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 168 indications[4].[1]

Precedex is one of 1622 small molecule programs targeting Alcohol Withdrawal. It is currently in Approved.

168

Indications

1,192

Total Trials

Active Trials

1,621

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Alcohol WithdrawalCompleted

Brain InjuryCompleted

DeliriumUnknown status

SepsisCompleted

Respiratory FailureTerminated

Familial DysautonomiaEnrolling by invitation

Kidney TransplantCompleted

Coronary Artery BypassUnknown status

DexmedetomidineUnknown status

AnesthesiaRecruiting

Alcohol WithdrawalApproved

Completed

Brain InjuryApproved

Completed

DeliriumApproved

Unknown status

SepsisApproved

Completed

Respiratory FailureApproved

Terminated

Familial DysautonomiaPhase 2

Enrolling by invitation

Kidney TransplantApproved

Completed

Coronary Artery BypassApproved

Unknown status

DexmedetomidineApproved

Unknown status

AnesthesiaApproved

Recruiting

Showing 10 of 157 indications

Competition

Competitive Landscape

348 competitors in Prostate Cancer

#DrugCompanyPhaseTrials

Precedex

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

Paraplatin

25 3

Rubraca

Bristol-Myers Squibb

Phase 3

9 4

Alinamin

Roche

Phase 3

6 5

Zejula

GGlaxo Dba Glaxosmithkline

Phase 3

10 6

Aglatimagene Besadenovec

CCandel Therapeutics, Inc.

Phase 3

2 7

Docetaxel /m²

AstraZeneca

Phase 3

2 8

PSMA-1007

AABX advanced biochemical compounds GmbH

Phase 3

3 9

INR101

YYunhe Pharmaceutical (Tianjin) Co., Ltd

Phase 3

3 10

Trexall

Jazz Pharmaceuticals

Preclinical

—

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

Timeline

Expected Milestones

Q4 2026

N/AActive, not recruiting

Dexmedetomidine

NCT06639659

N/ANot yet recruiting

Sedation

NCT07166666

Phase 3Not yet recruiting

Functional Endoscopic Sinus Surgery

NCT07213037

Recruiting

Extracorporeal Membrane Oxygenation

NCT03593408

N/ARecruiting

Dexmedetomidine

NCT07271147

Post-ApprovalNot yet recruiting

Dexmedetomidine

NCT07214701

Clinical

Trials by Indication[1]

Dexmedetomidine38 trials

Safety Study of Dexmedetomidine in Septic Patients

Completed·FFirst Affiliated Hospital of Zhejiang University·N/A·NCT01976754·40 enrolled

Dexmedetomidine Adjuvant in Retinal Surgery

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

Efficacy of Peritonsillar Dexmedetomidine Infiltration for Postadenotonsillectomy Pain

Completed·TTC Erciyes University·Phase 4·NCT02013570·71 enrolled

Show 35 more trials

Sphenopalatine Block vs Dexmedetomidine Infusion in Trans Nasal Endoscopic Pituitary Surgery

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

Dexmedetomidine and Remifentanil in NORA

Completed·—·Phase 4·NCT06403670·76 enrolled

Dexmedetomidine and HIPEC

Unknown status·UUniversity of British Columbia·Phase 2/3·NCT04106999·20 enrolled

Effects of Wound Infiltration With Ketamine Versus Dexmedetomidine Added to Bupivacaine on Cytokines

Completed·—·Phase 4·NCT03164590·60 enrolled

Oral Dexmedetomidine for Parental Separation in Pediatrics Undergoing Adenotonsillectomy

Completed·SSuez Canal University·Phase 4·NCT03551067·74 enrolled

Comparison Between Intrathecal Magnesium Sulphate & Dexmedetomidine in DHS

Not yet recruiting·—·Phase 3·NCT07326397·92 enrolled

Comparison of Two Doses of Intranasal Dexmedetomidine as Premedication in Children

Completed·TThe University of Hong Kong·Phase 3·NCT01065701·104 enrolled

Comparison the Hemodynamics Effects Between Dexmedetomidine and Propofol in Major Abdominal Surgical Patients

