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BG00012 (DMF)
BG00012 (dimethyl fumarate) activates the nuclear factor erythroid 2-related factor 2 (Nrf2) pathway to reduce oxidative stress and neuroinflammation.
BG00012 (dimethyl fumarate) activates the nuclear factor erythroid 2-related factor 2 (Nrf2) pathway to reduce oxidative stress and neuroinflammation. Used for Relapsing-remitting multiple sclerosis (RRMS), Primary progressive multiple sclerosis (PPMS).
At a glance
| Generic name | BG00012 (DMF) |
|---|---|
| Also known as | Tecfidera, DMF, dimethyl fumarate |
| Sponsor | Biogen |
| Drug class | Fumaric acid ester; immunomodulator |
| Target | Nrf2 (nuclear factor erythroid 2-related factor 2) |
| 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 anti-inflammatory genes. This reduces reactive oxygen species production and pro-inflammatory cytokine release in the central nervous system, thereby decreasing neuroinflammatory damage in multiple sclerosis. The drug also modulates immune cell populations, reducing pro-inflammatory T cells and promoting regulatory T cells.
Approved indications
- Relapsing-remitting multiple sclerosis (RRMS)
- Primary progressive multiple sclerosis (PPMS)
Common side effects
- Flushing
- Gastrointestinal disturbances (nausea, diarrhea, abdominal pain)
- Lymphopenia
- Elevated liver enzymes
- Headache
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 (DMF) CI brief — competitive landscape report
- BG00012 (DMF) updates RSS · CI watch RSS
- Biogen portfolio CI