Data updated: May 26, 2026
SIPONIMOD
CNS
Approved 2025-04-22
2
Indications
--
Phase 3 Trials
1
Years on Market
Details
- Status
- None (Tentative Approval)
- First Approved
- 2025-04-22
- Routes
- ORAL
- Dosage Forms
- TABLET
SIPONIMOD Approval History
2026
Original
New Indication
New Form
Label Update
6 FDA actions from 2025 to 2026
Mar 2026 ORIGINAL
Update
Apr 2025 ORIGINAL
Update
What SIPONIMOD Treats
2 FDA approvalsOriginally approved for its first indication in 2025 . Covers 2 distinct patient populations.
- Other (2)
Other
(2 approvals)- • Approved indication (Apr 2025)
- • Approved indication (Mar 2026) New
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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 |
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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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
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.