Dimethyl fumarate

Generic Name: Dimethyl fumarate

Brand Names: Tecfidera, Skilarence, Dimethyl fumarate Neuraxpharm, Dimethyl fumarate Mylan, Dimethyl fumarate Accord

Drug Type: Small Molecule

Chemical Formula: C_₆H_₈O_₄

CAS Number: 624-49-7

Unique Ingredient Identifier: FO2303MNI2

Background: Dimethyl fumarate is an agent indicated for the treatment of relapsing forms of multiple sclerosis. 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, and it was the third oral disease-modifying agent for multiple sclerosis approved by the FDA, following fingolimod and teriflunomide. Prior to its FDA approval, dimethyl fumarate had been used in Germany for treatment of psoriasis.

Indication: Dimethyl fumarate is indicated for the treatment of relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.

Associated Conditions: Clinically Isolated Syndrome (CIS), Relapsing Forms of MS, Relapsing Remitting Multiple Sclerosis (RRMS), Active Secondary Progressive Multiple Sclerosis (SPMS)

Clinical Trials

Phase 3 Efficacy and Safety Study of BG00012 in Pediatric Subjects With Relapsing-remitting Multiple Sclerosis (RRMS)

Phase 3

Active, not recruiting

Conditions: Relapsing-Remitting Multiple Sclerosis

Interventions: Drug: Interferon β-1a
Drug: dimethyl fumarate

First Posted Date: 2014-11-05

Last Posted Date: 2024-07-16

Lead Sponsor: Biogen

Target Recruit Count: 156

Registration Number: NCT02283853

Locations: 🇧🇬
MHATNP 'Sv.Naum', EAD, Sofia, Bulgaria
🇮🇱
Chaim Sheba Medical Center, Ramat Gan, Israel
🇫🇷
Hopital Roger Salengro - CHU Lille, Lille Cedex, Nord, France

and more 59 locations

Restoring Glutathione Synthesis With Tecfidera: An in Vivo H-MRS Single-Arm Study at 7T in Patients With RR MS

Terminated

Conditions: Multiple Sclerosis

Interventions: Drug: Tecfidera

First Posted Date: 2014-08-18

Last Posted Date: 2016-09-05

Lead Sponsor: Yale University

Target Recruit Count: 7

Registration Number: NCT02218879

Locations: 🇺🇸
Yale University, New Haven, Connecticut, United States

Real-world Outcomes on Tecfidera (BG00012, Dimethyl Fumarate) Post-Tysabri (BG00002, Natalizumab)

Completed

Conditions: Relapsing-Remitting Multiple Sclerosis

First Posted Date: 2014-06-10

Last Posted Date: 2016-06-07

Lead Sponsor: Biogen

Target Recruit Count: 530

Registration Number: NCT02159573

Locations: 🇺🇸
Research Site, Milwaukee, Wisconsin, United States

Gastrointestinal Tolerability Study Of Dimethyl Fumarate In Participants With Relapsing-Remitting Multiple Sclerosis In Germany

Phase 4

Completed

Conditions: Relapsing-Remitting Multiple Sclerosis

Interventions: Drug: dimethyl fumarate

First Posted Date: 2014-04-29

Last Posted Date: 2017-04-18

Lead Sponsor: Biogen

Target Recruit Count: 214

Registration Number: NCT02125604

Locations: 🇩🇪
Research Site, Siegen, Germany

Vaccination Response in Tecfidera-Treated Versus Interferon-Treated Participants With Relapsing Forms of Multiple Sclerosis.

Phase 2

Completed

Conditions: Relapsing Forms of Multiple Sclerosis

Interventions: Biological: tetanus diphtheria toxoids vaccine
Drug: dimethyl fumarate
Biological: 23-valent pneumococcal polysaccharide vaccine
Drug: non-pegylated interferon
Biological: meningococcal polysaccharide diphtheria conjugate vaccine (quadrivalent)