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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
C6H8O4
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)

Efficacy and Safety Study of Oral BG00012 With Active Reference in Relapsing-Remitting Multiple Sclerosis

Phase 3
Completed
Conditions
Relapsing-Remitting Multiple Sclerosis
Interventions
First Posted Date
2007-03-23
Last Posted Date
2015-01-26
Lead Sponsor
Biogen
Target Recruit Count
1417
Registration Number
NCT00451451
Locations
🇺🇦

Research Site, Zaporozhye, Ukraine

Efficacy and Safety of Oral BG00012 in Relapsing-Remitting Multiple Sclerosis

Phase 3
Completed
Conditions
Relapsing-Remitting Multiple Sclerosis
Interventions
Drug: Placebo
First Posted Date
2007-01-11
Last Posted Date
2015-01-26
Lead Sponsor
Biogen
Target Recruit Count
1234
Registration Number
NCT00420212
Locations
🇻🇮

Research Site, Vienna, Virgin Islands (U.S.)

Efficacy and Safety of BG00012 in MS

Phase 2
Completed
Conditions
Multiple Sclerosis
First Posted Date
2005-09-15
Last Posted Date
2023-08-28
Lead Sponsor
Biogen
Target Recruit Count
260
Registration Number
NCT00168701
Locations
🇸🇪

MS Centrum, Molndal, Sweden

🇨🇿

Faculty Hospital, Hradec Kralove, Czechia

🇨🇿

General Teaching Hospital, Prague, Czechia

and more 28 locations
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