NDAORALTABLETPriority Review
Approved
Mar 2019
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
12
Data completeness
7/8 — Comprehensive
Priority Review
MAYZENT (siponimod) by Novartis is sphingosine 1-phosphate receptor modulators [moa]. Approved for sphingosine 1-phosphate receptor modulator [epc]. First approved in 2019.
Drug data last refreshed 19h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
MAYZENT (siponimod) is an oral sphingosine 1-phosphate receptor modulator approved by the FDA on March 26, 2019. It is indicated for treating secondary progressive multiple sclerosis (SPMS) by modulating immune cell trafficking to reduce neuroinflammation. As a small-molecule S1P receptor modulator, siponimod represents an important immunomodulatory option for SPMS patients seeking to slow disease progression, positioning itself within the growing MS treatment armamentarium alongside other DMTs.
$0.1BPart D
10.0 years to LOEMechanism of Action
Sphingosine 1-Phosphate Receptor Modulators
Pharmacologic Class:
Sphingosine 1-phosphate Receptor Modulator
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (12)
Repurposing Siponimod for Alzheimer's Disease
Started Aug 2025
105 enrolled
Alzheimer DiseaseMild Alzheimer DiseaseMCI With Increased Risk for Alzheimer Disease+1 more
A Real-world Study About the Impact of Siponimod Treatment on Secondary Progressive Multiple Sclerosis Patients in Russia
Started Apr 2024
606 enrolled
Secondary Progressive Multiple Sclerosis
A Study to Assess the Effectiveness and Safety of Mayzent in Chinese Patients With Relapsing Forms of Multiple Sclerosis
Started Apr 2023
113 enrolled
Relapsing Multiple SclerosisClinically Isolated SyndromeRelapsing Remitting Multiple Sclerosis+1 more
A Real-world Study to Assess the Use of Siponimod in Spain to Treat Patients With Secondary Progressive Multiple Sclerosis
Started Nov 2022
210 enrolled
Secondary Progressive Multiple Sclerosis
Impact of Mayzent on aSPMS Patients in a Long-term NIS in Italy
Started Jun 2022
134 enrolled
Active Secondary Progressive Multiple Sclerosis
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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.