Fingolimod

Drug Profile

Fingolimod

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

Latest Information Update: 25 Nov 2016

Price : $50

At a glance

  • Originator Mitsubishi Pharma Corporation; Taito
  • Developer ALS Therapy Development Institute; Mitsubishi Pharma Corporation; Mitsubishi Tanabe Pharma Corporation; Novartis
  • 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
  • On Fast track

    Fast track status is assigned by the US FDA so therapies with the potential to address unmet needs can move faster through development.

    No
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Multiple sclerosis
  • Phase III Chronic inflammatory demyelinating polyradiculoneuropathy
  • Phase II Amyotrophic lateral sclerosis
  • Discontinued Graft-versus-host disease; Myocarditis; Optic neuritis; Renal transplant rejection; Rheumatoid arthritis; Type 1 diabetes mellitus

Most Recent Events

  • 14 Sep 2016 Efficacy data from the phase III PARADIGMS trial in Multiple sclerosis presented at the 32nd Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS-2016)
  • 01 Sep 2016 Novartis Pharmaceuticalscompletes a phase-III clinical trial in Chronic inflammatory demyelinating polyradiculoneuropathy in Australia, USA, United Kingdom, Belgium, France, Germany, Greece, Italy, Netherlands, Poland, Spain, Norway, Canada, Israel and Japan (PO) (NCT01625182)
  • 16 May 2016 First generic equivalent launched in Belorussia for Multiple sclerosis
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