Molecule
Ganaxolone is a neuroactive steroid gamma-aminobutyric acid A receptor positive modulator indicated for the treatment of seizures associated with cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder (CDD) in patients 2 years of age and older. MedsAcross supplies Ganaxolone for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
ZTALMY is indicated for the treatment of seizures associated with cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder (CDD) in patients 2 years of age and older. ZTALMY is a 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) in patients 2 years of age and older.
Source: US FDA prescribing information
The precise mechanism by which ganaxolone exerts its therapeutic effects in the treatment of seizures associated with CDD is unknown, but its anticonvulsant effects are thought to result from positive allosteric modulation of the gamma-aminobutyric acid type A (GABA A ) receptor in the CNS.
Source: US FDA prescribing information
Administer ZTALMY orally three times daily with food. Titrate ZTALMY gradually according to the recommended schedules. See full prescribing information. Dosage for patients weighing 28 kg or less: the starting dosage is 2 mg/kg three times daily (6 mg/kg/day) the maximum dosage is 21 mg/kg three times daily (63 mg/kg/day). Dosage for patients weighing over 28 kg: the starting dosage is 50 mg three times daily (150 mg daily) the maximum dosage is 600 mg three times daily (1800 mg daily). Patients with severe hepatic impairment: see full prescribing information for dosage recommendation.
Source: US FDA prescribing information
None. None.
Source: US FDA prescribing information
Somnolence and Sedation: Monitor for somnolence and sedation and advise patients not to drive or operate machinery until they have gained sufficient experience with ZTALMY. Concomitant use with other CNS depressants or alcohol could potentiate adverse effects. Suicidal Behavior and Ideation: Monitor patients for suicidal behavior and thoughts. Withdrawal of Antiepileptic Drugs: ZTALMY should be withdrawn gradually to minimize the risk of increased seizure frequency and status epilepticus.
Source: US FDA prescribing information
The following important adverse reactions are described elsewhere in the labeling: Somnolence and Sedation Suicidal Behavior and Ideation Withdrawal of Antiepileptic Drugs Most common adverse reactions (incidence of at least 5% for ZTALMY and at least twice the rate of placebo) are somnolence, pyrexia, salivary hypersecretion, and seasonal allergy.
Source: US FDA prescribing information
UGT inhibitors may increase ganaxolone exposures, consider reduction of a stable ZTALMY dosage when initiating a UGT inhibitor. Cytochrome P450 inducers will decrease ganaxolone exposure. It is recommended to avoid concomitant use with strong or moderate CYP3A4 inducers, if unavoidable, consider a dosage increase of ZTALMY, but do not exceed the maximum recommended dosage.
Source: US FDA prescribing information
Store ZTALMY in its original bottle in an upright position at 20°C to 25°C (68°F to 77°F), excursions permitted from 15°C to 30°C (59°F to 86°F).
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
1 presentations of Ganaxolone, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Ztalmy 50 mg/mL oral suspensionOral | Immedica Pharma | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
Yes, on request. MedsAcross lists 1 presentations of Ganaxolone and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Ganaxolone, including Ztalmy.
Yes. The US FDA first approved Ganaxolone on 18 March 2022, according to Drugs@FDA.
Yes. Ganaxolone has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.
No listed presentation of Ganaxolone is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Ganaxolone is classified under ATC code N03AX (Anticonvulsant agent, subgroup N03AX).
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