Unknown status·FFirst Affiliated Hospital, Sun Yat-Sen University··NCT01669044·80 enrolled

Propofol Versus the Use of Dexmedetomidine as a Sedative Agent for Colonosopy

Unknown status·TTanta University·Phase 3·NCT03466632·100 enrolled

Effect of Ketalar or Dexmedetomidine on Increased Sensitivity to Pain Following Treatment With Remifentanil

Recruiting·—·N/A·NCT06473896·90 enrolled

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

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

The Effects of Dexmedetomidine and Remifentanil on Carotid Patients

Terminated·TThe Cleveland Clinic·Phase 4·NCT00335972·142 enrolled

The Effect of Intraoperative Infusion of Dexmedetomidine Versus Low Dose Ketamine

Unknown status·—·Phase 1·NCT05828199·80 enrolled

Mini-dose Esketamine-dexmedetomidine Supplemented Analgesia and Long-term Outcomes

Completed·PPeking University First Hospital·Phase 4·NCT05718544·199 enrolled

Evaluation of the Hemodynamic Effect of Dexmedetomidine in Scheduled Outpatient Surgery

Recruiting·—·N/A·NCT06082856·594 enrolled

Effects of taVNS Combined With Dexmedetomidine on POVN

Recruiting·—·N/A·NCT07271147·176 enrolled

Sedative and Analgesic Effects of Dexmedetomidine Versus Ketamine in Patients Undergoing Varicocelectomy Under Spinal Anaesthesia: A Prospective Randomized Comparative Trial

Not yet recruiting·—·Phase 4·NCT07214701·58 enrolled

Comparison of Doses of Dexmedetomidine With Bupivacaine in Caudal Block for Duration of Analgesia in Paediatric Infraumblical Surgeries.

Unknown status·—·Phase 4·NCT04700228·162 enrolled

Patient-Controlled Anxiolysis With Dexmedetomidine (PCA-DEX) for Burn-care Dressing Changes

Completed·OOhio State University·Phase 1/2·NCT02409810·20 enrolled

Comparing the Hemodynamic Effects of Epinephrine Versus Dexmedetomidine as an Adjuvant to Bupivacaine in Caudal Anaesthesia Assessed by Cardiometry

Unknown status·KKasr El Aini Hospital·N/A·NCT05860010·39 enrolled

Effect of Dexmedetomidine on Plasmatic Cortisol Response in Transsphenoidal Surgery

Unknown status·PPontificia Universidad Catolica de Chile·Phase 4·NCT02549768·40 enrolled

Pre-emptive Analgesia Using Nebulized Ketamine Versus Nebulized Dexmedetomidine in Endoscopic Nasal Surgeries

Recruiting·SSohag University·N/A·NCT07056582·105 enrolled

A Comparison of Two Doses of Intranasal Dexmedetomidine for Premedication in Children

Unknown status·TThe University of Hong Kong·Phase 4·NCT02459509·140 enrolled

Intranasal Dexmedetomidine Premedication

Completed·GGuangzhou First People's Hospital·N/A·NCT02108171·81 enrolled

Dexmedetomidine vs Labetalol for Airway Stress in Hypertensive Craniotomy Patients

Enrolling by invitation·—·Phase 4·NCT07034898·60 enrolled

Effect of Dexmedetomidine on the Minimum Alveolar Concentration of Sevoflurane

Recruiting·—·Phase 4·NCT03384563·180 enrolled

Safety, Efficacy and Pharmacokinetic Study of Dexmedetomidine in Pediatrics Ages ≥28 Weeks to ≤44 Weeks Gestational Age

Completed· Pfizer logo

Pfizer·Phase 2/3·NCT01159262·36 enrolled

Comparison of the Effects of Dexmedetomidine and Lidocaine on Blood Pressure and Heart Rate Response

Completed·UUniversitas Padjadjaran·N/A·NCT06573957·42 enrolled

Evaluation of the Analgesic Effect of Dexmedetomidine Versus Fentanyl as Adjuvants to Epidural Bupivacaine in Patients Undergoing Lumbar Spine Surgeries

Completed·—·N/A·NCT03463083·60 enrolled

Effect of Midazolam and Dexmedetomidine on Heart Function - A Randomized MRI-based Study.

