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Mayzent
Published
Product name
Mayzent
Active ingredient
Siponimod
Submission type
New chemical entity
Decision
Approved
Decision date
Registration date
What this medicine was approved for
Mayzent (siponimod) was approved for the following therapeutic use:
Mayzent is indicated for the treatment of adult patients with secondary progressive multiple sclerosis (SPMS).
How this medicine works
Siponimid is a selective immunosuppressant. Siponimod is a sphingosine-1-phosphate (S1P) receptor modulator. Siponimod binds selectively on two out of five G-protein-coupled receptors (GPCRs) for S1P, namely S1P1 and S1P5. By acting as a functional antagonist on S1P1 receptors on lymphocytes, siponimod prevents egress from lymph nodes. This reduces the recirculation of T-cells into the central nervous system (CNS) to limit central inflammation. Siponimod spares effector memory T cells in peripheral tissues and blood and does not impair lymphocyte activation. Siponimod readily crosses the blood brain barrier. In animal studies direct effects have been demonstrated for siponimod on neural cells, via S1P1 on astrocytes and S1P5 on oligodendrocytes. In a mouse model of experimental autoimmune encephalomyelitis a direct neuroprotective effect, independent from effects on lymphocytes, was also demonstrated for siponimod applied centrally (via intracerebroventricular infusions).
Why the TGA approved or did not approve this medicine
The decision was based on quality (chemistry and manufacturing), nonclinical (pharmacology and toxicology), clinical (pharmacology, safety and efficacy) and risk management plan information submitted by the sponsor. The benefit-risk profile of Mayzent was considered favourable for the therapeutic use approved.