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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: 10 Dec 2025

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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; Tanabe Pharma Corporation; 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

  • 01 Dec 2025 Mitsubishi Tanabe Pharma Corporation is now called Tanabe Pharma Corporation
  • 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)

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