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BG00012 (DMF) (Tecfidera®.)
BG00012 (dimethyl fumarate) activates the nuclear factor erythroid 2-related factor 2 (Nrf2) pathway to reduce oxidative stress and modulate immune responses in the central nervous system.
BG00012 (dimethyl fumarate) activates the nuclear factor erythroid 2-related factor 2 (Nrf2) pathway to reduce oxidative stress and modulate immune responses in the central nervous system. Used for Relapsing-remitting multiple sclerosis (RRMS), Secondary progressive multiple sclerosis (SPMS) with relapses.
At a glance
| Generic name | BG00012 (DMF) (Tecfidera®.) |
|---|---|
| Sponsor | Multiple Sclerosis Center of Northeastern New York |
| Drug class | Fumaric acid ester; Nrf2 activator |
| Target | Nuclear factor erythroid 2-related factor 2 (Nrf2) |
| Modality | Small molecule |
| Therapeutic area | Neurology; Immunology |
| Phase | FDA-approved |
Mechanism of action
Dimethyl fumarate is a fumaric acid ester that crosses the blood-brain barrier and activates Nrf2, a transcription factor that upregulates antioxidant and cytoprotective genes. This reduces neuroinflammation and oxidative stress in multiple sclerosis lesions. Additionally, DMF modulates immune cell populations, reducing pro-inflammatory T cells and promoting regulatory immune responses.
Approved indications
- Relapsing-remitting multiple sclerosis (RRMS)
- Secondary progressive multiple sclerosis (SPMS) with relapses
Common side effects
- Flushing
- Gastrointestinal distress (nausea, diarrhea, abdominal pain)
- Lymphopenia
- Elevated liver enzymes
- Headache
Key clinical trials
- A Trial Comparing the Efficacy of Subcutaneous Injections of Brodalumab to Oral Administrations of Fumaric Acid Esters in Adults With Moderate to Severe Plaque Psoriasis (PHASE4)
- Covid-19 Vaccine Immune Response in Multiple Sclerosis
- Exploring the Immune Response to SARS-CoV-2 modRNA Vaccines in Patients With Secondary Progressive Multiple Sclerosis (AMA-VACC) (PHASE4)
- Effectiveness and Safety of Generic Delayed-Release Dimethyl Fumarate (Sclera® or Marovarex ®, Hikma) in Routine Medical Practice in the Treatment of Relapsing-Remitting Multiple Sclerosis in MENA Region
- Targeting the Gut Dysbiosis to Treat Inflammation-driven Synaptopathy in MS (NA)
- Dimethyl Fumarate (DMF, Tecfidera®) Persistence in RR-MS Patients Included in the French Patient Support Program OroSEP
- Comparative Bioavailability of BAFIERTAM™ (Monomethyl Fumarate) and Tecfidera® (Dimethyl Fumarate) in Healthy Subjects (PHASE1)
- Efficacy and Safety of Tildrakizumab in Participants With Moderate-to-Severe Chronic Plaque Psoriasis Who Are Non-Responders to Dimethyl Fumarate Therapy (PHASE4)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
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