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

Conclusions

1 evidence topic · 5 sources

Summary

The randomized EMBOLD evidence supports reduced motor seizure frequency in the studied SCN2A- and SCN8A-DEE populations. Longer-term seizure reduction is reported from an open-label extension involving 13 participants, which lacks a concurrent placebo comparison. Relutrigine remains investigational; the updated FDA target action date is December 27, 2026. Reported seizure outcomes do not, by themselves, establish improvement in health-related quality of life.