DIROXIMEL FUMARATE
Details
- Status
- Prescription
- First Approved
- 2025-11-12
- Routes
- ORAL
- Dosage Forms
- CAPSULE, DELAYED RELEASE
DIROXIMEL FUMARATE Approval History
What DIROXIMEL FUMARATE Treats
4 indicationsDIROXIMEL FUMARATE is approved for 4 conditions since its original approval in 2025. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Multiple Sclerosis
- Clinically Isolated Syndrome
- Relapsing-Remitting Multiple Sclerosis
- 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.
DIROXIMEL FUMARATE FDA Label Details
ProIndications & Usage
VUMERITY 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. VUMERITY 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.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.