Company profile

BioXcel Therapeutics, Inc.

Pipeline6 assets

BXCL501BXCL501 / IGALMI / alpha-2 receptor agonist / orally dissolving/sublingual film formulation of dexmedetomidine / Neuroscience
Acute agitation associated with bipolar disorders or schizophrenia, at homePhase 3Company-sponsored SERENITY programAcute agitation associated with Alzheimer's dementiaPhase 3Company-sponsored TRANQUILITY program; paused subject to fundingOpioid use disorderPhase 2Investigator-sponsored
BXCL701BXCL701 / DPP8/9 and FAP / oral innate immune activator / Immuno-oncology
Small cell neuroendocrine prostate cancerPhase 2Company-sponsored; FDA meeting expectedUSUKSmall cell lung cancerPreclinicalCompany-sponsored; initiate Phase 1b/2 expectedMetastatic pancreatic ductal adenocarcinomaPhase 2Investigator-sponsored; Phase 2 readout expected
BXCL502BXCL502 / latrepirdine / Neuroscience
Chronic agitation in dementiaPreclinicalDevelopment paused due to strategic reprioritization
BXCL503BXCL503 / Neuroscience
Apathy in dementiaPreclinicalDevelopment paused due to strategic reprioritization
BXCL504BXCL504 / Neuroscience
Aggression in dementiaPreclinicalDevelopment paused due to strategic reprioritization
BXCL702BXCL702 / DPP inhibitor / novel DPP inhibitor / Immuno-oncology
Solid tumorsPreclinicalBXCL701 follow-on; candidate nomination expected

Latest news12 items

May 28, 2026

BioXcel Therapeutics Presents New Data from SERENITY At-Home Phase 3 Trial for Agitation Associated with Bipolar Disorders or Schizophrenia at 2026 ASCP Annual Meeting

NEW HAVEN, Conn., May 28, 2026 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company built on artificial intelligence (“AI”) to develop transformative medicines in neuroscience, today announced the presentation of new positive data from the Phase 3 SERENITY

Presentation / Abstract • Phase 3Poster presentation Thu, May 28, 2026, 11:30 AM

May 15, 2026

BioXcel Therapeutics Provides Business Update and Reports First Quarter 2026 Financial Results

FDA accepted sNDA for IGALMI® use in at-home (outpatient) setting; set Nov. 14, 2026, as PDUFA date Advancing BXCL501 as a potential acute treatment for agitation associated with Alzheimer’s dementia Evaluating strategic options with an advisor to maximize shareholder value and advance the

Apr 17, 2026

BioXcel Therapeutics Announces Virtual Event to Discuss Commercial Launch Plan Based on Market Opportunity Assessment for IGALMI® in the At-Home Setting

Live event to be held on Thursday, April 23, at 2:00 p.m. ET Company focused on advancing launch strategy ahead of November 14 PDUFA target action date NEW HAVEN, Conn., April 17, 2026 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company built on artificial

Apr 8, 2026

BioXcel Therapeutics Announces Enrollment of First Patients in U.S. Department of War-Funded Study of BXCL501 (Sublingual Dexmedetomidine) for Treatment of Acute Stress Reactions

DoW-funded Phase 2a trial led by University of North Carolina at Chapel Hill (UNC) Institute for Trauma Recovery Positive outcomes from trial can potentially impact Veteran Affairs/Department of War Clinical Practice Guidelines for management of acute stress reactions (ASR) NEW HAVEN, Conn., April

Trial Start • Phase 2

Apr 1, 2026

BioXcel Therapeutics Announces Food & Drug Administration Acceptance of Supplemental New Drug Application for Use of IGALMI® in the At-Home Setting

PDUFA target action date of November 14, 2026 Potential first FDA-approved treatment option for the acute treatment of agitation associated with bipolar disorders or schizophrenia in the at-home (outpatient) setting NEW HAVEN, Conn., April 01, 2026 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc.

Mar 27, 2026

BioXcel Therapeutics Reports Fourth Quarter and Full-Year 2025 Financial Results as Company Prepares for Potential IGALMI® Approval in Outpatient Setting

sNDA submitted seeking approval of IGALMI ® in the at-home (outpatient) setting for the treatment of acute agitation associated with bipolar disorders or schizophrenia sNDA submission timeline supports potential approval as early as year-end 2026 Advancing commercial and launch plans based on

Mar 11, 2026

BioXcel Therapeutics Announces Closing of $8.0 Million Registered Direct Offering

NEW HAVEN, Conn., March 11, 2026 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (the “Company”) (Nasdaq: BTAI), a biopharmaceutical company built on artificial intelligence to develop transformative medicines in neuroscience, today announced the closing of its previously announced registered direct

Mar 10, 2026

BioXcel Therapeutics Announces Approximately $8.0 Million Registered Direct Offering

NEW HAVEN, Conn., March 10, 2026 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (the “Company”) (Nasdaq: BTAI), a biopharmaceutical company built on artificial intelligence to develop transformative medicines in neuroscience, today announced that it has entered into a securities purchase agreement

Mar 5, 2026

BioXcel Therapeutics Announces Positive Phase 2 Topline Results from Columbia University-Led Study of BXCL501 for Treatment of Opioid Withdrawal

BXCL501 demonstrated clinical benefits and favorable tolerability profile for treatment of opioid withdrawal symptoms Results from this NIDA-funded study support potential future development of BXCL501 in opioid withdrawal Opioid use disorder is a global health crisis, affecting approximately

Trial Results • Phase 2

Feb 19, 2026

BioXcel Therapeutics to Host Virtual Roundtable Featuring Leading Medical Experts Addressing Latest Developments in Treatment of Acute Agitation in Alzheimer’s Dementia

Discussion will focus on the high unmet need and the lack of FDA-approved treatment options associated with acute agitation episodes in Alzheimer’s dementia Large patient population affected by Alzheimer’s agitation, with approximately ~100 million annual episodes 1 KOL Roundtable to be held on

Feb 12, 2026

BioXcel Therapeutics Completes Market Opportunity Assessment and Advances Commercialization Plans for IGALMI® in the At-Home Setting

Third party commercial assessment shows larger than expected potential total addressable market for IGALMI ® in the at-home setting Strong prescriber interest, patient demand, and positive payer feedback on formulary coverage NEW HAVEN, Conn., Feb. 12, 2026 (GLOBE NEWSWIRE) -- BioXcel Therapeutics,

Jan 20, 2026

BioXcel Therapeutics Submits Supplemental New Drug Application to U.S. Food and Drug Administration for IGALMI® Label Expansion in the At-Home Setting

sNDA submission supports the acute treatment of agitation associated with bipolar disorders or schizophrenia in the at-home (outpatient) setting with IGALMI ® Submission timeline supports potential approval of IGALMI ® label expansion as early as year-end 2026 NEW HAVEN, Conn., Jan.