IGALMI (dexmedetomidine) sublingual film
Acute agitation associated with bipolar disorders or schizophrenia in the at-home setting · Adults with agitation associated with bipolar I or II disorder or schizophrenia receiving treatment in an at-home outpatient setting
BTAI · BioXcel
Regulatory designations
Full timeline
4 milestonesFDA decision expected
FDA assigned a November 14, 2026 PDUFA target action date to the IGALMI at-home-use sNDA.
BioXcel — sNDA acceptance and PDUFA date↗FDA accepted the sNDA
FDA accepted the application seeking use of IGALMI without healthcare-provider supervision in the at-home setting.
BioXcel — sNDA acceptance↗SERENITY At-Home met its primary endpoint
The pivotal Phase 3 safety study found BXCL501 was well tolerated for repeated treatment of agitation episodes in patients' homes.
BioXcel — SERENITY At-Home topline results↗Phase 3 SERENITY III study started
SERENITY III began evaluating at-home sublingual dexmedetomidine for acute agitation associated with bipolar disorder or schizophrenia.
ClinicalTrials.gov — SERENITY III study record (NCT05658510)↗Related News
BioXcel Therapeutics Enters Into Asset Sale Agreement with Teva Pharmaceuticals
May 28, 2026BioXcel Therapeutics Presents New Data from SERENITY At-Home Phase 3 Trial for Agitation Associated with Bipolar Disorders or Schizophrenia at 2026 ASCP Annual Meeting
May 15, 2026BioXcel Therapeutics Provides Business Update and Reports First Quarter 2026 Financial Results
Apr 17, 2026BioXcel Therapeutics Announces Virtual Event to Discuss Commercial Launch Plan Based on Market Opportunity Assessment for IGALMI® in the At-Home Setting
Apr 8, 2026BioXcel Therapeutics Announces Enrollment of First Patients in U.S. Department of War-Funded Study of BXCL501 (Sublingual Dexmedetomidine) for Treatment of Acute Stress Reactions