Ivacaftor/tezacaftor - Vertex Pharmaceuticals

Drug Profile

Ivacaftor/tezacaftor - Vertex Pharmaceuticals

Alternative Names: Ivacaftor/VX 661; TEZ/IVA; Tezacaftor/ivacaftor; VX-661/ivacaftor; VX-661/VX-770; VX-770/VX-661

Latest Information Update: 06 Nov 2017

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At a glance

  • Originator Cystic Fibrosis Foundation Therapeutics; Vertex Pharmaceuticals
  • Class Amides; Aminophenols; Cyclopropanes; Fluorobenzenes; Quinolones; Small molecules
  • Mechanism of Action Cystic fibrosis transmembrane conductance regulator stimulants
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Cystic fibrosis
  • New Molecular Entity No

Highest Development Phases

  • Preregistration Cystic fibrosis

Most Recent Events

  • 25 Oct 2017 Efficacy and safety data from a phase III trial in Cystic fibrosis released by Vertex Pharmaceuticals
  • 01 Sep 2017 Vertex Pharmaceuticals completes a phase III trial in Cystic fibrosis (Combination therapy, In the elderly, In adolescents, In adults) in USA, Belgium, Canada, France, Greece, Ireland, Italy, United Kingdom, Australia, Austria and Germany (PO) (NCT02412111)
  • 28 Aug 2017 US FDA and EMA accepts NDA and MAA respectively for ivacaftor/tezacaftor for Cystic fibrosis for review
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