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Siponimod - Novartis

Drug Profile

Siponimod - Novartis

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

Latest Information Update: 23 Oct 2023

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At a glance

  • Originator Novartis
  • Class Anti-inflammatories; Azetidines; Carboxylic acids; Cyclohexanes; Imines; Neuroprotectants; Skin disorder therapies; 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

  • 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)
  • 19 Dec 2022 Efficacy data from the phase III EXCHANGE trial in Multiple sclerosis presented at the 38th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS-2022)
  • 06 Jul 2022 Novartis completes a phase III EXCHANGE trial for multiple sclerosis in USA and Puerto Rico (NCT03623243)
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