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Siponimod

Alternative Names: siponimod, baf312, mayzent, baf-312, baf 312
Latest Update: 2024-10-14
Latest Update Note: Clinical Trial Update

Product Description

Siponimod is a medication that has been approved by the FDA to treat relapsing forms of multiple sclerosis, which has been defined to include relapsing remitting multiple sclerosis (RRMS), clinically isolated syndrome (CIS), and secondary progressive multiple sclerosis (SPMS) with active disease. SPMS with active disease refers to those patients who are in a progressive phase of the disease and continue to have clinical relapses. Siponimod is a sphingosine 1-phosphate receptor (S1P) modulator that selectively binds the S1P subtypes 1 and 5. (Sourced from: https://my.clevelandclinic.org/departments/neurological/depts/multiple-sclerosis/ms-approaches/siponimod)

Mechanisms of Action: S1P1 Agonist

Novel Mechanism: No

Modality: Small Molecule

Route of Administration: Oral

FDA Designation: None *

Approval Status: Approved

Approved Countries: Argentina | Australia | Austria | Belgium | Bosnia | Canada | Chile | Colombia | Croatia | Cyprus | Czech | Denmark | Ecuador | Egypt | Estonia | European Medicines Agency | Finland | Germany | Greece | Hong Kong | Hungary | Iceland | Ireland | Israel | Italy | Japan | Jordan | Latvia | Lebanon | Lithuania | Luxembourg | Malaysia | Mexico | Netherlands | New Zealand | Peru | Poland | Portugal | Romania | Russia | Saudi Arabia | Serbia | Singapore | Slovakia | Slovenia | South Africa | Spain | Sweden | Switzerland | Taiwan | Turkey | United Arab Emirates | United Kingdom | United States

Approved Indications: Multiple Sclerosis | Multiple Sclerosis, Relapsing-Remitting

Known Adverse Events: Hypertension | Headache

Company: Novartis
Company Location: BASEL V8 CH 4056
Company CEO: Vasant Narasimhan
Additonal Commercial Interests: None

Clinical Description

Map of Global Clinical Trials for Siponimod

Countries in Clinic: Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Croatia, Estonia, France, Germany, Guatemala, India, Israel, Italy, Latvia, Mexico, Poland, Portugal, Puerto Rico, Romania, Russia, Serbia, Slovakia, Spain, Taiwan, Turkey, United Kingdom, United States

Active Clinical Trial Count: 5

Highest Development Phases

Phase 3: Multiple Sclerosis

Phase 2: Alzheimer Disease|Cognitive Dysfunction

Trial

Phase

Trial Status

Disease

Primary Completion Date

Probability of Success

NEOS

P3

Active, not recruiting

Multiple Sclerosis

2029-10-19

SIPO1-AD

P2

Not yet recruiting

Alzheimer Disease|Cognitive Dysfunction

2029-10-01

CBAF312D2301

P3

Unknown Status

Multiple Sclerosis

2029-06-01

NEOS

P3

Recruiting

Multiple Sclerosis

2027-03-02

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