SymbolBTAI
NameBIOXCEL THERAPEUTICS, INC.
SectorHEALTH CARE
RegionNorth America
IndustryBiotechnology: Pharmaceutical Preparations
Address555 LONG WHARF DRIVE,12TH FLOOR, NEW HAVEN, Connecticut, 06511, United States
Telephone+1 475 238-6837
Fax
Email
Websitehttps://www.bioxceltherapeutics.com
IncorporationUNDEFINED
Incorporated On
Employees
Fiscal Year
Public Since
ExchangesNASDAQ
Auditor
Audit StatusNOT PROVIDED
Reporting Status
CIK0001720893
Description

BioXcel Therapeutics Inc is a clinical-stage biopharmaceutical company. It is focused on drug development utilizing novel artificial intelligence (AI) to identify the next wave of medicines across neuroscience and immuno-oncology. The pipeline products of the company are BXCL501, and BXCL701.

Additional info from NASDAQ:
BioXcel Therapeutics Inc is a clinical-stage biopharmaceutical company. It is focused on drug development utilizing novel artificial intelligence (AI) to identify the next wave of medicines across neuroscience and immuno-oncology. The pipeline products of the company are BXCL501, and BXCL701.

2026-07-06 10:00

(99% Neutral) BIOXCEL THERAPEUTICS, INC. (BTAI) Announces Business Combination

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2026-06-18 00:01

Rodriguez Javier 🟡 adjusted position in 0 shares (1 derivative) of BioXcel Therapeutics, Inc. (BTAI) Transaction Date: Jun 15, 2026 | Filing ID: 075302

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2026-06-18 00:00

Steinhart Richard I 🟡 adjusted position in 0 shares (1 derivative) of BioXcel Therapeutics, Inc. (BTAI) Transaction Date: Jun 15, 2026 | Filing ID: 075301

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2026-06-18 00:00

Yocca Frank 🟡 adjusted position in 0 shares (1 derivative) of BioXcel Therapeutics, Inc. (BTAI) Transaction Date: Jun 15, 2026 | Filing ID: 075300

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2026-06-18 00:00

Director Mehta Vimal 🟡 adjusted position in 0 shares (1 derivative) of BioXcel Therapeutics, Inc. (BTAI) Transaction Date: Jun 15, 2026 | Filing ID: 075298

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2026-05-22 23:02

Yocca Frank 🟡 adjusted position in 6.8K shares (1 derivative) of BioXcel Therapeutics, Inc. (BTAI) at $1.08 Transaction Date: May 04, 2026 | Filing ID: 065841

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2026-05-22 23:02

Rodriguez Javier 🟡 adjusted position in 6.6K shares (1 derivative) of BioXcel Therapeutics, Inc. (BTAI) at $1.08 Transaction Date: May 04, 2026 | Filing ID: 065839

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2026-05-22 23:01

Steinhart Richard I 🟡 adjusted position in 6.8K shares (1 derivative) of BioXcel Therapeutics, Inc. (BTAI) at $1.08 Transaction Date: May 04, 2026 | Filing ID: 065838

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2026-05-22 23:00

Director Mehta Vimal 🟡 adjusted position in 19.4K shares (1 derivative) of BioXcel Therapeutics, Inc. (BTAI) at $1.09 Transaction Date: May 04, 2026 | Filing ID: 065836

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2026-05-20 20:29

📋 Mehta Vimal (Officer) plans to sell 19K shares of BioXcel Therapeutics, Inc. (at $1.09 each, total $21K) Filed: May 20, 2026 | ID: 000255

