NDAORALSUSPENSIONPriority Review
Approved
Mar 2022
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
16
Data completeness
6/8 — Strong
Priority Review
ZTALMY (ganaxolone) by Marinus Pharmaceuticals is gaba a receptor positive modulators [moa]. Approved for drug resistant epilepsy, status epilepticus, tuberous sclerosis complex. First approved in 2022.
Drug data last refreshed Yesterday · AI intelligence enriched 2w 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. It treats a broad portfolio of rare genetic epilepsies, infantile spasms, catamenial epilepsy, and psychiatric conditions including postpartum depression, major depressive disorder, and PTSD. The mechanism leverages allosteric modulation of GABA-A receptors to restore GABAergic tone across multiple CNS disorders.
$0.953MPart D
Peak16.4 years to LOEEarly-stage rare disease product in peak lifecycle with modest Part D penetration; commercial infrastructure scaling across epilepsy and psychiatry verticals.
Mechanism of Action
GABA A Receptor Positive Modulators
Pharmacologic Class:
Neuroactive Steroid Gamma-Aminobutyric Acid A Receptor Positive Modulator
Indications (3)
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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.