Precedex

(Dexmedetomidine)

ApprovedSmall molecule

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

Dexmedetomidine is used to sedate patients who are on mechanical ventilation in intensive care units, and to provide sedation during medical procedures. It helps keep patients calm and reduces anxiety while allowing them to be easily awakened.[2] Precedex is currently approved and in use across 157 indications[4].[1]

Precedex is one of 2003 small molecule programs targeting Glioma. It is currently in Approved.

157

Indications

1,169

Total Trials

Active Trials

2,002

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

GliomaActive, not recruiting

Coronary Artery DiseaseActive, not recruiting

SleepApproved

ArrhythmiaActive, not recruiting

Cleft PalateApproved

Cervical SpondylosisActive, not recruiting

Response to StressApproved

Respiratory Distress Syndrome in Premature InfantsActive, not recruiting

MetastasisActive, not recruiting

Cardiac ArrhythmiaActive, not recruiting

GliomaPreclinical

Active, not recruiting

Coronary Artery DiseasePreclinical

Active, not recruiting

SleepApproved

Approved

ArrhythmiaPreclinical

Active, not recruiting

Cleft PalateApproved

Approved

Cervical SpondylosisPreclinical

Active, not recruiting

Response to StressApproved

Approved

Respiratory Distress Syndrome in Premature InfantsPreclinical

Active, not recruiting

MetastasisPreclinical

Active, not recruiting

Cardiac ArrhythmiaApproved

Active, not recruiting

Showing 10 of 145 indications

Competition

Competitive Landscape

2828 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Precedex

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

Approved

4 2

Halaven

Eisai

Preclinical

38 3

Trodelvy

Gilead

Preclinical

37 4

Avastin

Lexiscan

1 6

Voltaren

Novartis

Preclinical

1 7

Effexor

WWyeth-Lederle Vaccines

Preclinical

2 8

Avastin

Roche

Preclinical

4 9

Systemic Therapy

Bristol-Myers Squibb

Preclinical

1 10

Apatinib Mesylate

BBukwang Pharmaceutical

Preclinical

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

Timeline

Expected Milestones

Q4 2026

N/ANot yet recruiting

Total Intravenous Anesthesia

NCT07271459

Post-ApprovalNot yet recruiting

Dexmedetomidine

NCT07462195

N/AActive, not recruiting

Dexmedetomidine

NCT06639659

Phase 2/3Not yet recruiting

Agitation

NCT06620393

Phase 3Not yet recruiting

Functional Endoscopic Sinus Surgery

NCT07213037

Recruiting

Extracorporeal Membrane Oxygenation

NCT03593408

Clinical

Trials by Indication[1]

Dexmedetomidine52 trials

Articaine vs Dexmedetomidine Supplemented Articaine

Completed·—·Phase 1·NCT04171349·50 enrolled

The Effect of Dexmedetomidine on Kidney Perfusion in Paediatric Patients

Unknown status·MMai Madkour·Phase 2·NCT03425734·40 enrolled

Dexmedetomidine Effect on Mitochondrial Function

Unknown status·TThe Hospital for Sick Children·Phase 4·NCT02299063·36 enrolled

Show 49 more trials

Two-channel IV-PCA With Dexmedetomidine

Recruiting·KKorea University Guro Hospital·N/A·NCT05672225·110 enrolled

Dexmedetomidine Versus Nalbuphine as an Adjuvant to Intrathecal Bupivacaine

Completed·MMansoura University·N/A·NCT05347173·60 enrolled

Regional Nasal Block and Dexmedetomidine in Endoscopic Sinus Surgery

Unknown status·—·N/A·NCT05361642·70 enrolled

Tranexamic Acid Versus Dexmedetomidine for Improving Surgical Field Quality During Spine Surgeries

Completed·ZZagazig University·N/A·NCT06587620·78 enrolled

Dexmedetomidine Intra Venous Arthroplasty

Completed·CCMC Ambroise Paré·Phase 3·NCT03834129·94 enrolled

The Effects of Dexmedetomidine on cTnI and GP-BB in Patients Undergoing OPCABG

Unknown status·GGeneral Hospital of Ningxia Medical University·N/A·NCT03163693·40 enrolled

Dexmedetomidine Premedication in Hypertensive Patients

Completed·—·Phase 3·NCT02058485·162 enrolled

Effect of Dexmedetomidine After Thyroidectomy

Completed·—·N/A·NCT02412150·139 enrolled

Study of Dexmedetomidine in Spine Surgery

Completed·UUniversity of Virginia·Phase 4·NCT01850017·142 enrolled

Intraoperative Dexmedetomidine and Long-term Outcomes in Elderly After Major Surgery

Completed·PPeking University First Hospital·Phase 4·NCT04111926·619 enrolled

Effect of Dexmedetomidine on Postoperative Glucose and Insulin Levels.

Completed·PPontificia Universidad Catolica de Chile·Phase 4·NCT03809182·40 enrolled

Dexmedetomidine Versus Magnesium Sulphate in Patients Undergoing Craniotomy for Deeply Settled Intracranial Tumours

Unknown status·—·N/A·NCT05743725·150 enrolled

Dexamethasone vs Dexmedetomidine vs Combination as Adjuvants to Popliteal Sciatic Nerve Block in Children

Recruiting·PPoznan University of Medical Sciences·N/A·NCT07289620·120 enrolled

Dexmedetomidine-ketamine Combination Versus Fentanyl-midazolam During Bronchoscopy

Completed·UUniversity of Patras·Phase 3·NCT06185127·50 enrolled

Dexmedetomidine vs Fentanyl in Controlling Labor Pain

Completed·—·N/A·NCT06392321·90 enrolled

The Effects of Dexmedetomidine Dose on Motor Evoked Potentials

Terminated·HHospital for Special Surgery, New York·Phase 4·NCT03378973·7 enrolled

