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Fingolimod - Novartis

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Drug Profile

Fingolimod - Novartis

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

Latest Information Update: 24 Nov 2023

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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

  • 11 Oct 2023 Pooled efficacy data from a phase III FREEDOMS I, II and TRANSFORMS trial in Multiple sclerosis presented at the 9th Triennial joint meeting of Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS-2023) and the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS-2023)
  • 26 Dec 2022 Finolimod is still registered for Multiple sclerosis in (Taiwan) (PO)
  • 28 Oct 2022 Long-term efficacy data and adverse event data from the phase III PARADIGMS trial in multiple sclerosis presented at the 38th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS-2022)

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