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BioXcel Therapeutics

BioXcel Therapeutics logo
🇺🇸United States
Ownership
Public
Established
2017-01-01
Employees
74
Market Cap
$26.8M
Website
http://www.bioxceltherapeutics.com
Introduction

BioXcel Therapeutics, Inc. is a biopharmaceutical company, which engages in the development of artificial intelligence solutions in neuroscience and immuno-oncology. It also focuses on utilizing technology and research to develop therapeutics solutions. The company was founded by Vimal D. Mehta on March 29, 2017 and is headquartered in New Haven, CT.

Clinical Trials

17

Active:3
Completed:9

Trial Phases

6 Phases

Early Phase 1:1
Phase 1:6
Phase 2:2
+3 more phases

Drug Approvals

1

FDA:1

Drug Approvals

IGALMI

Approval Date
Dec 14, 2022
FDA

Clinical Trials

Distribution across different clinical trial phases (16 trials with phase data)• Click on a phase to view related trials

Phase 1
6 (37.5%)
Phase 3
5 (31.3%)
Phase 2
2 (12.5%)
Early Phase 1
1 (6.3%)
Not Applicable
1 (6.3%)
Phase 4
1 (6.3%)

Tachyphylaxis, Tolerance, & Withdrawal Post Treatment With Igalmi for Agitation in Schizophrenia or Bipolar Disorder

Phase 4
Completed
Conditions
Bipolar Disorder
Schizophrenia
Agitation,Psychomotor
Schizophreniform Disorders
Schizo Affective Disorder
Interventions
Drug: Sublingual film containing Igalmi
First Posted Date
2023-09-18
Last Posted Date
2024-05-13
Lead Sponsor
BioXcel Therapeutics Inc
Target Recruit Count
23
Registration Number
NCT06041646
Locations
🇺🇸

BioXcel Clinical Research Site, Rogers, Arkansas, United States

Dexmedetomidine in the Treatment of Agitation Associated With Dementia (TRANQUILITY III)

Phase 3
Terminated
Conditions
Agitation
Dementia
Interventions
Drug: Matching Placebo
First Posted Date
2022-12-27
Last Posted Date
2023-12-11
Lead Sponsor
BioXcel Therapeutics Inc
Target Recruit Count
13
Registration Number
NCT05665088
Locations
🇺🇸

BioXcel Clinical Research Site, Toms River, New Jersey, United States

Dexmedetomidine in the Treatment of Agitation Associated With Schizophrenia and Bipolar Disorder (SERENITY III)

Phase 3
Active, not recruiting
Conditions
Agitation,Psychomotor
Bipolar I Disorder
Bipolar II Disorder
Schizophrenia
Schizoaffective Disorder
Schizophreniform Disorders
Interventions
Drug: Matching Placebo
First Posted Date
2022-12-20
Last Posted Date
2025-06-06
Lead Sponsor
BioXcel Therapeutics Inc
Target Recruit Count
452
Registration Number
NCT05658510
Locations
🇺🇸

BioXcel Clinical Research Site 137, Las Vegas, Nevada, United States

🇺🇸

BioXcel Clinical Research Site 136, Austin, Texas, United States

🇺🇸

BioXcel Clinical Research Site 113, Bellflower, California, United States

and more 21 locations

Study of BXCL501 In Agitation Associated With Delirium in ICU Patients

Phase 2
Withdrawn
Conditions
Delirium
Agitation
Interventions
Drug: Placebo film
First Posted Date
2022-04-06
Last Posted Date
2022-04-06
Lead Sponsor
BioXcel Therapeutics Inc
Registration Number
NCT05313386
Locations
🇺🇸

BioXcel Clinical Research Site, Nashville, Tennessee, United States

An Efficacy, and Safety Study Of BXCL501 For The Treatment Of Agitation Associated With Dementia

Phase 2
Terminated
Conditions
Agitation
Dementia
Interventions
Drug: Placebo film
First Posted Date
2022-03-11
Last Posted Date
2023-08-25
Lead Sponsor
BioXcel Therapeutics Inc
Target Recruit Count
5
Registration Number
NCT05276830
Locations
🇺🇸

Bioxcel Clinical Research Site, Springfield, Massachusetts, United States

🇺🇸

BioXcel Clinical Research Site, Toms River, New Jersey, United States

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BioXcel Therapeutics Secures $14M Through Direct Stock Offering to Institutional Investors

BioXcel Therapeutics has entered into a securities purchase agreement with institutional investors, raising $14M through a registered direct offering of common stock and warrants.

FDA Concludes Inspection of BioXcel's TRANQUILITY II Phase 3 Trial Site with VAI Status

The FDA has completed its inspection of BioXcel Therapeutics' TRANQUILITY II Phase 3 trial site, designating it as "Voluntary Action Indicated" and releasing the Establishment Inspection Report.

BioXcel Therapeutics Advances Phase 3 Trials for BXCL501 in Agitation Treatment

BioXcel Therapeutics has initiated the SERENITY At-Home Phase 3 trial evaluating BXCL501 for acute agitation in patients with bipolar disorders or schizophrenia, addressing an estimated 23 million annual episodes.

FDA Approves Rexulti as Breakthrough Treatment for Alzheimer's-Related Agitation

Lundbeck and Otsuka's Rexulti (brexpiprazole) becomes the first FDA-approved medication specifically for treating agitation in Alzheimer's disease patients, affecting approximately 50% of cases.

BioXcel Therapeutics Advances Phase 3 Trials of BXCL501 for Agitation

BioXcel Therapeutics has randomized the first patient in the SERENITY At-Home trial, evaluating BXCL501 for acute agitation associated with bipolar disorders or schizophrenia.

Bioxcel Therapeutics Gains Analyst Confidence with Agitation Treatment Advancements

H.C. Wainwright reiterated a Buy rating for Bioxcel Therapeutics (BTAI), citing the Phase 3 trial of BXCL501 for agitation in bipolar disorder and schizophrenia.

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