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BioXcel Therapeutics Advances Pivotal Phase 3 Trials of BXCL501 for Acute Treatment of Agitation Associated with Bipolar Disorders, Schizophrenia, and Alzheimer's Dementia
First patient randomized in SERENITY At-Home trial of BXCL501 for acute treatment of agitation associated with bipolar disorders or schizophrenia
Received FDA feedback on protocol for TRANQUILITY In-Care trial of BXCL501 for agitation associated with Alzheimer's dementia (AAD)
Estimated 140 million annual acute agitation episodes associated with these conditions 1-3
NEW HAVEN, Conn., Nov. 12, 2024 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (NASDAQ:BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience, today announced the achievement of clinical and regulatory progress for its pivotal Phase 3 clinical trials of BXCL501 for the acute treatment of agitation associated with bipolar disorders or schizophrenia (SERENITY At-Home) and agitation associated with Alzheimer's dementia (TRANQUILITY In-Care). There are no FDA-approved acute therapies for these conditions.
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