Stelara
A biologic for psoriasis, psoriatic arthritis and Crohn's disease.
Where Ustekinumab is approved
All regulators →Of the three regulators tracked here, the first to approve Ustekinumab was Canada, on 12 Dec 2008. It is approved in 3 of the 3 regulators tracked here.
- 10 FDA-approved biosimilars, 10 interchangeable: Imuldosa, Otulfi, Pyzchiva, Pyzchiva and others
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 Ustekinumab
All medicines →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 Ustekinumab works
All drug targets →- Interleukin-12 inhibitor InhibitorTarget: Interleukin-12ChEMBL only
- Interleukin-23 inhibitor InhibitorTarget: Interleukin-23ChEMBL only
- Takayasu arteritisPhase 3
- Ankylosing spondylitisPhase 3
- DermatomyositisPhase 3
- Intestinal obstructionPhase 3
- Palmoplantar pustulosisPhase 3
- PolymyositisPhase 3
- PouchitisPhase 3
- Psoriasis-related juvenile idiopathic arthritisPhase 3
- Rheumatoid arthritisPhase 3
- Systemic lupus erythematosusPhase 3
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL1201835, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3), ligand 6885, 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 Ustekinumab
All NICE appraisals →NICE, which decides whether the NHS in England should fund new medicines, has published 5 technology appraisals of Ustekinumab. 5 are current, and 5 of these recommend it for at least some patients.
| Appraisal | NICE recommendation | Published | Status |
|---|---|---|---|
| Ustekinumab for treating moderately to severely active ulcerative colitis NICE TA633 | Optimised | 17 Jun 2020 | Current |
| Adalimumab, etanercept and ustekinumab for treating plaque psoriasis in children and young people NICE TA455 | Optimised | 12 Jul 2017 | Current |
| Ustekinumab for moderately to severely active Crohn’s disease after previous treatment NICE TA456 | Recommended | 12 Jul 2017 | Current |
| Ustekinumab for treating active psoriatic arthritis NICE TA340 | Optimised | 4 Jun 2015 Updated 3 Mar 2017 | Current |
| Ustekinumab for treating moderate to severe plaque psoriasis NICE TA180 | Recommended | 23 Sep 2009 Updated 3 Mar 2017 | Current |
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 Ustekinumab
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 49 products on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- EU
- UKUnited Kingdom: Search MHRA ProductsPatient information leaflets and SmPCs for UK-licensed products.
- USUnited States: Search DailyMedFDA-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.
Reference identifiers for Ustekinumab
- ATC code
- L04AC05
- ChEMBL
- CHEMBL1201835
- DrugBank
- DB05679
- CAS number
- 815610-63-0
- FDA UNII
- FU77B4U5Z0
- Wikidata
- Q420305
- Wikipedia
- Ustekinumab
Codes that identify this medicine in other databases, from Wikidata (CC0), matched by its ChEMBL ID. The ATC code is the WHO classification of what the medicine is used for.
What Stelara is used for
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 …
How it works
12.1 Mechanism of Action Ustekinumab is a human IgG1қ monoclonal antibody that binds with specificity to the p40 protein subunit used by both the IL-12 and IL-23 cytokines. IL-12 and IL-23 are naturally occurring cytokines that are involved in inflammatory and immune responses, such as natural killer cell activation and CD4+ T-cell differentiation and activation. In in vitro models, ustekinumab was shown to disrupt IL-12 and IL-23 mediated signaling and cytokine cascades by disrupting the interaction of these cytokines with a shared cell-surface receptor chain, IL-12Rβ1. The cytokines IL-12 and IL-23 have been implicated as important contributors to the chronic inflammation that is a hallma…
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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.
- FDA Drug Label (openFDA) ↗ Indications, mechanism of action and pharmacologic class
- Drugs@FDA ↗ First FDA approval date and the company holding the application
- FDA Drug Shortage Database ↗ Current US supply / shortage status
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.