Lundbeck Presents Bexicaserin Dual-Action Data at Epilepsy Congress

Valby, Denmark – September 07, 2026 -- Lundbeck will present preclinical data at the European Epilepsy Congress in Athens showing its investigational drug bexicaserin simultaneously increases inhibitory and decreases excitatory neuronal activity in hippocampal brain tissue, a dual mechanism the company says supports broad-spectrum antiseizure potential across multiple epilepsy types.

Preclinical study links dual mode of action to broader seizure control

The data, to be shown in an oral presentation at the September 5-9 congress, indicate bexicaserin's effects in preclinical models span focal, generalized motor and absence seizures across different underlying etiologies. Researchers attribute the effects to the compound's high affinity and selectivity for the 5-HT2C receptor, where it acts as a superagonist.

Phase III DEEp Program targets rare, treatment-resistant epilepsies

Bexicaserin is currently in a global Phase III program comprising two trials: DEEp OCEAN, enrolling children and adults with developmental and epileptic encephalopathies (DEEs) including Lennox-Gastaut syndrome, and DEEp SEA, enrolling patients with Dravet syndrome. Both trials use a 15-week treatment period with a 3-week titration phase and 12-week maintenance phase, followed by an optional 52-week open-label extension. No antiseizure medication is currently approved across all DEE types, according to the company.

Regulators in two markets grant Breakthrough Therapy status

The U.S. FDA has granted Breakthrough Therapy designation to bexicaserin for seizures associated with DEEs in patients aged two and older, and China's regulator has granted the same designation. The compound showed no engagement with 5-HT2B and 5-HT2A receptor subtypes in prior research, a profile the company says may reduce cardiovascular toxicity risk.

Safety data from PACIFIC trial show common adverse events

In the PACIFIC trial, the most frequently reported treatment-emergent adverse events linked to bexicaserin included somnolence, decreased appetite, constipation, diarrhea, lethargy, tremor, urinary tract infection, fatigue, pyrexia, agitation and hypertension. Bexicaserin remains unapproved by any regulatory authority worldwide, and its efficacy and safety have not been established.

"The data being presented at the European Epilepsy Congress highlight the strong scientific rationale for bexicaserin and its dual mode of action," said Tarek Samad, Executive Vice President and Head of Research & Development at Lundbeck.