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A Clinical Study to Assess the Efficacy and Safety of Leriglitazone in Adult Male Subjects With Cerebral Adrenoleukodystrophy

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Trial Profile

A Clinical Study to Assess the Efficacy and Safety of Leriglitazone in Adult Male Subjects With Cerebral Adrenoleukodystrophy

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 10 Apr 2025

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At a glance

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

Most Recent Events

  • 26 Jan 2024 According to a Minoryx Therapeutics media release, Minoryx and Neuraxpharm companies are going to request re-examination of leriglitazone for conditional marketing authorisation for treatment of patients with cALD based on additional evidence generated from the two ongoing confirmatory trials (CALYX and NEXUS).
  • 26 Jan 2024 According to a Minoryx Therapeutics media release, Minoryx and Neuraxpharm strongly believe that leriglitazone has a positive benefit-risk balance in patients with cALD. Result data from this ADVANCE study is now supported by 24 week data from NEXUS trial. Findings are being validated through confirmatory long term follow-up from ongoing trials NEXUS and CALYX, in adult patients with progressive cALD.
  • 16 Nov 2023 According to Minoryx Therapeutics media release, In Europe, review of the Marketing Authorization Application (MAA) is currently ongoing at EMA.

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