Siponimod

Overview

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.

Background

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)

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Repurposing Siponimod for Alzheimer's Disease	2024/10/15	NCT06639282	Phase 2	Not yet recruiting	St. Joseph's Hospital and Medical Center, Phoenix
A Study to Assess Pregnancy Outcomes in Women Exposed to Diroximel Fumarate	2023/01/18	NCT05688436	N/A	Recruiting	Biogen
Efficacy and Safety of Ofatumumab and Siponimod Compared to Fingolimod in Pediatric Patients With Multiple Sclerosis	2021/06/15	NCT04926818	Phase 3	Active, not recruiting	Novartis Pharmaceuticals
Study to Assess the Efficacy of Mayzent on Microglia in Secondary Progressive Multiple Sclerosis	2021/06/14	NCT04925557	Phase 2	Terminated	State University of New York at Buffalo
Exploring the Immune Response to SARS-CoV-2 modRNA Vaccines in Patients With Secondary Progressive Multiple Sclerosis (AMA-VACC)	2021/03/11	NCT04792567	Phase 4	Completed	Novartis Pharmaceuticals
Long Term Special Drug Use-results Surveillance for Mayzent in SPMS Patients	2020/10/20	NCT04593927	N/A	Completed	Novartis Pharmaceuticals
Managed Access Program (MAP) for Patients Diagnosed With Secondary Progressive Multiple Sclerosis With Active Disease	2020/09/07	NCT04540861	N/A	AVAILABLE	Novartis Pharmaceuticals
Safety and Tolerability of Conversion From Oral, Injectable, or Infusion Disease Modifying Therapies to Dose-titrated Oral Siponimod (Mayzent) in Advancing RMS Patients	2018/08/09	NCT03623243	Phase 3	Completed	Novartis Pharmaceuticals
Safety and Efficacy of BAF312 in Dermatomyositis	2014/01/07	NCT02029274	Phase 2	Terminated	Novartis Pharmaceuticals
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	2013/07/22	NCT01904214	Phase 1	Completed	Novartis Pharmaceuticals

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
MAYZENT	Novartis Pharmaceuticals Corporation	0078-0979	ORAL	0.25 mg in 1 1	6/18/2025
MAYZENT	Novartis Pharmaceuticals Corporation	0078-1014	ORAL	1 mg in 1 1	6/18/2025
MAYZENT	Novartis Pharmaceuticals Corporation	0078-0986	ORAL	2 mg in 1 1	6/18/2025

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
MAYZENT FILM-COATED TABLET 0.25MG	NOVARTIS PHARMA STEIN AG, Siegfried Barbera S.L. (primary packager and secondary packager)	SIN16040P	TABLET, FILM COATED	0.25mg	11/16/2020
MAYZENT FILM-COATED TABLET 2MG	NOVARTIS PHARMA STEIN AG, Siegfried Barbera S.L. (primary packager and secondary packager)	SIN16039P	TABLET, FILM COATED	2mg	11/16/2020

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
Siponimod Tablets	Novartis Pharma Schweiz AG	国药准字HJ20200011	化学药品	片剂	11/20/2024
Siponimod Tablets	Novartis Pharma Schweiz AG	国药准字HJ20200010	化学药品	片剂	11/20/2024
Siponimod Tablets	Novartis Pharma Schweiz AG	H20200011	化学药品	片剂	5/7/2020
Siponimod Tablets	Novartis Pharma Schweiz AG	H20200010	化学药品	片剂	5/7/2020

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

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