Peer-Reviewed Publication Highlights Potential of BioXcel’s Dexmedetomidine (BXCL501) for Stress-Related Disorders

August 6, 2025

DENVER, Colo., Aug 06, 2025 (247marketnews.com)- BioXcel Therapeutics (NASDAQ:BTAI) reported the publication of a new study in the peer-reviewed journal Frontiers in Pharmacology, titled Dexmedetomidine potently and reversibly regulates stress-mediated behaviors, which highlights compelling preclinical data showing that dexmedetomidine, the active ingredient in BXCL501, produces significant effects in translational behavioral models associated with psychiatric conditions. These findings suggest the potential of BXCL501 to address chronic stress-related disorders, in addition to its already-approved use in acute agitation.

BXCL501, marketed as IGALMI, is an orally dissolving film formulation of dexmedetomidine that is FDA-approved for the treatment of acute agitation associated with schizophrenia or bipolar I or II disorder. As an alpha2-adrenergic receptor agonist, dexmedetomidine has a well-characterized mechanism of action that supports its broader application across psychiatric and neurological conditions.

The data featured in Frontiers in Pharmacology further reinforce this mechanism and provide a scientific rationale for the continued clinical exploration of BXCL501 beyond acute agitation.

“The promising results presented in this study suggest that dexmedetomidine reduces agitation through potent, selective agonist action at central alpha-2 adrenergic receptors, providing an additional underlying scientific rationale for the safety and efficacy established by our current clinical programs, as well as indicating a potential as a treatment for chronic stress-induced behaviors,” commented Frank Yocca, Ph.D, BioXcel’s CSO.

Ongoing studies at leading academic institutions are evaluating daily dosing of BXCL501 in several stress-related and neuropsychiatric disorders, including:

  • Opioid withdrawal
  • Acute stress disorder
  • Alcohol use disorder in patients with PTSD

These exploratory efforts underscore BioXcel Therapeutics’ broader vision to address unmet needs in mental health through novel, AI-enabled drug development and repurposing strategies.

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