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)
Investigating Indirect Mechanism of Neuroprotection of Tecfidera® (Dimethyl Fumarate) in RRMS and Progressive Patients
- First Posted Date
- 2017-03-28
- Last Posted Date
- 2018-03-22
- Lead Sponsor
- Multiple Sclerosis Center of Northeastern New York
- Target Recruit Count
- 57
- Registration Number
- NCT03092544
- Locations
- 🇺🇸
Multiple Sclerosis Center of Northeastern New York, Latham, New York, United States
A Study of Efficacy and Safety of M2951 in Participants With Relapsing Multiple Sclerosis
- Conditions
- Relapsing-remitting Multiple Sclerosis
- Interventions
- First Posted Date
- 2016-11-29
- Last Posted Date
- 2025-05-14
- Target Recruit Count
- 267
- Registration Number
- NCT02975349
- Locations
- 🇺🇦
Research Site, Zaporizhzhia, Ukraine
🇧🇬Research Site 1, Pleven, Bulgaria
🇧🇬Research Site 2, Pleven, Bulgaria
Study of Utilization Patterns of Dimethyl Fumarate in Germany
- First Posted Date
- 2016-11-21
- Last Posted Date
- 2017-07-19
- Lead Sponsor
- Biogen
- Target Recruit Count
- 930
- Registration Number
- NCT02969304
- Locations
- 🇩🇪
Research Site, Leipzig, Saxony, Germany
Dimethyl Fumarate Treatment of Primary Progressive Multiple Sclerosis
- Conditions
- Primary Progressive Multiple Sclerosis
- Interventions
- Drug: Placebo
- First Posted Date
- 2016-11-09
- Last Posted Date
- 2020-12-24
- Lead Sponsor
- Rigshospitalet, Denmark
- Target Recruit Count
- 54
- Registration Number
- NCT02959658
- Locations
- 🇩🇰
Danish Multiple Sclerosis Center, Department of neurology, Copenhagen, Denmark
Monitoring of Patients Followed for a Multiple Sclerosis and Treated by Dimethyl-fumarate
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Interventions
- First Posted Date
- 2016-09-15
- Last Posted Date
- 2019-01-09
- Lead Sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Target Recruit Count
- 11
- Registration Number
- NCT02901106
- Locations
- 🇫🇷
Fondation Ophtalmique Adolphe de Rothschild, Paris, France
Patient Real-world Clinical, Neurological, Tolerability, and Safety Outcomes for Tecfidera® and Rebif®
- First Posted Date
- 2016-07-06
- Last Posted Date
- 2018-03-01
- Lead Sponsor
- IMS HEALTH GmbH & Co. OHG
- Target Recruit Count
- 479
- Registration Number
- NCT02823951
- Locations
- 🇺🇸
Savannah Neurology Specialists, Savannah, Georgia, United States
🇺🇸Northshore University, Evanston, Illinois, United States
🇺🇸Washington university, Saint Louis, Missouri, United States
Dimethylfumarate (DMF) in Relapsed/Refractory CLL/SLL
- Conditions
- Chronic Lymphocytic LeukemiaSmall Lymphocytic Lymphoma
- Interventions
- First Posted Date
- 2016-05-27
- Last Posted Date
- 2019-09-19
- Lead Sponsor
- Michael Choi
- Target Recruit Count
- 2
- Registration Number
- NCT02784834
- Locations
- 🇺🇸
UC San Diego Moores Cancer Center, La Jolla, California, United States
RItuximab Versus FUmarate in Newly Diagnosed Multiple Sclerosis.
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Interventions
- First Posted Date
- 2016-04-21
- Last Posted Date
- 2021-10-12
- Lead Sponsor
- Anders Svenningsson
- Target Recruit Count
- 200
- Registration Number
- NCT02746744
- Locations
- 🇸🇪
Fredrik Piehl, Stockholm, Sweden
🇸🇪South Älvsborg Hospital, Borås, Sweden
🇸🇪Falun Hospital, Falun, Sweden
Assessment of Tecfidera® in Radiologically Isolated Syndrome (RIS)
- First Posted Date
- 2016-04-15
- Last Posted Date
- 2022-05-11
- Lead Sponsor
- University of Texas Southwestern Medical Center
- Target Recruit Count
- 87
- Registration Number
- NCT02739542
- Locations
- 🇺🇸
Johns Hopkins University - Neurology, Baltimore, Maryland, United States
🇺🇸Keck School of Medicine - USC - Department of Neurology, Los Angeles, California, United States
🇺🇸Mayo Clinic Department of Neurology, Rochester, Minnesota, United States
Impact of Tecfidera on Gut Microbiota
- Conditions
- Multiple Sclerosis
- First Posted Date
- 2016-04-13
- Last Posted Date
- 2016-11-04
- Lead Sponsor
- Virginia Simnad
- Target Recruit Count
- 25
- Registration Number
- NCT02736279
- Locations
- 🇺🇸
EvergreenHealth MS Center, Kirkland, Washington, United States
Drug Development Updates
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