Treats seizures associated with cyclin-dependent kinase-like … deficiency disorder (CDD). Sold as Ztalmy. Every FDA application for this active ingredient.
As of Nov 15, 2026, FDA lists 1 application for Ganaxolone (sold as Ztalmy), first approved Mar 18, 2022, with 1 new use approved and 0 published complete response letters.
| Product | Part | Spending, 2025 | Change | Beneficiaries |
|---|---|---|---|---|
| Ztalmy | Part D | $2.5M | +27% | 12 |
| Clinical Trial Evaluating the Effects of Ganaxolone in Children With AutismAutism in Children, Autistic Disorder in Children and Adolescents · Stanford University | Phase 2 | Not yet recruiting | Jun 9, 2026 |
| Open-label, Single-arm Trial of Ganaxolone in CDD Patients 6 Months to Less Than 2 Years OldCDKL5 Deficiency Disorder · Immedica Pharma AB | Phase 3 | Not yet recruiting | Feb 21, 2022 |
| Approved | Application | Sponsor | Supplements | Marketing |
|---|---|---|---|---|
| Mar 18, 2022 | ZtalmyNDA 215904 · New molecular entity | Immedica Pharma | 7 | Marketed |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA
