BioXcel says on track to initiate BXCL501 first-in-human PK and safety study

BioXcel Therapeutics provided an update on the company’s progress advancing its lead neuroscience program, BXCL501, a proprietary, first-in-class sublingual thin film formulation of dexmedetomidine hydrochloride being developed for the acute treatment of agitation. BTI is on track to initiate an IND-opening Phase 1 pharmacokinetic, or PK, and safety study with BXCL501 by the end of this year, following approval of its IND application. Prior to its recently completed pre-IND meeting with the FDA, BTI submitted a pre-IND briefing book containing regulatory, chemistry, manufacturing, controls, or CMC, and non-clinical work, along with a proposed clinical study synopsis and a broader development plan. During the pre-IND meeting with the FDA, BTI received valuable feedback that will help guide further clinical development of BXCL501.

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