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: C_₆H_₈O_₄

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)

Clinical Trials

Efficacy and Safety of Dimethyl Fumarate Among Patients with Mild Cognitive Impairment and Dementia Due to Alzheimer's Disease

Phase 2

Recruiting

Conditions: MCI
MCI-AD, Early Stage Alzheimer's Disease
Alzheimer's Disease

Interventions: Drug: dimethyl fumarate

First Posted Date: 2025-02-27

Last Posted Date: 2025-02-27

Lead Sponsor: Medical University of Lodz

Target Recruit Count: 30

Registration Number: NCT06850597

Locations: 🇵🇱
Department of Old Age Psychiatry and Psychotic Disorders Medical University of Lodz, Łódź, Poland

Dimethyl Fumarate in Adrenomyeloneuropathy

Phase 2

Recruiting

Conditions: Adrenomyeloneuropathy Without Cerebral Involvement

Interventions: Other: Placebo
Drug: Dimethyl fumarate

First Posted Date: 2024-07-22

Last Posted Date: 2024-07-25

Lead Sponsor: Pujol, Aurora, M.D.

Target Recruit Count: 40

Registration Number: NCT06513533

Locations: 🇪🇸
Bellvitge University Hospital, L'Hospitalet De Llobregat, Barcelona, Spain
🇪🇸
University Hospital 12 de Octubre, Madrid, Spain
🇪🇸
Donostia University Hospital, Donostia, Spain

Dimethyl Fumarate Treatment for Intracranial Unruptured Aneurysms.

Phase 4

Not yet recruiting

Conditions: Intracranial Aneurysm
Aneurysm, Brain
Inflammation Vascular

Interventions: Drug: Placebo
Drug: Dimethyl fumarate

First Posted Date: 2023-07-25

Last Posted Date: 2023-07-25

Lead Sponsor: Beijing Tiantan Hospital

Target Recruit Count: 60

Registration Number: NCT05959759

Locations: 🇨🇳
Beijing Neurosurgical Institute & Beijing Tiantan Hospital, Beijing, Beijing, China

A Study to Evaluate Long-Term Safety of Vumerity and Tecfidera in Participants With Multiple Sclerosis (MS)

Not yet recruiting

Conditions: Multiple Sclerosis

Interventions: Drug: Diroximel Fumarate
Drug: Dimethyl Fumarate
Drug: Disease-Modifying Therapies (DMTs)

First Posted Date: 2023-03-14

Last Posted Date: 2024-05-28

Lead Sponsor: Biogen

Target Recruit Count: 10500

Registration Number: NCT05767736

Locations: 🇺🇸
Research Site, Cambridge, Massachusetts, United States

Pregnancy Exposure Registry for Vumerity (Diroximel Fumarate)

Recruiting

Conditions: Multiple Sclerosis

Interventions: Drug: Avonex
Drug: Diroximel Fumarate
Drug: Dimethyl Fumarate
Biological: Tysabri

First Posted Date: 2022-12-20

Last Posted Date: 2024-06-24

Lead Sponsor: Biogen

Target Recruit Count: 908

Registration Number: NCT05658497

Locations: 🇨🇭
Inselspital, Bern, Switzerland
🇺🇸
IQVIA US Office, Durham, North Carolina, United States
🇮🇪
St Vincent's University Hospital, Dublin, Ireland

and more 2 locations

A Study of Dimethyl Fumarate (DMF) in Relapsing Forms of Multiple Sclerosis (RMS) Participants in China

Phase 4

Completed

Conditions: Multiple Sclerosis

Interventions: Drug: Dimethyl fumarate

First Posted Date: 2022-12-20

Last Posted Date: 2025-05-16

Lead Sponsor: Biogen

Target Recruit Count: 60

Registration Number: NCT05658484

Locations: 🇨🇳
Beijing Hospital, Beijing, China
🇨🇳
Xiangya Hospital Central South University, Changsha, China
🇨🇳
West China Hospital of Sichuan University, Chengdu City, China

and more 12 locations