependent immune responses.
Approved indications
- Moderate to severe plaque psoriasis
- Crohn's disease
- Ulcerative colitis
Common side effects
- Nasopharyngitis
- Upper respiratory tract infection
- Headache
- Injection site reactions
Key clinical trials
- 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)
- Study of Targeted Therapies for the Treatment of Adult Participants With Moderate to Severe Crohn's Disease (PHASE2)
- A Study to Assess the Change in Disease Activity in Adult Participants With Moderate to Severe Ulcerative Colitis Treated With Risankizumab Compared to Vedolizumab (PHASE3)
- A Study to Assess How Intravenous and Subcutaneous Administrations of Risankizumab Moves Through the Body of Healthy Adult Participants (PHASE1)
- Evaluation of Sonelokimab in Patients With Active Psoriatic Arthritis and Anti-TNFα Inadequate Response (PHASE3)
- A Study to Assess the Concentrations of Risankizumab in the Breast Milk of Adult Lactating Women With Inflammatory Bowel Disease (PHASE4)
- A Study to Learn How Safe and Effective Risankizumab is When Compared to Deucravacitinib to Treat Participants With Moderate Plaque Psoriasis and Who Need to Try Systemic Treatment (Works Throughout the Whole Body) (PHASE4)
- A Study to Assess Adverse Events, Change in Disease Activity, and How the Drug Moves Through the Body in Children With Juvenile Psoriatic Arthritis (jPsA) Receiving Subcutaneously Injected Risankizumab or Adalimumab (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 |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- risankizumab SC CI brief — competitive landscape report
- risankizumab SC updates RSS · CI watch RSS
- AbbVie portfolio CI
Frequently asked questions about risankizumab SC
What is risankizumab SC?
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What is risankizumab SC used for?
Who makes risankizumab SC?
Is risankizumab SC also known as anything else?
What drug class is risankizumab SC in?
What development phase is risankizumab SC in?
What are the side effects of risankizumab SC?
What does risankizumab SC target?
Related
- Drug class: All IL-23 inhibitor (monoclonal antibody) drugs
- Target: All drugs targeting IL-23 p19 subunit
- Manufacturer: AbbVie — full pipeline
- Therapeutic area: All drugs in Immunology
- Indication: Drugs for Moderate to severe plaque psoriasis
- Indication: Drugs for Crohn's disease
- Indication: Drugs for Ulcerative colitis
- Also known as: ABBV-066 BI 655066, SKYRIZI, BI 655066, ABBV-066
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing