Bexicaserin for Lennox-Gastaut syndrome
Fact-checked by What is bexicaserin for Lennox-Gastaut syndrome?
Bexicaserin is an oral therapy being developed by Lundbeck to treat seizures associated with Lennox-Gastaut syndrome (LGS) and other forms of severe pediatric epilepsy.
The medication is designed to bind to a receptor that responds to serotonin, a chemical messenger in the brain. This is expected to boost inhibitory signals that can calm the excessive nerve cell activity that causes seizures.
Relative to other medications that target serotonin signaling, bexicaserin is designed to have more specific actions that minimize the risk of off-target side effects, such as cardiovascular problems.
U.S. regulators have granted bexicaserin breakthrough therapy status for the treatment of seizures in people ages 2 and older with developmental and epileptic encephalopathies (DEEs), a group of rare and severe pediatric epilepsies that includes LGS. That designation aims to speed the therapy’s clinical development.
A Phase 3 clinical trial assessing the safety, tolerability, and effectiveness of the treatment candidate versus a placebo in children and adults with DEEs is underway and expected to finish this year.
Therapy snapshot
| Treatment name | Bexicaserin |
| Administration | Oral liquid taken by mouth or feeding tube |
| Clinical testing | Now in Phase 3 testing |
How will bexicaserin be administered in LGS?
In clinical trials, bexicaserin has been administered as an oral liquid, taken by mouth or feeding tube, three times a day. The dose is gradually titrated, or continually adjusted, to the maximum tolerated dose for each individual.
Bexicaserin in LGS clinical trials
Bexicaserin is being tested against a placebo in a Phase 3 trial, dubbed DEEp OCEAN (NCT06719141), involving people ages 2 to 65 with LGS and other DEEs. The study’s main goal is to evaluate changes in motor seizure frequency during treatment. Participants who complete the study will have the option to continue treatment in an open-label extension study (NCT06908226).
An earlier Phase 1b/2a trial called PACIFIC (NCT05364021) compared bexicaserin with a placebo, added to standard antiepileptic medications, in adults and adolescents with DEEs.
The results showed that treatment with bexicaserin was associated with a 33.4% greater median reduction in motor seizure frequency compared with the placebo among participants ages 12 to 65 with LGS. Reductions in seizure frequency were sustained for up to one year in a subsequent open-label extension study (NCT05626634) and as long as two years in an expanded access program (NCT06149663).
Bexicaserin side effects
In a Phase 1/2 trial, the most common side effects associated with treatment included:
- drowsiness
- decreased appetite
- constipation
- diarrhea
- lethargy
- tremor
- urinary tract infection
- fatigue
- fever
- agitation
- high blood pressure
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