Phase 3 Study on Treatment of Agitation in Alzheimer Disease Doses First Patient


Top-line data for study is expected in late 2022, early 2023.

brain Alzheimer_Orawan/Adobe Stock

brain Alzheimer_Orawan/Adobe Stock

The first patient has been dosed in the TRANQUILITY II study of an acute treatment for agitation in patients with Alzheimer disease.

The TRANQUILITY II study, led by BioXcel Therapeutics, focuses on BXCL501, an orally dissolving thin film formulation of dexmedetomidine. In research incorporating multiple measurement scales, BXCL501 has demonstrated statistically significant reductions in agitation with no severe adverse events at doses of both 30 mcg and 60 mcg.1 The US Food and Drug Administration (FDA) granted BXCL501 breakthrough therapy designation for the acute treatment of agitation in connection with dementia in March 2021.2

“We believe the recent FDA approval of BXCL501 for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults has laid a strong foundation for pursuing this Alzheimer’s-related agitation program to potentially address this debilitating symptom for patients,” Robert Risinger, MD, chief medical officer of BioXcel Therapeutics, said in a press release. “Importantly, we are also expanding TRANQUILITY II to more than 10 clinical trial sites in the US, and with no current FDA-approved treatments for agitation associated with this disease, we are making strong and swift efforts to potentially bring BXCL501 and its proven ability to address agitation to this large market.”

TRANQUILITY II is 1 of 2 studies—along with TRANQUILITY III—in BioXcel Therapeutics’ Phase 3 TRANQUILITY program, in which both studies measure the efficacy of BXCL501 in adults aged 65 years and older currently in assisted living facilities or nursing homes. BioXcel has reported that top-line data for TRANQUILITY II is expected in late 2022 or early 2023, and patient enrollment in TRANQUILITY III will begin later in 2022.1


1. BioXcel Therapeutics. BioXcel Therapeutics announces first patient dosed in TRANQUILITY II phase 3 trial for acute treatment of agitation in patients with Alzheimer’s disease. News release. GlobeNewswire. May 3, 2022. Accessed May 3, 2022.

2. BioXcel Therapeutics receives FDA Breakthrough Therapy Designation for BXCL501 for the acute treatment of agitation associated with dementia. News release. BioSpace. March 15, 2021. Accessed May 3, 2022.

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