Is Ganaxolone approved by the US FDA?

Drugs@FDA lists 1 application product line for Ganaxolone, including ZTALMY (Prescription).

Is Ganaxolone authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Ganaxolone: Ztalmy.

Are there safety signals or safety updates for Ganaxolone?

US FDA: 1 entry (latest 2025-10-16).

Active substance

Ganaxolone

US FDA 1
EMA 1
Safety 1

Open in the medicines table

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
ZTALMY	50MG/ML	suspension · oral	IMMEDICA PHARMA	Prescription	18 Mar 2022

EMA European Union — centrally authorised medicines

Ztalmy Marinus Pharmaceuticals Emerald Limited · Authorised · authorised 26 Jul 2023 · ATC N03AX

Therapeutic indication (EMA)

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.

Safety signals and safety-related labeling changes

US FDA 16 Oct 2025 ZTALMY — safety-related labeling change
Labeling sections changed: Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for ganaxolone →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.