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Vumerity (DIROXIMEL FUMARATE)
Vumerity works by binding to the hydroxycarboxylic acid receptor 2, which helps to reduce inflammation in the central nervous system.
Diroximel Fumarate (Vumerity), marketed by Biogen, is indicated for relapsing forms of multiple sclerosis and competes in a crowded market with several off-patent and patent-protected drugs. A key strength of Vumerity is its mechanism of action through the hydroxycarboxylic acid receptor 2, which differentiates it by potentially reducing inflammation in the central nervous system more effectively. The primary risk is the key composition patent expiry in 2028, which could lead to increased competition from generics.
At a glance
| Generic name | DIROXIMEL FUMARATE |
|---|---|
| Sponsor | Biogen |
| Target | Hydroxycarboxylic acid receptor 2 |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | FDA-approved |
| First approval | 2019 |
| Annual revenue | 500 |
Mechanism of action
The mechanism by which monomethyl fumarate (MMF) exerts its therapeutic effect in multiple sclerosis is unknown. MMF has been shown to activate the Nuclear factor (erythroid-derived 2)-like (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 nicotinic acid receptor agonist in vitro.
Approved indications
- Relapsing Forms of Multiple Sclerosis
Common side effects
- Flushing
- Abdominal pain
- Diarrhea
- Nausea
- Vomiting
- Pruritus
- Rash
- Albumin urine present
- Erythema
- Dyspepsia
- Aspartate aminotransferase increased
- Lymphopenia
Drug interactions
- dimethyl fumarate
Key clinical trials
- 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) (PHASE3)
- A NIS Evaluating Various Injectable and Oral Treatments in Patients With Relapsing Multiple Sclerosis
- Open Label Randomized Multicenter to Assess Efficacy & Tolerability of Ofatumumab 20mg vs. First Line DMT in RMS (PHASE3)
- 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) (PHASE2)
- Investigating the Effect of Diroximel Fumarate on Glutathione in Schizophrenia (NA)
- DIROXIMEL FUMARATE TO REDUCE PERIHAEMATOMAL OEDEMA IN INTRACEREBRAL HAEMORRHAGE: DOUBLE BLIND RANDOMIZED CLINICAL TRIAL (PHASE2)
- A Study of Diroximel Fumarate (DRF) in Adult Participants From the Asia-Pacific Region With Relapsing Forms of Multiple Sclerosis (RMS) (PHASE3)
- A Study to Learn More About The Safety of Diroximel Fumarate (VUMERITY®) in Participants Who Took it During Pregnancy And About the Health of Their Babies
Patents
| Patent | Expiry | Type |
|---|---|---|
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
| SEC EDGAR | Revenue + earnings |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Vumerity CI brief — competitive landscape report
- Vumerity updates RSS · CI watch RSS
- Biogen portfolio CI