Pharmacodynamics and Pharmacokinetics of Dexmedetomidine in Pediatric

Unknown status·CChinese Medical Association·Phase 4·NCT03337581·187 enrolled

Effects of Dexmedetomidine on Modulation of Perioperative Blood Glucose and Related Hormones

Completed·ZZhuan Zhang·N/A·NCT03788538·75 enrolled

Polysomnographic Study Comparing the Use of Dexmedetomidine and Zolpidem to Induce Natural Sleep

Completed·MMassachusetts General Hospital·N/A·NCT01485393·10 enrolled

Dexmedetomidine for Improved Pain Relief and Recovery in Spine Surgery

Completed·MMenoufia University·N/A·NCT06685081·150 enrolled

Dexmedetomidine-Enhanced PCIA After Lobectomy in Nicotine-Dependent Patients

Completed·SShenyang Sixth People's Hospital·Phase 4·NCT07306702·102 enrolled

Dexmedetomidine as an Adjuvant for Sub-Tenon's Anesthesia

Completed·—·Phase 3·NCT02327156·60 enrolled

Effect of Intrathecal Morphine, Dexmedetomidine or Both in Combination to Bupivacaine on Immunity

Unknown status·—·Phase 1/2·NCT03024957·30 enrolled

PENG Block With Dexmedetomidine in Older Adults

Recruiting·PPoznan University of Medical Sciences·N/A·NCT07327372·30 enrolled

Dexmedetomidine, Ketamine and Dexmetedomidine-Ketamine Combination for Control of Shivering During Regional Anaethesia

Completed·—·Phase 4·NCT03302351·94 enrolled

The Effect of Dexmedetomidine for Emergence Cough

Completed·—·N/A·NCT03622502·48 enrolled

Dexmedetomidine Versus Ketamine Versus Midazolam in Endoscopic Procedures

Completed·NNational Cancer Institute, Egypt·N/A·NCT04597268·75 enrolled

Dexmedetomidine Versus Dexmedetomidine and Ketamine (Ketodex) in Ear and Nose Surgeries

Recruiting·SSohag University·N/A·NCT06981494·84 enrolled

Dexmedetomidine Facilitate Analgesia

Completed·CChina International Neuroscience Institution·Phase 4·NCT04675372·181 enrolled

Dexmedetomidine for LISA Procedure in Preterm Infants

Unknown status·UUniversity of Padova·N/A·NCT04820101·40 enrolled

Dexmedetomidine vs Propofol on the Recordings of Deep Brain Activity Measured Through Implanted Stimulators

Completed·—·Phase 4·NCT02256319·12 enrolled

Suprainguinal Fascia Iliaca Block With vs Without Dexmedetomidine

Recruiting·RRhode Island Hospital·Phase 4·NCT07316166·120 enrolled

Dexmedetomidine Premedication in Children

Completed·—·Phase 4·NCT03174678·100 enrolled

Dexmedetomidine Ropivacaine Versus Plain Ropivacaine in Bilateral Pectoralis Nerve (PECS) Block

Recruiting·FFayoum University·Phase 4·NCT06636578·90 enrolled

Dexmedetomidine-propofol-remifentanil Anaesthesia and Reactivity to Noxious Stimuli

Completed·AArvi Yli-Hankala·Phase 4·NCT01076790·44 enrolled

Dexmedetomidine as an Adjuvant to Bupivacaine in Bilateral PECs for Pain Control After Cardiac Surgeries

Completed·KKasr El Aini Hospital·Phase 4·NCT06453681·60 enrolled

Dose Response Study of Dexmedetomidine in Orthopaedic Spine Surgery Patients

Completed·TTurku University Hospital·Phase 4·NCT02454881·107 enrolled

Comparison of Pain Using CPOT Score With Ketamine vs. Dexmedetomidine in Post-Craniotomy ICU Patients

Completed·UUniversitas Sumatera Utara·N/A·NCT07254936·38 enrolled

Dexmedetomidine for Improving Emergence Quality in Thyroid Surgery

Not yet recruiting·—·Phase 4·NCT07462195·100 enrolled

Intranasal Dexmedetomidine vs Intranasal Midazolam as Anxiolysis Prior to Pediatric Laceration Repair

Completed·UUniversity of Pittsburgh·Phase 4·NCT02168439·40 enrolled

Dexmedetomidine Adjuvant in Retinal Surgery

Unknown status·KKing Saud University·Phase 3·NCT02282787·90 enrolled

Dexmedetomidine and Remifentanil in NORA

Completed·—·Phase 4·NCT06403670·76 enrolled

The Bolus Dose of Dexmedetomidine (ED50) That Avoids Hemodynamic Compromise in Children

Completed·UUniversity of British Columbia·N/A·NCT01498380·21 enrolled

Sphenopalatine Block vs Dexmedetomidine Infusion in Trans Nasal Endoscopic Pituitary Surgery

Active, not recruiting·ZZagazig University·N/A·NCT06639659·69 enrolled

Perioperative Dexmedetomidine and Long-term Survival After Cancer Surgery

Recruiting·PPeking University First Hospital·N/A·NCT06030804·4,532 enrolled

Dexmedetomidine Infusion During Laparoscopic Adrenalectomy

Completed·YYonsei University·N/A·NCT06037135·40 enrolled

Antitussive Effect of Single-dose Dexmedetomidine With Low-dose Remifentanil Infusion

Completed·YYonsei University·Phase 4·NCT02208505·168 enrolled

Intranasal Dexmedetomidine Dose-finding Study

Completed·LLondon Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's·Phase 2·NCT03957304·55 enrolled

Intra-nasal Dexmedetomidine for Children Undergoing MRI Imaging

Unknown status·UUniversity of British Columbia·Phase 4·NCT03806777·180 enrolled

Sedation25 trials

The Synergistic Effect of Dexmedetomidine on Propofol for Sedation for Pediatric Endoscopy

