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# FDA Approves Marinus’ Ztalmy for Rare Epilepsy
- URL: https://www.fdaweb.com/fda-approves-marinus-ztalmy-for-rare-epilepsy/
- Published: 2022-03-18T12:00:00.000Z
- Updated: 2026-09-14T17:37:03.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5151406

FDA has approved Marinus Pharmaceuticals’ Ztalmy (ganaxolone) oral suspension to treat seizures associated with cyclin-dependent kinase-like 5 deficiency disorder (CDD), a rare form of genetic epilepsy in patients age 2 and older. The company [says](https://ir.marinuspharma.com/news/news-details/2022/Marinus-Pharmaceuticals-Announces-FDA-Approval-of-ZTALMY-ganaxolone-for-CDKL5-Deficiency-Disorder/default.aspx?ref=fdaweb.com) it is the first FDA-approved treatment specifically in CDD.

Ztalmy’s approval was based on data from the Phase 3 Marigold trial in which patients treated with the drug showed a median 30.7% reduction in 28-day major motor seizure frequency, compared to a median 6.9% reduction for those receiving placebo.

The drug is described as a neuroactive steroid that acts as a positive allosteric modulator of the GABA receptor.