Dexmedetomidine Hydrochloride

Phase 3Small molecule

Dexmedetomidine Hydrochloride is a small molecule that works as Adrenergic Receptor Alpha-2 Agonist.[2] It is being investigated across 8 indications, with its most advanced program in Phase 3.[1]

Dexmedetomidine Hydrochloride is one of 118 small molecule programs targeting Septic Shock. It is currently in Phase 3.

Indications

Total Trials

Active Trials

117

Competitors

Pipeline

Status by Indication[3][1]

Indication

Septic ShockActive, not recruiting

General AnesthesiaCompleted

Acute Postoperative PainWithdrawn

Thoracic SurgeryCompleted

DeliriumUnknown status

DexmedetomidineUnknown status

Post Operative Cognitive DysfunctionRecruiting

Septic ShockPreclinical

Active, not recruiting

General AnesthesiaPreclinical

Completed

Acute Postoperative PainPreclinical

Withdrawn

Thoracic SurgeryPreclinical

Completed

DeliriumPhase 3

Unknown status

DexmedetomidinePhase 3

Unknown status

Post Operative Cognitive DysfunctionPhase 3

Recruiting

Competition

Competitive Landscape

78 competitors in Delirium

#DrugCompanyPhaseTrials

Precedex

MMcNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Approved

58 2

Exelon

Novartis

Approved

6 3

Rozerem

Takeda

Approved

6 4

Seroquel

EEngelhard Arzneimittel GmbH & Co.KG

Approved

10 5

Aleve

Jazz Pharmaceuticals

Approved

1 6

Voltaren

Novartis

Approved

1 7

Duragesic

CCephalon

Approved

7 8

Anerem

AAcacia Pharma Ltd

Approved

5 9

Spravato

WWim Janssens

Approved

4 10

Belsomra

CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Approved

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Post-ApprovalRecruiting

Dexmedetomidine

NCT05793060

Post-ApprovalNot yet recruiting

Sedation

NCT07298525

Clinical

Trials by Indication[1]

Dexmedetomidine8 trials

Dexmedetomidine and Ketamine in VATS Surgery

Recruiting·CCiusss de L'Est de l'Île de Montréal·N/A·NCT03596424·120 enrolled

Dexmedetomidine Versus Dexamethasone as Adjuvants to Bupivacaine for Intermediate Cervical Plexus Block

Recruiting·—·Phase 4·NCT05793060·60 enrolled

Intranasal Dexmedetomidine for Sedated Hearing Testing

Completed·FFondation Lenval·Phase 3·NCT03530371·60 enrolled

Show 5 more trials

Efficacy of Dexmedetomidine vs Midazolam for Early Extubation in Critically Ill Agitated Patients Undergoing Weaning

Not yet recruiting·SSheikh Zayed Medical College·Phase 1·NCT05264077·66 enrolled

A Comparative Study to Measure the Effect of Nebulized Dexmedetomidine

Unknown status·KKasr El Aini Hospital·Phase 3·NCT05158348·60 enrolled

Dexmedetomidine an Effective Drug in Reducing Anesthetic Requirements in External Dacrocystorhinostomy (DCR) Patients

Recruiting·RResearch Institute of Ophthalmology, Egypt·Phase 1·NCT06808295·24 enrolled

Immunomodulatory Effect of Dexmedetomidine as an Adjuvant Drug in Laparoscopic Cholecystectomies

Unknown status·UUniversidade Federal do Rio de Janeiro·Phase 3·NCT05489900·52 enrolled

Pharmacokinetics-pharmacodynamics and Safety of Dexmedetomidine in Children

Completed·SSeoul National University Hospital·Phase 2·NCT04027829·13 enrolled

Sedation7 trials

Sedation Efficacy and Safety of Remazolam Besylate in Ventilated Surgical Critically Ill Patients

Recruiting·—·Phase 4·NCT06575530·306 enrolled

Intranasal Sedation With Dexmedetomidine and Ketamine in Pediatric Dentistry (NASO II)

Completed·UUniversidade Federal de Goias·Phase 4·NCT03290625·12 enrolled

Safety Exploration and Evaluation of Dexmedetomidine Hydrochloride Nasal Spray for Pre-anesthesia Sedation in Low-Monitoring Settings

Not yet recruiting·SSichuan Provincial People's Hospital·Phase 4·NCT07298525·564 enrolled

