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Phase I/II multicenter, multi-arm, randomized, double-blind and placebo-controlled trial of vafidemstat in Kabuki syndrome patients

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Trial Profile

Phase I/II multicenter, multi-arm, randomized, double-blind and placebo-controlled trial of vafidemstat in Kabuki syndrome patients

Status: Planning
Phase of Trial: Phase I/II

Latest Information Update: 31 Oct 2023

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At a glance

  • Drugs Vafidemstat (Primary)
  • Indications Kabuki syndrome
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms HOPE
  • Sponsors Oryzon

    • Most Recent Events

    • 27 Oct 2023 According to an Oryzon media release, the company is in a dialogue with the regulatory agencies to refine the final design of this trial and expects to submit an IND for HOPE to the U.S. Food and Drug Administration (FDA) in 2024.
    • 27 Oct 2023 According to an Oryzon media release, the company is expecting to initiate this trial in 2024.
    • 17 Feb 2023 Oryzon expects to submit the IND to the FDA for HOPE in 2023.

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