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risankizumab IV
risankizumab IV is a IL-23 inhibitor Small molecule drug developed by AbbVie. It is currently in Phase 3 development for Moderate to severe plaque psoriasis, Active psoriatic arthritis, Moderate to severe Crohn's disease. Also known as: ABBV-066 BI 655066, SKYRIZI, BI 655066, ABBV-066.
Risankizumab is a humanized monoclonal antibody that selectively binds to and blocks the interleukin-23 (IL-23) p19 subunit.
Risankizumab IV is an interleukin-23 inhibitor, a type of antibody that belongs to the drug class of inhibitors. It is being studied for the treatment of Crohn's Disease and Ulcerative Colitis, among other conditions.
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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 IV |
|---|---|
| Also known as | ABBV-066 BI 655066, SKYRIZI, BI 655066, ABBV-066 |
| Sponsor | AbbVie |
| Drug class | IL-23 inhibitor |
| Target | IL-23 p19 subunit |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | Phase 3 |
Mechanism of action
By inhibiting IL-23, risankizumab reduces the production of pro-inflammatory cytokines, thereby modulating the immune response and alleviating symptoms of autoimmune diseases.
Approved indications
- Moderate to severe plaque psoriasis
- Active psoriatic arthritis
- Moderate to severe Crohn's disease
Common side effects
- Upper respiratory tract infection
- Nausea
- Headache
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)
- A Study to Learn More About How Risankizumab Works in Young Participants With Ulcerative Colitis (PHASE3)
- A Study of the Efficacy and Safety of Risankizumab in Participants With Crohn's Disease (PHASE3)
- Study Comparing Intravenous (IV)/Subcutaneous (SC) Risankizumab to IV/SC Ustekinumab to Assess Change in Crohn's Disease Activity Index (CDAI) in Adult Participants With Moderate to Severe Crohn's Disease (CD) (PHASE3)
- PATHFINDER: Evaluating the Optimal First-Line Treatment Strategy for Moderate-to-Severely Active Ileal-dominant Crohn's Disease (PHASE4)
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 IV CI brief — competitive landscape report
- risankizumab IV updates RSS · CI watch RSS
- AbbVie portfolio CI
Frequently asked questions about risankizumab IV
What is risankizumab IV?
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Related
- Drug class: All IL-23 inhibitor 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 Active psoriatic arthritis
- Indication: Drugs for Moderate to severe Crohn's disease
- Also known as: ABBV-066 BI 655066, SKYRIZI, BI 655066, ABBV-066
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing