Overview
Ustekinumab is a human immunoglobulin (Ig) G1 kappa monoclonal antibody directed against interleukin(IL)-12 and IL-23, which are cytokines that are involved in immune and inflammatory responses. It was generated via recombinant human IL-12 immunization of human Ig (hu-Ig) transgenic mice. It is a targeted biologic disease-modifying anti-rheumatic drug (bDMARDs) that is used in the management of various inflammatory conditions that involve the activation of IL-12 and IL-23 signalling pathways. The therapeutic use of the drug started in Canada, the US, and Europe since 2009 when it was first approved for the treatment of adult patients with moderate to severe plaque psoriasis and active psoriatic arthritis, alone or in combination with methotrexate. In September 2016, ustekinumab was additionally approved for the management of moderate to severe Crohn's disease in selected adult patients. In October 2019, it was also approved by the FDA for use to manage moderately to severely active ulcerative colitis in adults. Ustekinumab is currently the first and only approved biologic therapy for ulcerative colitis that targets the interleukin (IL)-12 and IL-23 cytokines. The dosing regimen for ustekinumab is based on the patient's weight and there are intravenous and subcutaneous formulations of the drug based on the dosing schedule and condition being treated. Ustekinumab is commonly marketed under the trade name STELARA.
Indication
Ustekinumab is indicated for the management of moderate to severe plaque psoriasis in patients 6 years of age and older who are candidates for phototherapy or systemic therapy. In adult patients, it is also indicated for the management of active psoriatic arthritis (PsA) alone or in combination with methotrexate, moderately to severely active Crohn’s disease (CD) and moderately to severely active ulcerative colitis.
Associated Conditions
- Severe Plaque psoriasis
- Ulcerative Colitis, Active Severe
- Active Psoriatic arthritis
- Moderate Plaque psoriasis
- Moderate Ulcerative colitis
- Moderate, active Crohn´s Disease
- Severe, active Crohn´s Disease
Research Report
Ustekinumab (Stelara®): A Comprehensive Monograph on a First-in-Class IL-12/23 Inhibitor
Executive Summary
Ustekinumab is a first-in-class, fully human IgG1κ monoclonal antibody that represents a significant milestone in the treatment of immune-mediated inflammatory diseases. Marketed under the brand name Stelara® and now available as multiple biosimilars, it functions as a dual inhibitor, uniquely targeting the shared p40 protein subunit of two critical cytokines: Interleukin-12 (IL-12) and Interleukin-23 (IL-23).[1] This targeted mechanism of action allows Ustekinumab to potently downregulate the Th1 and Th17 inflammatory pathways, which are central to the pathophysiology of several autoimmune conditions.[1]
The therapeutic utility of Ustekinumab has been firmly established through a robust clinical development program, leading to regulatory approvals for a range of indications. These include the treatment of moderate-to-severe plaque psoriasis (PsO), active psoriatic arthritis (PsA), moderately to severely active Crohn's disease (CD), and moderately to severely active ulcerative colitis (UC).[1] Its approval extends to pediatric populations for both plaque psoriasis and psoriatic arthritis, underscoring its well-characterized efficacy and safety profile across different age groups.[7] Clinical trials have consistently demonstrated that Ustekinumab can achieve significant clinical endpoints, including skin clearance in psoriasis, joint symptom improvement in psoriatic arthritis, and clinical and endoscopic remission in inflammatory bowel diseases.[9]
Clinical Trials
View More Clinical Trials
Sign in to access the complete clinical trial database with detailed study information.
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|
No clinical trials found
No clinical trials found for this drug
FDA Drug Approvals
View More FDA Approvals
Sign in to access additional FDA-approved drug information with detailed regulatory data.
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| No FDA approvals found for this drug. | |||||
EMA Drug Approvals
View More EMA Approvals
Sign in to access additional EMA-approved drug information with detailed regulatory data.
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
View More HSA Approvals
Sign in to access additional HSA-approved drug information with detailed regulatory data.
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
View More NMPA Approvals
Sign in to access additional NMPA-approved drug information with detailed regulatory data.
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
View More PPB Approvals
Sign in to access additional PPB-approved drug information with detailed regulatory data.
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
View More TGA Approvals
Sign in to access additional TGA-approved drug information with detailed regulatory data.
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
Health Canada Drug Approvals
View More Health Canada Approvals
Sign in to access additional Health Canada approved drug information with detailed regulatory data.
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| No Health Canada approvals found for this drug. | |||||
CIMA AEMPS Drug Approvals
View More CIMA AEMPS Approvals
Sign in to access additional CIMA AEMPS approved drug information with detailed regulatory data.
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
View More Philippines FDA Approvals
Sign in to access additional Philippines FDA approved drug information with detailed regulatory data.
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
View More Saudi SFDA Approvals
Sign in to access additional Saudi SFDA approved drug information with detailed regulatory data.
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
View More Malaysia NPRA Approvals
Sign in to access additional Malaysia NPRA approved drug information with detailed regulatory data.
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
View More UK EMC Drug Information
Sign in to access additional UK EMC drug information with detailed pharmaceutical data.
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
Help Us Improve
Your feedback helps us provide better drug information and insights.