# IGALMI (dexmedetomidine) sublingual film PDUFA Event: Acute agitation associated with bipolar disorders or schizophrenia in the at-home setting

Canonical URL: https://biopharmsignal.com/pdufa-calendar/BTAI/igalmi-at-home-agitation

Ticker: BTAI

Company: BioXcel

Event date: 2026-11-14

Event type: FDA Decision

Stage: PDUFA

Result: Pending

Application type: sNDA

FDA decision expected. FDA assigned a November 14, 2026 PDUFA target action date to the IGALMI at-home-use sNDA.

## Event Timeline

### November 14, 2026 — FDA 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](https://ir.bioxceltherapeutics.com/news-releases/news-release-details/bioxcel-therapeutics-announces-food-drug-administration)

### April 1, 2026 — FDA accepted the sNDA

FDA accepted the application seeking use of IGALMI without healthcare-provider supervision in the at-home setting.

[BioXcel — sNDA acceptance](https://ir.bioxceltherapeutics.com/news-releases/news-release-details/bioxcel-therapeutics-announces-food-drug-administration)

### August 27, 2025 — 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](https://ir.bioxceltherapeutics.com/news-releases/news-release-details/bioxcel-therapeutics-announces-serenity-home-pivotal-phase-3)

### November 21, 2022 — 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)](https://clinicaltrials.gov/study/NCT05658510)

## Regulatory Designations

- Fast Track FDA: [BioXcel — IGALMI sNDA acceptance and BXCL501 designations](https://ir.bioxceltherapeutics.com/news-releases/news-release-details/bioxcel-therapeutics-announces-food-drug-administration)

## Related Pages

- BTAI PDUFA calendar: https://biopharmsignal.com/pdufa-calendar/BTAI.md

- BTAI company profile: https://biopharmsignal.com/company/BTAI.md

- PDUFA calendar: https://biopharmsignal.com/pdufa-calendar.md

## Related News

- 2026-08-28 — BioXcel Therapeutics Enters Into Asset Sale Agreement with Teva Pharmaceuticals: https://biopharmsignal.com/news/BTAI/bioxcel-therapeutics-enters-into-asset-sale-agreement-with-teva-pharmaceuticals-f7d2be81.md

- 2026-05-28 — BioXcel Therapeutics Presents New Data from SERENITY At-Home Phase 3 Trial for Agitation Associated with Bipolar Disorders or Schizophrenia at 2026 ASCP Annual Meeting: https://biopharmsignal.com/news/BTAI/bioxcel-therapeutics-presents-new-data-from-serenity-at-home-phase-3-trial-for-agitation-associated-with-bipolar-disorders-or-schizophrenia-at-2026-ascp-annual-meeting.md

- 2026-05-15 — BioXcel Therapeutics Provides Business Update and Reports First Quarter 2026 Financial Results: https://biopharmsignal.com/news/BTAI/bioxcel-therapeutics-provides-business-update-and-reports-first-quarter-2026-financial-results.md

- 2026-04-17 — BioXcel Therapeutics Announces Virtual Event to Discuss Commercial Launch Plan Based on Market Opportunity Assessment for IGALMI® in the At-Home Setting: https://biopharmsignal.com/news/BTAI/bioxcel-therapeutics-announces-virtual-event-to-discuss-commercial-launch-plan-based-on-market-opportunity-assessment-for-igalmir-in-the-at-home-setting.md

- 2026-04-08 — BioXcel Therapeutics Announces Enrollment of First Patients in U.S. Department of War-Funded Study of BXCL501 (Sublingual Dexmedetomidine) for Treatment of Acute Stress Reactions: https://biopharmsignal.com/news/BTAI/bioxcel-therapeutics-announces-enrollment-of-first-patients-in-u-s-department-of-war-funded-study-of-bxcl501-sublingual-dexmedetomidine-for-treatment-of-acute-stress-reactions.md