BioXcel Therapeutics' BXCL501 Meets Primary Endpoint in SERENITY At-Home Phase 3 Trial

BioXcel Therapeutics' sublingual dexmedetomidine film, BXCL501, has met its primary endpoint in the SERENITY At-Home Phase 3 trial for acute agitation in bipolar disorder or schizophrenia. The results show consistent symptom reduction across 2,400+ episodes and will support an FDA supplemental filing to expand Igalmi's label for at-home use in Q1 2026. The trial found that a higher percentage of patients receiving BXCL501 achieved full resolution of mild-to-severe agitation compared to placebo, with consistent benefits observed on repeat dosing. The 120 mcg dose was well-tolerated, met the primary endpoint, and caused no discontinuations. Adverse events aligned with the approved Igalmi label and prior institutional trials.

BioXcel Therapeutics' sublingual dexmedetomidine film, BXCL501, has achieved its primary endpoint in the SERENITY At-Home Phase 3 trial for acute agitation in patients with bipolar disorder or schizophrenia. The results, announced on July 02, 2025, show consistent symptom reduction across 2,400+ episodes and will support an FDA supplemental filing to expand Igalmi's label for at-home use in Q1 2026 [1].

The trial, which enrolled 246 patients and collected data on 2,628 agitation episodes, demonstrated that a higher percentage of patients receiving BXCL501 achieved full resolution of mild-to-severe agitation compared to placebo. The 120 mcg dose was well-tolerated, meeting the primary endpoint, and caused no discontinuations due to tolerability. Adverse events aligned with the approved Igalmi label and prior institutional trials, with no drug-related serious adverse events, syncopes, or falls reported [1].

The consistent benefits observed with repeat dosing further enhance the medication's profile for outpatient use. BioXcel plans to submit a supplemental New Drug Application (sNDA) in Q1 2026, aiming to provide patients with access to Igalmi in the home setting. The trial's success underscores the significant unmet medical need for at-home agitation treatment, as there are currently no FDA-approved therapies for this indication [1].

References:
[1] https://www.quiverquant.com/news/BioXcel+Therapeutics+Reports+Successful+Results+from+SERENITY+At-Home+Trial+for+BXCL501+as+At-Home+Treatment+for+Agitation+in+Bipolar+Disorders+and+Schizophrenia