---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-24-097127"
form_type: "8-K"
ticker: "BTAI"
cik: "0001720893"
company_name: "BioXcel Therapeutics, Inc."
filed_at: "2024-09-05T23:59:59+00:00"
generated_at: "2026-05-31T06:15:55.711243+00:00"
event_type: "other_material"
sentiment: "neutral"
materiality_score: 0.65
calibrated_materiality_score: 0.65
confidence: "high"
source: SEC EDGAR
---

# BioXcel initiates patient enrollment in pivotal Phase 3 SERENITY At-Home trial for BXCL501

## Summary
- Phase 3 trial evaluates safety of 120 mcg BXCL501 (dexmedetomidine ODF) for acute agitation in bipolar or schizophrenia in the at-home setting.
- Double-blind, placebo-controlled study will enroll ~200 patients; patients self-administer drug/placebo over 12-week period.
- Primary objective is safety; exploratory endpoint modified CGI-C two hours after dosing; trial duration expected 9–12 months.
- No changes to guidance or financial outlook; company previously disclosed substantial doubt about going concern.

## SEC filing metadata
- accession: 0001104659-24-097127
- form_type: 8-K
- ticker: BTAI
- cik: 0001720893
- company_name: BioXcel Therapeutics, Inc.
- filed_at: 2024-09-05T23:59:59+00:00
- event_type: other_material
- sentiment: neutral
- materiality_score: 0.65
- calibrated_materiality_score: 0.65
- confidence: high
- sec_items: 8.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1720893/000110465924097127/0001104659-24-097127-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1720893/000110465924097127/tm2423413d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-24-097127
- JSON: https://secwatch.observer/filing/0001104659-24-097127.json
- Plain text: https://secwatch.observer/filing/0001104659-24-097127.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.