Completed·KKeira Mason·Phase 4·NCT02952222·39 enrolled

Sedation With Dexmedetomidine During Cardiac Catheterization

Terminated·AAruna Nathan·Phase 2/3·NCT01072643·4 enrolled

A Comparison of Sedative Drugs for Conscious Sedation During Ultrasound Guided Transbronchial Needle Aspiration

Completed·SSeoul National University Hospital·N/A·NCT02157818·110 enrolled

Show 22 more trials

Sedation With Remimazolam During Spinal Anesthesia

Completed·GGangnam Severance Hospital·N/A·NCT05305248·62 enrolled

Dexmedetomidine vs. Remifentanil Conscious Sedation for Stapedotomy/Stapedectomy

Completed·IIuliu Hatieganu University of Medicine and Pharmacy·N/A·NCT06283836·74 enrolled

Sedation of Mechanically Ventilated Critically Ill Patients: Midazolam Versus Dexmedetomidine

Unknown status·HHospital Sao Domingos·Phase 4·NCT01256866·146 enrolled

Comparison of Two Sedation Regimens for Awake Fiberoptic Intubation

Recruiting·UUniversity of Illinois at Chicago··NCT05736198·96 enrolled

Dexmedetomidine Versus Ketofol for Moderate Sedation in Endoscopic Retrograde Cholangiopancreatography

Completed·SSindh Institute of Urology and Transplantation·Phase 4·NCT06212401·62 enrolled

Dexmedetomidine-Esketamine Combination for Sedation and Analgesia in ICU Patients

Not yet recruiting·PPeking University First Hospital·N/A·NCT06468436·1,508 enrolled

The Use of Ketamine and Dexmedetomidine in Intensive Care Sedation

Unknown status·LLebanese American University Medical Center·Phase 3·NCT04096768·394 enrolled

Dexmedetomidine Use in ICU Sedation and Postoperative Recovery in Elderly Patients and Post-cardiac Surgery

Unknown status·UUniversity of British Columbia·N/A·NCT02699801·70 enrolled

IN Dexmedetomidine for Procedural Sedation in Pediatric Closed Reductions for Distal Forearm Fractures

Withdrawn·PPhoenix Children's Hospital·Phase 1·NCT03466242

The Use of Dexmedetomidine for EEG Sedation in Children With Behavioural Disorders

Completed·AAzienda Ospedaliera di Padova·Phase 2·NCT03799783·19 enrolled

Safety and Efficacy of Dexmedetomidine (DEX) for Sedation of Subjects ≥1 Month to <17 Years Undergoing MRI Scans

Completed· Pfizer logo

Pfizer·Phase 4·NCT04237792·128 enrolled

Propofol Versus Dexmedetomidine for Sedation of Cancer Patients Undergoing ERCP

Completed·NNational Cancer Institute, Egypt·N/A·NCT06409104·202 enrolled

Sedation by Dexmedetomidine and Propofol

Completed·SSeoul National University Bundang Hospital·N/A·NCT02993718·52 enrolled

Correlation of Narcotrend Index and the Observer's Assessment of Alertness/Sedation (OAA/S) Scale

Unknown status·GGuangzhou General Hospital of Guangzhou Military Command·Phase 4·NCT02845661·60 enrolled

Determination of ED50 and ED95 With Clinical Efficacy of Intranasal Dexmedetomidine Combined With Esketamine for Preoperative Sedation in Pediatric General Anesthesia

Recruiting·SSecond Affiliated Hospital of Wenzhou Medical University·Phase 4·NCT06853431·80 enrolled

Propofol and Dexmedetomidine Versus a Propofol Only Regimen for Sedation During Colonoscopy

Completed·SState University of New York - Downstate Medical Center·Phase 4·NCT03139279·122 enrolled

Closed Loop Acoustic Stimulation During Sedation With Dexmedetomidine

Active, not recruiting·WWashington University School of Medicine·N/A·NCT04206059·20 enrolled

Dexmedetomidine Compared to Ketofol for Sedation in Paediatrics

Completed·—·Phase 1·NCT04678050·40 enrolled

The Deep Sedation for Ablation Study

Completed·IInsel Gruppe AG, University Hospital Bern·Phase 4·NCT03844841·160 enrolled

Sedation in Patients at Risk for Upper Airway Collapse

Completed·UUniversity of Rochester·N/A·NCT01045122·15 enrolled

Dexmedetomidine Use for Sedation in Patients Submitted to Tracheal Surgery

Completed·UUniversity of Roma La Sapienza··NCT03723538·14 enrolled

Bispectral Index(BIS) on Depth of Sedation With Dexmedetomidine, Propofol and Midazolam During Spinal Anesthesia

Unknown status·HHallym University Medical Center·N/A·NCT03399019·45 enrolled

Delirium10 trials

Different Administration Routes of Dexmedetomidine on Postoperative Delirium

Unknown status·—·N/A·NCT05952050·120 enrolled

Effects of Dexmedetomidine on Delirium Duration of Non-intubated ICU Patients (4D Trial)

Completed·UUniversity Hospital, Clermont-Ferrand·Phase 3·NCT03317067·151 enrolled

Low-dose Dexmedetomidine and Postoperative Delirium After Cardiac Surgery

Active, not recruiting·DDong-Xin Wang·N/A·NCT03624595·502 enrolled

Show 7 more trials

MENDS Study: Trial in Ventilated ICU Patients Comparing an Alpha2 Agonist Versus a Gamma Aminobutyric Acid (GABA)-Agonist to Determine Delirium Rates, Efficacy of Sedation, Analgesia and Discharge Cognitive Status

Completed·VVanderbilt University·Phase 2·NCT00095251·100 enrolled

Dexmedetomidine for Prevention of Postoperative Delirium After Intracranial Operation for Brain Tumor

Unknown status·—·Phase 4·NCT04399343·700 enrolled

Dexmedetomidine Alleviates Postoperative Delirium After Brain Tumor Resections

Completed·—·N/A·NCT04674241·260 enrolled

Comparison of Dexmedetomidine and Propofol on the Delirium and Neuroinflammation in Patients With SIRS.

Withdrawn·MMoscow Regional Research and Clinical Institute (MONIKI)·Phase 4·NCT02366299

Effect of Dexmedetomidine on Postoperative Delirium Inflammasome Activation Inhibition

Unknown status·YYonsei University·N/A·NCT03588988·100 enrolled

Brain Tumor Surgery and Postoperative Delirium

Not yet recruiting·KKaohsiung Medical University Chung-Ho Memorial Hospital·N/A·NCT06863064·140 enrolled

Intraoperative Sedation and Postoperative Delirium

Completed·SSeoul National University Bundang Hospital··NCT02573558·855 enrolled

Agitation9 trials

Emergence Agitation Between Dexmedetomidine and Sevoflurane Anesthesia

Completed·—·N/A·NCT06482125·121 enrolled

The Effect of Dexmedetomidine on Emergence Agitation in Children Undergoing a Surgery Under Desflurane Anesthesia

Unknown status·SSeoul National University Hospital·Phase 4·NCT01578161·116 enrolled

Dexmedetomidine as a Rapid Bolus in Children for Emergence Agitation

Completed·PPeter Davis·Phase 3·NCT01528891·418 enrolled

Show 6 more trials

Dexmedetomidine in Reducing Incidence of Emergence Agitation After Nasal Surgery

Completed·SSecurity Forces Hospital·Phase 3·NCT05634148·42 enrolled

Effects of Dexmedetomidine on Agitation in Critically Ill TBI Patients

Not yet recruiting·CCentre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal·Phase 2/3·NCT06620393·72 enrolled

Transbucal Dexmedetomidine for Prevention of Sevoflurane Emergence Agitation in Pre-school Children

Completed·—·Phase 2/3·NCT02720705·90 enrolled

Evaluation of the Postoperative Agitation Prevention and Analgesic Efficacy of Perioperative Dexmedetomidine Infusion in a Pediatric Patient Group to Undergo Tonsillectomy and Adenoidectomy

Completed·BBurak Omur··NCT05986942·80 enrolled

Efficacy of Intraoperative Magnesium Sulphate vs Dexmedetomidine on Emergence Agitation in Pediatric Patients

Completed·—·N/A·NCT06977425·60 enrolled

ED50 of Dexmedetomidine to Prevent Emergence Agitation in Children

Unknown status·SSeoul National University Hospital·Phase 4·NCT01374737·25 enrolled

General Anesthesia4 trials

Cardiac Index and General Anesthesia Without Opioid.

Completed·—·Phase 2/3·NCT05446623·120 enrolled

The Effect of Orexin on Delayed Emergence of General Anesthesia in Dexmedetomidine

Completed·GGeneral Hospital of Ningxia Medical University·N/A·NCT03025295·51 enrolled

Small-dose Dexmedetomidine Effects on Recovery Profiles of Supratentorial Tumors Patients From General Anesthesia

Unknown status·—·N/A·NCT02007798·150 enrolled

Show 1 more trial

Dexmedetomidine Different Doses as Adjuvant to Entropy-assisted General Anesthesia During Functional Endoscopy Sinus Surgery.

Completed·—·N/A·NCT05226325·99 enrolled

82 more indications

Nausea and vomiting3 trials

Effects of a Dexmedetomidine on Quality of Recovery 40 and Postoperative Nausea and Vomiting in Breast Cancer Surgery

Completed·YYonsei University·N/A·NCT01548209·97 enrolled

Dexmedetomidine or Dexmedetomidine Combined With Dexamethasone on Postoperative Nausea and Vomiting in Breast Cancer

Completed·GGachon University Gil Medical Center·N/A·NCT02550795·150 enrolled

Effect of Dexmedetomidine on Prevention of Postoperative Nausea and Vomiting in Children

Completed·TTanta University·Phase 1·NCT05124067·4 enrolled

Safety and Efficacy3 trials

Long-term Clinical Study Evaluating the Safety and Efficacy of Dexmedetomidine in ICU Subjects

Completed· Pfizer logo

Pfizer·Phase 3·NCT00526760·80 enrolled

a Phase III Trial of Safety and Efficacy of Premedication With Dexmedetomidine and Midazolam in Pediatric Patients

Unknown status·KKing Faisal Specialist Hospital & Research Center·Phase 3·NCT04356638·80 enrolled

Safety and Efficacy of Intranasal Dexmedetomidine

Unknown status·UUnknown Sponsor·Phase 4·NCT02985697·100 enrolled

Hemodynamic Response3 trials

Comparision Between Hemodynamic Response of Dexmedetomidine and Remifentanil on Anesthesia in Endoscopic Sinus Surgery

Unknown status·KKorea University Anam Hospital·Phase 4·NCT02464722·50 enrolled

Oral Melatonin VS Nebulized Dexmedetomidine Premedication on Attenuation of Hemodynamic Response to Direct Laryngoscopy and Tracheal Intubation in Hypertensive Patients

Not yet recruiting·TTanta University·Phase 2/3·NCT06935292·70 enrolled

Comparison of Dexmedetomidin and Remifentanil for the Effect on Airway Reflex and Hemodynamic Response During Emergence in Patients Undergoing Craniotomy

Completed·YYonsei University·Phase 4·NCT01365923·74 enrolled

Post Operative Pain3 trials

A Comparison of Remifentanil and Dexmedetomidine for Craniotomy Perioperative Hemodynamics and Postoperative Pain

Completed·TThe Cleveland Clinic·N/A·NCT01269918·142 enrolled

Low Dose Dexmedetomidine as a Postoperative Pain Adjunct

Enrolling by invitation·NNichole Doyle·Phase 4·NCT06067893·160 enrolled

Dexmedetomidine for the Control of Post-Operative Pain in Thoracotomy Patients

Completed·—·Phase 1/2·NCT00345384·38 enrolled

Cesarean Section2 trials

Intravenous Dexmedetomidine for Treatment of Shivering During Cesarean Section Under Neuraxial Anesthesia

