Mayzent (siponimod) for multiple sclerosis
Last updated June 10, 2025, by Andrea Lobo, PhD
Fact-checked by Ines Martins, PhD
What is Mayzent for MS?
Mayzent (siponimod) is an oral medication approved for adults with relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome (CIS), relapsing-remitting MS (RRMS), and active secondary progressive MS (SPMS).
Marketed by Novartis, the medication is designed to reduce the frequency of relapses, prevent the development of new lesions visible on MRI scans, and slow the progression of disability. It is taken once daily as an oral tablet.
Mayzent works to inhibit sphingosine 1-phosphate (S1P) receptors located at the surface of certain immune cells and which are important for controlling the migration of these cells from lymph nodes — where they are matured and stored — to the blood.
By modulating S1P receptors, Mayzent essentially traps immune cells inside lymph nodes, preventing them from getting into the brain or spinal cord and causing damaging inflammation.
Mayzent is also believed to act on S1P receptors in some cells of the brain and spinal cord, including those responsible for producing myelin, providing other neuroprotective effects such as promoting myelin repair and preventing nerve cell damage.
Therapy Snapshot
| Brand name: | Mayzent |
| Chemical name: | Siponimod |
| Usage: | Used to reduce disease activity and slow disability progression in relapsing forms of MS |
| Administration: | Oral tablets |
Who can take Mayzent?
Mayzent is approved in the U.S. for adults with CIS, RRMS, and active SPMS.
The medication is contraindicated in people:
- with a CYP2C9*3/*3 genotype, or a specific variation in the two copies of the CYP2C9 gene, which affect how the medication is processed in the body
- who experienced certain cardiovascular problems in the last six months, such as a heart attack, some forms of chest pain (unstable angina), stroke or mini-stroke, or certain types of heart failure
- with certain types of heart block or abnormal heart rhythms, unless they have a functioning pacemaker.
It is also not recommended for people being treated with drugs that activate or inhibit certain enzymes, with uncontrolled high blood pressure, severe and untreated sleep apnea, or other cardiac and cerebrovascular diseases. Patients who previously received another MS therapy called Lemtrada (alemtuzumab) also should not receive Mayzent.
In the European Union, Mayzent is only approved to treat adults with SPMS and active disease, defined by the presence of relapses or imaging features suggestive of active inflammation.
How is Mayzent administered?
Mayzent comes in the form of oral tablets, which must be swallowed whole with or without food, preferably at the same time each day.
The recommended dose is 2 mg once daily, but treatment is typically initiated at a lower 0.25 mg dose and increased gradually to the full 2 mg maintenance dose over the first six days. Dose adjustments may be needed for patients with specific variants of the CYP2C9 gene.
A 12-tablet starter pack is available for those initiating the therapy for the first time, and also for those who missed a dose for at least four consecutive days.
Mayzent treatment can cause a decrease in heart rate, so people with certain heart conditions might need to be monitored for a few hours after taking their first dose or after restarting treatment.
Mayzent in clinical trials
Mayzent’s approval in the U.S. was largely supported by data from the Phase 3 EXPAND trial (NCT01665144), which tested Mayzent against a placebo in 1,651 adults with SPMS for up to three years. Th results showed:
- a significant 21% reduction in the risk of sustained disability progression in people taking Mayzent compared with those on a placebo
- a significant reduction in relapse rates, by 55%,
- a significant reduction in the number of new or enlarging lesions, and in lesions with active inflammation
- significantly less brain volume loss with Mayzent, indicating less neurodegeneration.
In the open-label extension part of the trial, patients who received treatment with Mayzent for up to five years continued to have a lower risk of confirmed disability progression, fewer relapses, and fewer lesions than those who were initially on a placebo.
A Phase 2 trial, called BOLD (NCT00879658) tested Mayzent in adults with RRMS. The findings demonstrated that Mayzent reduced the number of lesions and relapses compared with a placebo after six months. Benefits were sustained for at least two more years in the trial’s long-term extension study (NCT01185821).
Common side effects of Mayzent
The most common side effects associated with Mayzent include:
- headache
- high blood pressure
- elevated levels of liver enzymes, indicating liver damage.
Other less common, but serious side effects that may occur while on treatment with Mayzent include:
- infections, including progressive multifocal leukoencephalopathy (PML), a potentially fatal brain infection
- swelling in parts of the eye, which can lead to permanent vision loss
- temporary disturbances in heart rhythm and decreases in heart rate
- reduced lung function
- liver damage, which may require treatment discontinuation
- skin cancer
- increased blood pressure
- swelling and narrowing of blood vessels in the brain, which may lead to stroke if left untreated.
Patients will be monitored for these risks before and during treatment and will receive guidance on what signs and symptoms to watch for.
Mayzent may cause harm to a developing fetus, and women who could become pregnant should use effective contraception while taking Mayzent and for at least 10 days after stopping the medication. Women who are pregnant or planning to become pregnant should inform their healthcare provider before initiating treatment.
When stopping Mayzent, patients should be monitored for any potential worsening of their condition. While rare, a severe disease exacerbation and severe increase in disability can happen.
Multiple Sclerosis News Today is strictly a news and information website about the disease. It does not provide medical advice, diagnosis, or treatment. This content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read on this website.
FAQs about Mayzent
Mayzent was approved by the U.S. Food and Drug Administration in March 2019 to treat adults with relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting MS, and active secondary progressive MS.
Animal studies suggest that Mayzent can cause damage to a developing fetus, so patients should inform their healthcare provider if they are pregnant or planning to become pregnant. Effective birth control methods are recommended to all women of childbearing potential while on Mayzent and for 10 days after ceasing treatment.
Interactions between alcohol and Mayzent have not been reported. However, both can cause damage to the liver, and alcohol is known to sometimes exacerbate disease symptoms or interfere with medications. It is recommended that patients on Mayzent discuss with their healthcare team whether it is safe for them to drink alcohol.
Mayzent works rapidly to reduce circulating immune cells, with effects seen in the first few hours of treatment, but it could take several months before a person notices clinical effects. As the disease manifests differently in each person, and responses to treatment may also vary, patients should discuss with their care team how Mayzent could help in their specific case.
Neither hair loss nor weight gain has been reported in clinical trials as side effects of Mayzent. Patients are advised to speak with their healthcare provider if they experience any unusual symptoms while on the medication.
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