NDAORALCAPSULE, DELAYED RELEASE
Approved
Mar 2013
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
7/8 — Comprehensive
TECFIDERA (dimethyl fumarate) by Biogen is (dmf) exerts its therapeutic effect in multiple sclerosis is unknown. Approved for multiple sclerosis. First approved in 2013.
Drug data last refreshed Yesterday · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
TECFIDERA (dimethyl fumarate) is an oral delayed-release capsule approved in 2013 by Biogen for relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. The drug works through activation of the Nrf2 pathway, which regulates cellular response to oxidative stress, and its metabolite monomethyl fumarate acts as a nicotinic acid receptor agonist. TECFIDERA represents a foundational oral immunomodulatory therapy in the MS treatment landscape and remains a standard-of-care option for relapsing MS forms.
$0.2BPart D
9.5 years to LOEMechanism of Action
(DMF) exerts its therapeutic effect in multiple sclerosis is unknown. DMF and the metabolite, monomethyl fumarate (MMF), have been shown to activate the Nuclear factor (erythroid-derived 2)-like 2 (Nrf2) pathway in vitro and in vivo in animals and humans. The Nrf2 pathway is involved in the…
Indications (1)
Clinical Trials (20)
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)
Started Nov 2026
185 enrolled
Relapsing Forms of Multiple Sclerosis
Clinical Study for Dimethyl Fumarate in Preserving Islet β-Cell Function in Type 1 Diabetes Mellitus
Started Jan 2026
90 enrolled
Type 1 Diabetes
A Phase IV Study of Dimethyl Fumarate Enteric-coated Capsules for Relapsing Multiple Sclerosis (RMS)
Started Sep 2025
50 enrolled
Relapsing Multiple Sclerosis
A Study to Evaluate Long-Term Safety of Vumerity and Tecfidera in Participants With Multiple Sclerosis (MS)
Started Jun 2024
10,500 enrolled
Multiple Sclerosis
A Study of Dimethyl Fumarate (DMF) in Relapsing Forms of Multiple Sclerosis (RMS) Participants in China
Started Jun 2023
60 enrolled
Multiple Sclerosis
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.