monomethyl fumarate

Trade name: Tecfidera

Small moleculeapproved

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

Phase 1
3
Phase 2
0
Phase 3
0
Phase 4
0

Earliest trial started Jan 6, 2017 (NCT04570670)

Timeline

2010s

  1. Mar 27, 2013

    Biogen-IDEC — First NDA Organization

  2. Mar 27, 2013

    Biogen-IDEC — NDA Organization

  3. Jan 1, 2017

    Banner Life Sciences LLC — Earliest Phase 1 Sponsor(trial)

  4. Nov 16, 2018

    Earliest FDA Approval

  5. Nov 16, 2018

    Banner Life Sciences LLC — Marketing Organization

2020s

  1. Apr 28, 2020

    Banner Life Sciences LLC — NDA Secondary Org

Indications

Mechanism of action

Approval history

  • approvedNov 16, 2018

Chemistry & pharmacology

Loading structure…

SMILES

COC(=O)\C=C\C(O)=O
Mol. weight
130.0987 g/mol

Oral

No

Parenteral

No

Topical

No

Sources

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT05181215Phase 1May 14, 2021Banner Life Sciences LLC
NCT04022473Phase 1Jul 7, 2019Banner Life Sciences LLC, BioPharma Services
NCT04570670Phase 1Jan 6, 2017Banner Life Sciences LLC
Showing 3 of 3 trials
Page 1 / 1

Organizations

Research & Development (2)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Banner Life Sciences LLCFor profit3312017
BioPharma ServicesFor profit1012019
2 organizations
Page 1 / 1

Marketing (4)

OrganizationOrg typeRelationshipDate
Banner Life Sciences LLCFor profitSYNApr 28, 2020
Banner Life Sciences LLCFor profitMKTGNov 16, 2018
Banner Life Sciences LLCFor profitNDA2Apr 28, 2020
Biogen-IDECFor profitNDAMar 27, 2013