The company said that no discontinuations due to tolerability were observed in the arm of the study that received BXCL501.
BioXcel Therapeutics, Inc. (BTAI) on Wednesday said that its late-stage trial evaluating the safety of the company’s BXCL501 as a treatment for agitation associated with bipolar disorders or schizophrenia in the at-home setting met its primary goal of being well-tolerated.
BXCL501 is an investigational, orally dissolving film formulation of Dexmedetomidine. The company said that the data from the study will form the basis of a submission to the U.S. Food and Drug Administration slated for the first quarter of 2026 and aimed at expanding the label for its dexmedetomidine sublingual film called Igalmi in the at-home setting.
Igalmi is already approved for the acute treatment of agitation associated with bipolar I or II disorder or schizophrenia in medically supervised settings.
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BioXcel said that no discontinuations due to tolerability were observed in the arm of the study that received BXCL501.
“By meeting its primary endpoint, the SERENITY At-Home Pivotal Phase 3 trial reinforces BXCL501’s potential to be safely used at home like it is already used in the previously FDA approved institutional setting. The unmet medical need in the at-home setting is significant with no FDA-approved treatments,” CEO Vimal Mehta said, while adding that the company believes the total addressable market is “significantly larger” than previously reported.
The company said that a total of 246 patients were part of the trial, and 2,437 agitation episodes in 208 patients were treated. All patients were able to successfully self-administer the film, and an average of 11.7 agitation episodes were recorded per treated patient.
The company said that available data demonstrate that treatment with BXCL501 regularly reduced symptoms of agitation throughout the trial. A greater percentage of patients experiencing mild, moderate, or severe agitation had full resolution of symptoms in the BXCL501 arm compared with placebo. Complete analyses of the full data set are ongoing and will be shared in time, the company said.
BTAI stock is down by 24% this year and by 57% over the past 12 months.
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