Guselkumab
As of the edition of 20 October 2026, Guselkumab is an antibody: marketed, first approved in 2017 (US); acts on IL23A; US protection ends in 2029.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2018
- Kind
- Antibody
- Brand name
- Tremfya
- First approved
- 13 July 2017 (US)
- Approvals on record
- 23 in 5 regions
- Holder of the most recent approval
- Johnson & Johnson; 5 holders in all
- Registered trials
- 99, 8 stopped early
- Disease areas
- Skin and connective tissue; Digestive system; Bones, joints and muscles; Immune system; Inherited and neonatal; Infections
US protection
US protection ends in 2029.
US protection ends in 2029, 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 product1 listing counts towards this date. The exact date and each listing are in the product.
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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 Guselkumab.
See the 1 company on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| IL23A | Interleukin-23 subunit alpha | Q9NPF7 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 19 | 1 | 15 | 2 |
| Phase 1 | 15 | 11 | 1 | 3 |
| Phase 2 | 16 | 9 | 5 | 2 |
| Phase 3 | 34 | 19 | 15 | 0 |
| Phase 4 | 15 | 4 | 10 | 1 |
| All trials | 99 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Johnson & Johnson | Applicant and Lead sponsor of trials | 2009 to now |