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Delirium

13
Pipeline Programs
25
Companies
30
Clinical Trials
7 recruiting
2
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
6
4
Early DiscoveryClinical DevelopmentMarket

On Market (2)

Approved therapies currently available

Novartis
EXELONApproved
rivastigmine
Novartis
Cholinesterase Inhibitor [EPC]transdermal2007
20M Part D
BioXcel Therapeutics
IGALMIApproved
dexmedetomidine
BioXcel Therapeutics
Central alpha-2 Adrenergic Agonist [EPC]buccal, sublingual2022
65K Part D

Competitive Landscape

24 companies ranked by most advanced pipeline stage

Sandoz
SandozAustria - Kundl
4 programs
2
2
RivastigminePhase 4
Rivastigmine PatchPhase 4
Rivastigmine prevention of deliriumPhase 3
Rivastigmine transdermal patchPhase 3
Novartis
NovartisBASEL, Switzerland
1 program
1
Rivastigmine prevention of deliriumPHASE_31 trial
Active Trials
NCT00257868Completed120Est. Jul 2007
BioXcel Therapeutics
BioXcel TherapeuticsCT - New Haven
1 program
1
1
Dexmedetomidine sublingual filmPhase 21 trial
Active Trials
NCT04382170Withdrawn0Est. Jun 2021
Pfizer
PfizerNEW YORK, NY
3 programs
2
DexmedetomidinePhase 31 trial
PregabalinPhase 31 trial
PropofolN/A1 trial
Active Trials
NCT01378741Completed185Est. Apr 2015
NCT00464763Withdrawn0Est. Sep 2007
NCT00819988Completed240Est. Oct 2011
MSD
MSDIreland - Ballydine
1 program
1
SuvorexantPhase 31 trial
Active Trials
NCT04571944Completed207Est. Dec 2022
Sharp Therapeutics
Sharp TherapeuticsPA - Pittsburgh
1 program
1
SuvorexantPhase 3
Colorado Therapeutics
Colorado TherapeuticsCO - Louisville
1 program
1
HaloperidolPhase 21 trial
Active Trials
NCT00429676Completed20Est. Sep 2007
UNION therapeutics
UNION therapeuticsDenmark - Hellerup
5 programs
1
MidazolamPhase 11 trial
Intestinal microbiota suspensionN/A1 trial
Spot monitoring device, excl. ShamN/A1 trial
Spot monitoring device, excl. ShamN/A1 trial
VRFSN/A1 trial
Active Trials
NCT07348471Recruiting60Est. Dec 2028
NCT03735927Terminated3,907Est. Jun 2021
NCT03735940Terminated3,630Est. Jun 2021
+2 more trials
Masimo
MasimoIRVINE, CA
2 programs
Cerebral Monitoring and Post-operative Delirium and OutcomesN/A1 trial
Study of Sleep and Delirium in the Intensive Care Unit (ICU)N/A1 trial
Active Trials
NCT04643834Completed153Est. Nov 2023
NCT01280097Completed57Est. Nov 2012
Bilim Pharmaceuticals
Bilim PharmaceuticalsTurkey - Istanbul
2 programs
Delirium Prevention GuidelineN/A1 trial
PRE-DELIRIC modelN/A1 trial
Active Trials
NCT06403410Not Yet Recruiting160Est. Dec 2024
NCT04218461Completed172Est. Apr 2020
Medtronic
MedtronicNJ - Phillipsburg
2 programs
Impact of Neuromonitoring During Cardiac ProceduresN/A1 trial
Sedation,RASS Targeted plus BIS MonitoringN/A1 trial
Active Trials
NCT02681731Completed250,000Est. Dec 2017
NCT00469482Completed28Est. Sep 2016
Oregon Therapeutics
Oregon TherapeuticsFrance - Paris
1 program
Acute Care of Elders focused geriatric careN/A1 trial
Active Trials
NCT02119078Unknown300Est. Dec 2020
Heidelberg Pharma
Heidelberg PharmaGermany - Ladenburg
1 program
BIS guidance of anesthesiaN/A1 trial
Active Trials
NCT05656703Completed130Est. Mar 2021
Abbott
AbbottABBOTT PARK, IL
1 program
DexmedetomidineN/A1 trial
Active Trials
NCT00417664Completed90Est. Apr 2004
Ceribell
CeribellCA - Sunnyvale
1 program
ElectroencephalogramN/A1 trial
Active Trials
NCT04962815Recruiting200Est. Apr 2026
Utah Medical
Utah MedicalIreland - Dublin
1 program
HELPN/A1 trial
Active Trials
NCT05929703Recruiting1,900Est. Aug 2027
Lumos Pharma
Lumos PharmaTX - Austin
1 program
LumosityN/A1 trial
Active Trials
NCT02908464Completed45Est. Sep 2019
Neurosteer
NeurosteerIsrael - Tel Aviv
1 program
Neurosteer's single-channel EEG monitoring deviceN/A1 trial
Active Trials
NCT06718764Recruiting100Est. Jul 2025
Eppendorf
EppendorfGermany - Hamburg
1 program
Patient-reported Outcome Measures After Post-anesthesia Care Unit DeliriumN/A1 trial
Active Trials
NCT04168268Completed222Est. Dec 2018
Nordic Pharma
Nordic PharmaFrance - Paris
1 program
Sedation Influence on Delirium and Post-traumatic Stress-disorder as a Result of Hospitalization in N/A1 trial
Active Trials
NCT01291368Completed248Est. Feb 2012
Orion
OrionUK - Cambridge
1 program
Subsyndromal Delirium in Intensive Care UnitN/A1 trial
Active Trials
NCT03813459Completed400Est. Mar 2020
Orion Pharma
Orion PharmaUK - Reading
1 program
Subsyndromal Delirium in Intensive Care UnitN/A
Hamilton medical
Hamilton medicalSwitzerland - Bonaduz
1 program
The Delirium-CS Canada StudyN/A1 trial
Active Trials
NCT02206880Completed235Est. Jul 2018
Providence Therapeutics
1 program
Dexmedetomidine Hydrochloride GroupPHASE_41 trial
Active Trials
NCT04289142Recruiting2,400Est. Mar 2029

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
2028
2029
Providence TherapeuticsDexmedetomidine Hydrochloride Group
MSDSuvorexant
PfizerPregabalin
PfizerDexmedetomidine
NovartisRivastigmine prevention of delirium
BioXcel TherapeuticsDexmedetomidine sublingual film
Colorado TherapeuticsHaloperidol
UNION therapeuticsMidazolam
UNION therapeuticsIntestinal microbiota suspension
NeurosteerNeurosteer's single-channel EEG monitoring device
Bilim PharmaceuticalsDelirium Prevention Guideline
UNION therapeuticsVRFS
Utah MedicalHELP
CeribellElectroencephalogram
MasimoCerebral Monitoring and Post-operative Delirium and Outcomes

Showing 15 of 30 trials with date data

Clinical Trials (30)

Total enrollment: 265,923 patients across 30 trials

NCT04289142Providence TherapeuticsDexmedetomidine Hydrochloride Group

Cognitive Outcomes After Dexmedetomidine Sedation in Cardiac Surgery Patients

Start: Dec 2019Est. completion: Mar 20292,400 patients
Phase 4Recruiting
NCT04571944MSDSuvorexant

Efficacy and Safety of Suvorexant (MK-4305) for Reducing Incidence of Delirium in Japanese Participants at High Risk of Delirium (MK-4305-085)

Start: Oct 2020Est. completion: Dec 2022207 patients
Phase 3Completed
NCT00819988PfizerPregabalin

Pregabalin in the Prevention of Postoperative Delirium and Pain

Start: May 2009Est. completion: Oct 2011240 patients
Phase 3Completed
NCT00464763PfizerDexmedetomidine

A Research Study to Evaluate the Effectiveness of Dexmedetomidine in Preventing Delirium After Heart Surgery

Start: Apr 2007Est. completion: Sep 20070
Phase 3Withdrawn
NCT00257868NovartisRivastigmine prevention of delirium

Rivastigmine for the Prevention of Postoperative Delirium in Patients Undergoing Cardiac Surgery

Start: Jan 2006Est. completion: Jul 2007120 patients
Phase 3Completed
NCT04382170BioXcel TherapeuticsDexmedetomidine sublingual film

Dexmedetomidine Sublingual Film for the Management of Agitation in Delirium: Safety and Preliminary Efficacy

Start: Jun 2020Est. completion: Jun 20210
Phase 2Withdrawn
NCT00429676Colorado TherapeuticsHaloperidol

Pilot Study of Haloperidol to Treat Critical Illness Delirium

Start: Dec 2005Est. completion: Sep 200720 patients
Phase 2Completed
NCT06963112UNION therapeuticsMidazolam

Intraoperative Midazolam on Delirium Outcome of Elderly Patients

Start: Apr 2025Est. completion: Aug 2026612 patients
Phase 1Recruiting
NCT07348471UNION therapeuticsIntestinal microbiota suspension

Fecal Microbiota Transplantation for the Treatment of ICU Delirium

Start: Mar 2026Est. completion: Dec 202860 patients
N/ARecruiting
NCT06718764NeurosteerNeurosteer's single-channel EEG monitoring device

Neurosteer Bedside Monitoring System

Start: Jul 2024Est. completion: Jul 2025100 patients
N/ARecruiting
NCT06403410Bilim PharmaceuticalsDelirium Prevention Guideline

Delirium Prevention Guideline for Intensive Care Patients

Start: Jun 2024Est. completion: Dec 2024160 patients
N/ANot Yet Recruiting
NCT05525702UNION therapeuticsVRFS

VR Interventions to Reduce the Prevalence of Delirium in ICU Patients

Start: Dec 2023Est. completion: Dec 2026102 patients
N/ARecruiting
NCT05929703Utah MedicalHELP

Evaluating Novel Healthcare Approaches to Nurturing and Caring for Hospitalized Elders

Start: Dec 2023Est. completion: Aug 20271,900 patients
N/ARecruiting
NCT04962815CeribellElectroencephalogram

Ceribell Delirium Data Collection Study

Start: Nov 2021Est. completion: Apr 2026200 patients
N/ARecruiting
NCT04643834MasimoCerebral Monitoring and Post-operative Delirium and Outcomes

Cerebral Monitoring and Post-operative Delirium and Outcomes

Start: Nov 2019Est. completion: Nov 2023153 patients
N/ACompleted
NCT04218461Bilim PharmaceuticalsPRE-DELIRIC model

PREdiction of DELIRium in Medical ICU Patients

Start: Nov 2019Est. completion: Apr 2020172 patients
N/ACompleted
NCT03735940UNION therapeuticsSpot monitoring device, excl. Sham

Clinical Evaluation Program of DeltaScan (ICU)

Start: Mar 2019Est. completion: Jun 20213,630 patients
N/ATerminated
NCT03735927UNION therapeuticsSpot monitoring device, excl. Sham

Clinical Evaluation Program of DeltaScan (Ward)

Start: Jan 2019Est. completion: Jun 20213,907 patients
N/ATerminated
NCT03813459OrionSubsyndromal Delirium in Intensive Care Unit

Subsyndromal Delirium in Intensive Care Unit

Start: Aug 2018Est. completion: Mar 2020400 patients
N/ACompleted
NCT04168268EppendorfPatient-reported Outcome Measures After Post-anesthesia Care Unit Delirium

Patient-reported Outcome Measures After Post-anesthesia Care Unit Delirium

Start: Nov 2017Est. completion: Dec 2018222 patients
N/ACompleted
NCT02908464Lumos PharmaLumosity

Prevention of Early Postoperative Decline

Start: Nov 2016Est. completion: Sep 201945 patients
N/ACompleted
NCT02681731MedtronicImpact of Neuromonitoring During Cardiac Procedures

Impact of Neuromonitoring During Cardiac Procedures

Start: Mar 2016Est. completion: Dec 2017250,000 patients
N/ACompleted
NCT05656703Heidelberg PharmaBIS guidance of anesthesia

Anesthesia Depth Increases Delirium Incidence

Start: Sep 2015Est. completion: Mar 2021130 patients
N/ACompleted
NCT02206880Hamilton medicalThe Delirium-CS Canada Study

The Delirium-CS Canada Study

Start: Nov 2014Est. completion: Jul 2018235 patients
N/ACompleted
NCT02119078Oregon TherapeuticsAcute Care of Elders focused geriatric care

Acute Care for Elders (ACE) Program at OHSU Hospital

Start: Jan 2014Est. completion: Dec 2020300 patients
N/AUnknown
NCT01378741PfizerPropofol

Reducing Delirium After Cardiac Surgery: A Multifaceted Approach Of Perioperative Care

Start: Apr 2011Est. completion: Apr 2015185 patients
N/ACompleted
NCT01280097MasimoStudy of Sleep and Delirium in the Intensive Care Unit (ICU)

Study of Sleep and Delirium in the Intensive Care Unit (ICU)

Start: Dec 2010Est. completion: Nov 201257 patients
N/ACompleted
NCT01291368Nordic PharmaSedation Influence on Delirium and Post-traumatic Stress-disorder as a Result of Hospitalization in

Sedation Influence on Delirium and Post-traumatic Stress-disorder as a Result of Hospitalization in Intensive Care

Start: Sep 2009Est. completion: Feb 2012248 patients
N/ACompleted
NCT00469482MedtronicSedation,RASS Targeted plus BIS Monitoring

The SOMNUS Study: Sedative Optimization Via Monitoring Neurological Status

Start: Jun 2007Est. completion: Sep 201628 patients
N/ACompleted
NCT00417664AbbottDexmedetomidine

Is Dexmedetomidine Associated With a Lower Incidence of Postoperative Delirium When Compared to Propofol or Midazolam in Cardiac Surgery Patients

Start: Apr 2002Est. completion: Apr 200490 patients
N/ACompleted

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

6 late-stage (Phase 3) programs, potential near-term approvals
7 actively recruiting trials targeting 265,923 patients
25 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.