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MARCH 23, 2022

FDA Approves Ztalmy for Rare Seizure Disorder

By SPC News Staff

The FDA approved ganaxolone (Ztalmy, Marinus Pharmaceuticals) to treat seizures associated with cyclin-dependent kinase–like 5 (CDKL5) deficiency disorder (CDD) in patients aged 24 months and older. This is the first treatment for seizures associated with CDD and the first treatment specifically for CDD.

Ganaxolone, a neuroactive steroid GABAA receptor modulator, acts on a well-characterized target in the brain known to have anti-seizure effects. It is being developed in