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

Latest Information Update: 01 Feb 2024

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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

    • 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 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.
    • 26 Jan 2024 According to a Minoryx Therapeutics media release, 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, company announced that the EMAs Committee for Medicinal Products for Human Use (CHMP) has recommended not to grant marketing authorization for leriglitazone as a treatment of X-ALD. Companies are seeking a re-examination for conditional approval for patients with cerebral adrenoleukodystrophy, which is characterized by demyelinating brain lesions which can become rapidly progressive, leading to acute neurological decline and death in 3-4 years.
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