Ivacaftor/tezacaftor - Vertex Pharmaceuticals

Drug Profile

Ivacaftor/tezacaftor - Vertex Pharmaceuticals

Alternative Names: Ivacaftor/VX 661; PrSYMDEKO; SYMDEKO; Symkevi; TEZ/IVA; Tezacaftor/ivacaftor; Tezacaftor/ivacaftor and ivacaftor; VX-661/ivacaftor; VX-661/VX-770; VX-770/VX-661

Latest Information Update: 31 Jul 2018

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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

  • Registered Cystic fibrosis

Most Recent Events

  • 09 Aug 2018 University of Alabama at Birmingham plans an early phase I trial for Cystic Fibrosis in USA (NCT03624101)
  • 27 Jul 2018 The Committee for Medicinal Products for Human Use of EMA grants a positive opinion for marketing authorization of ivacaftor/ tezacaftor for the treatment of cystic fibrosis
  • 28 Jun 2018 Registered for Cystic fibrosis (In adolescents, In adults) in Canada (PO)
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