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siponimod

Generic: SIPONIMOD·Brand: MAYZENT, Mayzent, SIPONIMOD

siponimod: developed by 1 company · 3 clinical trials tracked · 1 FDA decision.

siponimod evidence translation

What we can confirm

1 FDA record · 3 tracked trials

What it means

Source-backed records connect siponimod to NVS; that link alone does not prove the drug works.

What to watch

Watch active trials and any change in FDA or trial status.
BioSniper AIPage evidence connected

Prepared research question

How could siponimod → NVS affect its developer, and what evidence supports the link?

Run cited research

Traceable citations · Unknowns marked

See linked entities and source evidence3 indications · 1 study sponsors

Related indications

Development Pipeline (1)
CompanyPhase
Novartis AG (NVS)
Multiple Sclerosis (MS)
Phase 3
Clinical Trials (3)

SIPO1-AD: A Phase II Clinical Trial for the Assessment of Safety, Tolerability, and Efficacy of Siponimod in Patients With Mild Alzheimer's Disease

NCT06639282·Phase 2
Recruiting

Primary endpoint: Monitoring and recording of all adverse events (AEs) and serious adverse events (SAEs)

InterventionalRandomizedquadruple105 targetStarted 2025-08Completion 2029-101 site · United StatesSt. Joseph's Hospital and Medical Center, Phoenix

A 2-year Randomized, 3-arm, Double-blind, Non-inferiority Study Comparing the Efficacy and Safety of Ofatumumab and Siponimod Versus Fingolimod in Pediatric Patients With Multiple Sclerosis Followed by an Open-label Extension

NCT04926818·Phase 3·NVS
Active, not recruiting

Primary endpoint: Annualized relapse rate (ARR) in target pediatric participants

InterventionalRandomizedquadruple129 targetStarted 2021-10Completion 2031-0250 sites · Argentina, Australia, Austria, Belgium…Novartis Pharmaceuticals

Pregnancy Outcomes in Women Exposed to Diroximel Fumarate

Active, not recruiting

Primary endpoint: Number of Major Congenital Malformations (MCMs)

Observational1,178 targetStarted 2021-09Completion 2031-011 site · United StatesBiogen
FDA Decisions1 records
Approval(NVS)FDA ↗
NDA209884Type 1 - New Molecular EntityPriorityOralTablet

Frequently asked questions

Who is developing siponimod?

siponimod is being developed by Novartis AG.

How many clinical trials involve siponimod?

BioSniper tracks 3 clinical trials involving siponimod.

What is siponimod's latest FDA decision?

The most recent tracked FDA decision for siponimod is Approval, dated March 26, 2019.