NDAORALCAPSULE, DELAYED RELEASE
Approved
Oct 2019
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
10
Data completeness
4/8 — Partial
Drug data last refreshed 13h ago · AI intelligence enriched 18h ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
VUMERITY (diroximel fumarate) is an oral delayed-release capsule approved in 2019 for multiple sclerosis, representing a reformulation of dimethyl fumarate designed to improve gastrointestinal tolerability. It is a small molecule that modulates immune responses in MS patients. The delayed-release formulation aims to reduce flushing and GI side effects compared to earlier fumarate therapies.
$152MPart D
Peak7.1 years to LOEPeak lifecycle with $152M in Part D spending (2023) indicates mature commercial infrastructure and stable field team size, though growth phase is transitioning toward maturity.
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 (10)
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
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
Pregnancy Exposure Registry for Vumerity (Diroximel Fumarate)
Started Oct 2023
908 enrolled
Multiple Sclerosis
A Study to Learn About the Safety of BIIB091 and Its Effect on Brain Inflammation When Taken Alone or With Diroximel Fumarate (DRF) in Adults With Relapsing Forms of Multiple Sclerosis (MS)
Started Jul 2023
127 enrolled
Relapsing Forms of Multiple Sclerosis
Prospective Evaluation of De-Escalation From antiCD-20 Therapies to Dimethyl Fumarate (Tecfidera) or Diroximel Fumarate (Vumerity)
Started Mar 2023
11 enrolled
Multiple Sclerosis (MS) Relapsing Remitting
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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.