monomethyl fumarate
Trade name: Tecfidera
Approved
Nov 16, 2018
Dimethyl fumarate (DMF) is the methyl ester of fumaric acid. DMF was initially recognized as a very effective hypoxic cell radiosensitizer. Later, DMF combined with three other fumaric acid esters (FAE) was licensed in Germany as oral therapy for psoriasis (trade name Fumaderm). Phase III clinical trials found that DMF (BG-12) successfully reduced relapse rate and increased time to progression of disability in multiple sclerosis (trade name Tecfidera). DMF is thought to have immunomodulatory properties without significant immunosuppression. The mechanism of action of dimethyl fumarate in multiple sclerosis is not well understood. It is thought to involve dimethyl fumarate degradation to its active metabolite monomethyl fumarate (MMF) then MMF up-regulates the Nuclear factor (erythroid-derived 2)-like 2 (Nrf2) pathway that is activated in response to oxidative stress. Dimethyl fumarate is marketed under the brand name Tecfidera. — NCATS
Clinical trial activity
3 trials · 2 clinical orgs · 2 marketing orgs
Earliest trial started Jan 6, 2017 (NCT04570670)
Timeline
2010s
- Mar 27, 2013
Biogen-IDEC — First NDA Organization
- Mar 27, 2013
Biogen-IDEC — NDA Organization
- Jan 1, 2017
Banner Life Sciences LLC — Earliest Phase 1 Sponsor(trial)
- Nov 16, 2018
Earliest FDA Approval
- Nov 16, 2018
Banner Life Sciences LLC — Marketing Organization
2020s
- Apr 28, 2020
Banner Life Sciences LLC — NDA Secondary Org
Indications
Approved for
Mechanism of action
- Sphingosine-1-phosphate receptor 1ANTAGONIST
S1PR1 antagonist
Approval history
- approvedNov 16, 2018
Chemistry & pharmacology
SMILES
COC(=O)\C=C\C(O)=O- Mol. weight
- 130.0987 g/mol
Oral
No
Parenteral
No
Topical
No
Sources
- WikipediaMonomethyl fumarate ↗
- NCATS45IUB1PX8R ↗
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT05181215 | Phase 1 | May 14, 2021 | Banner Life Sciences LLC |
| NCT04022473 | Phase 1 | Jul 7, 2019 | Banner Life Sciences LLC, BioPharma Services |
| NCT04570670 | Phase 1 | Jan 6, 2017 | Banner Life Sciences LLC |
Organizations
Research & Development (2)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Banner Life Sciences LLC | For profit | 3 | 3 | 1 | 2017 |
| BioPharma Services | For profit | 1 | 0 | 1 | 2019 |
Marketing (4)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Banner Life Sciences LLC | For profit | SYN | Apr 28, 2020 |
| Banner Life Sciences LLC | For profit | MKTG | Nov 16, 2018 |
| Banner Life Sciences LLC | For profit | NDA2 | Apr 28, 2020 |
| Biogen-IDEC | For profit | NDA | Mar 27, 2013 |