Business
BioXcel Therapeutics Reports Positive Topline Exploratory Efficacy Data from SERENITY At-Home Pivotal Phase 3 Safety Trial for Agitation Associated with Bipolar Disorders or Schizophrenia
BXCL501 demonstrated a significant mean reduction in mCGI-S score from baseline compared to placebo at 2 hours across 2,433 treated episodes (p<.05) Complete resolution of agitation was significantly higher with BXCL501 compared to placebo across agitation episode severity (p<.0001) BXCL501 showed a similar reduction in agitation symptoms over both the duration of the trial and number of treated episodes, demonstrating continued effects and consistent benefit with repeat dosing of BXCL501 Based
About this update from Bioxcel Therapeutics, Inc.
[{"type":"image","alt":"BioXcel Therapeutics","displaySize":"","headline":null,"caption":"BioXcel Therapeutics","className":"","disableSlideshowImg":false,"size":{"original":{"width":220,"height":123,"url":"https://media.zenfs.com/en/globenewswire.com/184443491f4795fadfc360af09172b87"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/Ugin_5Up8vRFuzpQTrOKug--/YXBwaWQ9aGlnaGxhbmRlcjt3PTQyMDtoPTIzNTtjZj13ZWJw/https://media.zenfs.com/en/globenewswire.com/184443491f4795fadfc360af09172b87","width":220,"height":123}},"lazy":false},{"type":"text","content":"BXCL501 demonstrated a significant mean reduction in mCGI-S score from baseline compared to placebo at 2 hours across 2,433 treated episodes (p<.05)","length":151,"tagName":"p"},{"type":"text","content":"Complete resolution of agitation was significantly higher with BXCL501 compared to placebo across agitation episode severity (p<.0001)","length":137,"tagName":"p"},{"type":"text","content":"BXCL501 showed a similar reduction in agitation symptoms over both the duration of the trial and number of treated episodes, demonstrating continued effects and consistent benefit with repeat dosing of BXCL501","length":209,"tagName":"p"},{"type":"text","content":"Based on the large body of evidence and positive FDA feedback, Company plans to submit a sNDA in Q1 2026 for expanded usage of IGALMI® in the outpatient setting","length":160,"tagName":"p"},{"type":"text","content":"Company to host virtual KOL call with Dr. Leslie Citrome on SERENITY At-Home program at 2 p.m. today","length":100,"tagName":"p"},{"type":"text","content":"NEW HAVEN, Conn., Sept. 10, 2025 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience, today announced positive topline exploratory efficacy data from the SERENITY At-Home Pivotal Phase 3 safety trial, which demonstrated BXCL501 had continued effects and consistent benefit with repeat dosing. The trial in the home setting evaluated 120 mcg dose of BXCL501, the Company’s proprietary, sublingual film formulation of dexmedetomidine, IGALMI®, for treatment of agitation associated with bipolar disorders or schizophrenia.","length":656,"tagName":"p"},{"type":"text","content":"BioXcel previously reported positive topline safety results, the primary objective of the...