BioXcel Seeks FDA Label Expansion For Schizophrenia Treatment

Author: Vandana Singh | August 27, 2025 11:01am

BioXcel Therapeutics Inc. (NASDAQ:BTAI) announced that its SERENITY At-Home Phase 3 trial of BXCL501—its sublingual dexmedetomidine film for acute agitation in bipolar disorder or schizophrenia—met its primary endpoint.

The results show consistent symptom reduction across 2,400+ episodes. It will now support an FDA supplemental filing to expand Igalmi's label for at-home use in Q1 2026.

Efficacy in institutional settings was already established in SERENITY I and II.

Also Read: BioXcel Therapeutics’ Approved Drug For Bipolar Disorders/Schizophrenia Shows No Evidence Of Worsening Or Withdrawal In Post-Marketing Study

A higher percentage of patients receiving BXCL501 achieved full resolution of mild-to-severe agitation compared with placebo, with consistent benefits observed on repeat dosing.

The 120 mcg dose was well-tolerated, met the primary endpoint, and caused no discontinuations. Adverse events aligned with the approved Igalmi label and prior institutional trials.

Full Phase 3 analyses are ongoing, with additional results to be presented at upcoming medical meetings.

Igalmi is FDA-approved for acute agitation in bipolar I/II disorder or schizophrenia in supervised settings and is available in 120 mcg and 180 mcg doses.

Previous estimates of 23 million annual agitation episodes, based on historic claims, assumed 1.2 episodes per patient per month. Recent market research and surveys suggest 3–4 episodes monthly, mostly moderate to severe.

Data from 2,600+ episodes in the SERENITY At-Home Phase 3 trial support this higher frequency, suggesting 57–77 million annual at-home episodes in the U.S.

Price Action: BTAI stock is down 11.45% at $4.64 at the last check on Wednesday.

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Posted In: BTAI