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
Countries in Clinic: Israel, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Croatia, Estonia, France, Germany, Guatemala, India, 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 |