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
Price :
$35
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At a glance
- Drugs Leriglitazone (Primary)
- Indications Adrenoleucodystrophy; Adrenomyeloneuropathy
- Focus Adverse reactions; Registrational; Therapeutic Use
- Acronyms ADVANCE
- Sponsors Minoryx Therapeutics
- 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.