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The Phase I/II multicenter, open-label, dose-escalation clinical trial will evaluate the safety, tolerability and efficacy of VG801.

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Trial Profile

The Phase I/II multicenter, open-label, dose-escalation clinical trial will evaluate the safety, tolerability and efficacy of VG801.

Status: Planning
Phase of Trial: Phase I/II

Latest Information Update: 23 Dec 2024

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At a glance

  • Drugs VG 801 (Primary)
  • Indications Retinal disorders
  • Focus Adverse reactions

    • Most Recent Events

    • 18 Dec 2024 According to a ViGeneron media release, the company announced that as part of a global regulatory strategy for VG801s clinical development, with a Clinical Trial Application (CTA) submission to the European Medicines Agency (EMA) planned in the coming months.
    • 18 Dec 2024 According to a ViGeneron media release, the company announced that the United States Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for the Phase I/II study of VG801, a potentially transformative gene therapy to treat Stargardt disease and other retinal dystrophies associated with mutations in the ABCA4 gene.
    • 31 Oct 2023 New trial record

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