Ztalmy (ganaxolone) (Ganaxolone SUSPENSION) 50 mg/mL

Ztalmy (ganaxolone) is an FDA-approved oral medication developed by Immedica Pharma for treating CDKL5 Deficiency Disorder (CDD), a rare genetic neurological condition. This orphan drug represents a significant therapeutic advance for patients with this severe seizure disorder. Ztalmy is classified as a neuroactive steroid indicated for reducing seizure frequency in this pediatric population.

Strength

50 mg/mL

Pack Size

1 BOTTLE, PLASTIC in 1 CARTON (81583-100-01) / 110 mL in 1 BOTTLE, PLASTIC

Manufacturer / TM Owner

Immedica Pharma

Select Quantity

Pack/s

Request a Quote

Please fill out the form below and our team will get back to you shortly with pricing and further information.

First Name

Last Name

Phone

Delivery Country

Delivery PostCode/Zipcode

Select Your Profile

I have read and agree to the terms & conditions, including the privacy policy, return policy, and usage terms as applicable to this request.

Indications & Clinical Uses

Ztalmy is indicated for the treatment of CDKL5 Deficiency Disorder (CDD), a rare genetic disorder caused by mutations in the cyclin-dependent kinase-like 5 (CDKL5) gene. CDD primarily affects infants and young children, presenting with early-onset, treatment-resistant seizures typically beginning within the first three months of life. Patients with CDD often experience developmental delays, hypotonia, and other neurological complications. Ganaxolone, the active ingredient in Ztalmy, is a neuroactive steroid that modulates GABAergic neurotransmission by acting as a positive allosteric modulator of GABA-A receptors. This mechanism enhances inhibitory neurotransmission in the central nervous system, thereby reducing abnormal neuronal firing and seizure activity. Ztalmy is specifically designed for pediatric patients with genetically confirmed CDKL5 mutations who have limited treatment options and often experience inadequate seizure control with conventional antiepileptic drugs.

Side Effects

Common side effects of Ztalmy include somnolence, fatigue, decreased appetite, and gastrointestinal disturbances such as diarrhea and vomiting. Serious adverse events may include severe sedation, respiratory depression, and hypersensitivity reactions. Patients may experience behavioral changes, mood alterations, or increased irritability. Monitoring requirements include regular assessment of seizure frequency, developmental milestones, and behavioral status. Liver function tests should be performed periodically, and healthcare providers should monitor for signs of CNS depression. Caregivers should report any unusual behavioral changes, persistent drowsiness, or signs of allergic reactions immediately.

Precautions & Warnings

Ztalmy is contraindicated in patients with known hypersensitivity to ganaxolone or any excipients. Use with caution in patients with hepatic impairment, as ganaxolone undergoes hepatic metabolism. Renal impairment may require dose adjustments. Safety in pregnancy has not been established; use only if potential benefits justify risks to the fetus. Ztalmy is indicated for pediatric patients with CDD; safety and efficacy in other age groups require clinical evaluation. Concurrent use with other CNS depressants may potentiate sedation. Abrupt discontinuation should be avoided due to risk of seizure exacerbation. Regular monitoring of therapeutic response and adverse effects is essential.

Avoid Interactions

Ganaxolone may interact with other CNS depressants, including benzodiazepines, opioids, and other antiepileptic drugs, potentially increasing sedation and respiratory depression. Concurrent administration with strong CYP3A4 inhibitors may increase ganaxolone plasma concentrations. Patients taking oral contraceptives should be monitored, as ganaxolone may affect their efficacy. Alcohol consumption should be avoided due to additive CNS depression. Healthcare providers should review all concomitant medications and adjust dosing accordingly to minimize adverse interactions.

Frequently Asked Questions

Ztalmy (ganaxolone) is used to treat CDKL5 Deficiency Disorder (CDD), a rare genetic neurological condition characterized by early-onset, treatment-resistant seizures in infants and young children. It works by enhancing inhibitory neurotransmission in the brain to reduce seizure frequency and improve seizure control in patients with this severe condition.

Ztalmy is administered orally as a liquid suspension. The dosage is individualized based on patient weight and clinical response, typically initiated at a low dose and titrated gradually under medical supervision. Dosing schedules and adjustments should be determined by a healthcare provider experienced in treating CDKL5 Deficiency Disorder.

Common side effects include somnolence, fatigue, decreased appetite, diarrhea, and vomiting. Some patients may experience behavioral changes or mood alterations. Most side effects are mild to moderate and may diminish with continued use, though any concerning symptoms should be reported to a healthcare provider.

Ztalmy is manufactured by Immedica Pharma, a biopharmaceutical company dedicated to developing treatments for rare neurological disorders.

Yes, Ztalmy received FDA Orphan Drug Designation for CDKL5 Deficiency Disorder due to the rarity of the condition and the significant unmet medical need. This designation provides regulatory incentives and support for the development and commercialization of treatments for rare diseases affecting small patient populations.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated: 17 Jun 2026

Disclaimer

At GNH India, we aim to provide information that is expert-reviewed, accurate, and reliable. However, all content on this platform is intended for general informational purposes only and does not constitute professional medical advice, diagnosis, or treatment. While efforts are made to maintain accuracy and currency, the information may contain errors, omissions, or may not reflect the latest developments. Always consult a qualified healthcare professional regarding any medical concerns.

All product names, brand names, trademarks and registered trademarks displayed on this website are the property of their respective owners. This website and its operator are not affiliated with, endorsed by, or authorized by any such trade mark owners unless expressly stated. Any reference to product names or trademarks is made solely for descriptive and informational purposes. No commercial relationship, sponsorship, approval, or association with any trademark owner should be inferred. Information provided herein does not constitute promotion, advertising, or an offer for sale of any medicinal product and is intended solely for general informational purposes.

All trademarks and brand names displayed on this website are used strictly in accordance with the provisions of the Trade Marks Act, 1999, specifically Sections 30 and 30(1) governing fair use. Trademark ownership has been accurately attributed under the "Manufacturer/ TM Owner" section in compliance with statutory requirements.