BioXcel Therapeutics Announces Successful Phase 3 Trial Results for BXCL501 in Treating Agitation at Home for Bipolar Disorder and Schizophrenia Patients

BioXcel Therapeutics Inc. has announced the successful completion of the SERENITY At-Home Pivotal Phase 3 trial, which evaluated the safety of their proprietary sublingual film formulation, BXCL501, at a 120 mcg dose. This study focused on the acute treatment of agitation associated with bipolar disorders or schizophrenia in the at-home setting. The trial met its primary endpoint and demonstrated that BXCL501 was well-tolerated, with no drug-related serious adverse events reported. The adverse event profile was consistent with the approved IGALMI® label and previous clinical trials conducted in institutional settings. The data collected from this study will form the basis of a supplemental New Drug Application (sNDA) for the label expansion of IGALMI® in the at-home setting, with submission planned for the first quarter of 2026. Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. BioXcel Therapeutics Inc. published the original content used to generate this news brief via EDGAR, the Electronic Data Gathering, Analysis, and Retrieval system operated by the U.S. Securities and Exchange Commission (Ref. ID: 0001104659-25-083402), on August 27, 2025, and is solely responsible for the information contained therein. © Copyright 2025 - Public Technologies (PUBT) Original Document: here