TECFIDERA
Tecfidera (dimethyl fumarate) is indicated for the treatment of relapsing forms of multiple sclerosis (MS) in adult patients. The medication is used to manage specific disease courses, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. It provides a therapeutic option for adults diagnosed with these various stages of relapsing MS.
How TECFIDERA Works
The precise mechanism by which dimethyl fumarate exerts its therapeutic effect in multiple sclerosis is unknown. The drug and its metabolite, monomethyl fumarate (MMF), have been shown to activate the Nuclear factor (erythroid-derived 2)-like 2 (Nrf2) pathway, which is involved in the cellular response to oxidative stress. Additionally, MMF has been identified as a nicotinic acid receptor agonist in laboratory settings.
Details
- Status
- Prescription
- First Approved
- 2013-03-27
- Routes
- ORAL
- Dosage Forms
- CAPSULE, DELAYED RELEASE
TECFIDERA Approval History
What TECFIDERA Treats
3 indicationsTECFIDERA is approved for 3 conditions since its original approval in 2013. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Clinically isolated syndrome
- Relapsing-remitting multiple sclerosis
- Active secondary progressive multiple sclerosis
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Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
TECFIDERA FDA Label Details
ProIndications & Usage
FDA Label (PDF)TECFIDERA is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. TECFIDERA is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.
TECFIDERA Patents & Exclusivity
Patents (36 active)
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.