Maralixibat
As of the edition of 20 October 2026, Maralixibat is a small molecule: marketed, first approved in 2021 (US); acts on SLC10A2; US protection ends in 2031.
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
- Livmarli
- First approved
- 29 September 2021 (US)
- Approvals on record
- 8 in 3 regions
- Holder of the most recent approval
- Mirum Pharmaceuticals; 3 holders in all
- Registered trials
- 26, 2 stopped early
- Disease areas
- Digestive system; Inherited and neonatal; Heart and blood vessels; Skin and connective tissue; Lungs and airways
US protection
US protection ends in 2031.
The last listed US exclusivity ends in 2031. The application that gives this date is held by Mirum Pharmaceuticals.
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 product19 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
2 companies on route B because of this drug.
Companies on route B for this drug
In the product2 companies are on route B because of Maralixibat.
See the 2 companies 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 | 3 | 0 | 2 | 0 |
| Phase 1 | 1 | 1 | 0 | 0 |
| Phase 2 | 14 | 11 | 2 | 1 |
| Phase 3 | 7 | 4 | 2 | 1 |
| Phase 4 | 1 | 0 | 1 | 0 |
| All trials | 26 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Mirum Pharmaceuticals | Originator, Applicant and Lead sponsor of trials | 2021 to now |
| Takeda | Applicant and Lead sponsor of trials | 2023 to now |