Ztalmy
Ztalmy ingredients
| Active ingredient | Strength |
|---|---|
| Ganaxolone | 50 mg/mL |
What Ztalmy is used for
The FDA lists the approved uses on the official label (below). In the EU, ganaxolone is approved as Ztalmy for:
Ztalmy is indicated for the adjunctive treatment of epileptic seizures associated with cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder (CDD) in patients 2 to 17 years of age. Ztalmy may be continued in patients 18 years of age and older.
EU wording from the European Medicines Agency; US approved uses can differ.
Key facts
- Brand
- Ztalmy
- Generic name
- Ganaxolone
- Made by
- Immedica Pharma US Inc
- Forms
- Suspension
- Given
- Oral
- Drug class
- Neuroactive Steroid Gamma-Aminobutyric Acid A Receptor Positive Modulator
- FDA approval
- New drug application (NDA) NDA215904
- On the US market since
- 2022
Official information
- MedlinePlus drug information (search for Ganaxolone)
Specialist medicine: started and supervised by a specialist doctor or hospital. This page is a plain-language summary of public official information, not medical advice; follow your doctor and the official product information.
Common questions
What is Ztalmy?
Ztalmy (Ganaxolone) is a specialist medicine made by Immedica Pharma US Inc, approved by the US FDA.
What are the ingredients of Ztalmy?
Ztalmy contains Ganaxolone (50 mg/mL).
Is Ztalmy approved in Europe?
The same active substance is approved in the EU as Ztalmy.
From the FDA National Drug Code directory (open.fda.gov, public domain) and the European Medicines Agency medicines list. Page made 5 November 2026 by Satya Babu.
← All specialty medicines, USA