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An open-label, multicenter study in male pediatric patients with cerebral X-linked Adrenoleukodystrophy (cALD) to assess the effect of MIN-102 treatment on disease progression prior to human stem cell transplant (HSCT)

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Trial Profile

An open-label, multicenter study in male pediatric patients with cerebral X-linked Adrenoleukodystrophy (cALD) to assess the effect of MIN-102 treatment on disease progression prior to human stem cell transplant (HSCT)

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

Latest Information Update: 20 Aug 2025

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At a glance

  • Drugs Leriglitazone (Primary)
  • Indications Adrenoleucodystrophy
  • Focus Registrational; Therapeutic Use
  • Acronyms NEXUS
  • Sponsors Minoryx Therapeutics

Most Recent Events

  • 23 Jul 2025 According to a Minoryx Therapeutics media release, based on recent data from NEXUS 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).
  • 11 Dec 2024 According to a Minoryx Therapeutics media release, The company intend to file for European Marketing Authorization of leriglitazone in pediatric and adult cerebral Adrenoleukodystrophy (cALD) patients by mid-2025.
  • 11 Dec 2024 Primary endpoint has been met. (arrested disease will be assessed at 24 weeks and at 96 weeks), according to Minoryx Therapeutics media release.

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