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Trial ID Title Phase Indication Status Start Date Completion Date Source
NCT06335407 Effect of Sublingual Formulation of Dexmedetomidine Hydrochloride (HCl) (BXCL50… Phase1 Alcohol Use Disorder (AUD) Recruiting 2025-07-28 2026-05-31 ClinicalTrials.gov
NCT07116694 Assessment of Acute Psychomotor Agitation Measures Associated With Schizophreni… Phase2 Bipolar I Disorder Completed 2025-06-19 2025-10-07 ClinicalTrials.gov
NCT06041646 Tachyphylaxis, Tolerance, & Withdrawal Post Treatment With Igalmi for Agitation… Phase4 Bipolar Disorder Completed 2023-10-02 2024-04-29 ClinicalTrials.gov
NCT05558982 BXCL701 and Pembrolizumab in Patients With Metastatic Pancreatic Ductal Adenoca… Phase2 Metastatic Pancreatic Ductal Adenocarcinoma Active_Not_Recruiting 2023-08-16 2027-11-01 ClinicalTrials.gov
NCT06093451 Evaluating Sublingual Dexmedetomidine For Moderate To Severe Agitation In Inpat… Phase4 Schizophrenia Agitation Unknown 2023-07-01 2024-07-01 ClinicalTrials.gov
NCT05712707 Sublingual Dexmedetomidine for Treating Opioid Withdrawal Phase1 Opioid Use Disorder Active_Not_Recruiting 2023-02-28 2026-08-31 ClinicalTrials.gov
NCT05665088 Dexmedetomidine in the Treatment of Agitation Associated With Dementia (TRANQUI… Phase3 Agitation Terminated 2022-12-14 2023-09-11 ClinicalTrials.gov
NCT05658510 Dexmedetomidine in the Treatment of Agitation Associated With Schizophrenia and… Phase3 Agitation,Psychomotor Completed 2022-11-21 2025-08-15 ClinicalTrials.gov
NCT05271552 Dexmedetomidine in the Treatment of Agitation Associated With Dementia (TRANQUI… Phase3 Agitation Completed 2022-04-27 2023-04-21 ClinicalTrials.gov
NCT05276830 An Efficacy, and Safety Study Of BXCL501 For The Treatment Of Agitation Associa… Phase2 Agitation Terminated 2022-02-08 2022-04-01 ClinicalTrials.gov
NCT04827056 Effect of Sublingual Formulation of Dexmedetomidine HCl (BXCL501) - Alcohol Int… Phase1 Alcohol Use Disorder (AUD) Completed 2021-11-09 2023-06-02 ClinicalTrials.gov
NCT05025605 Determining Efficacy and Safety of BXCL501 in Agitation Associated With Pediatr… Phase1 Schizophrenia Recruiting 2021-08-27 2027-12-31 ClinicalTrials.gov
NCT05313386 Study of BXCL501 In Agitation Associated With Delirium in ICU Patients Phase2 Agitation Withdrawn 2021-02-23 2022-02-21 ClinicalTrials.gov
NCT04470050 Dexmedetomidine in the Treatment of Symptoms Of Acute Opioid Withdrawal Phase1 Opioid Withdrawal Completed 2020-06-09 2021-02-18 ClinicalTrials.gov
NCT04382170 Dexmedetomidine Sublingual Film for the Management of Agitation in Delirium: Sa… Phase2 Delirium Withdrawn 2020-06-01 2021-06-01 ClinicalTrials.gov
NCT04276883 Dexmedetomidine in the Treatment of Agitation Associated With Bipolar Disorder Phase3 Agitation Associated With Bipolar Disorder Completed 2020-02-24 2020-05-21 ClinicalTrials.gov
NCT04268303 Dexmedetomidine in the Treatment of Agitation Associated With Schizophrenia Phase3 Agitation Completed 2020-01-24 2020-05-06 ClinicalTrials.gov
NCT04390152 Safety and Efficacy of Intravenous Wharton's Jelly Derived Mesenchymal Stem Cel… Phase1 Acute Respiratory Distress Syndrome Terminated 2020-01-13 2022-03-03 ClinicalTrials.gov
NCT04251910 Sub-Lingual Dexmedetomidine in Agitation Associated With Dementia Phase1 Agitation,Psychomotor Completed 2019-12-27 2022-01-24 ClinicalTrials.gov
