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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).

  • CDKL5 deficiency disorder (CDD) is a serious and rare genetic disorder that is caused by a mutation of the cyclin‑dependent kinase‑like 5 (CDKL5) gene, located on the X chromosome. CDD is characterized by early‑onset, difficult‑to‑control seizures and severe neuro‑developmental impairment.
  • Ztalmy works by exhibiting anti-seizure and anti-anxiety activity via its effects on synaptic and extrasynaptic GABAA receptors.
  • Ztalmy is indicated for use in CDD patients 2 years of age and older. It is is administered orally three times daily with food.
  • Ztalmy can cause serious adverse reactions including somnolence and sedation, and suicidal behavior and ideation. Common adverse reactions include somnolence, pyrexia, salivary hypersecretion, and seasonal allergy. 

Development timeline for Ztalmy

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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