Ritlecitinib
As of the edition of 20 October 2026, Ritlecitinib is a small molecule: marketed, first approved in 2023 (US); acts on BMX, BTK and ITK and 3 more; US protection ends in 2041.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2025
- Kind
- Small molecule
- Brand name
- Litfulo
- First approved
- 23 June 2023 (US)
- Approvals on record
- 6 in 5 regions
- Holder of the most recent approval
- Pfizer; 2 holders in all
- Registered trials
- 54, 4 stopped early
- Disease areas
- Skin and connective tissue; Immune system; Digestive system; Blood and lymph; Bones, joints and muscles; Cancer
US protection
US protection ends in 2041.
The last listed US drug-substance patent ends in 2041. The application that gives this date is held by Pfizer.
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 product3 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
5 company-target rows on route B because of this drug.
Companies on route B for this drug
In the product5 company-target rows are on route B because of Ritlecitinib.
See the 5 company-target rows on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Targets
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 8 | 2 | 5 | 0 |
| Phase 1 | 25 | 24 | 0 | 1 |
| Phase 2 | 14 | 7 | 4 | 3 |
| Phase 3 | 7 | 3 | 4 | 0 |
| All trials | 54 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Pfizer | Originator, Applicant and Lead sponsor of trials | 2022 to now |