Mayzent

(Siponimod)

Phase 3Small molecule

Novartis

Mayzent is one of 64 small molecule programs targeting Multiple Sclerosis. It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

Multiple SclerosisActive, not recruiting

Secondary Progressive Multiple SclerosisActive, not recruiting

Multiple SclerosisPhase 3

Active, not recruiting

Secondary Progressive Multiple SclerosisPreclinical

Active, not recruiting

Competition

Competitive Landscape

560 competitors in Multiple Sclerosis

#DrugCompanyPhaseTrials

Mayzent

Novartis

Phase 3

1 2

Betaseron

Bayer

Preclinical

16 3

Kesimpta

Novartis

Preclinical

15 4

Tysabri

Biogen

Preclinical

14 5

Avonex

EMD Serono

Preclinical

22 6

Campath

GGenzyme, a Sanofi Company

Preclinical

12 7

Zinbryta

Roche

Preclinical

2 8

Flomax

Sanofi

Preclinical

1 9

Pred Forte

Myfortic

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2029

Phase 2Recruiting

Alzheimer's Disease

NCT06639282

Q1 2031

Recruiting

Pregnancy

NCT05688436

Phase 3Active, not recruiting

Multiple Sclerosis

NCT04926818

Clinical

Trials by Indication[1]

Secondary Progressive Multiple Sclerosis1 trial

Managed Access Program (MAP) for Patients Diagnosed With Secondary Progressive Multiple Sclerosis With Active Disease

No longer available· Novartis logo

Novartis··NCT04540861

Pregnancy1 trial

A Study to Learn More About The Safety of Diroximel Fumarate (VUMERITY®) in Participants Who Took it During Pregnancy And About the Health of Their Babies

Recruiting· Biogen logo

Biogen··NCT05688436·1,178 enrolled

Alzheimer's Disease1 trial

Repurposing Siponimod for Alzheimer's Disease

Recruiting·SSt. Joseph's Hospital and Medical Center, Phoenix·Phase 2·NCT06639282·105 enrolled

Infusion1 trial

Safety and Tolerability of Conversion From Oral, Injectable, or Infusion Disease Modifying Therapies to Dose-titrated Oral Siponimod (Mayzent) in Advancing RMS Patients

Completed· Novartis logo

Novartis·Phase 3·NCT03623243·185 enrolled

Multiple Sclerosis1 trial

Efficacy and Safety of Ofatumumab and Siponimod Compared to Fingolimod in Pediatric Patients With Multiple Sclerosis

Active, not recruiting· Novartis logo

Novartis·Phase 3·NCT04926818·129 enrolled

Regulatory

FDA Approval Timeline[4]

Mar 26, 2019

MAYZENT

NDA NDA209884

Sources

References

[1]
ClinicalTrials.gov — 5 trial records for Siponimod. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Siponimod compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Siponimod. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA209884). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Mayzent. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Novartis company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: Novartis

Patent Landscape[5]

Patent Cliff

Aug 27, 2028

Earliest patent expiration — generic entry possible after this date

Patent #Expires

7939519Aug 27, 2028

8492441Nov 30, 2030

12071402Jan 5, 2032

12533340Apr 23, 2036

11944602Apr 23, 2036

Mayzent

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2029

Q1 2031

Trials by Indication[1]

Secondary Progressive Multiple Sclerosis1 trial

Pregnancy1 trial

Alzheimer's Disease1 trial

Infusion1 trial

Multiple Sclerosis1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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