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A Randomized, Double-blind, Placebo-controlled, Multinational, Multicenter Study With Open-label Treatment Extension to Assess the Effect of MIN-102 (IMP) on the Progression of Adrenomyeloneuropathy in Male Patients With X-linked Adrenoleukodystrophy

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Trial Profile

A Randomized, Double-blind, Placebo-controlled, Multinational, Multicenter Study With Open-label Treatment Extension to Assess the Effect of MIN-102 (IMP) on the Progression of Adrenomyeloneuropathy in Male Patients With X-linked Adrenoleukodystrophy

Status: Completed
Phase of Trial: Phase II/III

Latest Information Update: 21 Aug 2025

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At a glance

  • Drugs Leriglitazone (Primary)
  • Indications Adrenoleucodystrophy; Adrenomyeloneuropathy
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms ADVANCE
  • Sponsors Minoryx Therapeutics

Most Recent Events

  • 23 Jul 2025 According to a Minoryx Therapeutics media release, based on recent data from ADANCE trial, Marketing Authorization Application (MAA) of leriglitazone (NEZGLYAL) has been submitted to the European Medicines Agency (EMA) for the treatment of paediatric and adult male patients with cerebral adrenoleukodystrophy (cALD). EMA has now validated the MAA file and it is under review by the Committee for Medicinal Products for Human Use (CHMP).
  • 18 Mar 2025 Status changed from active, no longer recruiting to completed.
  • 03 Oct 2024 Results published in the Brain.

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