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)
Investigation of the Effect of Dimethyl Fumarate on T Cells in Patients With Relapsing Remitting Multiple Sclerosis
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Interventions
- First Posted Date
- 2015-06-03
- Last Posted Date
- 2018-10-11
- Lead Sponsor
- University Hospital Muenster
- Target Recruit Count
- 67
- Registration Number
- NCT02461069
- Locations
- 🇩🇪
University Hospital Muenster, Department of Neurology, Muenster, Germany
🇩🇪Neurologische Univ.-Klinik, Heidelberg, Germany
🇩🇪Klinik und Poliklinik für Neurologie, Universitätsklinikum Mainz, Mainz, Germany
Dimethyl Fumarate for Obstructive Sleep Apnea
- Conditions
- Obstructive Sleep ApneaOSASleep Apnea
- Interventions
- Drug: Placebo
- First Posted Date
- 2015-05-08
- Last Posted Date
- 2017-05-31
- Lead Sponsor
- University of Michigan
- Target Recruit Count
- 65
- Registration Number
- NCT02438137
- Locations
- 🇺🇸
University of Michigan, Ann Arbor, Michigan, United States
BG00012 and Delay of Disability Progression in Secondary Progressive Multiple Sclerosis
- Conditions
- Multiple Sclerosis, Secondary Progressive
- Interventions
- Other: Placebo
- First Posted Date
- 2015-04-30
- Last Posted Date
- 2017-04-26
- Lead Sponsor
- Biogen
- Target Recruit Count
- 58
- Registration Number
- NCT02430532
- Locations
- 🇸🇰
Research Site, Banska Bystrica, Slovakia
Placebo-Controlled Study of the Efficacy and Safety of BG00012 in Pediatric Subjects With Relapsing-Remitting Multiple Sclerosis (RRMS)
- Conditions
- Relapsing-Remitting Multiple SclerosisRelapsing Forms of Multiple Sclerosis
- Interventions
- Drug: Placebo
- First Posted Date
- 2015-04-28
- Last Posted Date
- 2016-04-13
- Lead Sponsor
- Biogen
- Registration Number
- NCT02428218
Tecfidera Slow-Titration Study
- First Posted Date
- 2015-04-28
- Last Posted Date
- 2017-05-05
- Lead Sponsor
- Biogen
- Target Recruit Count
- 62
- Registration Number
- NCT02428231
- Locations
- 🇮🇹
Research Site, Montichiari, Italy
Study of Montelukast on Gastrointestinal Tolerability in Patients With Relapsing Forms of Multiple Sclerosis Receiving Tecfidera
- Conditions
- Multiple Sclerosis
- Interventions
- First Posted Date
- 2015-04-07
- Last Posted Date
- 2020-03-31
- Lead Sponsor
- Biogen
- Target Recruit Count
- 102
- Registration Number
- NCT02410278
- Locations
- 🇺🇸
Research Site, Madison, Wisconsin, United States
Study of the Effect of BG00012 on MRI Lesions and Pharmacokinetics in Pediatric Subjects With RRMS
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Interventions
- First Posted Date
- 2015-04-07
- Last Posted Date
- 2017-10-23
- Lead Sponsor
- Biogen
- Target Recruit Count
- 22
- Registration Number
- NCT02410200
- Locations
- 🇹🇷
Research Site, Ankara, Turkey
Study to Evaluate Whether a Medication Event Monitoring System (MEMS) Can Improve Adherence to Tecfidera Treatment in Multiple Sclerosis Patients.
- Conditions
- Multiple Sclerosis
- Interventions
- Device: Medication Event Monitoring System (MEMS)Behavioral: Adherence counseling
- First Posted Date
- 2015-01-21
- Last Posted Date
- 2017-05-16
- Lead Sponsor
- Biogen
- Target Recruit Count
- 84
- Registration Number
- NCT02343159
- Locations
- 🇺🇸
Research Site, Winchester, Virginia, United States
Dimethyl Fumarate, Temozolomide, and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
- Conditions
- Adult Brain GlioblastomaAdult Giant Cell GlioblastomaAdult Gliosarcoma
- Interventions
- First Posted Date
- 2015-01-13
- Last Posted Date
- 2019-06-28
- Lead Sponsor
- Virginia Commonwealth University
- Target Recruit Count
- 12
- Registration Number
- NCT02337426
- Locations
- 🇺🇸
Virginia Commonwealth University/Massey Cancer Center, Richmond, Virginia, United States
Effectiveness of DMF (Dimethyl Fumarate) and Its Impact on PROs (Patient Reported Outcomes) in Treatment-Naive or Suboptimal IFN (Interferon) or GA (Glatiramer Acetate) Responders With RRMS (ImPROve)
- Conditions
- Multiple Sclerosis, Relapsing-RemittingRelapsing-Remitting Multiple Sclerosis
- Interventions
- First Posted Date
- 2014-12-23
- Last Posted Date
- 2016-04-08
- Lead Sponsor
- Biogen
- Target Recruit Count
- 24
- Registration Number
- NCT02323269
- Locations
- 🇨🇦
Research Site, Montreal, Quebec, Canada
Drug Development Updates
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