Fingolimod - Novartis

Drug Profile

Fingolimod - Novartis

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

Latest Information Update: 04 Nov 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 Ethanolamines; 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

  • 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)
  • 21 Sep 2018 CHMP recommends approval of fingolimod for relapsing remitting Multiple sclerosis (In children and adolescents) in the European Union
  • 21 Sep 2018 Novartis expects final decision from the European Commission (EC) in Multiple sclerosis (RRMS) (In children and adolescents) by December 2018
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