Relutrigine
Relutrigine is an oral sodium channel modulator developed by Praxis Precision Medicines for developmental and epileptic encephalopathies. The next event is the FDA decision on Relutrigine, on Dec 27, 2026 (source).
- Also known as
- PRAX-562
- Company
- Praxis Precision Medicines (PRAX) · Developer
- How it works
- Sodium channel modulator
- Approved
- Not approved in any market we track
Development by disease
| Developmental and epileptic encephalopathy | Filed |
Upcoming events
Firm dates · a specific day set by the company or regulator
Next 90 days
- Dec 27in 75 daysRelutrigine · FDA decision · SCN2A and SCN8A developmental and epileptic encephalopathy
Estimated timing · a month, quarter, half-year or year-end the company gave
Expected in Q4 2026
- Q4 2026Relutrigine · Enrollment complete (EMERALD) · Developmental and epileptic encephalopathy
- Q4 2026Relutrigine · Pivotal topline results (EMERALD) · Developmental and epileptic encephalopathy · broad DEE
Past results and milestones
- Feb 19, 2026EMBOLD Cohort 2 registrational study results were shared at 2025 AES meeting, demonstrating strong efficacy that supported NDA submission for relutrigine in SCN2A and SCN8A DEEs. Source
- Aug 4, 2025EMERALD registrational study for broad developmental and epileptic encephalopathies with relutrigine has been initiated as of August 2025, on track with enrollment of up to 160 patients expected to complete in 2026. Source
- Jul 1, 2025FDA granted Breakthrough Therapy Designation for relutrigine in treatment of seizures associated with SCN2A and SCN8A developmental and epileptic encephalopathies in July 2025. Source