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Siponimod

Generic Name
Siponimod
Brand Names
Mayzent 0.25 Mg Starter Pack, Mayzent
Drug Type
Small Molecule
Chemical Formula
C29H35F3N2O3
CAS Number
1230487-00-9
Unique Ingredient Identifier
RR6P8L282I
Background

Siponimod, also known as Mayzent, by Novartis, is a new drug formulated for the management of Multiple Sclerosis (MS). It was approved by the FDA on March 26, 2019 and by Health Canada on February 20, 2020. This drug is considered a sphingosine-1-phosphate (S1P) receptor modulator and is thought to play a role in suppressing the central nervous system inflammation that is associated with MS .

Multiple Sclerosis (MS) is an autoimmune disease of the central nervous system that is chronic and inflammatory, disrupting communication between the brain and other parts of the body. Most patients diagnosed with this illness experience their initial disease symptoms between the age of 20 to 40, often the most productive years of life. Symptoms may include but are not limited to fatigue, gait changes, bowel or bladder dysfunction, abnormal muscle twitching, vision disturbance, and depressing or mood swings. MS is one of the most common causes of neurological disability in young adults and is found to occur more frequently in women than in men.

Indication

This drug is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease in adults .

Associated Conditions
Relapsing Multiple Sclerosis (RMS)

Repurposing Siponimod for Alzheimer's Disease

Phase 2
Not yet recruiting
Conditions
Alzheimer Disease
Mild Alzheimer Disease
MCI With Increased Risk for Alzheimer Disease
Cognitive Impairment, Mild
Interventions
Drug: Placebo
First Posted Date
2024-10-15
Last Posted Date
2025-05-15
Lead Sponsor
St. Joseph's Hospital and Medical Center, Phoenix
Target Recruit Count
105
Registration Number
NCT06639282
Locations
🇺🇸

St. Joseph's Hospital and Medical Center, Phoenix, Arizona, United States

A Study to Assess Pregnancy Outcomes in Women Exposed to Diroximel Fumarate

First Posted Date
2023-01-18
Last Posted Date
2025-01-30
Lead Sponsor
Biogen
Target Recruit Count
1178
Registration Number
NCT05688436
Locations
🇺🇸

OptumInsight, Eden Prairie, Minnesota, United States

Efficacy and Safety of Ofatumumab and Siponimod Compared to Fingolimod in Pediatric Patients With Multiple Sclerosis

Phase 3
Active, not recruiting
Conditions
Multiple Sclerosis (MS)
Interventions
Other: Ofatumumab placebo
Other: Siponimod placebo
Other: Fingolimod placebo
First Posted Date
2021-06-15
Last Posted Date
2025-04-24
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
129
Registration Number
NCT04926818
Locations
🇹🇷

Novartis Investigative Site, Samsun, Turkey

🇺🇸

Arkansas Childrens Hosp Rsch Inst, Little Rock, Arkansas, United States

🇺🇸

Childrens Hospital Los Angeles, Los Angeles, California, United States

and more 6 locations

Study to Assess the Efficacy of Mayzent on Microglia in Secondary Progressive Multiple Sclerosis

Phase 2
Terminated
Conditions
Secondary-progressive Multiple Sclerosis
Interventions
First Posted Date
2021-06-14
Last Posted Date
2025-05-13
Lead Sponsor
State University of New York at Buffalo
Target Recruit Count
8
Registration Number
NCT04925557
Locations
🇺🇸

University at Buffalo, Buffalo General Hospital, Buffalo, New York, United States

Exploring the Immune Response to SARS-CoV-2 modRNA Vaccines in Patients With Secondary Progressive Multiple Sclerosis (AMA-VACC)

Phase 4
Completed
Conditions
Secondary Progressive Multiple Sclerosis
Interventions
Drug: Baseline disease modifying therapies (DMTs)
Biological: BNT162
Biological: mRNA-1273
First Posted Date
2021-03-11
Last Posted Date
2024-06-20
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
41
Registration Number
NCT04792567
Locations
🇩🇪

Novartis Investigative Site, Ulm, Germany

Long Term Special Drug Use-results Surveillance for Mayzent in SPMS Patients

Completed
Conditions
Secondary Progressive Multiple Sclerosis (SPMS)
Interventions
First Posted Date
2020-10-20
Last Posted Date
2024-02-12
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
451
Registration Number
NCT04593927
Locations
🇯🇵

Novartis Investigative Site, Tokushima, Japan

Managed Access Program (MAP) for Patients Diagnosed With Secondary Progressive Multiple Sclerosis With Active Disease

Conditions
Multiple Sclerosis
First Posted Date
2020-09-07
Last Posted Date
2024-10-29
Lead Sponsor
Novartis Pharmaceuticals
Registration Number
NCT04540861

Safety and Tolerability of Conversion From Oral, Injectable, or Infusion Disease Modifying Therapies to Dose-titrated Oral Siponimod (Mayzent) in Advancing RMS Patients

Phase 3
Completed
Conditions
Multiple Sclerosis
Relapsing Multiple Sclerosis
Advancing Multiple Sclerosis
Interventions
First Posted Date
2018-08-09
Last Posted Date
2024-06-20
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
185
Registration Number
NCT03623243
Locations
🇵🇷

Novartis Investigative Site, Guaynabo, Puerto Rico

🇺🇸

MS & Neuromuscular Center of Excellence, Clearwater, Florida, United States

🇺🇸

Alabama Neurology Associates, Homewood, Alabama, United States

and more 1 locations

Safety and Efficacy of BAF312 in Dermatomyositis

Phase 2
Terminated
Conditions
Active Dermatomyositis
Interventions
Drug: Placebo
First Posted Date
2014-01-07
Last Posted Date
2021-01-05
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
17
Registration Number
NCT02029274
Locations
🇯🇵

Novartis Investigative Site, Sendai city, Miyagi, Japan

A Single-dose, Open-label, Parallel-group Study to Assess the Pharmacokinetics of BAF312 in Subjects With Renal Impairment Compared to Subjects With Normal Renal Function

Phase 1
Completed
Conditions
Renal Impairment
Interventions
First Posted Date
2013-07-22
Last Posted Date
2020-12-08
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
16
Registration Number
NCT01904214
Locations
🇷🇴

Novartis Investigative Site, Bucuresti, Romania

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