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: BASEL V8 CH 4056
Company CEO: Vasant Narasimhan
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, Turkey, United States
Active Clinical Trial Count: 3
Recent & Upcoming Milestones
Highest Development Phases
Phase 3: Multiple Sclerosis
Phase 2: Alzheimer Disease|Cognitive Dysfunction
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|
| SIPO1-AD | P2 |
Not yet recruiting |
Cognitive Dysfunction|Alzheimer Disease |
2029-10-01 |
12% |
2025-05-16 |
Primary Endpoints |
| NEOS | P3 |
Active, not recruiting |
Multiple Sclerosis |
2027-03-02 |
82% |
2025-01-15 |
Patient Enrollment|Primary Endpoints|Treatments |
| CBAF312D2301 | P3 |
Active, not recruiting |
Multiple Sclerosis |
2029-06-01 |
2025-05-02 |
Treatments |
Recent News Events
Date |
Type |
Title |
|---|---|---|
|
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 |
|
01/17/2024 |
News Article |
Tr1X, Inc. Announces $75 Million Series A Financing to Develop Best-in-Class Universal Allogeneic Regulatory T (Treg) and CAR-Treg Cell Therapies to Treat and Potentially Cure Autoimmune and Inflammatory Diseases |
|
10/09/2023 |
News Article |
Multiple Sclerosis Treatment Market Size, Share 2024-2032 |