NDAORALCAPSULE, DELAYED RELEASE2 Generics Approved
Approved
Mar 2013
Lifecycle
Peak
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
4/8 — Partial
Drug data last refreshed 12h ago · AI intelligence enriched 4d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
TECFIDERA (dimethyl fumarate) is an oral, delayed-release small molecule immunomodulator approved in 2013 for relapsing-remitting multiple sclerosis (RRMS). It reduces disease activity and slows disability progression in MS patients by modulating immune cell function. The drug is currently in peak commercial performance with strong market penetration.
$0.235BPart D
PeakStable
9.1 years to LOETECFIDERA remains a revenue-generating peak franchise with significant commercial infrastructure; expect stable team size focused on market defense and patient retention.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
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.