BioXcel Therapeutics announced that the first 13 patients have been dosed in Part 1 of the pivotal Phase 3 SERENITY III trial investigating at-home use of BXCL501 sublingual film, the Company’s proprietary, orally dissolving film, for agitation associated with bipolar I or II disorder or schizophrenia. "Evaluating BXCL501 for at-home use is an exciting and important milestone that potentially expands the market opportunity for the treatment of agitation and drives the growth of our neuroscience franchise," said Robert Risinger, M.D., Chief Medical Officer, Neuroscience of BioXcel Therapeutics. "We anticipate top-line data from SERENITY III as well as our TRANQUILITY II trial for Alzheimer’s-related agitation in the first half of 2023."
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