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: *
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: None
Known Adverse Events: None
Company: Novartis
Company Location: Europe
Company Founding Year: 1996
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Croatia, Estonia, France, Germany, Guatemala, India, Israel, Italy, Latvia, Mexico, Poland, Portugal, Romania, Serbia, Slovakia, Spain, Taiwan, United States, Unknown Location
Active Clinical Trial Count: 3
Recent & Upcoming Milestones
Highest Development Phases
Phase 3: Multiple Sclerosis
Phase 2: Alzheimer Disease|Cognitive Dysfunction
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
NCT06639282 |
SIPO1-AD | P2 |
Not yet recruiting |
Alzheimer Disease|Cognitive Dysfunction |
2029-10-01 |
12% |
2025-05-16 |
Primary Endpoints |
NCT04926818 |
NEOS | P3 |
Active, not recruiting |
Multiple Sclerosis |
2026-04-01 |
43% |
2026-02-18 |
Primary Completion Date|Primary Endpoints|Study Completion Date |
2024-511686-11-00 |
CBAF312D2301 | P3 |
Active, not recruiting |
Multiple Sclerosis |
2029-06-01 |
2025-05-02 |
Treatments |
Recent News Events
Date |
Type |
Title |
|---|---|---|
|
02/02/2026 |
News Article |
Teva Canada Announces Strategic Partnership with Novartis Canada to Relaunch Mayzent® for Multiple Sclerosis Patients in Canada |
|
12/19/2025 |
News Article |
Novartis and US government reach agreement on lowering drug prices in the US |
|
08/26/2024 |
News Article |
Multiple Sclerosis (MS) Diagnosis and Treatment Market Size to Reach USD 30.28 Bn by 2032 |
|
07/09/2024 |
News Article |
Immunic Appoints Jason Tardio as Chief Operating Officer and President |