In April 2022, the U.S. Food and Drug Administration approved IGALMI™ (dexmedetomidine) sublingual film (BXCL501) for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults. BXCL501, our most advanced neuroscience asset, is also being evaluated as a potential treatment for agitation associated with multiple psychiatric and neurological disorders. Our most advanced immuno-oncology asset, BXCL701, is an investigational oral innate immune activator being developed as a potential therapy for the treatment of aggressive forms of prostate cancer, pancreatic cancer, and other solid and liquid tumors.
Our Neuroscience Clinical Pipeline
*Includes intermittent chronic agitation
**Program paused as part of company’s strategic reprioritization announced on August 14, 2023
***Regulatory path to be determined; device + drug combination to be evaluated after further evaluation of predictive algorithm
Pipeline as of Nov. 14, 2023
The safety and efficacy of
investigational agents and/or
investigational uses of approved
products have not been established
BXCL501 is our most advanced neuroscience clinical program. In indications other than those approved by the FDA as IGALMI™, BXCL501 remains an investigational, proprietary, orally dissolving film formulation of dexmedetomidine, a selective alpha-2 receptor agonist, targeting symptoms from stress-related behaviors such as agitation. BXCL501 is being evaluated for the acute treatment of agitation related to mild to moderate Alzheimer’s dementia in assisted living facilities or in the at-home setting and for the at-home acute treatment of agitation related to bipolar disorders or schizophrenia. BXCL501 has been granted Breakthrough Therapy and Fast Track designation for the acute treatment of agitation associated with dementia.
The Company’s most advanced immuno-oncology asset, BXCL701, is an investigational, orally administered systemic innate immune activator for the treatment of a rare form of prostate cancer and advanced solid tumors that are refractory or treatment naïve to checkpoint inhibitors. BXCL701 is an oral small molecule inhibitor of a class of enzymes called DPPs, specifically DPP8/9 and DPP4. Inhibition of DPP8/9 initiates the activation of the inflammasome and ultimately the activation of the innate immune system.
BXCL701 is being developed by OnkosXcel Therapeutics, a wholly owned, clinical-stage subsidiary of BioXcel Therapeutics. OnkosXcel is focused on advancing potentially transformative medicines in oncology using proprietary AI capabilities to drive capital-efficient development.