Completed·SSt. Justine's Hospital·Phase 3·NCT02384343·80 enrolled

Comparative Study of Fentanyl vs Dexmedetomidine as Adjuvants to Intrathecal Bupivacaine in Cesarean Section

Completed·SSohag University·N/A·NCT06785285·60 enrolled

Local Anesthetic2 trials

Comparative Study Between Dexmedetomidine & Neostigmine as an Adjuvant to Local Anesthetic Mixture in Peribulbar Block in Vitreoretinal Surgeries

Completed·—·Phase 1·NCT06501352·81 enrolled

Ketamine Versus Dexmedetomidine With Local Anesthetic in TAP Block

Completed·—·Phase 2/3·NCT03060070·90 enrolled

Spinal Anesthesia2 trials

Comparision of Different Doses of Dexmedetomidine With Low Dose Bupivacaine in Selective Spinal Anesthesia.

Unknown status·SServices Institute of Medical Sciences, Pakistan·Phase 4·NCT04037774·75 enrolled

Prevention of Shivering Associated With Spinal Anesthesia

Unknown status·—·Phase 2/3·NCT06082076·90 enrolled

Alcohol Withdrawal2 trials

Dexmedetomidine Addition to Benzodiazepines for Patients With Alcohol Withdrawal State in the ICU

Completed·—·Phase 4·NCT02496650·70 enrolled

Ketamine vs. Placebo as Adjunctive Therapies for Severe Alcohol Withdrawal

Withdrawn·UUniversity of Colorado, Denver·Phase 4·NCT02823977

Intrathecal Dexmedetomidine2 trials

Intrathecal Dexmedetomidine Versus Fentanyl With Bupivacaine in Children Undergoing Major Abdominal Cancer Surgery

Unknown status·SSouth Egypt Cancer Institute·Phase 2·NCT02861716·60 enrolled

Intrathecal Dexmedetomidine vs Midazolame

Completed·NNational Cancer Institute, Egypt·Phase 4·NCT06315634·75 enrolled

Coronary Artery Bypass2 trials

Comparison of Dexmedetomidine and Meperidine for the Prevention of Shivering Following Coronary Artery Bypass Graft

Unknown status·QQianfoshan Hospital·Phase 4·NCT04735965·180 enrolled

Intraoperative Dexmedetomidine and Coronary Artery Bypass Graft Surgery

Recruiting·UUniversity of Novi Sad·Phase 2/3·NCT06378827·100 enrolled

Pediatric Patients2 trials

A Pilot Study: a Non-opioid Technique for Postoperative Adenoidectomy Pain Relief in Pediatric Patients

Completed·AArlyne Thung·Phase 2·NCT03714919·10 enrolled

Combination With Intranasal Dexmedetomidine and Oral Midazolam for Premedication in Pediatric Patients

Unknown status·SSecond Affiliated Hospital of Wenzhou Medical University·Phase 4·NCT04135014·138 enrolled

Intensive Care Unit2 trials

Dexmedetomidine Versus Propofol in the Medical Intensive Care Unit (MICU)

Terminated·UUniversity of Chicago·Phase 4·NCT01059929·41 enrolled

Prospective, Randomized, Open Label Controlled Trial To Evaluate The Safety And Efficacy Of Dexmedetomidine Use Beyond 24 Hours Compared With Midazolam In Children Admitted To Pediatric Intensive Care Unit at King Abdullah Specialist Children Hospital- Ministry of National Guard Health Affairs.

Unknown status·KKing Abdullah International Medical Research Center·Phase 3·NCT05485519·430 enrolled

Functional Endoscopic Sinus Surgery2 trials

Lidocaine and Dexmedetomidine Infusions for Intraoperative Bleeding in Functional Endoscopic Sinus Surgery

Recruiting·—·N/A·NCT06848764·40 enrolled

Magnesium Sulfate Versus Lidocaine as Additives to Dexmedetomidine for Cough Suppression After Functional Endoscopic Sinus Surgery

Not yet recruiting·—·Phase 3·NCT07213037·102 enrolled

Cataract2 trials

Controlled Sedation for Cataract Surgery

Terminated·FFundación Universitaria de Ciencias de la Salud·Phase 4·NCT03401606·98 enrolled

Conscious Sedation for Cataract Operations Under Topical Anaesthesia

Completed·MMenoufia University·Phase 2·NCT03933280·100 enrolled

Post-Traumatic Stress Disorder1 trial

Intraoperative Subanesthetic Ketamine Versus Dexmedetomidine Infusion for Prevention of Post-traumatic Stress Disorder After Traumatic Brain Surgeries

Enrolling by invitation·ZZagazig University·N/A·NCT06498700·52 enrolled

Erector Spinae Plane Block1 trial

Dexmedetomidine Versus Fentanyl As Adjuvants to Erector Spinae Plane Block for Postoperative Analgesia Following Simple Nephrectomy: a Randomized Clinical Trial

Not yet recruiting·—·Phase 2/3·NCT06799442·46 enrolled

Phase II1 trial

Phase II Pharmacokinetic and Pharmacodynamic Study of DEX in Subjects Aged 12 Months Through <24 Months

Completed· Pfizer logo

Pfizer·Phase 2·NCT01378988·5 enrolled

Osteoarthritis1 trial

Effect of Intraarticular Ozone, Prolotherapy or Dexmedetomidine in Pain Limitation in Knee Osteoarthritis

Completed·TTanta University·N/A·NCT06909305·60 enrolled

Chronic Knee Pain1 trial

Intra-Articular Dexmedetomidine: A Treatment for Chronic Knee Pain

Recruiting·TTanta University·N/A·NCT06641206·70 enrolled

Cognitive Functions1 trial

Cognitive Functions After TIVA With Dexmedetomidine

Completed·UUludag University·Phase 4·NCT02631135·40 enrolled

Gastric Cancer1 trial

The Addition of Dexmedetomidine on Postoperative Sleep for Middle-aged and Elderly Patients With Gastric Cancer

