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Ztalmy FDA Approval History

Last updated by Judith Stewart, BPharm on March 19, 2022.

FDA Approved: Yes (First approved March 18, 2022)
Brand name: Ztalmy
Generic name: ganaxolone
Dosage form: Oral Suspension
Company: Marinus Pharmaceuticals, Inc.
Treatment for: CDKL5 Deficiency Disorder

Ztalmy (ganaxolone) is neuroactive steroid gamma-aminobutyric acid (GABA) A receptor positive modulator indicated for the treatment of seizures associated with cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder (CDD).

Development timeline for Ztalmy

DateArticle
Mar 18, 2022Approval FDA Approves Ztalmy (ganaxolone) for Seizures Associated with CDKL5 Deficiency Disorder
Sep 20, 2021Marinus Pharmaceuticals Announces FDA Acceptance for Filing and Priority Review of New Drug Application for Ganaxolone in CDKL5 Deficiency Disorder
Aug  3, 2021Marinus Pharmaceuticals Submits New Drug Application (NDA) to FDA for Ganaxolone for the Treatment of Seizures Associated with CDKL5 Deficiency Disorder and Provides Pipeline Update
Jan 13, 2021Marinus Pharmaceuticals Receives Positive Response from FDA on Sufficiency of One Phase 3 Clinical Trial for Filing of New Drug Application (NDA) for the Use of Ganaxolone in CDKL5 Deficiency Disorder (CDD)

Further information

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