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Skyrizi

Risankizumab

An injectable biological therapy used to treat plaque psoriasis, Crohn's disease, and psoriatic arthritis.

Generic name
Risankizumab
Brand name
Skyrizi
Route
Intravenous, Subcutaneous
Marketed by
AbbVie
FDA pharmacologic class
Interleukin-23 Antagonist; Interleukin-23 Antagonists
First FDA approval
23 Apr 2019

Where Risankizumab is approved

All regulators →

Of the three regulators tracked here, the first to approve Risankizumab was Canada, on 17 Apr 2019. It is approved in 3 of the 3 regulators tracked here.

USUnited States (FDA)
23 Apr 2019
Skyrizi
BLA761105 on Drugs@FDA
First original NDA/BLA approval
EUEuropean Union (EMA)
26 Apr 2019
Skyrizi
EMA product page
First centralised authorisation
CACanada (Health Canada)
17 Apr 2019
Skyrizi
Notice of Compliance 22070
First new-drug NOC

From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.

What health systems spend on Risankizumab

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ENNHS England
Not dispensed in the community in England in the last 12 months under this name
Net ingredient cost, community prescriptions
USUS Medicaid
$1.72bn
86,735 prescriptions in 2025 · Skyrizi
+58% on 2024
Amount Medicaid reimbursed, before rebates

From NHSBSA Prescription Cost Analysis (Open Government Licence v3.0) and CMS State Drug Utilization Data. Both are gross amounts: neither system publishes its discounts or rebates per drug. Products combining several substances are not counted here.

How Risankizumab works

All drug targets →
  • Interleukin-23 inhibitor Inhibitor
    Target: Interleukin-23
    ChEMBL only
Diseases it has been tested for in clinical trials, by furthest phase
  • Generalized pustular psoriasisPhase 3
  • Intestinal obstructionPhase 3
  • Palmoplantar pustulosisPhase 3
  • Psoriasis-related juvenile idiopathic arthritisPhase 3
  • COVID-19Phase 2
  • Ankylosing spondylitisPhase 2
  • AsthmaPhase 2
  • Atopic eczemaPhase 2
  • Hidradenitis suppurativaPhase 2

Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL3990029, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3), ligand 8922, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.

NICE appraisals of Risankizumab

All NICE appraisals →

NICE, which decides whether the NHS in England should fund new medicines, has published 4 technology appraisals of Risankizumab. 4 are current, and 4 of these recommend it for at least some patients.

AppraisalNICE recommendationPublishedStatus
Risankizumab for treating moderately to severely active ulcerative colitis
NICE TA998
Optimised22 Aug 2024Current
Risankizumab for previously treated moderately to severely active Crohn's disease
NICE TA888
Optimised17 May 2023Current
Risankizumab for treating active psoriatic arthritis after inadequate response to DMARDs
NICE TA803
Optimised13 Jul 2022Current
Risankizumab for treating moderate to severe plaque psoriasis
NICE TA596
Recommended21 Aug 2019Current

NICE decisions apply to the NHS in England. In Ireland the HSE decides on reimbursement, advised by the National Centre for Pharmacoeconomics. Titles, categories and dates link to the guidance on nice.org.uk. © NICE 2026 technology appraisal guidance. Available from www.nice.org.uk/guidance. All rights reserved. Subject to Notice of rights. NICE guidance is prepared for the National Health Service in England. All NICE guidance is subject to regular review and may be updated or withdrawn. NICE accepts no responsibility for the use of its content in this product/publication.

Patient leaflets for Risankizumab

The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.

  • IE
    Ireland: 9 products on the HPRA list
    Each product record links to the HPRA, which publishes the leaflet and SmPC.
  • EU
    European Union: Skyrizi
    EMA product information: package leaflet and summary of product characteristics in every EU language.
  • UK
    United Kingdom: Search MHRA Products
    Patient information leaflets and SmPCs for UK-licensed products.
  • US
    United States: Search DailyMed
    FDA-approved labels, including patient and medication guides.

Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.

What Skyrizi is used for

SKYRIZI is an interleukin-23 antagonist indicated for the treatment of: moderate-to-severe plaque psoriasis in adults and pediatric patients 6 years of age and older who are candidates for systemic therapy or phototherapy. ( 1.1 ) active psoriatic arthritis in adults and pediatric patients 6 years of age and older. ( 1.2 ) moderately to severely active Crohn's disease in adults. ( 1.3 ) moderately to severely active ulcerative colitis in adults. ( 1.4 ) 1.1 Plaque Psoriasis SKYRIZI ® is indicated for the treatment of moderate-to-severe plaque psoriasis in adults and pediatric patients 6 years of age and older who are candidates for systemic therapy or phototherapy. 1.2 Psoriatic Arthritis SKYRIZI is indicated for the treatment of active psoriatic arthritis in adults and pediatric patients 6 years of age and older. 1.3 Crohn’s Disease SKYRIZI is indicated for the treatment of moderately …

How it works

12.1 Mechanism of Action Risankizumab-rzaa is a 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 a naturally occurring cytokine that is involved in inflammatory and immune responses. Risankizumab-rzaa inhibits the release of pro-inflammatory cytokines and chemokines.

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How this page is built

The facts on this page are pulled directly from official U.S. FDA datasets — they are not written from memory. Each field below names the dataset it came from, so you can check it yourself.

Plain-English summaries and drug-class explainers are written and reviewed by Sreepriya Prasannan (MSc Digital Transformation of Life Sciences (Innopharma Education / Griffith College); MSc & BSc Botany). Data is retrieved automatically from the sources above and cross-checked with AI-assisted verification (Anthropic's Claude) — brand and generic names are matched against the exact FDA product record so that a combination product or a different formulation cannot be mistaken for the drug on this page. An editor reviews the result before publication. We describe this in full in our editorial standards and corrections policy. The FDA data on this page was last retrieved on 9 Oct 2026. How every register is built: methodology · fixes we have made: corrections log.

Please verify before you rely on this. This page is general information for life-science and pharmaceutical professionals. It is not medical advice, and it has not been reviewed by a clinician — our editorial team holds life-science qualifications, not clinical ones. It is not exhaustive and may not reflect the most recent label change. Always check the official prescribing information (US Prescribing Information or EU SmPC) and speak to your doctor or pharmacist before acting on anything here. Drugs in the same class are not automatically interchangeable, and approvals, brand names and indications differ between the US, the EU/Ireland (EMA/HPRA) and other regions. Spotted an error? Tell us — we correct promptly and log it.