Nezglyal (leriglitazone)

Orphan

Region: 🇪🇺 EU
Active substance: leriglitazone
Company: Minoryx Therapeutics S.L.
Status: Refused
Therapeutic area: Adrenoleukodystrophy
CHMP opinion: Tue 28 May 2024
Designations: Orphan
Application: EMEA/H/C/005757
ATC: A16AX23
Official record: www.ema.europa.eu

Indication

Nezglyal is indicated for the treatment of male ALD patients aged 2 years and older with brain lesions to delay progression of cerebral adrenoleukodystrophy (cALD).

Regulatory milestones

Mon 21 Sep 2026🇪🇺 EU approval (EC decision)

Nezglyal (leriglitazone) approved in the EU

Marketing authorisation to Minoryx Therapeutics S.L.; Orphan, Exceptional circumstances, Additional monitoring · source

Thu 23 Jul 2026🇪🇺 CHMP positive opinion

Nezglyal (leriglitazone): CHMP positive opinion

Minoryx Therapeutics S.L.; Orphan, Exceptional circumstances, Additional monitoring · source

Same substance in other markets

🇪🇺 Nezglyal Authorised · Minoryx Therapeutics S.L.

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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.