Praxis Precision Medicines’ oral vormatrigine stopped 100% of seizures in 22% of patients in a Phase II trial.
The RADIANT study (NCT06908356) enrolled around 50 patients with focal onset seizures.
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In the study, patients treated with vormatrigine for eight weeks experienced a 56.3% median reduction in seizure frequency.
Around 22% of patients reached 100% reduction in seizure frequency in the last 28 days of treatment. More than 54% of patients achieved a 50% response in the first week, with that being sustained throughout the study. The drug remained well-tolerated in the study.
Praxis CEO Marcio Souza said: “We are thrilled by the best-in-disease topline results of this first cohort for the RADIANT study and for the potential to deliver a fast-acting, highly efficacious and tolerable therapy to patients living with focal epilepsy.
“Many of the over three million patients living with common epilepsy in the US need to manage multiple anti-seizure medications, and vormatrigine is the only drug in development aiming to become first line and address the market at large.”
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By GlobalDataAdditional data from RADIANT will be presented at the 36th International Epilepsy Congress on 31 August 2025, in Lisbon, Portugal. The company also submitted a late-breaker abstract to present the full study results at the American Epilepsy Society Annual Meeting in December 2025 in Atlanta, Georgia.
Based on the RADIANT data, Praxis plans to initiate the Phase III POWER2 study of vormatrigine. The therapy is also being investigated in the pivotal, 12-week POWER1 study (NCT06999902), with data expected in Q4 2025.
Vormatrigine acts by blocking the voltage-gated sodium channel (NaV), which targets the hyperexcitable state of sodium channels in the brain. If approved, GlobalData predicts vormatrigine to make $456m in global sales in 2031.
GlobalData is the parent company of Clinical Trials Arena.
Market remains limited
There are several anti-seizure medications approved by the US Food and Drug Administration (FDA). SK Biopharmaceuticals’ Xcorpi (cenobamate) gained FDA approval in November 2019 for focal seizures. It acts by modulating sodium channels and enhancing GABAergic neurotransmission, which helps to stabilise neuronal activity and reduce seizure frequency.
GlobalData predicts that Xcorpi will reach blockbuster status in 2031, gaining $1.03bn in sales in the year.
Eisai’s Fycompa (perampanel) was approved in 2012 and is another medication approved for focal seizures. It is a selective antagonist of AMPA receptors, which are involved in excitatory neurotransmission in the brain. Fycoma’s sales are set to start dropping due to the patent expiring in 2026, with a 2031 sales forecast of $202m.
While there are more than 20 FDA-approved seizure drugs, a significant number of patients with focal epilepsy still experience uncontrolled seizures. Approximately 20%-40% of patients with focal onset seizures do not achieve sufficient control with anti-seizure medications, highlighting a real need for more effective treatments for this patient population.
