MAYZENT
MAYZENT (siponimod) is a sphingosine 1-phosphate (S1P) receptor modulator indicated for the treatment of relapsing forms of multiple sclerosis (MS) in adults. The medication is used to manage clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. It serves as a therapeutic option for patients across these specific stages of MS progression.
How MAYZENT Works
Siponimod functions as a sphingosine 1-phosphate (S1P) receptor modulator that binds with high affinity to S1P receptors 1 and 5. By binding to these receptors, the drug blocks the capacity of lymphocytes to egress from lymph nodes, which reduces the number of lymphocytes in peripheral blood. This mechanism is thought to produce therapeutic effects by reducing the migration of lymphocytes into the central nervous system.
Details
- Status
- Prescription
- First Approved
- 2019-03-26
- Routes
- ORAL
- Dosage Forms
- TABLET
MAYZENT Approval History
What MAYZENT Treats
3 indicationsMAYZENT is approved for 3 conditions since its original approval in 2019. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Clinically isolated syndrome
- Relapsing-remitting disease
- Active secondary progressive disease
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Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
MAYZENT FDA Label Details
ProIndications & Usage
FDA Label (PDF)MAYZENT is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. MAYZENT is a sphingosine 1-phosphate (S1P) receptor modulator indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.
MAYZENT Patents & Exclusivity
Patents (36 active)
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.