NCT04123574 A Pilot Study of BXCL701 in Patients With Pancreatic Cancer Early_Phase1 Cancer of Pancreas Withdrawn 2019-10-15 2021-12-06 ClinicalTrials.gov
NCT04010305 Sub-Lingual Dexmedetomidine in Agitation Associated With Schizophrenia Phase1 Agitation Completed 2019-05-22 2019-07-31 ClinicalTrials.gov
NCT03910660 A Trial of BXCL701 and Pembrolizumab in Patients With mCRPC Either Small Cell N… Phase1 Prostate Cancer Completed 2019-02-12 2025-08-31 ClinicalTrials.gov
Total clinical trials: 22
Product Name Type Development Stage Therapeutic Area Study Status Trial ID
Placebo Film Other Phase PHASE3 Agitation Associated With Bipolar Disorder COMPLETED NCT04276883
Sublingual film containing Dexmedetomidine (BXCL501) Other Phase PHASE3 Agitation Associated With Bipolar Disorder COMPLETED NCT04276883
Placebo Film Other Phase PHASE3 Agitation COMPLETED NCT04268303
Sublingual film containing dexmedetomidine (BXCL501) Other Phase PHASE3 Agitation COMPLETED NCT04268303
Placebo Other Phase PHASE1 Opioid Withdrawal COMPLETED NCT04470050
Dexmedetomidine Other Phase PHASE1 Opioid Withdrawal COMPLETED NCT04470050
Placebo film Other Phase PHASE2 Agitation TERMINATED NCT05276830
BXCL501 Other Phase PHASE2 Agitation TERMINATED NCT05276830
Sublingual Placebo Film Other Phase PHASE1 Agitation,Psychomotor COMPLETED NCT04251910
Sublingual film containing Dexmedetomidine Other Phase PHASE1 Agitation,Psychomotor COMPLETED NCT04251910
BXCL701 monotherapy Drug Phase PHASE1 Prostate Cancer COMPLETED NCT03910660
BXCL701 plus Pembrolizumab Other Phase PHASE1 Prostate Cancer COMPLETED NCT03910660
BXCL701 monotherapy Drug Phase PHASE1 Prostate Cancer COMPLETED NCT03910660
BXCL701 plus Pembrolizumab Other Phase PHASE1 Prostate Cancer COMPLETED NCT03910660
BXCL701 monotherapy Drug Phase PHASE1 Prostate Cancer COMPLETED NCT03910660
BXCL701 plus Pembrolizumab Other Phase PHASE1 Prostate Cancer COMPLETED NCT03910660
BXCL701 monotherapy Drug Phase PHASE1 Prostate Cancer COMPLETED NCT03910660
BXCL701 plus Pembrolizumab Other Phase PHASE1 Prostate Cancer COMPLETED NCT03910660
BXCL701 monotherapy Drug Phase PHASE1 Prostate Cancer COMPLETED NCT03910660
BXCL701 plus Pembrolizumab Other Phase PHASE1 Prostate Cancer COMPLETED NCT03910660
BXCL701 monotherapy Drug Phase PHASE1 Prostate Cancer COMPLETED NCT03910660
BXCL701 plus Pembrolizumab Other Phase PHASE1 Prostate Cancer COMPLETED NCT03910660
BXCL701 monotherapy Drug Phase PHASE1 Prostate Cancer COMPLETED NCT03910660
BXCL701 plus Pembrolizumab Other Phase PHASE1 Prostate Cancer COMPLETED NCT03910660
BXCL701 monotherapy Drug Phase PHASE1 Prostate Cancer COMPLETED NCT03910660
BXCL701 plus Pembrolizumab Other Phase PHASE1 Prostate Cancer COMPLETED NCT03910660
Talabostat Mesylate Other Phase EARLY_PHASE1 Cancer of Pancreas WITHDRAWN NCT04123574
Placebo film Other Phase PHASE2 Agitation WITHDRAWN NCT05313386
BXCL501 Other Phase PHASE2 Agitation WITHDRAWN NCT05313386
Placebo film Other Phase PHASE1 Agitation COMPLETED NCT04010305
Sublingual film containing BXCL501 (Dexmedetomidine) Other Phase PHASE1 Agitation COMPLETED NCT04010305
Placebo Film Other Phase PHASE3 Agitation COMPLETED NCT04268303
Sublingual film containing dexmedetomidine (BXCL501) Other Phase PHASE3 Agitation COMPLETED NCT04268303
Placebo film Other Phase PHASE2 Agitation TERMINATED NCT05276830
BXCL501 Other Phase PHASE2 Agitation TERMINATED NCT05276830
