Omaveloxolone
As of the edition of 20 October 2026, Omaveloxolone is a small molecule: marketed, first approved in 2023 (US); acts on NFE2L2; US protection ends in 2033.
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
- Skyclarys
- First approved
- 28 February 2023 (US)
- Approvals on record
- 3 in 3 regions
- Holder of the most recent approval
- BIOGEN BRASIL PRODUTOS FARMACEUTICOS LTDA; 3 holders in all
- Registered trials
- 24, 0 stopped early
- Disease areas
- Nervous system; Nutrition and metabolism; Inherited and neonatal; Cancer; Skin and connective tissue; Eye
US protection
US protection ends in 2033.
The last listed US drug-substance patent ends in 2033. The application that gives this date is held by Biogen.
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 product7 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 Omaveloxolone.
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 |
|---|---|---|
| NFE2L2 | Nuclear factor erythroid 2-related factor 2 | Q16236 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 4 | 0 | 3 | 0 |
| Phase 1 | 13 | 12 | 1 | 0 |
| Phase 2 | 6 | 6 | 0 | 0 |
| Phase 3 | 1 | 0 | 1 | 0 |
| All trials | 24 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Biogen | Applicant, Acquired holder and Lead sponsor of trials | 2018 to now |