Lundbeck hits recruitment milestone for Dravet syndrome trial

This trial, which focuses on a rare and severe form of childhood-onset epilepsy, marks a significant advancement for the company's broader DEEp research initiative. By completing the randomization process for over 100 participants aged two to 65, Lundbeck moves closer to determining the efficacy and safety of bexicaserin, a highly selective 5-HT2C receptor superagonist. Participants in the study, which utilizes a randomized, double-blind, placebo-controlled design, may eventually transition into a 52-week open-label extension to track long-term outcomes.

The DEEp SEA trial is one of two pivotal studies currently underway. The companion study, DEEp OCEAN, completed its own recruitment phase in July 2026 and focuses on developmental and epileptic encephalopathies excluding Dravet syndrome. Bexicaserin has already secured Breakthrough Therapy designation from the FDA and authorities in China, though it remains an investigational compound not yet approved for commercial use. Tarek Samad, Lundbeck’s head of research and development, noted that the milestone reflects the combined efforts of investigators and patient advocacy communities working to address the persistent challenge of seizure control in treatment-resistant populations.