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
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