BioXCel’s Igalmi Shows Promise for At-Home Agitation Management in Bipolar Disorder and Schizophrenia

BioXCel Therapeutics announced that its drug Igalmi (dexmedetomidine) met the primary endpoint in the Phase III SERENITY At-Home trial, supporting its potential use for managing agitation in patients with bipolar disorder and schizophrenia outside clinical settings. The company plans to seek FDA approval for at-home self-administration, which could make Igalmi the first drug available for this indication in an outpatient setting.

The trial showed that repeat dosing was tolerable and effective, with adverse events such as somnolence and dry mouth aligning with the drug’s established profile. While the discontinuation rate was 19%, BioXCel clarified that none were linked to efficacy or tolerability concerns.

If approved, Igalmi could help prevent escalation of agitation symptoms and reduce hospitalisations. Despite the positive results, BioXCel’s shares fell nearly 20%, reflecting investor caution. The company aims to regain confidence with its ongoing Phase III Alzheimer’s study, TRANQUILITY II.

29-08-2025