Name: Relutrigine in SCN2A- and SCN8A-related developmental and epileptic encephalopathies: Phase of product development
Published: 2026-09-14T15:39:06-04:00

Product information and disease description Product description

Phase of product development

11 evidence topics · 9 sources

Investigational status

“Relutrigine remains investigational and is not currently approved by the FDA.” (opens the source at this quote in a new tab)

Regulatory submission: NDA submitted in early 2026

“we started 2026 with two NDA submissions for ulixacaltamide and relutrigine” (opens the source at this quote in a new tab)
“Praxis has submitted an NDA for relutrigine for the treatment of SCN2A and SCN8A DEEs” (opens the source at this quote in a new tab)

FDA acceptance announcement

“has accepted for priority review its New Drug Application (NDA) for relutrigine” (opens the source at this quote in a new tab)

Updated regulatory timeline

“FDA sets updated PDUFA date of December 27, 2026” (opens the source at this quote in a new tab)

Additional clinical studies

“No new clinical studies were requested” (opens the source at this quote in a new tab)

Review extension: additional analyses

“submission of additional sensitivity analyses of existing clinical data” (opens the source at this quote in a new tab)

Advisory committee

“The agency confirmed that no advisory committee meeting is planned.” (opens the source at this quote in a new tab)

Breakthrough Therapy designation announcement

“Food and Drug Administration (FDA) has granted BTD for relutrigine” (opens the source at this quote in a new tab)

Other FDA designations

“Relutrigine has received Orphan Drug Designation (ODD) and Rare Pediatric Disease Designation from the FDA” (opens the source at this quote in a new tab)

FDA orphan designation: SCN8A

Information	Quoted record
Date designated	“04/08/2021”
Orphan designation	“Treatment of SCN8A Developmental and Epileptic Encephalopathy”
FDA orphan approval status	“Not FDA Approved for Orphan Indication”

European designations

“EMA: Orphan Drug Designations for SCN2A DEE and SCN8A DEE” (opens the source at this quote in a new tab)

Launch

No evidence found.