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NCT05025605Phase 1RECRUITING

Determining Efficacy and Safety of BXCL501 in Agitation Associated With Pediatric Schizophrenia and Bipolar Disorder

Study Summary

This is a study of the efficacy and safety of BXCL501 in children and adolescents with acute agitation and either bipolar disorder or schizophrenia.

Conditions
SchizophreniaSchizo-Affective DisorderSchizophreniform; SchizophrenicBipolar Disorder IBipolar Disorder II
Interventions / Drugs
BXCL501 80 MicrogramsPlacebo FilmBXCL501 120 MicrogramsBXCL501 60 Micrograms
View on ClinicalTrials.gov ↗
Sponsor
BTAI
BioXcel Therapeutics
Neuroscience
D43/100
Study Details
Enrollment140 participants
Primary Completion—
Lead SponsorBioXcel Therapeutics Inc
Data Retrieved2026-04-11 04:08:29.679060+00:00
What This Trial Means for Biotech Investors
Trial Phase Context

Phase 1 trials primarily test safety and dosing in a small number of participants (typically 20–100). Results do not yet speak to efficacy. FDA approval is typically many years away from this stage.

Status & Expected Data

Currently recruiting: the trial is enrolling patients. A data readout is not expected until after enrollment closes and the follow-up period is complete.

Enrolled: 140 participants
Sponsor Catalyst Profile

BioXcel Therapeutics (BTAI) is the sponsoring company for this trial. BiotechSign currently grades this company D (43/100) based on composite catalyst signals across its full pipeline. This trial is one data point in that overall catalyst picture.

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