BioXcel Therapeutics Completes Last Patient Visit in Key Phase 3 SERENITY At-Home Trial for Acute Agitation in Bipolar Disorder and Schizophrenia

August 1, 2025

DENVER, Colo., Aug 01, 2025 (247marketnews.com)- BioXcel Therapeutics (NASDAQ:BTAI) completes the last patient last visit (LPLV) in its pivotal Phase 3 SERENITY At-Home clinical trial. The trial is evaluating the safety of BXCL501 (dexmedetomidine) for the acute treatment of agitation associated with bipolar disorders or schizophrenia in the at-home setting.

Topline data are expected later this month, and results from the study are intended to support a planned supplemental New Drug Application (sNDA) to potentially expand the approved label of IGALMI for outpatient use.

Vimal Mehta, Ph.D.,  BioXcel’s CEO, stated, “This is another critical step toward advancing BXCL501 (IGALMI) as the first FDA-approved therapy for this indication in the home setting.”

Trial Overview

The SERENITY At-Home Phase 3 trial is a double-blind, placebo-controlled study evaluating the safety of a 120 mcg dose of BXCL501 administered at home. More than 200 patients were enrolled across 22 clinical sites in the U.S., with no single site contributing more than 11% of participants. Patient enrollment was evenly distributed between those with bipolar disorder and schizophrenia.

Participants self-administered either BXCL501 or placebo during agitation episodes over a 12-week period. Safety was the primary endpoint, with data on adverse events collected throughout the trial.

As exploratory endpoints, both patients and their caregivers/informants completed assessments of treatment response, including the modified Clinical Global Impression of Severity (mCGI-S) and the modified Clinical Global Impression of Change (mCGI-C) two hours post-dose.

Addressing a Significant Unmet Need

In the U.S. alone, an estimated 23 million episodes of bipolar or schizophrenia-related agitation occur annually in home settings. Currently, there are no FDA-approved treatments for the acute management of these episodes in outpatient environments.

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