Sublingual thin film formulation, oral small molecule

BioXcel Therapeutics Inc. employs an innovative AI-based approach to drug re-innovation, particularly in the field of neuroscience. This strategy focuses on identifying new therapeutic indications for existing drugs and late-stage candidates, thereby addressing the challenges of traditional drug development, which often involves lengthy timelines and high costs. By utilizing NovareAI, a composite of various AI tools, BioXcel aims to streamline the drug discovery process, enhance research and development efficiencies, and improve the probability of success in bringing new treatments to market. This approach has already facilitated the rapid advancement of their first commercial product, IGALMI™ (dexmedetomidine) sublingual film, from initial clinical trials to FDA approval in under four years.

In addition to IGALMI™, BioXcel is actively developing other investigational therapies, such as BXCL501, which targets agitation associated with various psychiatric and neurological disorders, and BXCL701, an oral innate immune activator aimed at treating aggressive prostate cancer and other tumors. The company collaborates with prestigious institutions like Columbia University and Yale University Medical School to further its research efforts. BioXcel's commitment to leveraging AI in drug development not only seeks to uncover new treatment options but also aims to address unmet medical needs in the neuroscience domain, ultimately improving patient outcomes.

United States

BioXcel Therapeutics, Inc. is a clinical-stage biopharmaceutical company utilizing artificial intelligence, or AI, to identify improved therapies in neuroscience and immuno-oncology.

Central Nervous System (CNS)

Nervous System Diseases

Psychological Diseases

BioXcel Therapeutics Inc

Bipolar depression

Bipolar disease

Mental health

Schizophrenia

BXCL501 is our most advanced neuroscience clinical program, being developed initially for the acute treatment of agitation in patients with schizophrenia and bipolar disorders. A selective adrenergic agent with a sublingual or buccal route of administration, BXCL501 is designed to be easy to administer and has shown a rapid onset of action in clinical studies. It is designed to generate a calming effect without producing excessive sedation. We believe it is highly differentiated from antipsychotics currently used as standard of care, which produce unwanted symptoms such as tremors, neutropenia and extra-pyramidal motor effects. Managing patient agitation in neuropsychiatric and neurodegenerative disorders represents a significant challenge for physicians and caregivers, and we believe BXCL501 has the potential to address these challenges while providing an efficient treatment regimen for patients.

IGALMI (dexmedetomidine) (BXCL501)

Agitation in Alzheimer's Disease

Alzheimer's disease

Dementia

BXCL501 

Agitation

BXCL501

Castration-resistant prostate cancer

Neuroendocrine prostate cancer

BXCL701 is an investigational orally administered innate immune activator designed to initiate inflammation in the tumor microenvironment. Approved and experimental immunotherapies often struggle to address cancers that appear “cold” or uninflamed. Therefore, BXCL701 may render “cold” tumors “hot,” making them more detectable by the adaptive immune system and thereby facilitating the development of a strong anti-cancer immune response. BTI’s preclinical data supports BXCL701’s synergy with both current checkpoint inhibitor-based therapies and emerging immunotherapies directed to activate T-cells, such as IL-2.
 
This candidate is currently being developed as therapy for treatment emergent Neuroendocrine Prostate Cancer (tNEPC) and pancreatic cancer (both “cold” tumors) and other advanced solid cancers that are “hot” or have become resistant to checkpoint inhibitors.

BXCL701 + KEYTRUDA

Cancer

Pancreatic cancer

Solid tumor/s

<ul class="font_7">
 <li>BXCL701 is an investigational orally administered innate immune activator designed to initiate inflammation in the tumor microenvironment. Approved and experimental immunotherapies often struggle to address cancers that appear “cold” or uninflamed. Therefore, BXCL701 may render “cold” tumors “hot,” making them more detectable by the adaptive immune system and thereby facilitating the development of a strong anti-cancer immune response. BTI’s preclinical data supports BXCL701’s synergy with both current checkpoint inhibitor-based therapies and emerging immunotherapies directed to activate T-cells, such as IL-2.</li>
 <li>This candidate is currently being developed as therapy for treatment emergent Neuroendocrine Prostate Cancer (tNEPC) and pancreatic cancer (both “cold” tumors) and other advanced solid cancers that are “hot” or have become resistant to checkpoint inhibitors.</li>
</ul>

BioXcel Therapeutics Inc

Company Details