BioXcel Therapeutics said its SERENITY At-Home pivotal Phase 3 trial met the primary safety endpoint for BXCL501, a proprietary sublingual film marketed in medical settings as IGALMI for acute agitation tied to bipolar disorder or schizophrenia. In the double-blind, placebo-controlled study, 208 patients self-administered the 120-mcg dose during 2,437 agitation episodes over 12 weeks; 81 percent completed the trial. No discontinuations occurred in the BXCL501 arm for tolerability reasons, and investigators reported no drug-related serious adverse events, syncopes or falls. The safety profile was consistent with the drug’s existing label, and tolerability remained stable with repeat dosing. On the back of the data, the New Haven-based company plans to file a supplemental New Drug Application in the first quarter of 2026 to allow at-home use without healthcare supervision. BioXcel estimates the potential U.S. market at 57 million to 77 million agitation episodes annually, far above earlier projections of 23 million.