Clinical Trials And Regulatory ProgressAll clinical trials required for supplemental New Drug Application submission completed.
Efficacy And Safety DataThe SERENITY At-Home pivotal Phase 3 trial yielded positive exploratory efficacy data, which demonstrated that BXCL501 had continued effects and consistent benefit with repeat dosing.
Regulatory Designations And ApprovalsBXCL501 was previously granted Fast Track Designation, and there are no FDA-approved therapies for the acute treatment of agitation in the at-home setting, suggesting a favorable regulatory outlook.