VUMERITY (diroximel fumarate)
VUMERITY is indicated for the treatment of Clinically isolated syndrome; Relapsing-remitting multiple sclerosis; Active secondary progressive multiple sclerosis.
How VUMERITY Works
The exact mechanism by which diroximel fumarate exerts its therapeutic effect in multiple sclerosis is unknown. Its active metabolite, monomethyl fumarate (MMF), has 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.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2019-10-29
- Patent Cliff
- 2033
- Revenue
- $200M (Q4-2025)
- Routes
- ORAL
- Dosage Forms
- CAPSULE, DELAYED RELEASE
VUMERITY Approval History
What VUMERITY Treats
3 indicationsVUMERITY is approved for 3 conditions since its original approval in 2019. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Clinically isolated syndrome
- Relapsing-remitting multiple sclerosis
- Active secondary progressive multiple sclerosis
VUMERITY Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in VUMERITY's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications VUMERITY treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to VUMERITY
3 of 13FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
3 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07483632 VOYAGE | 272MS304 2023-509409-60 | Ph 3 | not yet recruiting | 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) |
| NCT05083923 results posted | 272MS303 | Ph 3 | completed | A Study of Diroximel Fumarate (DRF) in Adult Participants From the Asia-Pacific Region With Relapsing Forms of Multiple Sclerosis (RMS) |
| NCT05127564 | 272HV111 | Ph 1 | completed | A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Diroximel Fumarate (DRF) in Chinese and Caucasian Adult Healthy Participants |
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.
VUMERITY FDA Label Details
Indications & Usage
FDA Label (PDF)VUMERITY is indicated for the treatment of Clinically isolated syndrome; Relapsing-remitting multiple sclerosis; Active secondary progressive multiple sclerosis.
Pro Intelligence Preview
Deep insights for VUMERITY
Revenue Insights
- • Q4-2025: $200M
- • Historical trend analysis
Patent Timeline
- • Cliff: 2033
- • 3 active patents
Trial Analysis
- • 3 total trials
- • Stage: Expansion
Competitive Landscape
- • 13 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment