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Agitation

8
Pipeline Programs
4
Companies
9
Clinical Trials
0
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
1
0
2
0
4
1
Early DiscoveryClinical DevelopmentMarket

Competitive Landscape

4 companies ranked by most advanced pipeline stage

Ferrer
FerrerSpain - Barcelona
1 program
1
Staccato® Delivery System LoxapinePhase 41 trial
Active Trials
NCT02525991Completed323Est. Dec 2019
BioXcel Therapeutics
BioXcel TherapeuticsCT - New Haven
6 programs
1
2
3
BXCL501Phase 31 trial
BXCL501Phase 31 trial
Sublingual film containing dexmedetomidinePhase 31 trial
BXCL501Phase 21 trial
BXCL501Phase 21 trial
+1 more programs
Active Trials
NCT04010305Completed135Est. Jul 2019
NCT05276830Terminated5Est. Apr 2022
NCT05313386Withdrawn0Est. Feb 2022
+3 more trials
Abbott
AbbottABBOTT PARK, IL
1 program
1
Depakote ERPhase 31 trial
Active Trials
NCT00315900Terminated20Est. Feb 2008
Teva
TevaIsrael - Petach Tikva
1 program
Naturalistic Adasuve Clinical Trial StudyN/A1 trial
Active Trials
NCT02877108Unknown100Est. Apr 2017

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
FerrerStaccato® Delivery System Loxapine
BioXcel TherapeuticsBXCL501
BioXcel TherapeuticsBXCL501
BioXcel TherapeuticsSublingual film containing dexmedetomidine
AbbottDepakote ER
BioXcel TherapeuticsBXCL501
BioXcel TherapeuticsBXCL501
BioXcel TherapeuticsSublingual film containing BXCL501
TevaNaturalistic Adasuve Clinical Trial Study

Clinical Trials (9)

Total enrollment: 1,127 patients across 9 trials

NCT02525991FerrerStaccato® Delivery System Loxapine

Phase IV to Evaluate the Safety of Self-administered ADASUVE® in Agitated Patients Outside the Hospital Setting

Start: Sep 2016Est. completion: Dec 2019323 patients
Phase 4Completed
NCT05665088BioXcel TherapeuticsBXCL501

Dexmedetomidine in the Treatment of Agitation Associated With Dementia (TRANQUILITY III)

Start: Dec 2022Est. completion: Sep 202313 patients
Phase 3Terminated
NCT05271552BioXcel TherapeuticsBXCL501

Dexmedetomidine in the Treatment of Agitation Associated With Dementia (TRANQUILITY II)

Start: Apr 2022Est. completion: Apr 2023151 patients
Phase 3Completed
NCT04268303BioXcel TherapeuticsSublingual film containing dexmedetomidine

Dexmedetomidine in the Treatment of Agitation Associated With Schizophrenia

Start: Jan 2020Est. completion: May 2020380 patients
Phase 3Completed
NCT00315900AbbottDepakote ER

Depakote Extended Release (ER) Versus Seroquel for Agitated Behaviors in Nursing Home Care Unit Patients With Dementia

Start: May 2006Est. completion: Feb 200820 patients
Phase 3Terminated
NCT05276830BioXcel TherapeuticsBXCL501

An Efficacy, and Safety Study Of BXCL501 For The Treatment Of Agitation Associated With Dementia

Start: Feb 2022Est. completion: Apr 20225 patients
Phase 2Terminated
NCT05313386BioXcel TherapeuticsBXCL501

Study of BXCL501 In Agitation Associated With Delirium in ICU Patients

Start: Feb 2021Est. completion: Feb 20220
Phase 2Withdrawn
NCT04010305BioXcel TherapeuticsSublingual film containing BXCL501

Sub-Lingual Dexmedetomidine in Agitation Associated With Schizophrenia

Start: May 2019Est. completion: Jul 2019135 patients
Phase 1Completed
NCT02877108TevaNaturalistic Adasuve Clinical Trial Study

Naturalistic Adasuve Clinical Trial Study

Start: Apr 2016Est. completion: Apr 2017100 patients
N/AUnknown

Phase Legend

Preclinical— Lab & animal studies
Phase 1— Safety & dosing
Phase 2— Efficacy testing
Phase 3— Large-scale trials
On Market— Approved & available

Key Insights

4 late-stage (Phase 3) programs, potential near-term approvals
4 companies competing in this space

The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.