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VX 659/ivacaftor/tezacaftor - Vertex Pharmaceuticals

Drug Profile

VX 659/ivacaftor/tezacaftor - Vertex Pharmaceuticals

Alternative Names: Tezacaftor/VX-659/ivacaftor; VX-659/ivacaftor/VX-661; VX-659/TEZ/IVA; VX-659/VX-770/VX-661; VX659/ivacaftor/tezacaftor

Latest Information Update: 05 Sep 2019

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At a glance

  • Originator Vertex Pharmaceuticals
  • Class Amides; Aminophenols; Antifibrotics; 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.

    No
  • New Molecular Entity Yes

Highest Development Phases

  • Phase III Cystic fibrosis

Most Recent Events

  • 21 Aug 2019 Vertex Pharmaceuticals terminates a phase III trial for Cystic fibrosis (In children) in USA after Part A due to Sponsor's discretion (PO) (NCT03633526)
  • 06 Mar 2019 Vertex Pharmaceuticals plans to submit a MAA for Cystic fibrosis (In adolescents, In adults) with two F508del mutations or one F508del mutation and one minimal function mutation with the EMA in the fourth quarter of 2019
  • 06 Mar 2019 Vertex Pharmaceuticals plans to submit a NDA for Cystic fibrosis (In adolescents, In adults) with two F508del mutations or one F508del mutation and one minimal function mutation with the US FDA in the third quarter of 2019
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