Cravacitinib
As of the edition of 20 October 2026, Cravacitinib is a small molecule: marketed, first approved in 2022 (US); acts on TYK2; US protection ends in 2033.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2023
- Kind
- Small molecule
- Brand name
- Sotyktu
- First approved
- 9 September 2022 (US)
- Approvals on record
- 5 in 4 regions
- Holder of the most recent approval
- Bristol Myers Squibb
- Registered trials
- 90, 11 stopped early
- Disease areas
- Skin and connective tissue; Immune system; Bones, joints and muscles; Digestive system; Urinary and reproductive; Blood and lymph
US protection
US protection ends in 2033.
The last listed US drug-substance patent ends in 2033. The application that gives this date is held by Bristol Myers Squibb.
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 product5 listings count 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 Cravacitinib.
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 |
|---|---|---|
| TYK2 | Non-receptor tyrosine-protein kinase TYK2 | P29597 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 13 | 0 | 11 | 2 |
| Phase 1 | 31 | 30 | 0 | 1 |
| Phase 2 | 20 | 9 | 5 | 6 |
| Phase 3 | 14 | 5 | 9 | 0 |
| Phase 4 | 12 | 5 | 5 | 2 |
| All trials | 90 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Bristol Myers Squibb | Originator and Lead sponsor of trials | 2015 to now |