drug
ganaxolone
Marketedupdated 3mo agoby Marinus Pharmaceuticals Inc
Approvedcommunity read0 votes
🐶 often sniffed alongside
top 3indications
investigational
Epilepsy
all catalysts(8)
approval · 8
Mar 18, 2022
approval
ZTALMY (GANAXOLONE) — FDA approval
ganaxolone
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Nov 9, 2022
approval
ZTALMY (GANAXOLONE) — FDA approval
ganaxolone
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Nov 9, 2022
approval
ZTALMY (GANAXOLONE) — FDA approval
ganaxolone
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Jun 21, 2023
approval
ZTALMY (GANAXOLONE) — FDA approval
ganaxolone
→
Jun 21, 2023
approval
ZTALMY (GANAXOLONE) — FDA approval
ganaxolone
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Aug 6, 2025
approval
ZTALMY (GANAXOLONE) — FDA approval
ganaxolone
→
Oct 16, 2025
approval
ZTALMY (GANAXOLONE) — FDA approval
ganaxolone
→
Oct 16, 2025
approval
ZTALMY (GANAXOLONE) — FDA approval
ganaxolone
→
Trials studying ganaxolone
- phase3Double-blind, Randomized, Placebo-controlled Trial of Ganaxolone in CDKL5 Deficiency Patients 6 Months to Less Than 2 Years Old
- phase3Open-label Study of Adjunctive GNX Treatment in Children and Adults With TSC-related Epilepsy
- phase3Adjunctive GNX Treatment Compared With Placebo in Children and Adults With TSC-related Epilepsy
- phase3Randomized Therapy In Status Epilepticus
- phase2Open-label Extension to Protocol 1042-0500
- phase3To Evaluate the Efficacy, Safety, and Tolerability of Intravenous Ganaxolone Added to Standard of Care in Refractory Status Epilepticus (RSE)
- phase2Safety and Efficacy Study of IV Ganaxolone as Adjuvant Therapy for Established Status Epilepticus (ESE)
- —Ganaxolone Expanded Access Program Compassionate Use
Patent cliff
source: FDA Orange Bookfirst barrier falls
Nov 28, 2026
109 days
Earliest of all listed patents + FDA exclusivities. Generic / biosimilar entry typically only becomes possible AFTER both patent and exclusivity barriers expire.
patents (11)
- Sep 30, 2042method-of-use (U-3374)US 12115169
- Sep 30, 2042method-of-use (U-3374)US 12268696
- Aug 10, 2037method-of-use (U-3374)US 10603308
- Aug 10, 2037method-of-use (U-4034)US 12144801
- Nov 28, 2031formulationUS 8318714
- Nov 28, 2026formulationUS 7858609109d
- Nov 28, 2026formulationUS 8022054109d
- Nov 28, 2026formulationUS 8367651109d
- Nov 28, 2026method-of-use (U-3374)US 8618087109d
- Nov 28, 2026formulationUS 9029355109d
- Nov 28, 2026method-of-use (U-3374)US 9056116109d
FDA exclusivities (3)
- Jun 1, 2029ODE-395Orphan Drug (7y)2.8y
- Oct 16, 2028D-197New Indication (3y)2.2y
- Jun 1, 2027NCENew Chemical Entity (5y)294d
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