Bulevirtide
As of the edition of 20 October 2026, Bulevirtide is a protein: marketed, first approved in 2020 (EU); acts on SLC10A1; US protection ends in 2038.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2026
- Kind
- Protein
- Brand name
- Hepcludex
- First approved
- 31 July 2020 (EU)
- Approvals on record
- 2 in 2 regions
- Holder of the most recent approval
- Gilead Sciences; 2 holders in all
- Registered trials
- 17, 1 stopped early
- Disease areas
- Digestive system; Infections; Mouth and teeth
US protection
US protection ends in 2038.
US protection ends in 2038, 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 Gilead Sciences. 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.
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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 Bulevirtide.
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 |
|---|---|---|
| SLC10A1 | Hepatic sodium/bile acid cotransporter | Q14973 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 10 | 1 | 5 | 1 |
| Phase 1 | 2 | 2 | 0 | 0 |
| Phase 2 | 2 | 1 | 1 | 0 |
| Phase 3 | 3 | 1 | 2 | 0 |
| All trials | 17 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Gilead Sciences | Applicant and Lead sponsor of trials | 2020 to now |