Ganaxolone
As of the edition of 20 October 2026, Ganaxolone is a small molecule: marketed, first approved in 2022 (US); US protection ends in 2029.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2023
- Kind
- Small molecule
- Brand name
- Ztalmy
- First approved
- 1 June 2022 (US)
- Approvals on record
- 2 in 2 regions
- Holder of the most recent approval
- Marinus Pharmaceuticals Emerald; 2 holders in all
- Registered trials
- 25, 5 stopped early
- Disease areas
- Nervous system; Mental health; Inherited and neonatal; Cancer; Pregnancy and women's health; Urinary and reproductive
US protection
US protection ends in 2029.
The last listed US exclusivity ends in 2029. The application that gives this date is held by Immedica Pharma.
This is the US only, and it is not the date generics or biosimilars can enter.
The exact date and the listings behind it
In the product3 listings count towards this date. The exact date and each listing are in the product.
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Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 2 | 1 | 0 | 0 |
| Phase 2 | 15 | 13 | 0 | 2 |
| Phase 3 | 8 | 4 | 1 | 3 |
| All trials | 25 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Immedica Pharma | Originator, Applicant and Lead sponsor of trials | 2022 to now |
| Marinus Pharmaceuticals Emerald | Applicant | 2023 to now |