Drug profile · INN
ustekinumab
STELARA
ustekinumab (STELARA) is a interleukin-23 inhibitor. Associated with Janssen-Cilag Pty Ltd. Route of administration: injection. Current US regulatory status: approved.
Drug details — ustekinumab
- US status
- approved
- Class
- Antineoplastic and immunomodulating agents (L04)
- Route
- INJECTION
- Patents
- 20
- Programs
- 12
- Data quality
- 0.84
Quick answer
ustekinumab (STELARA) is a interleukin-23 inhibitor. Associated with Janssen-Cilag Pty Ltd. Route of administration: injection. Current US regulatory status: approved.
Key facts
Mechanism of action
Interleukin-23 inhibitor
Primary target: Interleukin-12
Approval history
| Authority | Status | Date |
|---|---|---|
| FDA | approved | — |
| EMA | approved | — |
| TGA | approved | — |
| PMDA | approved | — |
Recent coverage
Rise of Biosimilars in US: FDA Approval Trends & Market Impact
The article delves into the growing presence of biosimilars in the US market, focusing on FDA approval trends and their implications for drug pricing and patient access.
FDA Approves Stelara: New Ulcerative Colitis Treatment from J&J
Stelara, recently approved by the FDA, provides a new treatment option for ulcerative colitis, promising improved outcomes for patients.
FDA Approves First Interchangeable Biosimilar for Stelara (Ustekinumab)
The FDA has approved the first interchangeable biosimilar for Stelara (Ustekinumab), expanding treatment options for patients with psoriasis and Crohn's disease.
Pipeline programs
Related & competitor drugs
Related patents
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Frequently asked questions
What is ustekinumab?
ustekinumab (STELARA) is a interleukin-23 inhibitor. Associated with Janssen-Cilag Pty Ltd. Route of administration: injection. Current US regulatory status: approved.
What is the brand name for ustekinumab?
STELARA is a marketed brand name for ustekinumab. Check FDA Drugs@FDA for the current US label holder and prescribing information.
What is the US approval status of ustekinumab?
ustekinumab has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.