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Dimethyl Fumarate · Tecfidera, BG00012

Small molecule · Agonist of Nuclear factor (erythroid-derived 2)-like 2 (NFE2L2) · developed by Biogen

Approved FDA, Mar 2013

BIIB Developer

1 Registered trials

What is Dimethyl Fumarate?

Dimethyl fumarate (Tecfidera) is a small molecule that activates the Nrf2 pathway, which regulates cellular response to oxidative stress. Its metabolite monomethyl fumarate acts as a nicotinic acid receptor agonist.

Summary written with AI from the sources listed at the end of this page.

At a glance

Also known as: Tecfidera, BG00012, AZL-0211089
Drug type: Small molecule
Targets: Nuclear factor (erythroid-derived 2)-like 2 (NFE2L2), nicotinic acid receptor (HCAR2) (secondary target)
Mechanism: Agonist of Nuclear factor (erythroid-derived 2)-like 2 (NFE2L2)
Pathways: oxidative stress response
Therapy area: Neurology
Developer: Biogen (BIIB)
FDA status: Approved as Tecfidera (March 27, 2013), NDA204063 · FDA label
UNII: FO2303MNI2

✅ FDA-approved uses

Relapsing forms of multiple sclerosis

From the indications section of the FDA label (version of Jun 4, 2025). Read the full label for the exact wording, limitations and safety information.

🧪 Clinical trials

Trial	Phase	Condition	Status	Sponsor
NCT02283853	Phase 3	Relapsing-Remitting Multiple Sclerosis	Completed	BIIB

Trials of the companies BioRadar tracks, from ClinicalTrials.gov, most advanced phase first.

Conditions studied

Relapsing-Remitting Multiple Sclerosis

Other drugs acting on NFE2L2

Diroximel Fumarate FDA approved Omaveloxolone FDA approved

More from Biogen

Diroximel Fumarate FDA approved Interferon Beta-1A FDA approved Natalizumab FDA approved Nusinersen FDA approved Omaveloxolone FDA approved Tofersen FDA approved Zuranolone FDA approved BIIB115 Phase 1 BIIB122 Phase 3 BIIB144 Phase 1 BIIB147 Phase 1/2 Diranersen Phase 2

Sources

Updated Oct 3, 2026. Something wrong or missing? Report it on the BIIB page.

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Data: FDA (Drugs@FDA, Purple Book, DailyMed), NIH (NCI Thesaurus, GSRS, RxNorm), ClinicalTrials.gov • Informational purposes only, not medical or investment advice. • All drugs A–Z