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)
Biogen Multiple Sclerosis Pregnancy Exposure Registry
- Conditions
- Multiple SclerosisExposure During Pregnancy
- Interventions
- First Posted Date
- 2013-07-30
- Last Posted Date
- 2022-06-21
- Lead Sponsor
- Biogen
- Target Recruit Count
- 408
- Registration Number
- NCT01911767
- Locations
- 🇬🇧
Research Site, Salford, Greater Manchester, United Kingdom
Effectiveness of DMF and Its Impact on PROs in Suboptimal GA Responders With RMS
- First Posted Date
- 2013-07-19
- Last Posted Date
- 2016-07-25
- Lead Sponsor
- Biogen
- Target Recruit Count
- 333
- Registration Number
- NCT01903291
- Locations
- 🇺🇸
Research Site, Neenah, Wisconsin, United States
An Efficacy and Safety Study of BG00012 (Dimethyl Fumarate) in Asian Subjects With Relapsing Remitting Multiple Sclerosis (RRMS)
- Conditions
- Relapsing-Remitting Multiple SclerosisMultiple Sclerosis
- Interventions
- Drug: Placebo
- First Posted Date
- 2013-04-24
- Last Posted Date
- 2018-11-20
- Lead Sponsor
- Biogen
- Target Recruit Count
- 225
- Registration Number
- NCT01838668
- Locations
- 🇨🇳
National Taiwan University Hospital, Taipei, Taiwan
🇵🇱Miedzyleski Szpital Specjalistyczny, Warszawa, Poland
🇵🇱Nzoz Novo-Med, Katowice, Poland
Efficacy Study on Dimethyl Fumarate to Treat Moderate to Severe Plaque Psoriasis
- Conditions
- Plaque Psoriasis
- Interventions
- First Posted Date
- 2013-03-21
- Last Posted Date
- 2016-08-09
- Lead Sponsor
- Forward-Pharma GmbH
- Registration Number
- NCT01815723
- Locations
- 🇨🇦
Probity Medical Research, Waterloo, Ontario, Canada
LAS41008 in Moderate to Severe Chronic Plaque Psoriasis
- First Posted Date
- 2012-11-15
- Last Posted Date
- 2015-12-02
- Lead Sponsor
- Almirall, S.A.
- Target Recruit Count
- 839
- Registration Number
- NCT01726933
- Locations
- 🇳🇱
Investigatives site names will not be disclosed to avoid competitive information. Specify at least one site as follows: Almirall Investigative Site, Various, Netherlands
🇵🇱Investigatives site names will not be disclosed to avoid competitive information. Specify at least one site as follows:Almirall Investigative Site #, Various, Poland
BG00012 Phase 2 Combination Study in Participants With Multiple Sclerosis
- Conditions
- Relapsing-Remitting Multiple SclerosisMultiple Sclerosis
- Interventions
- First Posted Date
- 2010-07-02
- Last Posted Date
- 2017-03-21
- Lead Sponsor
- Biogen
- Target Recruit Count
- 108
- Registration Number
- NCT01156311
- Locations
- 🇺🇸
Research Site, Milwaukee, Wisconsin, United States
Pharmacokinetics Profile Study of BG00012 Standard Formulation and BG00012 Active Pharmaceutical Ingredient
- First Posted Date
- 2010-02-17
- Last Posted Date
- 2010-02-17
- Lead Sponsor
- Biogen
- Target Recruit Count
- 14
- Registration Number
- NCT01069913
A 24-Hour Pharmacokinetic Determination of BG00012 After Single-Day Oral Administration in Subjects With MS
- First Posted Date
- 2009-02-05
- Last Posted Date
- 2018-02-15
- Lead Sponsor
- Biogen
- Target Recruit Count
- 48
- Registration Number
- NCT00837785
- Locations
- 🇩🇪
Research Site, Berlin, Germany
BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS)
- Conditions
- Relapsing-Remitting Multiple Sclerosis
- Interventions
- Drug: Placebo
- First Posted Date
- 2009-02-04
- Last Posted Date
- 2020-12-31
- Lead Sponsor
- Biogen
- Target Recruit Count
- 1736
- Registration Number
- NCT00835770
- Locations
- 🇬🇧
Research Site, Stoke on Trent, United Kingdom
🇺🇸research Site, Mesa, Arizona, United States
Efficacy and Safety Study of BG00012 With Methotrexate in Patients With Active Rheumatoid Arthritis
- First Posted Date
- 2008-12-18
- Last Posted Date
- 2013-09-16
- Lead Sponsor
- Biogen
- Target Recruit Count
- 153
- Registration Number
- NCT00810836
- Locations
- 🇸🇰
Research Site, Piestany, Slovakia
Drug Development Updates
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