Lotilaner
As of the edition of 20 October 2026, Lotilaner is a small molecule: marketed, first approved in 2023 (US); US protection ends in 2030.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2023
- Kind
- Small molecule
- Brand name
- Xdemvy
- First approved
- 24 July 2023 (US)
- Approvals on record
- 1 in 1 region
- Holder of the most recent approval
- Tarsus Pharmaceuticals
- Registered trials
- 10, 0 stopped early
- Disease areas
- Eye; Skin and connective tissue; Infections
US protection
US protection ends in 2030.
The last listed US drug-substance patent ends in 2030. The application that gives this date is held by Tarsus 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 product2 listings count towards this date. The exact date and each listing are in the product.
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Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase 1 | 3 | 3 | 0 | 0 |
| Phase 2 | 3 | 2 | 1 | 0 |
| Phase 3 | 2 | 2 | 0 | 0 |
| Phase 4 | 2 | 1 | 1 | 0 |
| All trials | 10 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Tarsus Pharmaceuticals | Originator and Lead sponsor of trials | 2020 to now |