Fingolimod - Novartis

Drug Profile

Fingolimod - Novartis

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

Latest Information Update: 29 Jun 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

  • 11 May 2018 Launched for Multiple sclerosis (In adolescents, In children) in USA (PO)
  • 11 May 2018 Registered for Multiple sclerosis (In adolescents, In children) in USA (PO)
  • 01 Apr 2018 The University Hospital of Basel and Novartis complete the phase I/II FINGORETT trial in Rett syndrome (In children, In adolescents, In adults) in Switzerland (NCT02061137)
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