Ustekinumab
As of the edition of 20 October 2026, Ustekinumab is an antibody: marketed, first approved in 2008 (CA); acts on IL12B; US protection ended in 2021.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2011
- Kind
- Antibody
- Brand name
- Stelara
- First approved
- 12 December 2008 (CA)
- Approvals on record
- 33 in 5 regions
- Holder of the most recent approval
- Amgen; 10 holders in all
- Withdrawn from market
- 12 June 2026 (in some regions)
- Registered trials
- 145, 15 stopped early
- Disease areas
- Digestive system; Skin and connective tissue; Immune system; Bones, joints and muscles; Inherited and neonatal; Heart and blood vessels
US protection
US protection ended in 2021.
US protection ended in 2021, computed as 12 years from the first US licence because FDA publishes no date for this product. The application that gives this date is held by Johnson & Johnson. The date is computed, not published.
This is the US only, and it is not the date generics or biosimilars can enter.
The exact date and the listings behind it
In the product2 listings count towards this date. The exact date and each listing are in the product.
Companies that need a new molecule because of this drug
1 company on route B because of this drug.
Companies on route B for this drug
In the product1 company is on route B because of Ustekinumab.
Target
| Gene | Protein | UniProt |
|---|---|---|
| IL12B | Interleukin-12 subunit beta | P29460 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 42 | 20 | 14 | 1 |
| Phase 1 | 14 | 12 | 1 | 1 |
| Phase 2 | 37 | 26 | 5 | 5 |
| Phase 3 | 39 | 26 | 5 | 7 |
| Phase 4 | 13 | 3 | 6 | 1 |
| All trials | 145 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Johnson & Johnson | Applicant and Lead sponsor of trials | 2003 to now |
| Amgen | Later holder and Lead sponsor of trials | 2020 to now |
| Celltrion HealthCare | Later holder and Lead sponsor of trials | 2025 to now |
| Nipro | Later holder | 2025 to now |