Sebetralstat
As of the edition of 20 October 2026, Sebetralstat is a small molecule: marketed, first approved in 2025 (US); acts on KLKB1; US protection ends in 2037.
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
- Ekterly
- First approved
- 3 July 2025 (US)
- Approvals on record
- 5 in 4 regions
- Holder of the most recent approval
- Chiesi Farmaceutici; 2 holders in all
- Registered trials
- 9, 0 stopped early
- Disease areas
- Heart and blood vessels; Immune system; Inherited and neonatal; Skin and connective tissue
US protection
US protection ends in 2037.
The last listed US drug-substance patent ends in 2037. The application that gives this date is held by Chiesi Farmaceutici.
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 product6 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 Sebetralstat.
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 |
|---|---|---|
| KLKB1 | Plasma kallikrein | P03952 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 2 | 0 | 0 | 0 |
| Phase 1 | 1 | 1 | 0 | 0 |
| Phase 2 | 1 | 1 | 0 | 0 |
| Phase 3 | 4 | 4 | 0 | 0 |
| Phase 4 | 1 | 0 | 1 | 0 |
| All trials | 9 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Chiesi Farmaceutici | Originator, Applicant and Lead sponsor of trials | 2025 to now |