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Siponimod - Novartis

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Drug Profile

Siponimod - Novartis

Alternative Names: BAF-312; Mayzent; NVP BAF312 AEA; NVP-BAF312-NX; Siponimod fumarate

Latest Information Update: 03 Feb 2026

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At a glance

  • Originator Novartis
  • Class Anti-inflammatories; Azetidines; Carboxylic acids; Cyclohexanes; Imines; Neuroprotectants; Small molecules; Vascular disorder therapies
  • Mechanism of Action Sphingosine 1 phosphate receptor modulators
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Multiple sclerosis
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Multiple sclerosis
  • Phase II Stroke
  • Discontinued Dermatomyositis; Polymyositis

Most Recent Events

  • 03 Feb 2026 Siponimod is still in phase III trial for Multiple sclerosis (In adolescents, In children) in Lithuania, Austria, Belgium, Croatia, Estonia, France, Germany, India, Italy, Latvia, Mexico, Poland, Russia, Portugal, Slovakia, Spain, USA, Trukey and Australia (PO) (NCT04926818)
  • 02 Feb 2026 Teva Canada and Novartis Pharmaceuticals agree to co-promote siponimod in Canada for Multiple sclerosis
  • 30 Mar 2023 Novartis completes a phase III trial in Multiple sclerosis in USA, Argentina, Australia, Austria, Belgium, Bulgaria, Canada, China, Czech Republic, Estonia, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Latvia, Lithuania, Netherlands, Poland, Portugal, Romania, Russia, Slovakia, Spain, Sweden Switzerland, Turkey, United Kingdom (NCT01665144) (EudraCT2012-003056-36)

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