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BG00012 (dimethyl fumarate)
Dimethyl fumarate activates the nuclear factor erythroid 2-related factor 2 (Nrf2) pathway, which reduces oxidative stress and inflammatory responses in immune cells.
Dimethyl fumarate activates the nuclear factor erythroid 2-related factor 2 (Nrf2) pathway, which reduces oxidative stress and inflammatory responses in immune cells. Used for Relapsing-remitting multiple sclerosis (RRMS), Relapsing forms of multiple sclerosis.
At a glance
| Generic name | BG00012 (dimethyl fumarate) |
|---|---|
| Also known as | BG-12, oral fumarate, DMF |
| Sponsor | Biogen |
| Drug class | Fumaric acid ester; immunomodulator |
| Target | Nrf2 (nuclear factor erythroid 2-related factor 2) |
| Modality | Small molecule |
| Therapeutic area | Immunology; Neurology |
| Phase | Phase 3 |
Mechanism of action
Dimethyl fumarate (DMF) is a fumaric acid ester that crosses cell membranes and activates Nrf2, a transcription factor that upregulates antioxidant and cytoprotective genes. This leads to reduced production of pro-inflammatory cytokines and a shift in immune cell populations toward anti-inflammatory phenotypes. The drug also has direct effects on dendritic cells and T cells, suppressing their pro-inflammatory activity.
Approved indications
- Relapsing-remitting multiple sclerosis (RRMS)
- Relapsing forms of multiple sclerosis
Common side effects
- Flushing
- Gastrointestinal disturbances (nausea, diarrhea, abdominal pain)
- Lymphopenia
- Headache
- Proteinuria
Key clinical trials
- A Study to Learn About the Safety of Diroximel Fumarate (DRF) and Dimethyl Fumarate (DMF) and Their Effects on Relapses in Pediatric Participants With Relapsing Forms of Multiple Sclerosis (RMS) (PHASE3)
- Effect of Anti-Psoriatic Biologics on Risk of Anogenital Warts (CONDYPSO)
- A Non-interventional Study Evaluating Clinical Utility and Implications on Improved Patient Management of Serum Neurofilament as a Prognostic Marker for Disease Activity in Patients With Relapsing Multiple Sclerosis
- A NIS Evaluating Various Injectable and Oral Treatments in Patients With Relapsing Multiple Sclerosis
- Clinical Study for Dimethyl Fumarate in Preserving Islet β-Cell Function in Type 1 Diabetes Mellitus (PHASE3)
- Open Label Randomized Multicenter to Assess Efficacy & Tolerability of Ofatumumab 20mg vs. First Line DMT in RMS (PHASE3)
- Study of the Mechanisms of Action of Cladribine in Multiple Sclerosis (NA)
- Long-Term Analysis of DImethyl Fumarate, to Slow the Growth of Areas of Geographic Atrophy (PHASE2)
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 |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- BG00012 (dimethyl fumarate) CI brief — competitive landscape report
- BG00012 (dimethyl fumarate) updates RSS · CI watch RSS
- Biogen portfolio CI