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Phase 3 study of AZ-3102 in patients with GM1/GM2 gangliosidoses

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Trial Profile

Phase 3 study of AZ-3102 in patients with GM1/GM2 gangliosidoses

Status: Planning
Phase of Trial: Phase III

Latest Information Update: 19 May 2025

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At a glance

  • Drugs Nizubaglustat (Primary)
  • Indications GM1 gangliosidosis; GM2 gangliosidoses
  • Focus Registrational; Therapeutic Use
  • Sponsors Azafaros

Most Recent Events

  • 13 May 2025 According to an Azafaros media release, company expects to initiate this study later this year.
  • 08 Jan 2025 According to an Azafaros media release, the company's Clinical Trial Application (CTA) for two global Phase 3 studies investigating the drug's efficacy and safety in GM1/GM2 gangliosidoses and Niemann-Pick Type C (NPC) was approved by multiple European countries. Company expects to initiate this two trials in Q2, 2025.
  • 19 Nov 2024 According to an Azafaros media release, the company will host a satellite symposium on February 4, 2025 at 12:15, which will outline the company's Phase 3 global development plans for nizubaglustat. These upcoming global Phase 3 studies for GM1 and GM2 gangliosidoses and NPC are set to be conducted across major regions including the United States, Europe, Latin America, and other select countries.

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