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A Multi-center, Open-label, Uncontrolled, Single-arm, Extension Study to Determine the Long-term Safety and Tolerability of Oral Lucerastat in Adult Subjects With Fabry Disease

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Trial Profile

A Multi-center, Open-label, Uncontrolled, Single-arm, Extension Study to Determine the Long-term Safety and Tolerability of Oral Lucerastat in Adult Subjects With Fabry Disease

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 21 Jan 2025

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At a glance

  • Drugs Lucerastat (Primary)
  • Indications Fabry's disease
  • Focus Adverse reactions; Registrational
  • Sponsors Idorsia Pharmaceuticals

    • Most Recent Events

    • 15 Jan 2025 According to an Idorsia media release, kidney biopsy sub-study results expected in Q2 2025-regulatory pathway to be further discussed with FDA.
    • 16 Oct 2024 According to an Idorsia media release, data from the Phase 3 program with lucerastat will be presented as a poster at the American Society of Nephrology (ASN) Kidney Week 2024, taking place in San Diego, CA, October 23-27, 2024.
    • 12 Jan 2023 Planned number of patients changed from 108 to 107.

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