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BioXcel Therapeutics, Inc.
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  5. BioXcel - Model BXCL501 - Neuroscience ...

BioXcel - Model BXCL501 - Neuroscience Medicine

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BXCL501 is our most advanced neuroscience clinical program. BXCL501 is a proprietary, sublingual film formulation of dexmedetomidine, a selective alpha-2 receptor agonist. It is being investigated for at-home use for the acute treatment of agitation in bipolar and schizophrenia patients, for agitation in Alzheimer’s disease, and as an adjunctive treatment for major depressive disorder.

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BXCL501 has received Breakthrough Therapy and Fast Track designation for the acute treatment of agitation associated with dementia. In 2021, the Company announced positive topline results from the TRANQUILITY Phase 1b/2 trial for the acute treatment of agitation associated with dementia, including Alzheimer’s disease. Following discussions with the FDA in Q4 2021, we initiated our pivotal phase 3 program of BXCL501 for acute treatment of agitation in patients with Alzheimer’s disease. The Company has also submitted an Investigational New Drug (IND) application to evaluate BXCL501 as adjunctive treatment for major depressive disorder (MDD).