Mayzent (siponimod)
An approved treatment for Multiple Sclerosis.
The same compound appears under different names depending on the context. Here is how to identify Siponimod wherever you encounter it, plus the key facts at a glance.
- Generic name
- Siponimod
- Brand name
- Mayzent
- Drug class
- S1P receptor modulator
- Manufacturer
- Novartis
- How it's taken
- A tablet taken once daily by mouth.
An oral drug that traps immune lymphocytes in lymph nodes and directly addresses brain inflammation. It is approved for adults with relapsing forms of MS, which include clinically isolated syndrome, relapsing-remitting MS, and active secondary progressive MS.
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Where Siponimod fits
First oral therapy specifically approved for active secondary progressive MS, filling a gap where few treatments had shown benefit. Also approved for relapsing MS.
How Siponimod works
Siponimod is a pill that binds to receptors on lymphocytes (immune cells) and traps them in lymph nodes, away from your brain and spinal cord. With fewer immune cells attacking your nervous system, inflammation decreases and nerve damage slows.
Mechanism: Selective S1P1 and S1P5 receptor modulator that prevents lymphocyte egress from lymph nodes and crosses the blood-brain barrier to modulate CNS inflammation
Side effects and safety
Common side effects include headache and high blood pressure. When starting, the drug temporarily slows your heart rate. Serious effects include infections such as herpes zoster, low lymphocyte counts, swelling in the back of the eye (macular edema), liver injury, seizures, and allergic reactions including swelling of the face or throat (angioedema). A rare brain infection called PML, which usually leads to death or severe disability, has been reported; tell your doctor right away about new weakness on one side of the body, clumsiness, vision changes, or changes in thinking or memory. Mayzent may harm an unborn baby, so women who can become pregnant should use effective birth control during treatment and for 10 days after stopping. MS can come back much worse after stopping Mayzent, so do not stop without talking to your doctor. The label also warns about breathing problems, skin cancers (skin checks are recommended), a rare brain swelling condition called PRES, extra immune suppression when switching from other immune drugs, and immune effects that can last after stopping. The drug can slow your heart rate when you start it; an ECG is done before the first dose, and heart monitoring after the first dose is recommended for people with certain heart conditions.
This is not a complete list of side effects. Talk to your doctor or pharmacist about what to expect and when to seek medical attention.
Taking Siponimod
A tablet taken once daily by mouth. Treatment starts with a 5-day titration (0.25 mg on days 1 and 2, then 0.5 mg, 0.75 mg and 1.25 mg), and the 2 mg maintenance dose begins on day 6. People with a CYP2C9*1/*3 or *2/*3 genotype use a shorter titration and a 1 mg maintenance dose. Swallow tablets whole. Take with or without food.
Availability and cost
Only available as the brand-name product.
Selective S1P receptor modulator specifically studied in secondary progressive MS. Specialty pricing for a targeted oral therapy in a difficult-to-treat MS population.
Help paying for Mayzent
Pick your insurance to see which help fits. Drugmaker copay cards can't be used with Medicare, Medicaid or TRICARE; charity funds are the usual route there.
- Free medicine program
Novartis Patient Assistance Foundation may provide the medicine at no cost to patients who are uninsured or have government insurance and meet income guidelines.
For: no insurance, Medicare, Medicaid, TRICARE · source
Good to know: MAYZENT is listed as supported by the Novartis Patient Assistance Foundation (see medications list). Ask the prescriber or Novartis about commercial copay help. No current Mayzent copay program is listed on official pages; the Novartis Patient Assistance Foundation still lists Mayzent for free medicine.
- From a charity · TotalAssist (formerly PAN Foundation)Multiple Sclerosis fundOpen
Pays for: Out-of-pocket costs for approved medications, up to $8,000 per year. Requires Medicare, Medicaid or TRICARE.
- From a charity · The Assistance FundMultiple Sclerosis fundWaitlist
Pays for: Copays, coinsurance, deductibles and other health-related expenses.
The foundation says: “WAITLIST — Accepting Waitlist Patients. TAF is currently accepting requests to join the enrollment waitlist for this program. Waitlists a…”
Clinical trial results
The Phase 3 EXPAND trial with 1,651 patients showed siponimod reduced disability worsening by 21-26%, slowed brain volume loss by 23%, and reduced relapses by 55%. Novartis called it the first oral drug to treat secondary progressive MS with active disease.
Development history
Developed by Novartis and approved by the FDA on March 26, 2019, siponimod is the first oral drug approved to treat secondary progressive MS with active disease.
Explore Multiple Sclerosis trials
Other Multiple Sclerosis treatments
Common questions about Siponimod
▸What is Siponimod (Mayzent)?
An oral drug that traps immune lymphocytes in lymph nodes and directly addresses brain inflammation. It is approved for adults with relapsing forms of MS, which include clinically isolated syndrome, relapsing-remitting MS, and active secondary progressive MS.
▸How does Siponimod work?
Siponimod is a pill that binds to receptors on lymphocytes (immune cells) and traps them in lymph nodes, away from your brain and spinal cord. With fewer immune cells attacking your nervous system, inflammation decreases and nerve damage slows.
▸What are the side effects of Siponimod?
Common side effects include headache and high blood pressure. When starting, the drug temporarily slows your heart rate. Serious effects include infections such as herpes zoster, low lymphocyte counts, swelling in the back of the eye (macular edema), liver injury, seizures, and allergic reactions including swelling of the face or throat (angioedema). A rare brain infection called PML, which usually leads to death or severe disability, has been reported; tell your doctor right away about new weakness on one side of the body, clumsiness, vision changes, or changes in thinking or memory. Mayzent may harm an unborn baby, so women who can become pregnant should use effective birth control during treatment and for 10 days after stopping. MS can come back much worse after stopping Mayzent, so do not stop without talking to your doctor. The label also warns about breathing problems, skin cancers (skin checks are recommended), a rare brain swelling condition called PRES, extra immune suppression when switching from other immune drugs, and immune effects that can last after stopping. The drug can slow your heart rate when you start it; an ECG is done before the first dose, and heart monitoring after the first dose is recommended for people with certain heart conditions.
▸How is Siponimod taken?
A tablet taken once daily by mouth. Treatment starts with a 5-day titration (0.25 mg on days 1 and 2, then 0.5 mg, 0.75 mg and 1.25 mg), and the 2 mg maintenance dose begins on day 6. People with a CYP2C9*1/*3 or *2/*3 genotype use a shorter titration and a 1 mg maintenance dose. Swallow tablets whole. Take with or without food.
▸Is Siponimod FDA approved?
Yes, Siponimod (Mayzent) is FDA approved (2019) for the treatment of Multiple Sclerosis.
▸What makes siponimod different from other S1P modulators?
Siponimod is the first oral therapy specifically studied and approved for secondary progressive MS (SPMS) with active disease. While fingolimod and ozanimod are primarily indicated for relapsing MS, the EXPAND trial specifically enrolled SPMS patients and showed that siponimod could slow disability accumulation in this harder-to-treat population. Siponimod also crosses the blood-brain barrier more effectively, which may help modulate CNS-resident inflammation.
▸What is secondary progressive MS and why is it harder to treat?
Secondary progressive MS (SPMS) is a phase of the disease where neurological function gradually worsens over time, with or without continued relapses. It typically follows an initial relapsing-remitting course. SPMS is driven more by chronic neurodegeneration and compartmentalized inflammation within the brain than by acute immune attacks from the bloodstream. This makes it harder to treat with standard immunosuppressive therapies. Siponimod's ability to cross into the brain may help address this CNS-compartmentalized inflammation.
▸Why does siponimod require genetic testing before starting?
Siponimod is metabolized by the CYP2C9 enzyme, and genetic variations in this enzyme affect how quickly your body processes the drug. Before starting, a CYP2C9 genotype test is required. Patients with certain genotypes (CYP2C9*3/*3) process siponimod much more slowly and should not take the drug. People with a CYP2C9*1/*3 or *2/*3 genotype need a lower maintenance dose of 1 mg instead of the standard 2 mg.
▸What did the EXPAND trial show?
The EXPAND trial enrolled 1,651 patients with secondary progressive MS and showed that siponimod reduced the risk of 3-month confirmed disability progression by 21% and 6-month confirmed progression by 26% compared to placebo. It also reduced relapse rate by 55% and slowed brain volume loss by 23%. Importantly, the benefit was most pronounced in patients with recent relapse activity or active MRI lesions, which is why the FDA approval specifies active SPMS.
▸Does siponimod require heart monitoring like fingolimod?
Siponimod uses a 5-day dose titration to gradually introduce the drug, which reduces cardiac effects at initiation. First-dose cardiac monitoring is generally not required for most patients. However, patients with certain pre-existing heart conditions (such as second-degree or higher heart block, heart failure, or recent cardiac events) may still need monitoring or may not be candidates for siponimod. Your neurologist will assess your cardiac risk before starting treatment.