Placebo Film Other Phase PHASE3 Agitation Associated With Bipolar Disorder COMPLETED NCT04276883
Sublingual film containing Dexmedetomidine (BXCL501) Other Phase PHASE3 Agitation Associated With Bipolar Disorder COMPLETED NCT04276883
Sublingual Placebo Film Other Phase PHASE1 Agitation,Psychomotor COMPLETED NCT04251910
Sublingual film containing Dexmedetomidine Other Phase PHASE1 Agitation,Psychomotor COMPLETED NCT04251910
Lorazepam 2 MG/ML Other Phase PHASE4 Schizophrenia Agitation UNKNOWN NCT06093451
Dexmedetomidine Other Phase PHASE4 Schizophrenia Agitation UNKNOWN NCT06093451
Alcohol Cue Reactivity Other Phase PHASE1 Alcohol Use Disorder (AUD) COMPLETED NCT04827056
PTSD Reactivity Condition Other Phase PHASE1 Alcohol Use Disorder (AUD) COMPLETED NCT04827056
Ethanol Infusion Other Phase PHASE1 Alcohol Use Disorder (AUD) COMPLETED NCT04827056
Dexmedetomidine (DEX) for sublingual (SL) administration (BXCL501) - 80µg Other Phase PHASE1 Alcohol Use Disorder (AUD) COMPLETED NCT04827056
Dexmedetomidine (DEX) for sublingual (SL) administration (BXCL501) - 40µg Other Phase PHASE1 Alcohol Use Disorder (AUD) COMPLETED NCT04827056
Placebo Other Phase PHASE1 Alcohol Use Disorder (AUD) COMPLETED NCT04827056
Placebo Other Phase PHASE1 Opioid Withdrawal COMPLETED NCT04470050
Dexmedetomidine Other Phase PHASE1 Opioid Withdrawal COMPLETED NCT04470050
Matching Placebo Other Phase PHASE3 Agitation TERMINATED NCT05665088
BXCL501 Other Phase PHASE3 Agitation TERMINATED NCT05665088
Dexmedetomidine sublingual film Other Phase PHASE2 Delirium WITHDRAWN NCT04382170
Hydroxychloroquine, lopinavir/ritonavir or azithromycin and placebo (standard therapy) Drug Phase PHASE1 Acute Respiratory Distress Syndrome TERMINATED NCT04390152
Wharton's jelly derived Mesenchymal stem cells. Other Phase PHASE1 Acute Respiratory Distress Syndrome TERMINATED NCT04390152
Hydroxychloroquine, lopinavir/ritonavir or azithromycin and placebo (standard therapy) Drug Phase PHASE1 Acute Respiratory Distress Syndrome TERMINATED NCT04390152
Wharton's jelly derived Mesenchymal stem cells. Other Phase PHASE1 Acute Respiratory Distress Syndrome TERMINATED NCT04390152
Matching Placebo Other Phase PHASE3 Agitation,Psychomotor COMPLETED NCT05658510
BXCL501 Other Phase PHASE3 Agitation,Psychomotor COMPLETED NCT05658510
BXCL701 monotherapy Drug Phase PHASE1 Prostate Cancer COMPLETED NCT03910660
BXCL701 plus Pembrolizumab Other Phase PHASE1 Prostate Cancer COMPLETED NCT03910660
Dexmedetomidine (DEX) for sublingual (SL) administration (BXCL501) - 80µg Other Phase PHASE1 Alcohol Use Disorder (AUD) RECRUITING NCT06335407
Dexmedetomidine (DEX) for sublingual (SL) administration (BXCL501) - 40µg Other Phase PHASE1 Alcohol Use Disorder (AUD) RECRUITING NCT06335407
Matching Placebo Other Phase PHASE3 Agitation COMPLETED NCT05271552
BXCL501 Other Phase PHASE3 Agitation COMPLETED NCT05271552
Sublingual film containing Igalmi Other Phase PHASE4 Bipolar Disorder COMPLETED NCT06041646
Pembrolizumab Other Phase PHASE2 Metastatic Pancreatic Ductal Adenocarcinoma ACTIVE_NOT_RECRUITING NCT05558982
BXCL701 Other Phase PHASE2 Metastatic Pancreatic Ductal Adenocarcinoma ACTIVE_NOT_RECRUITING NCT05558982
BXCL501 Sublingual Film Other Phase PHASE2 Bipolar I Disorder COMPLETED NCT07116694
BXCL501 60 Micrograms Other Phase PHASE1 Schizophrenia RECRUITING NCT05025605
BXCL501 120 Micrograms Other Phase PHASE1 Schizophrenia RECRUITING NCT05025605
Placebo Film Other Phase PHASE1 Schizophrenia RECRUITING NCT05025605
BXCL501 80 Micrograms Other Phase PHASE1 Schizophrenia RECRUITING NCT05025605
Lofexidine (Positive Control) Other Phase PHASE1 Opioid Use Disorder ACTIVE_NOT_RECRUITING NCT05712707
Placebo Other Phase PHASE1 Opioid Use Disorder ACTIVE_NOT_RECRUITING NCT05712707
BXCL501 (240 micrograms) Other Phase PHASE1 Opioid Use Disorder ACTIVE_NOT_RECRUITING NCT05712707
BXCL501 (180 micrograms) Other Phase PHASE1 Opioid Use Disorder ACTIVE_NOT_RECRUITING NCT05712707
BXCL501 Sublingual Film DRUG Phase PHASE2 Bipolar I Disorder COMPLETED NCT07116694
Lorazepam 2 MG/ML DRUG Phase PHASE4 Schizophrenia Agitation RECRUITING NCT06093451
Sublingual film containing Igalmi DRUG Phase PHASE4 Bipolar Disorder COMPLETED NCT06041646
Lofexidine (Positive Control) OTHER Phase PHASE1 Opioid Use Disorder ACTIVE_NOT_RECRUITING NCT05712707
BXCL501 (240 micrograms) DRUG Phase PHASE1 Opioid Use Disorder ACTIVE_NOT_RECRUITING NCT05712707
BXCL501 (180 micrograms) DRUG Phase PHASE1 Opioid Use Disorder ACTIVE_NOT_RECRUITING NCT05712707
Pembrolizumab DRUG Phase PHASE2 Metastatic Pancreatic Ductal Adenocarcinoma ACTIVE_NOT_RECRUITING NCT05558982
BXCL701 DRUG Phase PHASE2 Metastatic Pancreatic Ductal Adenocarcinoma ACTIVE_NOT_RECRUITING NCT05558982
Matching Placebo DRUG Phase PHASE3 Agitation TERMINATED NCT05665088
BXCL501 DRUG Phase PHASE3 Agitation TERMINATED NCT05665088
BXCL501 60 Micrograms DRUG Phase PHASE1 Schizophrenia RECRUITING NCT05025605
BXCL501 120 Micrograms DRUG Phase PHASE1 Schizophrenia RECRUITING NCT05025605
BXCL501 80 Micrograms DRUG Phase PHASE1 Schizophrenia RECRUITING NCT05025605
Alcohol Cue Reactivity BEHAVIORAL Phase PHASE1 Alcohol Use Disorder (AUD) COMPLETED NCT04827056
PTSD Reactivity Condition BEHAVIORAL Phase PHASE1 Alcohol Use Disorder (AUD) COMPLETED NCT04827056
Ethanol Infusion PROCEDURE Phase PHASE1 Alcohol Use Disorder (AUD) COMPLETED NCT04827056
Dexmedetomidine (DEX) for sublingual (SL) administration (BXCL501) - 80µg DRUG Phase PHASE1 Alcohol Use Disorder (AUD) RECRUITING NCT06335407
Dexmedetomidine (DEX) for sublingual (SL) administration (BXCL501) - 40µg DRUG Phase PHASE1 Alcohol Use Disorder (AUD) RECRUITING NCT06335407
Placebo OTHER Phase PHASE1 Opioid Use Disorder ACTIVE_NOT_RECRUITING NCT05712707
Dexmedetomidine DRUG Phase PHASE4 Schizophrenia Agitation RECRUITING NCT06093451
Dexmedetomidine sublingual film DRUG Phase PHASE2 Delirium WITHDRAWN NCT04382170
Sublingual film containing Dexmedetomidine (BXCL501) DRUG Phase PHASE3 Agitation Associated With Bipolar Disorder COMPLETED NCT04276883
Placebo Film DRUG Phase PHASE1 Schizophrenia RECRUITING NCT05025605
Sublingual film containing dexmedetomidine (BXCL501) DRUG Phase PHASE3 Agitation COMPLETED NCT04268303
Sublingual Placebo Film DRUG Phase PHASE1 Agitation,Psychomotor COMPLETED NCT04251910
Sublingual film containing Dexmedetomidine DRUG Phase PHASE1 Agitation,Psychomotor COMPLETED NCT04251910
Talabostat Mesylate DRUG Phase EARLY_PHASE1 Cancer of Pancreas WITHDRAWN NCT04123574
Placebo film DRUG Phase PHASE2 Agitation WITHDRAWN NCT05313386
Sublingual film containing BXCL501 (Dexmedetomidine) DRUG Phase PHASE1 Agitation COMPLETED NCT04010305
BXCL701 monotherapy DRUG Phase PHASE1 Prostate Cancer COMPLETED NCT03910660
BXCL701 plus Pembrolizumab DRUG Phase PHASE1 Prostate Cancer COMPLETED NCT03910660
Total products: 107