Tildrakizumab
As of the edition of 20 October 2026, Tildrakizumab is an antibody: marketed, first approved in 2018 (US); acts on IL23A; US protection ends in 2030.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2019
- Kind
- Antibody
- Brand name
- Ilumya
- First approved
- 20 March 2018 (US)
- Approvals on record
- 4 in 3 regions
- Holder of the most recent approval
- Almirall; 2 holders in all
- Registered trials
- 32, 4 stopped early
- Disease areas
- Skin and connective tissue; Immune system; Bones, joints and muscles; Blood and lymph; Cancer; Heart and blood vessels
US protection
US protection ends in 2030.
US protection ends in 2030, 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 SUN Pharmaceutical Industries. 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.
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 Tildrakizumab.
Target
| Gene | Protein | UniProt |
|---|---|---|
| IL23A | Interleukin-23 subunit alpha | Q9NPF7 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 6 | 2 | 4 | 0 |
| Phase 1 | 2 | 1 | 0 | 0 |
| Phase 2 | 5 | 3 | 0 | 2 |
| Phase 3 | 8 | 5 | 2 | 1 |
| Phase 4 | 11 | 7 | 3 | 1 |
| All trials | 32 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Merck & Co. | Originator and Lead sponsor of trials | 2010 to now |
| SUN Pharmaceutical Industries | Acquired holder and Lead sponsor of trials | 2012 to now |
| Almirall | Applicant and Lead sponsor of trials | 2018 to now |