BioXcel Therapeutics Announces Positive Correlation Study Results Supporting SERENITY Efficacy Outcomes

BioXcel Therapeutics has announced positive results from a correlation study supporting exploratory efficacy outcomes from the SERENITY At-Home trial. The study demonstrated a strong correlation between clinician and patient/caregiver assessments of acute agitation in schizophrenia and bipolar disorder. The results will be included in a supplemental New Drug Application submission planned for Q1 2026.

BioXcel Therapeutics, Inc. (BTAI) has announced positive results from a correlation study supporting exploratory efficacy outcomes from the SERENITY At-Home trial. The study, conducted in 33 patients, demonstrated a strong correlation between clinician assessments and patient/caregiver-rated outcomes using the Modified Clinical Global Impression – Severity Scale (mCGI-S), according to a StockTitan report. The findings will be included in a supplemental New Drug Application (sNDA) submission planned for the first quarter of 2026, per a TradingView article.

The SERENITY At-Home trial evaluated the correlation between the Positive and Negative Syndrome Scale – Excited Component (PEC) and mCGI-S scales in a prospective, open-label, in-clinic trial. The study found a statistically significant and strong correlation between PEC and mCGI-S scores, with correlation coefficients of ρ=0.89 for patients and ρ=0.88 for informants (p0.0001), as detailed in the StockTitan report. These results support the use of mCGI-S to assess efficacy in the outpatient setting, particularly for the acute treatment of agitation associated with schizophrenia and bipolar disorder.

No serious adverse events were reported during the study, and the safety profile remained consistent with the existing label for IGALMI® (dexmedetomidine), according to the StockTitan report. The study's findings will be presented at upcoming medical meetings and conferences.

BioXcel Therapeutics is leveraging artificial intelligence to develop transformative medicines in neuroscience. The company's drug re-innovation approach combines existing approved drugs and proprietary machine learning algorithms to identify new therapeutic indications, as described in the StockTitan report. BXCL501, an investigational orally dissolving film formulation of dexmedetomidine, is under investigation for the acute treatment of agitation associated with Alzheimer’s dementia and bipolar I or II disorder or schizophrenia in the at-home setting, per the StockTitan report.

The positive results from the SERENITY At-Home trial support BioXcel Therapeutics' plans to advance its SERENITY program and submit an sNDA to the FDA. The company's stock is currently trading on the Nasdaq under the ticker symbol BTAI.