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BioXcel Therapeutics Announces SERENITY At-Home Pivotal Phase 3 Safety Trial Met its Primary Endpoint in Support of sNDA Submission for Label Expansion of IGALMI®
BXCL501 achieved SERENITY At-Home’s primary endpoint of being well tolerated in the at-home treatment of agitation episodes in patients with bipolar disorders or schizophreniaNo discontinuations for tolerability in the BXCL501 armWhile not the primary objective of the SERENITY At-Home trial, the preliminary results demonstrate continued effects and consistent benefit with repeat dosing across the course of the trialFollowing previously disclosed positive FDA feedback, BioXcel plans to submit a s
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 achieved SERENITY At-Home’s primary endpoint of being well tolerated in the at-home treatment of agitation episodes in patients with bipolar disorders or schizophrenia","length":175,"tagName":"p"},{"type":"text","content":"No discontinuations for tolerability in the BXCL501 arm","length":55,"tagName":"p"},{"type":"text","content":"While not the primary objective of the SERENITY At-Home trial, the preliminary results demonstrate continued effects and consistent benefit with repeat dosing across the course of the trial","length":189,"tagName":"p"},{"type":"text","content":"Following previously disclosed positive FDA feedback, BioXcel plans to submit a sNDA in Q1 2026 for expanded usage of BXCL501 in the outpatient setting without the supervision of a healthcare provider","length":200,"tagName":"p"},{"type":"text","content":"More than 2400 episodes of agitation were treated in the SERENITY At-Home trial suggesting a significantly larger potential market opportunity ","length":142,"tagName":"p"},{"type":"text","content":"Company to host conference call at 8 a.m. EDT today","length":51,"tagName":"p"},{"type":"text","content":"NEW HAVEN, Conn., Aug. 27, 2025 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience, today announced that the SERENITY At-Home Pivotal Phase 3 trial evaluating the safety of BXCL501, the Company’s proprietary, sublingual film formulation of dexmedetomidine, as an acute treatment for agitation associated with bipolar disorders or schizophrenia in the at-home setting, met its primary endpoint. The data from this successful study will form the basis of the sNDA submission for label expansion of IGALMI® in the at-home setting planned for the first quarte...