BioXcel Therapeutics advances Phase 3 trials of BXCL501

BioXcel Therapeutics (BTAI) 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 and agitation associated with Alzheimer’s dementia. There are no FDA-approved acute therapies for these conditions. “We are pleased with the progress on our late-stage trials, which leverage our extensive clinical development experience,” said Vincent O’Neill, M.D., Chief of Product Development and Medical Officer of BioXcel Therapeutics. “With SERENITY At-Home, we are seeking to make BXCL501, which is currently approved under healthcare provider supervision as IGALMI(TM), available to millions of additional patients by potentially expanding its label for treating bipolar or schizophrenia-related agitation in the home. With TRANQUILITY In-Care, we have a unique opportunity in AAD, for which there is no U.S. regulatory precedent for episodic treatment. We look forward to continuing our development of BXCL501 for these critical unmet medical needs.”