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  • Updated 08.04.2021
  • Released 08.04.2021
  • Expires For CME 08.04.2024




Ponesimod, a once-daily oral therapy, is a sphingosine-1-phosphate receptor 1 immunomodulator that has been approved by the U.S. Food and Drug Administration for the treatment of multiple sclerosis. It is indicated in adults with relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting multiple sclerosis, and active secondary progressive multiple sclerosis. In a phase 3 clinical trial, ponesimod was shown to be superior to teriflunomide, another approved therapy for the management of relapsing-remitting multiple sclerosis.

Historical note and terminology

Oral disease-modifying therapies, such as dimethyl fumarate, teriflunomide, fingolimod, ozanimod, and siponimod, have increased the options for the management of multiple sclerosis. Fingolimod, a sphingosine 1-phosphate receptor (S1PR) modulator, was the first oral treatment. The adverse events associated with fingolimod limited its use in certain populations, thus, further stimulating the search for other S1PR modulators. Ozanimod, another S1PR modulator, was approved for relapsing multiple sclerosis in 2020. Other S1PR modulators, such as ceralifimod (ONO-4641) and amiselimod (MT-1303), are in development (07).

Despite significant progress in multiple sclerosis therapy, there is still an unmet need for effective, safe, and convenient treatments that can be used early in the disease course. To meet this need, ponesimod, another S1PR immunomodulator, was developed by the Janssen Pharmaceutical company as a once-daily oral therapy. A phase 3 clinical trial showed ponesimod to be superior to teriflunomide, a pyrimidine synthesis inhibitor that is approved for the treatment of relapsing multiple sclerosis. Ponesimod was approved by the U.S. Food and Drug Administration for the treatment of multiple sclerosis in March 2021 and was later approved by the European Medicines Agency (04). Because of its favorable risk-benefit ratio and convenience of administration, ponesimod might become a leading option among S1PR modulators used for relapsing multiple sclerosis (01).

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