SIPONIMOD · RICONPHARMA LLC
SIPONIMOD is FDA-approved to treat 3 conditions (same as MAYZENT).
Details
- Status
- Prescription
- First Approved
- 2019-03-26
- Routes
- ORAL
- Dosage Forms
- TABLET
SIPONIMOD Approval History
What SIPONIMOD Treats
3 indicationsSIPONIMOD is approved for 3 conditions since its original approval in 2025. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Clinically isolated syndrome
- Relapsing-remitting disease
- Active secondary progressive disease
Same approved indications as MAYZENT (same active ingredient).
Clinical Trial Registry
3 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 |
| 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.
SIPONIMOD FDA Label Details
Indications & Usage
SIPONIMOD is FDA-approved to treat 3 conditions — same approved indications as MAYZENT.
Looking for the branded version?
MAYZENT
Full clinical data, patents, trials, and competitive landscape for siponimod.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.