Berotralstat
As of the edition of 20 October 2026, Berotralstat is a small molecule: marketed, first approved in 2020 (US); acts on KLKB1; US protection ends in 2039.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2021
- Kind
- Small molecule
- Brand name
- Orladeyo
- First approved
- 3 December 2020 (US)
- Approvals on record
- 9 in 3 regions
- Holder of the most recent approval
- BioCryst Pharmaceuticals; 4 holders in all
- Registered trials
- 11, 0 stopped early
- Disease areas
- Heart and blood vessels; Immune system; Inherited and neonatal; Skin and connective tissue
US protection
US protection ends in 2039.
The last listed US drug-substance patent ends in 2039. The application that gives this date is held by BioCryst 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 product72 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 Berotralstat.
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 |
|---|---|---|
| KLKB1 | Plasma kallikrein | P03952 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 1 | 0 | 0 | 0 |
| Phase 1 | 3 | 3 | 0 | 0 |
| Phase 2 | 2 | 2 | 0 | 0 |
| Phase 3 | 5 | 3 | 2 | 0 |
| All trials | 11 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| BioCryst Pharmaceuticals | Originator and Lead sponsor of trials | 2020 to now |
| BioCryst | Applicant | 2021 to now |