---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-25-026388"
form_type: "8-K"
ticker: "BTAI"
cik: "0001720893"
company_name: "BioXcel Therapeutics, Inc."
filed_at: "2025-03-21T23:59:59+00:00"
generated_at: "2026-05-24T08:48:21.780944+00:00"
event_type: "other_material"
sentiment: "neutral"
materiality_score: 0.55
calibrated_materiality_score: 0.55
confidence: "high"
source: SEC EDGAR
---

# BioXcel Therapeutics reaches 50% enrollment in SERENITY At-Home Phase 3 trial for BXCL501

## Summary
- 100 patients enrolled out of 200 expected (50% of total); 24 sites open as of March 20, 2025.
- Trial evaluates BXCL501 (sublingual dexmedetomidine film) for acute agitation in bipolar disorder or schizophrenia at home.
- Topline data expected in second half of 2025 to support sNDA for expanded IGALMI label.
- Enrollment began September 2024; no safety or efficacy results reported yet.

## SEC filing metadata
- accession: 0001104659-25-026388
- form_type: 8-K
- ticker: BTAI
- cik: 0001720893
- company_name: BioXcel Therapeutics, Inc.
- filed_at: 2025-03-21T23:59:59+00:00
- event_type: other_material
- sentiment: neutral
- materiality_score: 0.55
- calibrated_materiality_score: 0.55
- confidence: high
- sec_items: 8.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1720893/000110465925026388/0001104659-25-026388-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1720893/000110465925026388/tm259958d2_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-25-026388
- JSON: https://secwatch.observer/filing/0001104659-25-026388.json
- Plain text: https://secwatch.observer/filing/0001104659-25-026388.txt

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