NDAORALCAPSULE, DELAYED RELEASE
Approved
Oct 2019
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
9
Data completeness
5/8 — Partial
VUMERITY (diroximel fumarate) by Biogen is unknown. First approved in 2019.
Drug data last refreshed 1h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
VUMERITY (diroximel fumarate) is an oral delayed-release capsule approved in 2019 for multiple sclerosis. The active metabolite MMF activates the Nrf2 pathway to modulate cellular response to oxidative stress and acts as a nicotinic acid receptor agonist. It represents an improved formulation of fumarate therapy with better gastrointestinal tolerability.
$0.152BPart D
Peak7.4 years to LOEPeak lifecycle positioning with $152M in Part D spending supports stable commercial team size and mature brand infrastructure across multiple therapeutic areas.
Mechanism of Action
unknown. MMF, the active metabolite of diroximel fumarate, has been shown to activate the nuclear factor (erythroid-derived 2)-like 2 (Nrf2) pathway in vitro and in vivo in animals and humans. The Nrf2 pathway is involved in the cellular response to oxidative stress. MMF has been identified as a…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (9)
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
Exploring Diroximel Fumarate Real-world Experience in Canada and Israel
Started Dec 2021
64 enrolled
Relapsing Forms of MS
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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.