Monomethyl fumarate
As of the edition of 20 October 2026, Monomethyl fumarate is a small molecule: marketed, first approved in 2020 (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 2020
- Kind
- Small molecule
- Brand name
- Bafiertam
- First approved
- 28 April 2020 (US)
- Approvals on record
- 1 in 1 region
- Holder of the most recent approval
- Banner Life Sciences
- Registered trials
- 5, 2 stopped early
- Disease areas
- Immune system; Nervous system
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.
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 Monomethyl fumarate.
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 |
|---|---|---|
| KEAP1 | Kelch-like ECH-associated protein 1 | Q14145 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 2 | 0 | 0 | 2 |
| Phase 1 | 3 | 3 | 0 | 0 |
| All trials | 5 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Banner Life Sciences | Originator and Lead sponsor of trials | 2017 to now |