The European Commission (EC) has granted marketing authorisation under exceptional circumstances for Nezglyal (leriglitazone), an orally bioavailable, brain penetrating, selective PPAR gamma agonist, as a treatment for male cALD patients. It is approved in patients aged two to 12 years with Gadolinium (Gd)-negative brain lesions and is… Read More
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended granting marketing authorisation approval under exceptional circumstances for Nezglyal (leriglitazone) as a treatment for male cALD patients, aged two to 12 years with gadolinium (Gd) negative brain lesions. European Commission approval… Read More
Leriglitazone has been shown to halt disease progression in adult patients with early cerebral adrenoleukodystrophy (cALD) in a compassionate-use study. cALD is a fatal neurodegenerative disorder that is characterised by growing, demyelinating brain lesions, with death occurring typically within three to four years of onset. Read More
Minoryx has announced enrollment of first patients with cerebral Adrenoleukodystrophy (cALD) in the US Phase III clinical trial, CALYX. As part of CALYX, Minoryx is conducting an extensive pre-screening MRI-based campaign aimed at identifying eligible adult X-linked Adrenoleukodystrophy (X-ALD) patients with cALD. In June… Read More
The US Food and Drug Administration (FDA) has approved Minoryx Therapeutics’ Phase III clinical trial (CALYX) of leriglitazone, to treat adult male X-linked Adrenoleukodystrophy (X-ALD) patients with cerebral Adrenoleukodystrophy (cALD). Patient recruitment is expected to start by the end of Q2 2023 with results anticipated by… Read More
Minoryx Therapeutics has revealed the findings from the first and largest international study to enroll adult male X-linked adrenoleukodystrophy patients. The Phase II/III ADVANCE clinical trial of lead candidate, leriglitazone, published in The Lancet Neurology, did not meet the primary outcome… Read More
