PharmaRadar360

PharmaRadar360

ImmunologyDrug intelligence

Skyrizi

Risankizumab

IL-23 p19 inhibitor. Developed by AbbVie. Clinical, regulatory, and source evidence are connected below.

Company
AbbVie
Target / MOA
IL-23 路 IL23A
Aliases
Skyrizi 路 ABBV-066
Signals
25
Clinical trials
15
Approvals
2
Evidence sources
25

Latest signals

What changed

The three most recent source-backed changes linked to this drug.

Approved uses

What regulators have approved

The indications section of each current US label, word for word, and the EU summary of each authorised product. Official sources as of Oct 21, 2026.

United States (FDA label)

Skyrizi 路 BLA761105, BLA761262 路 label version 179, effective Jun 15, 2026 路 DailyMed

Label section 1

1 INDICATIONS AND USAGE 1.1 Plaque Psoriasis SKYRIZI 庐 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鈥檚 Disease SKYRIZI is indicated for the treatment of moderately to severely active Crohn's disease in adults. 1.4 Ulcerative Colitis SKYRIZI is indicated for the treatment of moderately to severely active ulcerative colitis in adults.

European Union (EMA)

Skyrizi 路 EMEA/H/C/004759 路 Authorised, authorised Apr 26, 2019 (Commission decision C(2019) 3334) 路 EPAR

Adult plaque psoriasis Skyrizi is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. Paediatric plaque psoriasis Skyrizi is indicated for the treatment of moderate to severe plaque psoriasis in children and adolescents from the age of 6 years who are candidates for systemic therapy. Psoriatic Arthritis Skyrizi, alone or in combination with methotrexate (MTX), is indicated for the treatment of active psoriatic arthritis in adults who have had an inadequate response or who have been intolerant to one or more disease-modifying antirheumatic drugs (DMARDs). Crohn鈥檚 disease Skyrizi is indicated for the treatment of adult patients with moderately to severely active Crohn's disease who have had an inadequate response to, lost response to, or were intolerant to conventional therapy or a biologic therapy. Ulcerative colitis Skyrizi is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to, lost response to, or were intolerant to conventional therapy or a biologic therapy.

EMA's summary; the full indication is in the product information on the EPAR page.

Regulatory history

Approvals over time

US original approvals and efficacy supplements (new indications, populations or dosing) from Drugs@FDA; EU authorisations and CHMP opinions on extensions. Official sources as of Oct 21, 2026.

United States

BLA761105 路 ABBVIE INC 路 first approved Apr 23, 2019

10 efficacy supplements approved

BLA761262 路 ABBVIE INC 路 first approved Jun 16, 2022

2 efficacy supplements approved

European Union

  • Skyrizi: Authorised since Apr 26, 2019

Patents and exclusivity

What FDA lists (US)

Patents and exclusivity as FDA lists them in the Orange Book (drugs) and the Purple Book (biologics), with approved generics and biosimilars. Expired listings are not shown. Official sources as of Oct 21, 2026.

BLA761105 (Purple Book)

No exclusivity date listed.

BLA761262 (Purple Book)

No exclusivity date listed.

Generics and biosimilars

The Purple Book lists no licensed biosimilar.

FDA's listings only: an approved generic or licensed biosimilar may not be on the market yet. Not a forecast of when they may launch, and not legal advice.

Safety

Boxed warnings and FDA safety communications

The boxed warning on each current US label, and FDA Drug Safety Communications that name the drug (FDA's list from January 2020). Official sources as of Oct 21, 2026.

Boxed warning

The current US label has no boxed warning.

FDA Drug Safety Communications

None on FDA's list names this drug.

Clinical trials

Key active studies

A focused view of recently updated studies 路 15 linked records.

Source evidence

Where this profile comes from

Facts link back to original registries, regulators, labels, and publishers. Counts change as source records update.

Professional referenceThis profile summarizes linked public evidence. It is not medical, legal, regulatory, or investment advice. Verify decisions against original sources.