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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)

Combination of the Immune Modulator Dimethyl Fumarate With Intraarterial Treatment in Acute Ischemic Stroke

Phase 2
Withdrawn
Conditions
Acute Ischemic Stroke
Interventions
First Posted Date
2021-05-18
Last Posted Date
2023-10-25
Lead Sponsor
Xuanwu Hospital, Beijing
Registration Number
NCT04891497

Real World Analysis on Lymphocyte Reconstitution After Lymphopenia in Participants Treated by Tecfidera

Completed
Conditions
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Interventions
First Posted Date
2021-02-16
Last Posted Date
2023-10-23
Lead Sponsor
Biogen
Target Recruit Count
1507
Registration Number
NCT04756687
Locations
🇫🇷

Research Site, Île-de-France - Salpêtrière, France

Relationship Between Oral DMT Burden and Adherence in MS

First Posted Date
2020-12-19
Last Posted Date
2022-08-31
Lead Sponsor
Monash University
Target Recruit Count
323
Registration Number
NCT04676204
Locations
🇦🇺

Monash University, Melbourne, Victoria, Australia

Randomised Evaluation of COVID-19 Therapy

Phase 3
Recruiting
Conditions
Severe Acute Respiratory Syndrome
Interventions
Drug: Lopinavir-Ritonavir
Biological: Convalescent plasma
Biological: Immunoglobulin
Drug: Corticosteroid
Drug: Synthetic neutralising antibodies
Drug: High Dose Corticosteroid
Drug: Paxlovid
Drug: Molnupiravir
First Posted Date
2020-05-11
Last Posted Date
2024-01-05
Lead Sponsor
University of Oxford
Target Recruit Count
70000
Registration Number
NCT04381936
Locations
🇻🇳

Oxford University Clinical Research Unit, Centre for Tropical Medicine, Ho Chi Minh City, Vietnam

🇬🇭

Kumasi Center for Collaborative Research in Tropical Medicine KNUST, Kumasi, Ghana

🇮🇳

Indian Council of Medical Research, Division of Epidemiology and Communicable Diseases, New Delhi, India

and more 4 locations

Dimethyl Fumarate (DMF, Tecfidera®) Persistence in RR-MS Patients Included in the French Patient Support Program OroSEP

Completed
Conditions
Multiple Sclerosis, Relapsing-Remitting
Interventions
First Posted Date
2020-01-09
Last Posted Date
2023-08-01
Lead Sponsor
Biogen
Target Recruit Count
353
Registration Number
NCT04221191
Locations
🇫🇷

Pole de Sante Du Plateau, Clamart, France

🇫🇷

Cabinet du Dr Pierre Gras, Dijon, France

🇫🇷

Cabinet médical Montebello, Lille, France

and more 59 locations

Study to Compare GI Tolerability Following Oral Administration of Bafiertam™ or Tecfidera to Healthy Volunteers

Phase 1
Completed
Conditions
Multiple Sclerosis
Interventions
First Posted Date
2019-07-17
Last Posted Date
2020-01-18
Lead Sponsor
Banner Life Sciences LLC
Target Recruit Count
210
Registration Number
NCT04022473
Locations
🇺🇸

BioPharma Services, Inc., Columbia, Missouri, United States

Study to Evaluate the Efficacy and Safety of Dimethyl Fumarate (Tecfidera) and Peginterferon Beta-1a (Plegridy) for the Treatment of Relapsing-Remitting Multiple Sclerosis in Pediatric Participants

Phase 3
Terminated
Conditions
Multiple Sclerosis, Relapsing-Remitting
Interventions
First Posted Date
2019-03-12
Last Posted Date
2023-06-15
Lead Sponsor
Biogen
Target Recruit Count
11
Registration Number
NCT03870763
Locations
🇹🇷

Research Site, Samsun, Turkey

Teriflunomide Tecfidera LMCE

Completed
Conditions
Tecfidera
Teriflunomide
Interventions
First Posted Date
2018-05-16
Last Posted Date
2021-01-06
Lead Sponsor
University at Buffalo
Target Recruit Count
120
Registration Number
NCT03526224
Locations
🇺🇸

Buffalo Neuroimaging Analysis Center, Buffalo, New York, United States

Fingolimod Versus Dimethyl-fumarate in Multiple Sclerosis

Phase 4
Terminated
Conditions
Relapsing Remitting Multiple Sclerosis
Interventions
First Posted Date
2017-11-17
Last Posted Date
2019-10-31
Lead Sponsor
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Target Recruit Count
55
Registration Number
NCT03345940
Locations
🇮🇹

Fondazione IRCCS Istituto Neurologico C. Besta, Neuroimmunology Unit, Milan, Italy

A Tolerability Study of ALKS 8700 in Subjects With Relapsing Remitting Multiple Sclerosis (RRMS) EVOLVE-MS-2

Phase 3
Completed
Conditions
Relapsing Remitting Multiple Sclerosis
Interventions
First Posted Date
2017-03-28
Last Posted Date
2020-07-14
Lead Sponsor
Biogen
Target Recruit Count
506
Registration Number
NCT03093324
Locations
🇵🇱

Alkermes Investigational Site, Szczecin, Poland

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