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
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