Unknown status·NNanjing PLA General Hospital·Phase 3·NCT03117023·50 enrolled

Gastrointestinal1 trial

Effect of Dexmedetomidine of Gastrointestinal Motility

Completed·—·Phase 4·NCT04798482·22 enrolled

Arrhythmia1 trial

Effect of Sedative Agent on Reducing the Frequency of Arrhythmia in the Patients After Cardiac Surgery

Completed·AAnesthesia Research Group UA·N/A·NCT05450497·356 enrolled

Injury1 trial

Effects of Dexmedetomidine on the Liver Injury After Hepatectomy

Completed·—·Phase 4·NCT02833688·70 enrolled

Autism1 trial

Intranasal Dexmedetomidine vs Oral Triclofos Sodium for EEG in Children With Autism

Unknown status·RRabin Medical Center·Phase 4·NCT04270708·200 enrolled

Breast Cancer1 trial

Efficacy and Safety of Dexmedetomidine Added to Modified Pectoral's Block in Breast Cancer Patients

Unknown status·SSouth Egypt Cancer Institute·Phase 3·NCT03046238·60 enrolled

Premedication1 trial

Intranasal Remimazolam for Premedication in Pediatric Patient

Completed·SSecond Affiliated Hospital of Wenzhou Medical University·Phase 4·NCT04720963·90 enrolled

Nephrectomy1 trial

Comparison Between Different Anaesthesia Techniques Protecting Renal Function in Children Undergoing Radicle Nephrectomy

Completed·—·Phase 2/3·NCT05271253·75 enrolled

Transurethral Resection1 trial

The Effects of Intravenous Dexmedetomidine on Spinal Anesthesia Using Low Dose Diluted Bupivacaine for Transurethral Resection of Prostate

Completed·YYonsei University·N/A·NCT01224470·51 enrolled

Surgical Field1 trial

Can Head Position Improve Surgical Field During Ear Surgery?

Completed·—·N/A·NCT04095754·225 enrolled

Intraoperative1 trial

Intraoperative Sedatives and Postoperative Deilirium

Completed·SSeoul National University Bundang Hospital·N/A·NCT03251651·748 enrolled

Postoperative Pain Control1 trial

Intrathecal Morphine Versus Morphine-dexmedetomidine Combination for Postoperative Pain Control After Total Knee Replacement

Completed·TTanta University·N/A·NCT05439564·105 enrolled

Hydrocephalus1 trial

Isoflurane-induced Neuroinflammation in Children With Hydrocephalus

Terminated·NNationwide Children's Hospital·Phase 3·NCT02512809·25 enrolled

Critically Ill Patients1 trial

Dexmedetomidine vs Midazolam on Resting Energy Expenditure in Critically Ill Patients

Completed·—·Phase 4·NCT03030911·30 enrolled

Congenital Heart Disease1 trial

Pharmacokinetic Study of Intranasal Dexmedetomidine in Pediatric Patients With Congenital Heart Disease

Terminated·—·Phase 1·NCT03417999·28 enrolled

Total Knee Arthroplasty1 trial

Dexmedetomidine as an Adjuvant for Femoral Nerve Block and Functional Recovery After Total Knee Arthroplasty

Completed·PPeking University First Hospital·Phase 4·NCT04642651·170 enrolled

Thoracoscopic Surgery1 trial

Dexmedetomidine in Thoracoscopic Surgery: Opioid-Sparing Strategy

Completed·KKaohsiung Veterans General Hospital.·N/A·NCT05431322·73 enrolled

Opioid1 trial

DOSE Trial of Opioid Sparing Effect

Terminated·—·Phase 1·NCT03938857·30 enrolled

Post Spinal Anesthesia Shivering1 trial

Dexmedetomidine in Post Spinal Anesthesia Shivering

Completed·—·Phase 2·NCT02382432·120 enrolled

Inguinal hernia1 trial

Comparing the Synergistic Effect of Caudal Dexmedetomidine and Propofol Versus Caudal Dexmedetomidine Only or Propofol Only in Prevention of Sevoflurane Related Emergence Agitation in Pediatric Patients Undergoing Congenital Inguinal Hernia Repair

Not yet recruiting·—·Phase 4·NCT06734195·90 enrolled

Regional Anesthesia1 trial

Median Effective Dose of Dexmedetomidine in Elective Upper Limb Lidocaine Intravenous Regional Anesthesia

Completed·SSouth Valley University·Phase 4·NCT04304157·81 enrolled

Completed·PPeking University First Hospital·N/A·NCT03436472·700 enrolled

Open Heart Surgery1 trial

Understanding Dexmedetomidine in Neonates After Open Heart Surgery

Completed·AAthena Zuppa·Phase 1·NCT00576381·30 enrolled

Total Intravenous Anesthesia1 trial

Effect of Total Intravenous Anesthesia vs Inhalational Anesthesia on the Level of Inflammatory Markers

Not yet recruiting·—·N/A·NCT07271459·40 enrolled

Acute Kidney Injury1 trial

The Effect of Dexmedetomidine on Prevention of Postoperative Acute Kidney Injury in Patients Undergoing Aortic Surgery

Completed·YYonsei University·N/A·NCT02607163·108 enrolled

Ischemia1 trial

Effect of Dexmedetomidine on Ischemia-Reperfusion Injury in Lower Extremity Operations

Completed·YYonsei University·N/A·NCT02648958·68 enrolled

Hypospadias1 trial

Comparison of Caudal Block Versus Dexmedetomidine Infusion in Pediatric Patients Undergoing Hypospadias Repair Surgery

