DIROXIMEL FUMARATE
DIROXIMEL FUMARATE is indicated for the treatment of Multiple Sclerosis; Clinically Isolated Syndrome; Relapsing-Remitting Multiple Sclerosis; Secondary Progressive Multiple Sclerosis.
How DIROXIMEL FUMARATE Works
The exact mechanism by which diroximel fumarate exerts its therapeutic effect in multiple sclerosis is unknown. The drug's active metabolite, monomethyl fumarate (MMF), activates 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.
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
DIROXIMEL FUMARATE 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 DIROXIMEL FUMARATE's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications DIROXIMEL FUMARATE treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to DIROXIMEL FUMARATE
3 of 20FDA-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.
DIROXIMEL FUMARATE FDA Label Details
Indications & Usage
DIROXIMEL FUMARATE is indicated for the treatment of Multiple Sclerosis; Clinically Isolated Syndrome; Relapsing-Remitting Multiple Sclerosis; Secondary Progressive Multiple Sclerosis.
Looking for the branded version?
VUMERITY
Full clinical data, patents, trials, and competitive landscape for diroximel fumarate.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.