Relutrigine for SCN2A and SCN8A developmental and epileptic encephalopathies
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The FDA is expected to decide on Relutrigine for SCN2A and SCN8A developmental and epileptic encephalopathies by December 27, 2026, under an NDA from Praxis Precision Medicines.
What is being decided
Praxis Precision Medicines has an NDA under FDA review for Relutrigine in SCN2A and SCN8A developmental and epileptic encephalopathies. Review extended 3 months from the original September date.
About the drug
Relutrigine: functional state-selective sodium channel modulator that preferentially inhibits the persistent sodium current leaking through overactive Nav1.2 and Nav1.6 channels. Our full Relutrigine profile covers how it works, side effects in plain language, and its trial history.
What each outcome would mean
An approval starts a second race rather than ending the first one: specialty pharmacy setup, insurance review, and patient assistance typically take weeks even when everything goes right. Our guide to the 90 days after a rare disease approval explains the timeline and the moves families can make on day 1.
A complete response letter would mean the FDA declined to approve in the application's current form. CRLs are often about manufacturing or data presentation rather than efficacy, and resubmission is common. Either way, this page updates with the outcome and what it means.
We'll email you when the decision is public, with what it means in plain language, and when new trials open for the condition you pick. Unsubscribe anytime.
Frequently asked questions
When will the FDA decide on Relutrigine?
The FDA's target date (PDUFA date) for Relutrigine in SCN2A and SCN8A developmental and epileptic encephalopathies is December 27, 2026.
Who disclosed it: Praxis Precision Medicines. The FDA does not publish these dates.
Can it move: the FDA can act early, and a major amendment to the application can push the date back 3 months.
Source: Praxis press release
What is Relutrigine being reviewed for?
Praxis Precision Medicines submitted an NDA for Relutrigine in SCN2A and SCN8A developmental and epileptic encephalopathies.
What to know: Review extended 3 months from the original September date.
How it works: Functional state-selective sodium channel modulator that preferentially inhibits the persistent sodium current leaking through overactive Nav1.2 and Nav1.6 channels.
More: the Relutrigine drug page explains it in plain language.
What did the Relutrigine trials show?
EMBOLD (NCT05818553) is a Phase 2/3 study in children and young people aged 1 to 18 with early-onset SCN2A or SCN8A developmental and epileptic encephalopathy. In the double-blind part, participants were randomized to relutrigine for 16 weeks or to relutrigine for 12 weeks followed by 4 weeks of placebo, then continued into an open-label extension of up to 144 weeks.
More: the Relutrigine drug page has the full trial history and sources.
What are the side effects of Relutrigine?
In the EMBOLD study, Praxis reported no drug-related serious adverse events, and treatment-related adverse events were predominantly mild or moderate. The company has not published the rates of individual side effects in its announcements, and there is no US label yet, so the warnings and monitoring plan are not known.
More: the Relutrigine drug page lists the warnings in full.
How much will Relutrigine cost?
Praxis Precision Medicines has not announced a price. Drugmakers usually set it around approval.
Help paying: drugmaker programs and charity funds usually open at launch.
Find help: the patient assistance finder lists programs by insurance type.
What happens after the Relutrigine decision?
This page updates with the outcome the day it is announced.
If approved: getting the drug still takes time. Specialty pharmacy setup, insurance review and patient assistance often take weeks. Our guide covers what families can do on day 1.
If not approved: a complete response letter means the FDA declined the application in its current form. Many are about manufacturing or how data were presented, and companies often resubmit.
Where this date comes from
The FDA does not publish PDUFA dates; companies disclose them. This one comes from Praxis press release. Dates can move, and the FDA can act early or late. This page rechecks against our calendar, which is re-verified daily.