Linerixibat
As of the edition of 20 October 2026, Linerixibat is a small molecule: marketed, first approved in 2026 (US); acts on SLC10A2; US protection ends in 2033.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2026
- Kind
- Small molecule
- Brand name
- Lynavoy
- First approved
- 17 March 2026 (US)
- Approvals on record
- 1 in 1 region
- Holder of the most recent approval
- Alfasigma
- Registered trials
- 13, 0 stopped early
- Disease areas
- Digestive system; Skin and connective tissue; Hormones; Nutrition and metabolism
US protection
US protection ends in 2033.
The last listed US exclusivity ends in 2033. The application that gives this date is held by Alfasigma.
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
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 Linerixibat.
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 |
|---|---|---|
| SLC10A2 | Ileal sodium/bile acid cotransporter | Q12908 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 1 | 0 | 0 | 0 |
| Phase 1 | 6 | 6 | 0 | 0 |
| Phase 2 | 4 | 4 | 0 | 0 |
| Phase 3 | 2 | 1 | 1 | 0 |
| All trials | 13 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Alfasigma | Originator | 2026 to now |