MedPath

Siponimod

Generic Name
Siponimod
Brand Names
Mayzent 0.25 Mg Starter Pack, Mayzent
Drug Type
Small Molecule
Chemical Formula
C29H35F3N2O3
CAS Number
1230487-00-9
Unique Ingredient Identifier
RR6P8L282I
Background

Siponimod, also known as Mayzent, by Novartis, is a new drug formulated for the management of Multiple Sclerosis (MS). It was approved by the FDA on March 26, 2019 and by Health Canada on February 20, 2020. This drug is considered a sphingosine-1-phosphate (S1P) receptor modulator and is thought to play a role in suppressing the central nervous system inflammation that is associated with MS .

Multiple Sclerosis (MS) is an autoimmune disease of the central nervous system that is chronic and inflammatory, disrupting communication between the brain and other parts of the body. Most patients diagnosed with this illness experience their initial disease symptoms between the age of 20 to 40, often the most productive years of life. Symptoms may include but are not limited to fatigue, gait changes, bowel or bladder dysfunction, abnormal muscle twitching, vision disturbance, and depressing or mood swings. MS is one of the most common causes of neurological disability in young adults and is found to occur more frequently in women than in men.

Indication

This drug is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease in adults .

Associated Conditions
Relapsing Multiple Sclerosis (RMS)

Immunic's Vidofludimus Calcium Shows Promise in Multiple Sclerosis Trials

• Immunic's phase 2 CALLIPER trial of Vidofludimus Calcium in progressive multiple sclerosis is expected to report top-line data in April. • Interim analysis of the phase 3 ENSURE trials for relapsing multiple sclerosis showed positive outcomes, with completion expected in 2026. • Vidofludimus Calcium targets Nurr1 activation for neuroprotection and DHODH inhibition for anti-inflammatory and antiviral effects in MS.

Dr. Reddy's Siponimod Tablets Recommended for Marketing Approval in India for SPMS Treatment

• Dr. Reddy's Laboratories' Siponimod tablets (0.25 mg, 1 mg, and 2 mg) receive SEC recommendation for market authorization for secondary progressive multiple sclerosis (SPMS) treatment. • The approval is contingent on Dr. Reddy's conducting Phase IV clinical trials to further evaluate the drug's efficacy and safety in the Indian population. • The SEC advises including CYP2C9 Genotype determination in the prescribing information, as individuals with this genotype should not use the drug. • Siponimod, originally developed by Novartis as Mayzent, is the first oral treatment indicated for active SPMS in adults, addressing a critical unmet need.

Abata Therapeutics' ABA-101 Treg Therapy Receives FDA Fast Track Designation for Progressive Multiple Sclerosis

• Abata Therapeutics' ABA-101, an autologous regulatory T-cell (Treg) therapy, has been granted Fast Track designation by the FDA for progressive multiple sclerosis (MS). • ABA-101 has demonstrated a tolerable safety profile and therapeutic effect in animal models, showing antigen-dependent Treg functionality and anti-inflammatory cytokine production. • The therapy targets progressive MS patients with imaging evidence of ongoing inflammatory tissue injury who are HLA-DRB1*15:01 positive, representing approximately 45,000 individuals in the U.S. • A Phase 1 study is planned to evaluate ABA-101's impact, addressing the critical need for effective treatments for progressive MS, where limited options currently exist.

BMS Seeks FDA Approval for Zeposia in Ulcerative Colitis with May Decision Date

• Bristol-Myers Squibb has submitted Zeposia (ozanimod) for FDA review in treating moderate to severe ulcerative colitis, with a priority review decision expected by May 30. • In clinical trials, Zeposia demonstrated significant efficacy with 18.4% of patients achieving clinical remission at 10 weeks compared to 6.8% on placebo, and 37% maintaining remission at one year. • If approved, Zeposia would become the first S1P modulator for ulcerative colitis, potentially expanding BMS's market presence beyond its current multiple sclerosis indication.
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