BioXcel Outlines Trial Design for Agitation in Alzheimer’s Disease Patients

Biopharmaceutical company, BioXcel Therapeutics (Nasdaq: BTAI), has provided details of its upcoming TRANQUILITY In-Care Phase 3 trial which will evaluate BXCL501 as an acute treatment for agitation associated with Alzheimer’s dementia (AAD) in the care setting. BXCL501 is a proprietary, orally dissolving film formulation of dexmedetomidine.

“The design of our upcoming TRANQUILITY In-Care trial largely mirrors TRANQUILITY II, which demonstrated positive efficacy and safety results with a 60 mcg dose of BXCL501,” said Vincent O’Neill, M.D., Chief of Product Development and Medical Officer of BioXcel Therapeutics. “We have completed two recent meetings with the FDA on our TRANQUILITY program, and are pleased to have obtained clarity on the next steps for our AAD development path. This represents a major milestone since there is no U.S. regulatory precedent for episodic treatment of AAD. We are now intensely focused on advancing this important program.”

The TRANQUILITY In-Care trial is designed as a double blind, placebo-controlled study to evaluate the efficacy and safety of a 60 mcg dose of BXCL501 in an expected 150 patients over a 12-week period.

BioXcel attended a Type B/Breakthrough Therapy designation meeting with the FDA on February 20, 2024.

IGALMI™ (dexmedetomidine) sublingual film is a prescription medicine, administered under the supervision of a health care provider, that is placed under the tongue or behind the lower lip and is used for the acute treatment of agitation associated with schizophrenia and bipolar disorder I or II in adults. 

About BioXcel Therapeutics, Inc.

BioXcel Therapeutics, Inc. (Nasdaq: BTAI) is a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience. Its wholly owned subsidiary, OnkosXcel Therapeutics, is focused on the development of medicines in immuno-oncology. The Company’s drug re-innovation approach leverages existing approved drugs and/or clinically validated product candidates together with big data and proprietary machine learning algorithms to identify new therapeutic indications. For more information, please visit

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BioXcel Outlines Trial Design for Agitation in Alzheimer’s Disease Patients

Catie Corcoran

Biotech Editor