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Fingolimod - Novartis

Drug Profile

Fingolimod - Novartis

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

Latest Information Update: 21 Dec 2018

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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 - Renal transplant rejection; Multiple sclerosis
  • 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

  • 29 Nov 2018 Registered for Multiple sclerosis (In children, In adolescents) in Liechtenstein, Iceland, Norway, European Union (PO)
  • 19 Oct 2018 Novartis completes the LONGTERMS trial in Multiple sclerosis in USA, EU countries, Argentina, Australia, Brazil, Canada, Egypt, Greece, Guatemala, Israel, Jordan, South Korea, Malaysia, Panama, Peru, Russia, South Africa, Switzerland and Turkey (PO) (NCT01201356)
  • 10 Oct 2018 Updated efficacy and adverse events data from the phase III LONGTERMS trial in Multiple sclerosis presented at the 34th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS-2018)
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