Category: BXCL501

BioXcel Reports the US FDA’s Acceptance of BXCL501’s NDA for the Acute Treatment of Agitation Associated with Schizophrenia and Bipolar Disorders I and II

Shots: The NDA submission is based on P-III studies (SERENITY I & II) assessing BXCL501 (120 & 180mcg doses) vs PBO for the acute treatment of agitation associated with schizophrenia and bipolar disorders I and II, respectively Results: BXCL501 met its 1EPs & 2EPs in both the studies, demonstrating rapid, and durable improvements from baseline […]

BioXcel’s BXCL501 Receives the US FDA’s Breakthrough Therapy Designation for Acute Treatment of Agitation Associated with Dementia

Shots: The BTD is based on a P-Ib/II TRANQUILITY study assessing BXCL501 in patients with acute treatment of agitation associated with dementia, including AD The results demonstrated significant reductions in agitation measures @2hrs. post-dose with both 30 and 60 mcg doses as measured by multiple scales. The dose dependent response has the potential to support […]