Diroximel fumarate
As of the edition of 20 October 2026, Diroximel fumarate is a small molecule: marketed, first approved in 2019 (US); acts on KEAP1; US protection ends in 2033.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2021
- Kind
- Small molecule
- Brand name
- Vumerity
- First approved
- 29 October 2019 (US)
- Approvals on record
- 2 in 2 regions
- Holder of the most recent approval
- Biogen; 2 holders in all
- Registered trials
- 14, 2 stopped early
- Disease areas
- Immune system; Nervous system; Heart and blood vessels; Mental health
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 product2 listings count towards this date. The exact date and each listing are in the product.
See the exact date and the 2 listings behind itRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| KEAP1 | Kelch-like ECH-associated protein 1 | Q14145 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 8 | 0 | 5 | 2 |
| Phase 1 | 2 | 1 | 1 | 0 |
| Phase 3 | 4 | 3 | 1 | 0 |
| All trials | 14 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Biogen | Originator, Applicant and Lead sponsor of trials | 2015 to now |