Dimethyl fumarate
As of the edition of 20 October 2026, Dimethyl fumarate is a small molecule: marketed, first approved in 2013 (US); acts on KEAP1; no US protection is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2016
- Kind
- Small molecule
- Brand name
- Tecfidera
- First approved
- 27 March 2013 (US)
- Approvals on record
- 5 in 3 regions
- Holder of the most recent approval
- Almirall; 4 holders in all
- Withdrawn from market
- 13 December 2023 (in some regions)
- Registered trials
- 82, 19 stopped early
- Disease areas
- Nervous system; Immune system; Heart and blood vessels; Skin and connective tissue; Cancer; Blood and lymph
US protection
No US protection is listed.
The FDA registers list no drug-substance patent or exclusivity that counts for this drug.
This is the US only.
Target
| Gene | Protein | UniProt |
|---|---|---|
| KEAP1 | Kelch-like ECH-associated protein 1 | Q14145 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 25 | 16 | 3 | 4 |
| Phase 1 | 8 | 7 | 0 | 1 |
| Phase 2 | 13 | 6 | 2 | 4 |
| Phase 3 | 20 | 11 | 4 | 5 |
| Phase 4 | 16 | 10 | 1 | 5 |
| All trials | 82 |