Show 4 more trials

A Trial of Dexmedetomidine Hydrochloride Nasal Spray in Preoperative Sedation of Children

Completed· Shanghai Hengrui Pharmaceutical Co., Ltd. logo

Shanghai Hengrui Pharmaceutical Co., Ltd.·Phase 3·NCT05111431·159 enrolled

A Trial of Dexmedetomidine Hydrochloride Nasal Spray in Preoperative Sedation of Children

Completed·JJiangsu HengRui Medicine Co., Ltd.·Phase 1·NCT04200235·48 enrolled

Sedation for Non-invasive Ventilation in Blunt Chest Trauma

Completed·—·N/A·NCT05175781·45 enrolled

Clinical Study to Investigate the Efficacy and the Safety of DA-9501 in Sedation During the Surgery With Epidural Anesthesia or Spinal Anesthesia Without Intubation

Completed· Pfizer logo

Pfizer·Phase 3·NCT01438957·119 enrolled

Delirium3 trials

Dexmedetomidine Versus Morphine and Midazolam in Prevention and Treatment of Delirium After Adult Cardiac Surgery

Completed·—·Phase 4·NCT03078946·60 enrolled

Effects of Dexmedetomidine in Patients With Agitated Delirium in Palliative Care

Recruiting·—·Phase 1/2·NCT04824144·50 enrolled

Intravenous Dexmedetomidine for Emergence Delirium in Pediatric Patient

Unknown status·SSecurity Forces Hospital·Phase 4·NCT05813106·60 enrolled

General Anesthesia2 trials

Dexmedetomidine and Neuroprotection in Children Undergoing General Anesthesia

Completed·SSeoul National University Hospital·N/A·NCT03234660·60 enrolled

the Effect of Opioid-free General Anesthesia

Completed·TThe Catholic University of Korea·N/A·NCT04409964·78 enrolled

Children1 trial

A Study to Learn About the Study Medicine - Precedex in Children From Japan.

Completed· Pfizer logo

Pfizer··NCT06085573·111 enrolled

23 more indications

Amnesia1 trial

Effect of Affective Content on Drug Induced Amnesia of Episodic Memory

Completed·MMemorial Sloan Kettering Cancer Center·Phase 1·NCT00142493·79 enrolled

Interscalene Block1 trial

Dexmedetomidine Versus Dexamethasone With Levobupivacaine in Interscalene Block

Completed·MMenoufia University·Phase 4·NCT03940469·60 enrolled

Inguinal hernia1 trial

Dexmedetomidine to Levobupivacaine for Transversus Abdominis Plane Block in Elderly Patients Undergoing Inguinal Hernia Repair Surgery

Completed·—·Phase 2/3·NCT04971759·90 enrolled

Schizophrenia1 trial

BXCL501 for Agitation in Schizophrenia

Completed·YYale University·Phase 1·NCT03708315·11 enrolled

Pediatric Patients1 trial

Precedex Special Investigation (in Pediatric Patients)

Completed· Pfizer logo

Pfizer··NCT04040439·111 enrolled

Spinal Anesthesia1 trial

Intravenous Dexmeditomidine for Prevention of Spinal Anesthesia Induced Shivering.

Unknown status·RRehman Medical Institute - RMI·Phase 4·NCT05342376·80 enrolled

Thoracic Surgery1 trial

Dexmedetomidine Infusion and Postoperative Lung Aeration After Thoracic Surgery

Completed·—·N/A·NCT06502002·100 enrolled

Deep Brain Stimulation1 trial

Dexmedetomidine Effects on Microelectrode Recording in Deep Brain Stimulation

Withdrawn·VVanderbilt University·Phase 2/3·NCT00608231

Laparoscopic Sleeve Gastrectomy1 trial

Opioid Free vs Opioid Based Anesthesia for Laparoscopic Sleeve Gastrectomy

Completed·MMedical University of Warsaw·Phase 4·NCT04260659·59 enrolled

Encephalopathy1 trial

Dexmedetomidine Use in Infants Undergoing Cooling Due to Neonatal Encephalopathy (DICE Trial)

Completed·UUniversity of Utah·Phase 2·NCT04772222·50 enrolled

Cough Suppression1 trial

Efficacy of Dexmedetomidine for Cough Suppression in Patients Undergoing Thyroid Surgery

Unknown status·MMin Su·Phase 4·NCT03312413·400 enrolled

Acute Postoperative Pain1 trial

the Effect of Dexmedetomidine and Licodaine on Acute Postoperative Pain in Gynecological Laparoscopy

Withdrawn·TThe Catholic University of Korea·N/A·NCT04906889

Post Operative Cognitive Dysfunction1 trial

Dexmedetomidine on Postoperative Cognitive Dysfunction and Serum Tau-217 Protein.

