NDAORALSUSPENSIONPriority Review
Approved
Mar 2022
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
17
Data completeness
5/8 — Partial
Priority Review
ZTALMY (ganaxolone) by Marinus Pharmaceuticals is gaba a receptor positive modulators [moa]. First approved in 2022.
Drug data last refreshed 9h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ZTALMY (ganaxolone) is an oral neuroactive steroid that acts as a GABA-A receptor positive modulator, enhancing inhibitory neurotransmission in the central nervous system. Approved in March 2022, it represents a novel mechanism for treating seizure disorders and neurological conditions characterized by excessive neural excitability. The suspension formulation enables dosing flexibility, particularly beneficial for pediatric and adult populations.
$0.953MPart D
Peak16.3 years to LOEEarly commercial phase with modest Part D penetration suggests team is building market awareness and clinical adoption infrastructure post-approval.
Mechanism of Action
GABA A Receptor Positive Modulators
Pharmacologic Class:
Neuroactive Steroid Gamma-Aminobutyric Acid A Receptor Positive Modulator
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (17)
Clinical Trial Evaluating the Effects of Ganaxolone in Children With Autism
Started Jan 2027
66 enrolled
Autism in ChildrenAutistic Disorder in Children and AdolescentsAutism Spectrum Disorder
To Evaluate the Efficacy, Safety, and Tolerability of Intravenous Ganaxolone Added to Standard of Care in Refractory Status Epilepticus (RSE)
Started Mar 2024
0Refractory Status Epilepticus
Safety and Efficacy Study of IV Ganaxolone as Adjuvant Therapy for Established Status Epilepticus (ESE)
Started Apr 2023
0Status Epilepticus
Adjunctive Ganaxolone Treatment (Part A) in TSC Followed by Long-term Treatment (Part B)
Started Apr 2020
23 enrolled
Tuberous Sclerosis
Study of Adjunctive Ganaxolone Treatment in Female Children With Protocadherin 19 (PCDH19)-Related Epilepsy (Violet Study)
Started May 2019
29 enrolled
PCDH19-Related Epilepsy
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.