Acoltremon
As of the edition of 20 October 2026, Acoltremon is a small molecule: marketed, first approved in 2025 (US); acts on TRPM8; US protection ends in 2030.
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
- Tryptyr
- First approved
- 28 May 2025 (US)
- Approvals on record
- 1 in 1 region
- Holder of the most recent approval
- Alcon
- Registered trials
- 16, 0 stopped early
- Disease areas
- Eye
US protection
US protection ends in 2030.
The last listed US exclusivity ends in 2030. The application that gives this date is held by Alcon.
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 Acoltremon.
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 |
|---|---|---|
| TRPM8 | Transient receptor potential cation channel subfamily M member 8 | Q7Z2W7 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 2 | 0 | 2 | 0 |
| Phase 2 | 2 | 1 | 0 | 0 |
| Phase 3 | 6 | 6 | 0 | 0 |
| Phase 4 | 6 | 0 | 6 | 0 |
| All trials | 16 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Alcon | Originator and Lead sponsor of trials | 2020 to now |