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Mayzent (SIPONIMOD)
Mayzent works by binding to the sphingosine 1-phosphate receptor 1, which helps to reduce inflammation and slow disease progression.
Mayzent (SIPONIMOD) is a small molecule sphingosine 1-phosphate receptor 1 modulator developed by Novartis. It is used to treat relapsing remitting multiple sclerosis and secondary progressive multiple sclerosis. Mayzent works by binding to the sphingosine 1-phosphate receptor 1, which helps to reduce inflammation and slow disease progression. As of 2023, Mayzent is still patented, but generic manufacturers are available. Key safety considerations include potential liver enzyme elevations and increased risk of infections.
At a glance
| Generic name | SIPONIMOD |
|---|---|
| Sponsor | Novartis |
| Drug class | Sphingosine 1-phosphate Receptor Modulator [EPC] |
| Target | Sphingosine 1-phosphate receptor 1 |
| Modality | Small molecule |
| Therapeutic area | Neuroscience |
| Phase | FDA-approved |
| First approval | 2019 |
| Annual revenue | 1068 |
Mechanism of action
Siponimod is an S1P receptor modulator. Siponimod binds with high affinity to S1P receptors and 5. Siponimod blocks the capacity of lymphocytes to egress from lymph nodes, reducing the number of lymphocytes in peripheral blood. The mechanism by which siponimod exerts therapeutic effects in multiple sclerosis is unknown, but may involve reduction of lymphocyte migration into the central nervous system.
Approved indications
- Relapsing remitting multiple sclerosis
- Secondary progressive multiple sclerosis
Common side effects
- Headache
- Hypertension
- Transaminase increased
- Falls
- Edema peripheral
- Nausea
- Dizziness
- Diarrhea
- Pain in extremity
- Bradycardia
- Seizures
- Vascular events
Key clinical trials
- Efficacy and Safety of Ofatumumab and Siponimod Compared to Fingolimod in Pediatric Patients With Multiple Sclerosis (PHASE3)
- Repurposing Siponimod for Alzheimer's Disease (PHASE2)
- Survey Among Healthcare Professionals and MS Patients to Assess Their Understanding of RMP Materials
- Impact of Mayzent on aSPMS Patients in a Long-term NIS in Italy
- Managed Access Program (MAP) for Patients Diagnosed With Secondary Progressive Multiple Sclerosis With Active Disease
- 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
- Traditional Versus Early Aggressive Therapy for Multiple Sclerosis Trial (NA)
- A Real-world Study About the Impact of Siponimod Treatment on Secondary Progressive Multiple Sclerosis Patients in Russia
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:
- Mayzent CI brief — competitive landscape report
- Mayzent updates RSS · CI watch RSS
- Novartis portfolio CI