Evicenter
P&T meetings

Relutrigine

SCN2A- and SCN8A-related developmental and epileptic encephalopathies

Regulatory submission
NDA submitted in early 2026
Launch
Not announced
Last updated
72 sources

Executive summary

Relutrigine efficacy and safety

1 evidence topic · 4 sources

Summary

EMBOLD randomized 16 participants in cohort 1 and 53 in cohort 2. Reported placebo-adjusted motor seizure reductions over 16 weeks were 46% in cohort 1 and 53% in the confirmatory cohort. Cohort 1 adverse events included infections, vomiting, pyrexia, somnolence, and constipation. The healthy-volunteer PRAX-562-102 combination study is a separate safety dataset: one participant experienced three study-drug-related serious adverse events, and Part B stopped early.