MAYZENT (siponimod)
MAYZENT is indicated for the treatment of Clinically isolated syndrome; Relapsing-remitting disease; Active secondary progressive disease.
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.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2019-03-26
- Patent Cliff
- 2036
- 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
MAYZENT Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to MAYZENT
3 of 13FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
4 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04926818 NEOS | CBAF312D2301 | Ph 3 | active not recruiting | Efficacy and Safety of Ofatumumab and Siponimod Compared to Fingolimod in Pediatric Patients With Multiple Sclerosis |
| NCT06639282 SIPO1-AD | 23-500-037-10-03 7R01AG073212-02 | Ph 2 | recruiting | Repurposing Siponimod for Alzheimer's Disease |
| NCT04925557 results posted | 00003884 | Ph 2, Ph 3 | terminated | Study to Assess the Efficacy of Mayzent on Microglia in Secondary Progressive Multiple Sclerosis |
| NCT03623243 EXCHANGE results posted | CBAF312AUS02 | Ph 3 | completed | Safety and Tolerability of Conversion From Oral, Injectable, or Infusion Disease Modifying Therapies to Dose-titrated Oral Siponimod (Mayzent) in Advancing RMS Patients |
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
Indications & Usage
FDA Label (PDF)MAYZENT is indicated for the treatment of Clinically isolated syndrome; Relapsing-remitting disease; Active secondary progressive disease.
MAYZENT Patents & Exclusivity
Patents (5 active)
Pro Intelligence Preview
Deep insights for MAYZENT
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2036
- • 45 active patents
Trial Analysis
- • 4 total trials
- • Stage: Expansion
Competitive Landscape
- • 13 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment