NCT05025605 is a Phase 1 clinical trial of BXCL501 80 Micrograms in Schizophrenia, sponsored by BioXcel Therapeutics Inc.

Who is sponsoring NCT05025605?

NCT05025605 is sponsored by BioXcel Therapeutics Inc.

What drugs are being tested in NCT05025605?

Interventions in NCT05025605: BXCL501 80 Micrograms, Placebo Film, BXCL501 120 Micrograms, BXCL501 60 Micrograms.

What condition does NCT05025605 study?

NCT05025605 studies Schizophrenia, Schizo-Affective Disorder, Schizophreniform; Schizophrenic, Bipolar Disorder I, Bipolar Disorder II.

Is NCT05025605 still recruiting?

NCT05025605 is currently recruiting now. Last updated 13 April 2026.

Last reviewed 2026-04-13 · How we verify

NCT05025605

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Recruiting now Phase 1 Last updated 13 April 2026

What this trial tests

Phase 1 trial testing BXCL501 80 Micrograms in Schizophrenia in 140 participants. Currently enrolling.

Timeline

27 August 2021

Primary endpoint
31 July 2027

31 December 2027

Quick facts

Lead sponsor	BioXcel Therapeutics Inc
Phase	Phase 1
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	140
Start date	27 August 2021
Primary completion	31 July 2027
Estimated completion	31 December 2027
Sites	5 locations across United States

Drugs / interventions tested

BXCL501 80 Micrograms — full drug profile →
Placebo Film — full drug profile →
BXCL501 120 Micrograms — full drug profile →
BXCL501 60 Micrograms — full drug profile →

Conditions studied

Schizophrenia — all drugs for Schizophrenia →
Schizo-Affective Disorder — all drugs for Schizo-Affective Disorder →
Schizophreniform; Schizophrenic — all drugs for Schizophreniform; Schizophrenic →
Bipolar Disorder I — all drugs for Bipolar Disorder I →

Sponsor

BioXcel Therapeutics Inc — full company profile →

Who can join

Adults 10 to 17, any sex, with Schizophrenia or Schizo-Affective Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

A New Era of Artificial Intelligence (AI): Transforming Drug Discovery and Development.
Ali S, Tian X, Chen H, Zhou J. · · 2025 · cited 7× · PMID 41306069 · DOI 10.1021/acs.jmedchem.5c03159

Verify or expand the search:

Other recruiting trials for Schizophrenia

Currently open trials in the same condition.

NCT07424404 — A Study to Evaluate the Long-term Safety and Tolerability of KarXT and KarX-EC for the Treatment of Schizophrenia and Au · Phase 3 · recruiting
NCT07467993 — Study to Assess the Safety, Tolerability, and Treatment Response of GXV813 in Hospitalized Adults With Schizophrenia · Phase 2 · recruiting
NCT07379827 — Effectiveness and Adverse-effect Switch Evaluation of Xanomeline and Trospium Chloride (KarXT) · recruiting
NCT06758414 — CBT-CP for Veterans With SMI · NA · recruiting
NCT07395206 — Acceptability, Feasibility and Preliminary Outcomes of the Kiso Mind App for Outpatients With Schizophrenia Spectrum Dis · NA · recruiting

Other BioXcel Therapeutics Inc trials

Trials by the same sponsor.

NCT07116694 — Assessment of Acute Psychomotor Agitation Measures Associated With Schizophrenia and Bipolar Disorder · Phase 2 · completed
NCT06041646 — Tachyphylaxis, Tolerance, & Withdrawal Post Treatment With Igalmi for Agitation in Schizophrenia or Bipolar Disorder · Phase 4 · completed
NCT05665088 — Dexmedetomidine in the Treatment of Agitation Associated With Dementia (TRANQUILITY III) · Phase 3 · terminated
NCT05658510 — Dexmedetomidine in the Treatment of Agitation Associated With Schizophrenia and Bipolar Disorder (SERENITY III) · Phase 3 · completed
NCT05271552 — Dexmedetomidine in the Treatment of Agitation Associated With Dementia (TRANQUILITY II) · Phase 3 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05025605 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by BioXcel Therapeutics Inc
Last refreshed: 13 April 2026

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05025605.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing