Gilenya (fingolimod) for multiple sclerosis

Last updated July 24, 2025, by Marisa Wexler, MS
Fact-checked by Inês Martins, PhD

What is Gilenya for MS?

Gilenya (fingolimod) is an oral medication approved for treating people ages 10 and older with relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting MS (RRMS), and active secondary progressive MS (SPMS).

Taken once daily in the form of capsules, Gilenya is used to reduce disease relapses, prevent the development of new brain lesions, and potentially delay the progression of disability. It was the first disease-modifying therapy to be approved for use in children and adolescents with MS.

The therapy works by modulating the activity of the sphingosine 1-phosphate (S1P) receptor, a protein that helps to control the movement of immune cells from lymph nodes — immune organs where some immune cells are matured and stored — to the blood. By targeting the S1P receptor, Gilenya is thought to trap immune cells in lymph nodes, preventing them from getting into the nervous system to cause damage.

The brand-name medication is sold by Novartis, but several generic versions are also available.

Therapy snapshot

Who can take Gilenya?

Gilenya is approved in the U.S. for adults and children, ages 10 and older, with CIS, RRMS, and active SPMS.

However, the medication is contraindicated for anyone who:

• experienced certain cardiovascular events in the last six months, including a heart attack, chest pain (unstable angina), stroke or mini-stroke, or certain types of heart failure
• has certain types of heart block or abnormal heart rhythms, including patients in whom a heart finding called prolonged QT is seen on heart exams
• has experienced a hypersensitivity reaction (harmful immune responses, including allergic reactions) to fingolimod or any other ingredient in Gilenya.

Gilenya is also approved in dozens of other countries, but indications may vary. In the European Union, for example, it is approved for adults and children, ages 10 and older, with highly active RRMS.

How is Gilenya administered?

Gilenya is available in the form of oral capsules, which are taken once daily with or without food. The recommended dose depends on a person’s body weight:

• in adults and children weighing more than 40 kg (about 88 lbs), the recommended dose is 0.5 mg per day
• in children weighing 40 kg or less, the recommended dose is 0.25 mg per day.

Because initiating treatment with Gilenya can cause a decrease in heart rate, monitoring is required for patients who are starting treatment for the first time or restarting treatment after a pause longer than two weeks.

Gilenya in clinical trials

Gilenya’s approval in adults was mainly supported by data from two large Phase 3 trials — FREEDOMS (NCT00289978) and TRANSFORMS (NCT00340834) — which collectively enrolled more than 2,400 adults with RRMS and a recent history of relapses.

• The FREEDOMS trial involved 1,272 patients and randomly assigned them to receive Gilenya or a placebo for two years. Results showed that the now approved 0.5 mg dose significantly reduced relapse rates by 54% and delayed disability progression by 30%. It also reduced the number of active and new or enlarging brain lesions and reduced brain volume loss.
• The TRANSFORMS trial involved 1,153 patients and randomly assigned them to receive Gilenya or Avonex (interferon beta-1a) for about one year. In this trial, Gilenya also significantly reduced relapse rates, lowered the number of lesions, and slowed brain volume loss. However, the proportion of patients with sustained disability progression was low and similar in both groups.

The approval of Gilenya for children and adolescents was supported by data from PARADIGMS (NCT01892722), a Phase 3 trial that compared Gilenya against Avonex in 215 patients, ages 10–17, with relapsing forms of MS. Gilenya significantly reduced the annual rate of relapses by 82% and resulted in fewer new or enlarging brain lesions as well as lesions with active inflammation. Additional analyses also showed that patents given Gilenya took longer to experience confirmed disability worsening compared with those given Avonex.

Gilenya side effects

The most common side effects associated with Gilenya include:

• headache
• elevated levels of liver enzymes, indicating liver damage
• diarrhea
• cough
• flu-like symptoms
• sinus inflammation
• pain in the abdomen, back, and/or extremities.

Some people taking Gilenya may experience more serious or potentially life-threatening side effects, for which careful monitoring or adjustments to their treatment may be necessary:

• slow heart rate and abnormal heart rhythms (arrhythmias)
• serious infections, including progressive multifocal leukoencephalopathy, a potentially fatal brain infection
• swelling in parts of the eye, which can lead to permanent vision loss
• liver damage, which may lead to liver failure and require a transplant
• swelling and narrowing of blood vessels in the brain, which may lead to stroke if left untreated
• symptoms of MS that are similar to those of a brain tumor
• increased blood pressure
• cancer, including skin cancers and lymphoma
• hypersensitivity reactions, including rash, hives, and swelling.

Gilenya may cause fetal harm, and women of childbearing potential should use effective contraception during and for two months after stopping Gilenya.

Some people may experience a severe return of disease activity upon discontinuing treatment, in some cases exceeding their disease activity prior to starting the medication. Patients should be closely monitored when Gilenya is stopped and begin appropriate treatment as needed.

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.