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A Phase 2a, Open-label, Single-arm, 2-Part Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of VX-147 in Adults With APOL1-mediated Focal Segmental Glomerulosclerosis

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Trial Profile

A Phase 2a, Open-label, Single-arm, 2-Part Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of VX-147 in Adults With APOL1-mediated Focal Segmental Glomerulosclerosis

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 11 Jul 2023

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At a glance

  • Drugs Inaxaplin (Primary)
  • Indications Focal segmental glomerulosclerosis
  • Focus Proof of concept; Therapeutic Use
  • Sponsors Vertex Pharmaceuticals

    • Most Recent Events

    • 16 Mar 2023 According to Vertex Pharmaceuticals Media Release, data from the Phase 2 trial were published in the New England Journal of Medicine (NEJM)
    • 08 Jun 2022 According to a Vertex Pharmaceuticals media release, the U.S. Food and Drug Administration (FDA) has granted inaxaplin (VX-147) Breakthrough Therapy Designation for APOL1-mediated focal segmental glomerulosclerosis (FSGS), based on data from this trial.
    • 08 Jun 2022 According to a Vertex Pharmaceuticals media release, the European Medicines Agency (EMA) has granted inaxaplin Priority Medicines (PRIME) designation for APOL1-mediated chronic kidney disease (AMKD), based on data from this trial.

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