Completed·TTanta University·N/A·NCT04331418·135 enrolled

Mechanically Ventilated Patients1 trial

Midazolam Used Alone or Sequential Use of Midazolam and Propofol/Dexmedetomidine in Mechanically Ventilated Patients

Unknown status·WWest China Hospital·Phase 4·NCT02528513·240 enrolled

Aesthetic1 trial

A Study to Compare the Long-term Outcomes After Two Different Anaesthetics

Active, not recruiting·MMurdoch Childrens Research Institute·Phase 3·NCT03089905·450 enrolled

Bipolar Disorder1 trial

Evaluating Sublingual Dexmedetomidine For Moderate To Severe Agitation In Inpatients With Schizophrenia Or Bipolar Disorder

Unknown status·TTemple University·Phase 4·NCT06093451·32 enrolled

General Anaesthesia1 trial

Dexmetomidine in Children Undergoing General Anaesthesia

Completed·—·N/A·NCT03923075·60 enrolled

Bariatric Surgery1 trial

Ketamine Infusion vs Dexmedetomidine Infusion in Obese Patients Undergoing Bariatric Surgery

Unknown status·—·Phase 3·NCT04576975·90 enrolled

Knee Arthroscopic Surgery1 trial

Dexmedetomidine and Bupivacaine Intra-articular for Postoperative Analgesia After Knee Arthroscopic Surgery

Recruiting·—·Phase 3·NCT06665438·75 enrolled

Multimodal Analgesia1 trial

Perioperative Multimodal Analgesia for Supratentorial Craniotomy

Not yet recruiting·—·N/A·NCT07441421·2,000 enrolled

Mechanical Ventilation1 trial

The Diversity of Intestinal Microbiota in Patients With Different Sedative-hypnotics Undergoing Mechanical Ventilation

Withdrawn·SShanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University·N/A·NCT03401736

Post Operative Cognitive Dysfunction1 trial

Effects of Dexmedetomidine on Postoperative Cognitive Dysfunction During One-lung Ventilation in Elder Patients

Unknown status·TTang-Du Hospital·Phase 4·NCT02134093·120 enrolled

Midazolam1 trial

Comparison Between Dexmeditomidine, Midazolam and Ketamine as a Sedative to Help Cannula Insertion in Pediatric Patient

Completed·—·Phase 2/3·NCT04704622·150 enrolled

Inflammatory Response1 trial

Effects of Dexmedetomidine on Respiratory Function and Inflammatory Responses in Patient With Sepsis Undergoing Cleaning Focus of Infection

Unknown status·GGeneral Hospital of Ningxia Medical University·N/A·NCT02842437·50 enrolled

Intravenous Lidocaine1 trial

Continuous Nerve Block Block vs Combination of Single Block Plus Intravenous Lidocaine for Postoperative Pain.

Terminated·JJeremy Kearns·Phase 4·NCT04208516·17 enrolled

Sleep Disorder1 trial

DISE in Pediatric Sleep Disordered Breathing

Withdrawn·UUniversity of Iowa·Phase 2/3·NCT06756971

Anxiety1 trial

Evaluating Stress Response and Anxiety Score in Paediatric Patients

Completed·UUniversiti Sains Malaysia·Phase 2·NCT04526652·60 enrolled

Septic Shock1 trial

Decatecholaminisation of Septic Shock With Dexmedetomidine and In-hospital Mortality

Completed·MMansoura University·Phase 2·NCT05283083·90 enrolled

Post-Traumatic Stress Disorder, PTSD1 trial

Developing Anesthesia as Post Traumatic Stress Disorder (PTSD) Therapy

Unknown status·SSouthern California Institute for Research and Education·Phase 1·NCT01736020·293 enrolled

Anesthesia1 trial

The Electroencephalographic Mechanisms of Anesthesia and Human Consciousness

Recruiting·GGuangzhou General Hospital of Guangzhou Military Command·Phase 4·NCT07145697·30 enrolled

Residual Kidney Function1 trial

Effects of Dexmedetomidine on Microcirculation and Residual Kidney Function in Kidney Donors

Unknown status·NNational Taiwan University Hospital·Phase 4·NCT04346290·120 enrolled

Pilot Study1 trial

The T REX Pilot Study: a Study to Investigate the Use of an Alternative Anaesthetic in Infants.

Completed·MMurdoch Childrens Research Institute·Phase 4·NCT02353182·60 enrolled

Invasive Mechanical Ventilation1 trial

Dexmedetomidine Versus Standard Clinical Practice During Non Invasive Mechanical Ventilation

Unknown status·BBasque Health Service·Phase 4·NCT02958150·120 enrolled

Extracorporeal Membrane Oxygenation1 trial

Pharmacokinetics of Sedatives and Analgesics During Extracorporeal Membrane Oxygenation (ECMO) Support

Recruiting·—··NCT03593408·20 enrolled

Analgesia1 trial

Transverse Abdominal Block for Analgesia in Casarean Section

Completed·TTanta University·N/A·NCT02122510·120 enrolled

Drug1 trial

The Effects of the Drugs Used in Hypotensive Anaesthesia on Cochlea

Completed·TTC Erciyes University·Phase 4·NCT02062333·47 enrolled

Efficacy and Safety1 trial

A Comparison of Efficacy and Safety During Endoscopic Submucosal Dissection Between Dexmedetomidine-remifentanil and Propofol-remifentanil

Completed·YYonsei University·N/A·NCT01920113·60 enrolled

Sleep Apnea1 trial

Establishment of Ideal IV Sedative Regimen for Successful Fiberoptic Bronchoscopy in Assessing the Site, Severity of Sleep Apnea Syndrome

Completed·YYonsei University·N/A·NCT02148432·31 enrolled

Hyperbaric Bupivacaine1 trial

Low Dose Hyperbaric Bupivacaine and Dexmedetomidine as an Adjuvant, Caesarean Section

