BioXcel Therapeutics (NASDAQ: BTAI) has announced positive topline exploratory efficacy data from its SERENITY At-Home pivotal Phase 3 safety trial of BXCL501 (IGALMI) for agitation associated with bipolar disorders or schizophrenia.
According to BioXcel, the study demonstrated that BXCL501 had continued effects and consistent benefit with repeat dosing. Based on the large body of evidence and positive FDA feedback, the company plans to submit a supplemental new drug application in Q1 2026, for expanded usage of IGALMI in the outpatient setting.
In a statement, Vimal Mehta, PhD, CEO of BioXcel, commented, “The SERENITY At-Home results mark a pivotal step in advancing the potential for outpatient use of BXCL501 for the acute treatment of agitation in bipolar disorders and schizophrenia. These positive results, along with the safety and tolerability data previously announced (August 27, 2025), reinforce BXCL501’s potential in the at-home setting where there is substantial unmet need with no FDA-approved options currently available. We remain committed to redefining the treatment paradigm for these patients and families in the outpatient setting, which we believe represents a large addressable market and a catalyst for long-term growth and value creation.”
