Anpheros Search · Treatment

Ustekinumab

Also known as: Stelara · Uzpruvo · Pyzchiva · Wezenla · Steqeyma · Fymskina · Otulfi · Imuldosa · Yesintek · Usymro

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In short

Ustekinumab is a human interleukin-12 and -23 antagonist. In the European Union, it is indicated for moderate to severe plaque psoriasis in adults who failed, have a contraindication to, or are intolerant to other systemic therapies. The European Union also approves it for moderately to severely active Crohn's disease and ulcerative colitis in adults and paediatric patients from 2 years of age who had inadequate response, lost response, or intolerance to conventional or biologic therapies. In the United States, it is indicated for moderate to severe plaque psoriasis and active psoriatic arthritis in patients 6 years and older, and for moderately to severely active Crohn's disease and ulcerative colitis in patients 2 years and older. The cited sources connect ustekinumab to Crohn disease, ulcerative colitis, and psoriasis.

From: Data provided by the U.S. Food and Drug Administration. · Source: European Medicines Agency (EMA), Stelara — EPAR, 16/10/2026. © European Medicines Agency. · Source: European Medicines Agency (EMA) — EPAR. © European Medicines Agency.

AI-generated summary of the sources cited on this page, checked automatically against them. Not reviewed by a clinician; not medical advice.

Codes

RxNorm
847083 ustekinumab
EMA
EMEA/H/C/000958, EMEA/H/C/006101, EMEA/H/C/006183, EMEA/H/C/006132, EMEA/H/C/005918, EMEA/H/C/005805, EMEA/H/C/006544, EMEA/H/C/006221, EMEA/H/C/006444, EMEA/H/C/006467, EMEA/H/C/006794, EMEA/H/C/006667

Official indications

Quoted unchanged from official product information, in English. Listed alphabetically by product, not ranked.

EMA (EU) Stelara

Adult Crohn’s Disease Stelara is indicated for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a TNFα antagonist. Paediatric Crohn's Disease Stelara is indicated for the treatment of moderately to severely active Crohn’s disease in paediatric patients from the age of 2 years and older, who have had an inadequate response to, or were intolerant to either conventional or biologic therapy. Adult ulcerative colitis Stelara is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic. Paediatric ulcerative colitis Stelara is indicated for the treatment of moderately to severely active ulcerative colitis in paediatric patients from the age of 2 years and older, who have had an inadequate response to, or were intolerant to either conventional therapy or a biologic. Plaque psoriasis Stelara is indicated for the treatment of moderate to severe plaque psoriasis in adults who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate (MTX) or PUVA (psoralen and ultraviolet A) (see section 5.1). Paediatric plaque psoriasis Stelara is indicated for the treatment of moderate to severe plaque psoriasis in children and adolescent patients from the age of 6 years and older, who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies. Psoriatic arthritis (PsA) Stelara, alone or in combination with MTX, is indicated for the treatment of active psoriatic arthritis in adult patients when the response to previous non-biological disease modifying anti rheumatic drug (DMARD) therapy has been inadequate (see section 5.1).

Source: European Medicines Agency (EMA), Stelara — EPAR, 16/10/2026. © European Medicines Agency.

Document date: 16/10/2026 · Official document →

FDA (USA) Stelara

1 INDICATIONS AND USAGE STELARA is a human interleukin-12 and -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 phototherapy or systemic therapy. ( 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 and pediatric patients 2 years of age and older. ( 1.3 ) Moderately to severely active ulcerative colitis in adults and pediatric patients 2 years of age and older. ( 1.4 ) 1.1 Plaque Psoriasis (PsO) STELARA is indicated for the treatment of adults and pediatric patients 6 years of age and older with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy. 1.2 Psoriatic Arthritis (PsA) STELARA is indicated for the treatment of adults and pediatric patients 6 years of age and older with active psoriatic arthritis. 1.3 Crohn's Disease (CD) STELARA is indicated for the treatment of adults and pediatric patients 2 years of age and older with moderately to severely active Crohn's disease. 1.4 Ulcerative Colitis (UC) STELARA is indicated for the treatment of adults and pediatric patients 2 years of age and older with moderately to severely active ulcerative colitis.

Data provided by the U.S. Food and Drug Administration.

Document date: 20260908 · Official document →

Related terms in the cited sources

Has an official indication for

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External resources

Questions

What is Ustekinumab approved for in the European Union?

Adult Crohn’s Disease Stelara is indicated for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a TNFα antagonist. Paediatric Crohn's Disease Stelara is indicated for the treatment of moderately to severely active Crohn’s disease in paediatric patients from the age of 2 years and older, who have had an inadequate response to, or were intolerant to either conventional or biologic therapy. Adult ulcerative colitis Stelara is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic. Paediatric ulcerative colitis Stelara is indicated for the treatment of moderately to severely active ulcerative colitis in paediatric patients from the age of 2 years and older, who have had an inadequate response to, or were intolerant to either conventional therapy or a biologic. Plaque psoriasis Stelara is indicated for the treatment of moderate to severe plaque psoriasis in adults who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate (MTX) or PUVA (psoralen and ultraviolet A) (see section 5.1). Paediatric plaque psoriasis Stelara is indicated for the treatment of moderate to severe plaque psoriasis in children and adolescent patients from the age of 6 years and older, who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies. Psoriatic arthritis (PsA) Stelara, alone or in combination with MTX, is indicated for the treatment of active psoriatic arthritis in adult patients when the response to previous non-biological disease modifying anti rheumatic drug (DMARD) therapy has been inadequate (see section 5.1). (Source: European Medicines Agency (EMA), Stelara — EPAR, 16/10/2026. © European Medicines Agency.)

Sources and attribution

  • Source: European Medicines Agency (EMA) — EPAR. © European Medicines Agency.
  • Names other than the official source titles: Anpheros translations and plain-language names, made with AI assistance and checked automatically; the source names are in English.
  • Data provided by the U.S. Food and Drug Administration.
  • This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product.
  • Source: European Medicines Agency (EMA), Stelara — EPAR, 16/10/2026. © European Medicines Agency.

Anpheros Search catalog 2026.10.5, published 17 October 2026. About the data →