Recruiting·MMinia University Hospital·Phase 4·NCT06366412·94 enrolled

Septic Shock1 trial

Effect of Dexmedetomidine vs Esmolol or Placebo on Cerebral Hemodynamics in Septic Shock

Completed·XXinchen Wang·N/A·NCT06169475·14 enrolled

Atrial Fibrillation1 trial

Controlling Rapid Atrial Fibrillation With Dexmedetomidine

Terminated·SStony Brook University·Phase 2/3·NCT04042727·13 enrolled

Intrathecal Dexmedetomidine1 trial

Effects of Intrathecal Dexmedetomidine as an Adjuvant to Low Dose Hyperbaric 0.5% Bupivacaine

Completed·SSindh Institute of Urology and Transplantation·Phase 4·NCT05993975·108 enrolled

Total Knee Arthroplasty1 trial

Single-shot Adductor Canal Block With Levobupivacaine and Dexmedetomidine in Total Knee Arthroplasty

Completed·—·Phase 2/3·NCT04968392·60 enrolled

Safety and Efficacy1 trial

Safety and Efficacy of Intravenous (IV) Dexmedetomidine During Flexible Bronchoscopy and Endobronchial Ultrasound

Withdrawn·LLahey Clinic·Phase 4·NCT00691886

Hip Fracture1 trial

How Different Sedatives Affect Hip Fracture Patient's Postoperative Delirium

Unknown status·SShanghai Zhongshan Hospital·Phase 4·NCT03346226·1,000 enrolled

Erector Spinae Block1 trial

Dexametomedine Versus Ketamine as an Adjuvant in Erector Spinae Block for Perioperative Thoracotomy Pain Control

Completed·KKasr El Aini Hospital·Phase 4·NCT05552391·90 enrolled

Intensive Care Unit1 trial

Study of DA-9501 In Pediatric Subjects In The Intensive Care Unit

Completed· Pfizer logo

Pfizer·Phase 3·NCT02757625·63 enrolled

Behavior Problem1 trial

Intranasal Dexmedetomidine Versus Oral Midazolam Premedication for Postoperative Negative Behavior Changes in Children: A Randomized Controlled Trial

Completed·FFujian Provincial Hospital·Approved·NCT06417125·324 enrolled

Unspecified1 trial

Role of Airway Topicalization in Awake Fiberoptic Intubation

Completed·ZZagazig University·Phase 3·NCT06720220·56 enrolled

Sources

References

[1]
ClinicalTrials.gov — 44 trial records for Dexmedetomidine Hydrochloride. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Dexmedetomidine Hydrochloride compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Dexmedetomidine Hydrochloride. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Pfizer company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Adrenergic Receptor Alpha-2 Agonist[2]
Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: Pfizer

Dexmedetomidine Hydrochloride

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Trials by Indication[1]

Dexmedetomidine8 trials

Sedation7 trials

Delirium3 trials

General Anesthesia2 trials

Children1 trial

Amnesia1 trial

Interscalene Block1 trial

Inguinal hernia1 trial

Schizophrenia1 trial

Pediatric Patients1 trial

Spinal Anesthesia1 trial

Thoracic Surgery1 trial

Deep Brain Stimulation1 trial

Laparoscopic Sleeve Gastrectomy1 trial

Encephalopathy1 trial

Cough Suppression1 trial

Acute Postoperative Pain1 trial

Post Operative Cognitive Dysfunction1 trial

Septic Shock1 trial

Atrial Fibrillation1 trial

Intrathecal Dexmedetomidine1 trial

Total Knee Arthroplasty1 trial

Safety and Efficacy1 trial

Hip Fracture1 trial

Erector Spinae Block1 trial

Intensive Care Unit1 trial

Behavior Problem1 trial

Unspecified1 trial

References

Drug Info

Quick Facts

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