Trifarotene
As of the edition of 20 October 2026, Trifarotene is a small molecule: marketed, first approved in 2019 (US); acts on RARG; US protection ends in 2031.
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
- Aklief
- First approved
- 4 October 2019 (US)
- Approvals on record
- 4 in 4 regions
- Holder of the most recent approval
- Galderma Brasil Ltda; 4 holders in all
- Registered trials
- 12, 0 stopped early
- Disease areas
- Skin and connective tissue; Blood and lymph; Cancer; Immune system
US protection
US protection ends in 2031.
The last listed US drug-substance patent ends in 2031. The application that gives this date is held by Galderma.
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
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 Trifarotene.
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 |
|---|---|---|
| RARG | Retinoic acid receptor gamma | P13631 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase 1 | 3 | 3 | 0 | 0 |
| Phase 3 | 6 | 5 | 1 | 0 |
| Phase 4 | 3 | 3 | 0 | 0 |
| All trials | 12 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Galderma | Acquired holder | 2020 to now |
| Galderma Brasil Ltda | Applicant | 2025 to now |