BioXCel Therapeutics is applying for a label expansion to the outpatient setting for its key schizophrenia and bipolar asset, Igalmi (dexmedetomidine).
This follows the positive preliminary results of the SERENITY At-Home trial (NCT05658510), which found the sublingual film formulation could offer durable and consistent benefits when managing agitation episodes associated with the conditions at home.
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Repeat dosing of Igalmi was also found to be both tolerable and beneficial for schizophrenic or bipolar patients experiencing agitation episodes.
Though there were a range of adverse events (AEs) associated with Igalmi’s at-home administration – including somnolence and dry mouth – the drug’s AE profile was consistent with Igalmi in the institutional setting.
The trial’s discontinuation rate stood at 19%, though BioXCel clarified that these were “not linked to any drug-related events – be it tolerability or efficacy,” during an investor call on 27 August.
BioXCel has not yet released the full efficacy dataset for Igalmi in an at-home setting, though the US biopharma has announced plans to present further results at a range of unspecified upcoming medical meetings and conferences.
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By GlobalDataBioXCel’s CEO Vimal Mehta said: “By meeting its primary endpoint, the SERENITY At-Home Pivotal Phase III trial reinforces BXCL501’s potential to be safely used at home like it is already used in the previously FDA-approved institutional setting.
“We will now prepare for submission of our label expansion application to the FDA.”
This positive trial readout will be welcome for BioXCell, as the company is currently keen to expand Igalmi’s patient reach. This follows a sharp drop in the drug’s sales in Q2 2025 – bringing in $120,000 for the company compared with the $1.1m made this time last year. BioXCel attributes this to the associated costs of excess or obsolete inventory.
If Igalmi gets the FDA go-ahead in this indication, it would be the first drug available in this indication for at-home use. According to BioXCel, this could prevent the escalation of agitation symptoms, reducing patient hospitalisations.
Shaking controversy
Though BioXCell is moving full steam ahead with its plan to expand Igalmi’s use, investors do not seem convinced by the proposition, as the company’s stock value dropped by 19.5% from $4.92 at market opening on 27 August to $3.96 at market close on the same day.
However, BioXCell is hoping to win investors over with a second confirmatory Phase III trial in Alzheimer’s, noting that the FDA recently approved the initiation of the TRANQUILITY II (NCT05271552) follow-up exploring the efficacy of a 60µg dose in the 27 August investor call.
This follows the filing of a 2023 investor lawsuit against BioXCell related to the first trial in Alzheimer’s. Plaintiffs alleged that the trial’s principal investigator fabricated emails with a safety vendor related to the filing of a serious adverse event that occurred during the study. The suit was dropped in 2024.
