“Outside of its approved indication by the U.S. Food and Drug Administration as IGALMI® (dexmedetomidine) sublingual film, BXCL501 is an investigational proprietary, orally dissolving film formulation of dexmedetomidine, a selective alpha-2 adrenergic receptor agonist. BXCL501 is under investigation by BioXcel Therapeutics for the acute treatment of agitation associated with Alzheimer’s dementia and for the acute treatment of agitation associated with bipolar I or II disorder or schizophrenia in the at-home setting. The safety and efficacy of BXCL501 for these investigational uses have not been established. BXCL501 has been granted Breakthrough Therapy designation by the FDA for the acute treatment of agitation associated with dementia and Fast Track designation for the acute treatment of agitation associated with schizophrenia, bipolar disorders, and dementia.”
According to AI
“BXCL501 is an experimental drug being studied to treat acute agitation associated with dementia, schizophrenia, and bipolar disorders.
Features
It is a film that dissolves in the mouth and contains dexmedetomidine, a ⍺2 adrenoceptor agonist
It is an innovative treatment from BioXcel Therapeutics
It has received breakthrough therapy designation and fast track from the FDA”