Fingolimod

Drug Profile

Fingolimod

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

Latest Information Update: 07 Apr 2017

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
  • New Molecular Entity Yes

Highest Development Phases

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

Most Recent Events

  • 27 Jan 2017 Novartis has patent protection for fingolimod in USA and Europe (Novartis 20-F filed in 2017)
  • 27 Jan 2017 Novartis plans to submit fingolimod for approval to the US FDA for multiple sclerosis (In children, In adolescents) in 2017
  • 27 Jan 2017 Discontinued - Phase-III for Chronic inflammatory demyelinating polyradiculoneuropathy in Japan, Israel, Canada, Australia, USA, Italy, France, Belgium, Poland, Greece, Spain, Norway, United Kingdom, Germany, Netherlands (PO) (Novartis 20-F filed in 2017)
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