Completed·MMenoufia University·Phase 2/3·NCT03775655·40 enrolled

Bradycardia1 trial

Bradycardia Following Intraoperative Administration of Dexmedetomidine

Completed·JJoseph D. Tobias··NCT01917097·921 enrolled

External Oblique Intercostal Plane Block1 trial

Dexmedetomidine and Ketamine as an Adjuvant in External Oblique Intercostal Plane Block for Post Thoracotomy Pain

Completed·TTanta University·N/A·NCT06331182·40 enrolled

Liver Transplant1 trial

Dexmedetomidine to Prevent Hepatic Ischemia-reperfusion Injury-induced Glycocalyx Degradation and Early Allograft Dysfunction in Liver Transplantation

Active, not recruiting·—·Phase 4·NCT05031026·60 enrolled

Popliteal Nerve Block1 trial

Dexamethasone vs. Dexmedetomidine for Popliteal Nerve Block in Pain Management After Pediatric Ankle and Foot Surgery

Completed·PPoznan University of Medical Sciences·Phase 4·NCT06233565·90 enrolled

Perioperative Analgesia1 trial

Techniques for Perioperative Analgesia for Live Liver Donors; A Pilot Study

Unknown status·—·Phase 4·NCT03393988·20 enrolled

Laparoscopic Surgery1 trial

Dexmedetomidine and Laparoscopic Surgery

Completed·—·N/A·NCT03172065·60 enrolled

Unspecified1 trial

Effect of Anesthetic Method on Optic Nerve Sheath Diameter in Patients Undergoing RALP

Completed·—·N/A·NCT03529643·128 enrolled

Regulatory

FDA Approval Timeline[5]

Oct 21, 2015

DEXMEDETOMIDINE HYDROCHLORIDE

NDA NDA206628

Jan 31, 2020

PRECEDEX

NDA NDA021038

Apr 5, 2022

IGALMI

NDA NDA215390

Sources

References

[1]
ClinicalTrials.gov — 1169 trial records for Dexmedetomidine. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Precedex drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Dexmedetomidine compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Dexmedetomidine. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA215390). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Precedex. U.S. Food & Drug Administration.
[7]
SEC EDGAR — McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Adrenergic Receptor Alpha-2 Agonist[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: MMcNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Patent Landscape[6]

Patent Cliff

Jan 4, 2032

Earliest patent expiration — generic entry possible after this date

Patent #Expires

8455527Jan 4, 2032

9616049Jan 4, 2032

8242158Jan 4, 2032

10016396Jan 4, 2032

8338470Jan 4, 2032

24 more patents

8648106Jan 4, 2032

9320712Jan 4, 2032

8455527*PEDJul 4, 2032

8242158*PEDJul 4, 2032

9320712*PEDJul 4, 2032

8648106*PEDJul 4, 2032

8338470*PEDJul 4, 2032

9616049*PEDJul 4, 2032

9649296Apr 20, 2036

9717796Apr 20, 2036

11786508Dec 29, 2037

11839604Dec 29, 2037

11478422Jun 26, 2039

10792246Jun 26, 2039

11497711Jun 26, 2039

11517524Jun 26, 2039

11998529Jul 17, 2040

12109196Jul 17, 2040

11890272Jul 17, 2040

12090140Jan 12, 2043

12364683Jan 12, 2043

11998528Jan 12, 2043

11806334Jan 12, 2043

12138247Jan 12, 2043

Precedex

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2026

Trials by Indication[1]

Dexmedetomidine52 trials

Sedation25 trials

Delirium10 trials

Agitation9 trials

General Anesthesia4 trials

Nausea and vomiting3 trials

Safety and Efficacy3 trials

Hemodynamic Response3 trials

Post Operative Pain3 trials

Cesarean Section2 trials

Local Anesthetic2 trials

Spinal Anesthesia2 trials

Alcohol Withdrawal2 trials

Intrathecal Dexmedetomidine2 trials

Coronary Artery Bypass2 trials

Pediatric Patients2 trials

Intensive Care Unit2 trials

Functional Endoscopic Sinus Surgery2 trials

Cataract2 trials

Post-Traumatic Stress Disorder1 trial

Erector Spinae Plane Block1 trial

Phase II1 trial

Osteoarthritis1 trial

Chronic Knee Pain1 trial

Cognitive Functions1 trial

Gastric Cancer1 trial

Gastrointestinal1 trial

Arrhythmia1 trial

Injury1 trial

Autism1 trial

Breast Cancer1 trial

Premedication1 trial

Nephrectomy1 trial

Transurethral Resection1 trial

Surgical Field1 trial

Intraoperative1 trial

Postoperative Pain Control1 trial

Hydrocephalus1 trial

Critically Ill Patients1 trial

Congenital Heart Disease1 trial

Total Knee Arthroplasty1 trial

Thoracoscopic Surgery1 trial

Opioid1 trial

Post Spinal Anesthesia Shivering1 trial

Inguinal hernia1 trial

Regional Anesthesia1 trial

Mitochondrial Disease1 trial

Surgery1 trial

Elderly Patients1 trial

Open Heart Surgery1 trial

Total Intravenous Anesthesia1 trial

Acute Kidney Injury1 trial

Ischemia1 trial

Hypospadias1 trial

Mechanically Ventilated Patients1 trial

Aesthetic1 trial

Bipolar Disorder1 trial

General Anaesthesia1 trial

Bariatric Surgery1 trial

Knee Arthroscopic Surgery1 trial

Multimodal Analgesia1 trial

Mechanical Ventilation1 trial

Post Operative Cognitive Dysfunction1 trial

Midazolam1 trial

Inflammatory Response1 trial

Intravenous Lidocaine1 trial

Sleep Disorder1 trial

Anxiety1 trial

Septic Shock1 trial

Post-Traumatic Stress Disorder, PTSD1 trial

Anesthesia1 trial

Residual Kidney Function1 trial

Pilot Study1 trial

Invasive Mechanical Ventilation1 trial