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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

Overview

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.

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)

FDA Approved Products

Dimethyl Fumarate
Manufacturer:SOLA Pharmaceuticals, LLC
Route:ORAL
Strength:120 mg in 1 1
Approved: 2023/05/04
NDC:70512-852
DIMETHYL FUMARATE
Manufacturer:Accord Healthcare Inc.
Route:ORAL
Strength:240 mg in 1 1
Approved: 2023/08/31
NDC:16729-417
TECFIDERA
Manufacturer:Biogen Inc.
Route:ORAL
Strength:120 mg in 1 1
Approved: 2022/08/19
NDC:64406-005
Dimethyl fumarate
Manufacturer:Ascend Laboratories, LLC
Route:ORAL
Strength:120 mg in 1 1
Approved: 2023/05/19
NDC:67877-555
TECFIDERA
Manufacturer:Biogen Inc.
Route:ORAL
Strength:240 mg in 1 1
Approved: 2022/08/19
NDC:64406-006

Singapore Approved Products

TECFIDERA GASTRO-RESISTANT HARD CAPSULES 240 MG
Manufacturer:Corden Pharma Fribourg SA, JANSSEN CILAG S.P.A
Form:CAPSULE, ENTERIC COATED
Strength:240.0 mg
Online:Yes
Approved: 2016/07/26
Approval:SIN15054P
TECFIDERA GASTRO-RESISTANT HARD CAPSULES 120 MG
Manufacturer:Corden Pharma Fribourg SA, JANSSEN CILAG S.P.A. (Primary and Secondary Packaging)
Form:CAPSULE, ENTERIC COATED
Strength:120.0mg
Online:Yes
Approved: 2016/07/26
Approval:SIN15053P

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