BioXcel to Announce Topline Results from SERENITY At-Home Phase 3 Trial on August 27, 2025

BioXcel Therapeutics will announce topline results from the SERENITY At-Home Phase 3 trial on August 27, 2025. The study evaluates the safety of BXCL501 for agitation in bipolar and schizophrenia patients at home. Investors and stakeholders can access the data via a live webcast or conference call. The trial enrolled 200 patients who self-administered 120 mcg of BXCL501 or a placebo in response to agitation episodes over a 12-week period. BXCL501 has received Breakthrough Therapy and Fast Track designations from the FDA for certain agitation-related conditions.

BioXcel Therapeutics, Inc. (Nasdaq: BTAI) has scheduled an investor call and webcast for August 27, 2025, at 8:00 AM ET to present topline data from its SERENITY At-Home Pivotal Phase 3 safety trial. The study evaluates BXCL501, the company's proprietary sublingual film formulation of dexmedetomidine, for treating acute agitation in patients with bipolar disorders or schizophrenia in at-home settings. The results will be released via press release before the call, which can be accessed through a webcast link or by dialing in. Presentation materials will be available on the company's website, with a replay accessible until November 26, 2025 [1].

The SERENITY At-Home Phase 3 trial enrolled 200 patients with a history of agitation episodes despite being on stable treatment for their underlying bipolar or schizophrenia residing at home either alone or with caregivers/informants. Patients were required to self-administer 120 mcg of BXCL501 (the approved dose under medical supervision) or placebo when they experienced agitation episodes over the 12-week trial period, and their safety data (adverse events) was collected during the trial. In addition, patients or caregivers/informants completed a modified global impression of severity (mCGIs) two hours after dosing as an exploratory endpoint to assess their experience in the outpatient setting [1].

BXCL501, outside of its approved indication by the U.S. Food and Drug Administration as IGALMI® (dexmedetomidine) sublingual film, is an investigational proprietary, orally dissolving film formulation of dexmedetomidine. It is under investigation by BioXcel Therapeutics for the acute treatment of agitation associated with Alzheimer’s dementia and for the acute treatment of agitation associated with bipolar I or II disorder or schizophrenia in the at-home setting. The safety and efficacy of BXCL501 for these investigational uses have not been established [1].

BioXcel Therapeutics, Inc. 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 [1].

Investors and stakeholders can access the webcast at the following link: https://event.choruscall.com/mediaframe/webcast.html?webcastid=S598spob, or dial in at 877-407-5795 / +1 201-689-8722. A link to the webcast and accompanying presentation materials will also be available on the Investors section of the corporate website, bioxceltherapeutics.com, and a replay will be available through November 26, 2025 [1].

References:
[1] https://www.stocktitan.net/news/BTAI/bio-xcel-therapeutics-to-announce-topline-results-from-serenity-at-1rgy1omou6ip.html