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Fingolimod - Novartis

Drug Profile

Fingolimod - Novartis

Alternative Names: Fingolimod hydrochloride; FTY-720; Gilenia; Gilenya; Imusera; TDI-132

Latest Information Update: 31 Jul 2019

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At a glance

  • Originator Mitsubishi Pharma Corporation; Taito
  • Developer ALS Therapy Development Institute; Mitsubishi Pharma Corporation; Mitsubishi Tanabe Pharma Corporation; Novartis; The University Hospital of Basel
  • Class Anti-inflammatories; Ethanolamines; Eye disorder therapies; Immunotherapies; Propylene glycols; Small molecules
  • Mechanism of Action Apoptosis stimulants; Immunosuppressants; 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; Renal transplant rejection
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Multiple sclerosis
  • Phase II Amyotrophic lateral sclerosis
  • Phase I/II Rett syndrome
  • Discontinued Chronic inflammatory demyelinating polyradiculoneuropathy; Graft-versus-host disease; Myocarditis; Optic neuritis; Renal transplant rejection; Rheumatoid arthritis; Type 1 diabetes mellitus

Most Recent Events

  • 26 Jul 2019 The European Medicines Agency's Committee for Medicinal Products for Human Use recommends that fingolimod must not be used in pregnant women and in women able to have children who are not using effective contraception
  • 19 Jul 2019 Registered for Multiple sclerosis (In children, In adults, In adolescents) in China (PO)
  • 10 May 2019 Final efficacy and adverse events data from the phase IIIb ASSESS trial in Multiple sclerosis presented at the 2019 American Academy of Neurology Annual Meeting (AAN-2019)
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