sNDA Submission: Igalmi for Acute Treatment of Agitation Associated With Bipolar Disorders or Schizophrenia in Outpatient Setting

BioXcel Therapeutics today announced the submission of a supplemental New Drug Application (sNDA) to the US Food and Drug Administration (FDA) for dexmedetomidine (Igalmi) for the acute treatment of agitation associated with bipolar disorders or schizophrenia in the at-home (outpatient) setting. The sNDA was submitted on January 14, 2026.¹

Igalmi sublingual film is placed under the tongue or behind the lower lip and is used for the acute treatment of agitation associated with schizophrenia and bipolar disorder I or II in adults. As it currently stands, is administered under the supervision of a health care provider. The safety and effectiveness of Igalmi has not been studied beyond 24 hours from the first dose, and is not established for safe and effective use in children.

Back in April 2022, Igalmi was approved by the FDA as the first and only orally dissolving sublingual film for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults under the supervision of a health care provider.² The approval was based on data from 2 pivotal randomized, double-blinded, placebo-controlled, parallel group phase 3 trials evaluating Igalmi for the acute treatment of agitation associated with schizophrenia (SERENITY I) or bipolar I or II disorder (SERENITY II). In both trials, IGALMI met the primary endpoint at 2 hours after the first dose in patients treated with the 120 mcg and 180 mcg doses, demonstrating statistically significant improvements from baseline.

The new sNDA submission seeks to allow Igalmi, an orally dissolving sublingual film, to be used for the acute treatment of agitation associated with bipolar disorders or schizophrenia in patients at home without supervision of a health care provider, where there are no FDA-approved options currently available.

“We are pleased with the successful submission of this sNDA for Igalmi, which represents an important milestone in expanding access to patients who are experiencing acute agitation episodes in the at-home setting,” said Vimal Mehta, PhD, the chief executive officer of BioXcel Therapeutics. “The submission is supported by results from the phase 3 SERENITY At-Home safety trial, fulfilling a clear unmet medical need in the at-home setting where agitation often originates. This supports the Company’s mission of driving a broader and more convenient access to a critical treatment option across care-settings.”

Mehta continued, “We are advancing our pre-commercialization efforts including a market opportunity assessment, led by our newly appointed Interim Chief Commercial Officer, Mark Pavao, while continuing to evaluate our go-to-market options. We look forward to working closely with the FDA toward a potential approval by the end of this year.”

If the application is approved, the label expansion for IGALMI could be granted by the end of 2026.

References

1. BioXcel Therapeutics submits supplemental New Drug Application to U.S. Food and Drug Administration for IGALMI® label expansion in the at-home setting. News release. January 20, 2026. Accessed January 20, 2026. https://www.globenewswire.com/news-release/2026/01/20/3221555/0/en/BioXcel-Therapeutics-Submits-Supplemental-New-Drug-Application-to-U-S-Food-and-Drug-Administration-for-IGALMI-Label-Expansion-in-the-At-Home-Setting.html

2. BioXcel Therapeutics announces FDA Approval of IGALMI™ (dexmedetomidine) sublingual film for acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults. April 6, 2022. Accessed January 20, 2026. https://ir.bioxceltherapeutics.com/news-releases/news-release-details/bioxcel-therapeutics-announces-fda-approval-igalmitm