VALBY, Denmark, July 20, 2026
H. Lundbeck A/S has reached a major clinical development milestone with the last patient randomized in the global Phase III DEEp OCEAN trial, evaluating the investigational therapy bexicaserin for the treatment of seizures associated with Developmental and Epileptic Encephalopathies (DEEs). The completion of patient randomization marks significant progress for one of the largest and broadest pivotal epilepsy studies conducted to date, bringing Lundbeck closer to delivering a potential new treatment option for patients living with severe childhood-onset epileptic disorders that currently have few effective therapies. Headline clinical results are expected by the end of Q4 2026 or during Q1 2027, while recruitment in the companion DEEp SEA Phase III trial for Dravet syndrome continues to advance as planned.
Phase III DEEp OCEAN Trial Reaches Major Clinical Milestone
The DEEp OCEAN (NCT06719141) study is a global, randomized, double-blind, placebo-controlled Phase III clinical trial designed to evaluate the safety, tolerability, and efficacy of bexicaserin in reducing countable motor seizures among children and adults living with Developmental and Epileptic Encephalopathies (DEEs). More than 350 participants between two and 65 years of age have been enrolled across multiple international sites, making it the broadest pivotal clinical trial ever conducted in DEEs. Unlike previous epilepsy studies that focused primarily on individual syndromes such as Dravet syndrome or Lennox-Gastaut syndrome, DEEp OCEAN includes patients representing more than 60 different genetic DEE syndromes, reflecting the real-world diversity of these rare neurological disorders. Following completion of the blinded treatment period, eligible participants will be offered enrollment into a long-term 52-week open-label extension study, allowing researchers to further evaluate the therapy’s long-term safety and effectiveness.
Bexicaserin Targets Significant Unmet Need in Rare Epilepsy
Developmental and Epileptic Encephalopathies are among the most severe forms of epilepsy, typically beginning during infancy or early childhood and characterized by frequent, treatment-resistant seizures, developmental delay, and cognitive impairment. Despite advances in epilepsy treatment, no antiseizure medication is currently approved across the full spectrum of DEE subtypes, leaving many patients with limited therapeutic options. Bexicaserin is an investigational oral, highly selective 5-HT2C receptor superagonist that works through a dual mechanism of action, enhancing inhibitory neuronal activity while simultaneously reducing excitatory neuronal signaling. Earlier Phase IIa PACIFIC trial results demonstrated encouraging reductions in multiple seizure types across a wide range of DEE syndromes, supporting its advancement into late-stage clinical development. The therapy has also received Breakthrough Therapy Designation from both the U.S. Food and Drug Administration (FDA) and Chinese regulatory authorities, highlighting its potential to address a critical unmet medical need in rare pediatric epilepsy.
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Lundbeck Expands Leadership in Neuroscience Innovation
The successful completion of patient randomization in DEEp OCEAN represents another important milestone in Lundbeck’s strategy to advance innovative treatments for complex neurological disorders. The company also reported that enrollment in the companion DEEp SEA Phase III trial, evaluating bexicaserin in Dravet syndrome, is progressing well, with completion of patient randomization expected within the coming months. Together, the DEEp clinical program is designed to establish the efficacy, safety, and benefit-risk profile of bexicaserin across multiple rare epilepsy populations while generating valuable scientific insights into seizure control across genetically diverse patient groups. With more than 70 years of leadership in neuroscience research, Lundbeck continues to expand its pipeline beyond psychiatry into rare neurological diseases, reinforcing its commitment to developing transformative therapies for patients with limited treatment options. If successful, bexicaserin could become one of the first therapies capable of addressing seizures across a broad spectrum of Developmental and Epileptic Encephalopathies, potentially establishing a new standard of care for these devastating disorders.
Source: Lundbeck press release
