Lundbeck’s Bexicaserin Granted Breakthrough Therapy Designation in China for Treating Seizures in Severe Rare Epilepsies
Tuesday, October 14, 2025
Lundbeck has announced that its investigational drug bexicaserin has received Breakthrough Therapy Designation (BTD) from China’s Center for Drug Evaluation (CDE) for the treatment of seizures linked to Developmental and Epileptic Encephalopathies (DEEs).
DEEs are a group of rare, severe epilepsies that begin in childhood and are characterised by drug-resistant seizures and developmental delays or regression. The condition affects more than one in every 2,000 live births and carries a high mortality rate of 17–50%. Survivors often experience serious neurological disabilities, placing a significant burden on families and healthcare systems.
Bexicaserin (LP352) is an oral investigational therapy that selectively targets the 5-HT2C receptor while avoiding activity at 5-HT2B and 5-HT2A subtypes, aiming to reduce cardiovascular risks. The therapy has also been granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA) for the same indication.
The designation in China recognises the potential of bexicaserin to address an urgent medical need in one of the most challenging areas of epilepsy. It also supports the progress of Lundbeck’s global Phase 3 clinical programme for the drug.
The Breakthrough Therapy Designation procedure is designed to speed up the development and review of innovative medicines intended for serious or life-threatening diseases that lack effective treatments, or where early data suggest significant benefits over existing therapies. Under this pathway, the CDE provides priority guidance, resource support, and enhanced communication to help advance promising medicines more rapidly to patients in need.
Source: prnewswire.com
