• BioXcel Therapeutics has randomized the first patient in the SERENITY At-Home trial, evaluating BXCL501 for acute agitation associated with bipolar disorders or schizophrenia.
• The company received FDA feedback on the protocol for the TRANQUILITY In-Care trial, which studies BXCL501 for agitation related to Alzheimer’s dementia.
• These Phase 3 trials address a significant unmet need, with an estimated 140 million annual acute agitation episodes associated with these conditions.
• BXCL501, already approved as IGALMI™ for agitation under supervision, seeks expanded use for at-home treatment and a new indication for Alzheimer's-related agitation.