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  • News bot Jan. 29, 2026, 6:40 p.m.

    📋 BioXcel Therapeutics Inc. (BTAI) - Regulatory Update

    Filing Date: 2026-01-20

    Accepted: 2026-01-20 07:00:40

    Event Type: Regulatory Update

    Event Details:

    BioXcel Therapeutics Inc. (BTAI) Announces Regulatory Update BioXcel Therapeutics Inc. (BTAI) provided an update on regulatory developments for its product portfolio. Regulatory Update Details: None Clinical Development:

    🔬 Clinical Development Pipeline (BioXcel Therapeutics Inc.):

    Product Type Development Stage Therapeutic Area Source
    Lofexidine (Positive Control) OTHER Phase PHASE1 Opioid Use Disorder ClinicalTrials.gov
    Placebo OTHER Phase PHASE1 Opioid Use Disorder ClinicalTrials.gov
    BXCL501 (240 micrograms) DRUG Phase PHASE1 Opioid Use Disorder ClinicalTrials.gov
    BXCL501 (180 micrograms) DRUG Phase PHASE1 Opioid Use Disorder ClinicalTrials.gov
    Matching Placebo DRUG Phase PHASE3 Agitation ClinicalTrials.gov
    BXCL501 DRUG Phase PHASE3 Agitation ClinicalTrials.gov
    Dexmedetomidine (DEX) for sublingual (SL) administration (BXCL501) - 80µg DRUG Phase PHASE1 Alcohol Use Disorder (AUD) ClinicalTrials.gov
    Dexmedetomidine (DEX) for sublingual (SL) administration (BXCL501) - 40µg DRUG Phase PHASE1 Alcohol Use Disorder (AUD) ClinicalTrials.gov
    BXCL701 monotherapy DRUG Phase PHASE1 Prostate Cancer ClinicalTrials.gov
    BXCL701 plus Pembrolizumab DRUG Phase PHASE1 Prostate Cancer ClinicalTrials.gov
    Pembrolizumab DRUG Phase PHASE2 Metastatic Pancreatic Ductal Adenocarcinoma ClinicalTrials.gov
    BXCL701 DRUG Phase PHASE2 Metastatic Pancreatic Ductal Adenocarcinoma ClinicalTrials.gov
    BXCL501 Sublingual Film DRUG Phase PHASE2 Bipolar I Disorder ClinicalTrials.gov
    Placebo film DRUG Phase PHASE2 Agitation ClinicalTrials.gov
    Talabostat Mesylate DRUG Phase EARLY_PHASE1 Cancer of Pancreas ClinicalTrials.gov
    Sublingual film containing dexmedetomidine (BXCL501) DRUG Phase PHASE3 Agitation ClinicalTrials.gov
    Sublingual Placebo Film DRUG Phase PHASE1 Agitation,Psychomotor ClinicalTrials.gov
    Sublingual film containing Dexmedetomidine DRUG Phase PHASE1 Agitation,Psychomotor ClinicalTrials.gov
    Sublingual film containing BXCL501 (Dexmedetomidine) DRUG Phase PHASE1 Agitation ClinicalTrials.gov
    Dexmedetomidine sublingual film DRUG Phase PHASE2 Delirium ClinicalTrials.gov
    Lorazepam 2 MG/ML DRUG Phase PHASE4 Schizophrenia Agitation ClinicalTrials.gov
    Dexmedetomidine DRUG Phase PHASE4 Schizophrenia Agitation ClinicalTrials.gov
    Alcohol Cue Reactivity BEHAVIORAL Phase PHASE1 Alcohol Use Disorder (AUD) ClinicalTrials.gov
    PTSD Reactivity Condition BEHAVIORAL Phase PHASE1 Alcohol Use Disorder (AUD) ClinicalTrials.gov
    Ethanol Infusion PROCEDURE Phase PHASE1 Alcohol Use Disorder (AUD) ClinicalTrials.gov
    Sublingual film containing Igalmi DRUG Phase PHASE4 Bipolar Disorder ClinicalTrials.gov
    BXCL501 60 Micrograms DRUG Phase PHASE1 Schizophrenia ClinicalTrials.gov
    BXCL501 120 Micrograms DRUG Phase PHASE1 Schizophrenia ClinicalTrials.gov
    BXCL501 80 Micrograms DRUG Phase PHASE1 Schizophrenia ClinicalTrials.gov

    💼 Business Developments:

    • Partnership: Not available
    • Acquisition: Not available
    • Licensing: Not available
    • Regulatory Approval
    • Executive Changes: Not available

    Structured Data:

    • Company Name: BioXcel Therapeutics Inc.
    • Ticker Symbol: BTAI

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