Completed·—·Phase 4·NCT04529187·30 enrolled

Dexmedetomidine Versus Sevoflurane in Children With Anticipated Difficult Intubation

Unknown status·—·Phase 2·NCT04426552·40 enrolled

Dexmedetomidine and Desflurane Consumption

Completed·TTheodor Bilharz Research Institute·N/A·NCT02652312·40 enrolled

Intranasal Dexmedetomidine Versus Intranasal Midazolam for MRI In Pediatrics

Completed·TTanta University·Phase 4·NCT04652661·60 enrolled

Combined Dexmedetomidine and Glycopyrrolate Therapy

Withdrawn·KKangbuk Samsung Hospital·N/A·NCT05013320

Epidural Dexmedetomidine vs Nalbuphine for Labor Analgesia

Completed·—·Phase 2·NCT05327088·64 enrolled

Sedation31 trials

A Safety and Efficacy Study of Dexmedetomidine in Patients Requiring Sedation During Monitored Anesthesia Care (MAC)

Completed· Pfizer logo

Pfizer·Phase 3·NCT00398827·326 enrolled

Safety and Efficacy of Esketamine Combined With Dexmedetomidine for Sedation of Mechanically Ventilated Patients

Recruiting·TThe First Affiliated Hospital with Nanjing Medical University·Phase 4·NCT05466708·100 enrolled

Remimazolam for Sedation in ICU Patients Undergoing Mechanical Ventilation

Unknown status·TTianjin Nankai Hospital·Phase 4·NCT04815265·488 enrolled

Show 28 more trials

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

Dexmedetomidine for Prolonged Sedation in PICUs

Completed·AAzienda Ospedaliera di Padova··NCT03760978·163 enrolled

Dexmedetomidine in Children for Magnetic Resonance Imaging (MRI) Sedation

Completed·SSisli Hamidiye Etfal Training and Research Hospital·Phase 4·NCT02299232·60 enrolled

Sedation to Electroencephalography With Dexmedetomidine or Chloral Hydrate

Completed·FFederal University of Minas Gerais·Phase 3·NCT01083797·25 enrolled

Dexmedetomidine Versus Propofol for Prolonged Sedation in Critically Ill Trauma and Surgical Patients

Completed·UUniversity of Tennessee Graduate School of Medicine·Phase 4·NCT02548923·57 enrolled

Dexmedetomidine Versus Midazolam for Continuous Sedation in the Intensive Care Unit (ICU)

Completed· Orion Corporation, Orion Pharma logo

Orion Corporation, Orion Pharma·Phase 3·NCT00481312·501 enrolled

Dexmedetomidine Compared to Ketofol for Sedation in Paediatrics

Completed·—·Phase 1·NCT04678050·40 enrolled

Use of Dexmedetomidine for Sedation During Flexible Bronchoscopy in Patients With COPD: A Descriptive Study

Completed·TThe Cooper Health System·N/A·NCT00401206·12 enrolled

Sedation and Pain (The Effect of IV Sedation on Pain Perception)

Completed·UUniversity of Alabama at Birmingham·N/A·NCT00853333·86 enrolled

Dexmedetomidine vs. Remifentanil for Sedation During AFI

Completed·TThe University of Texas Health Science Center, Houston·Phase 4·NCT00349245·30 enrolled

Study Comparing Atomizerd Midazolam & Fentanyl and Dexmedomidine for Procedural Sedation in Adult and Pediatric Patient (2 to 60 Years Old)

Not yet recruiting·OOman Medical Speciality Board·N/A·NCT07166666·128 enrolled

A Comparison of Two Sedation Techniques in Children Undergoing Transthoracic Echocardiography (TTE)

Completed·—·Phase 1·NCT02250820·280 enrolled

Study to Determine if the Midazolam-Meperidine-Dexmedetomidine is Superior to the Midazolam-Meperidine for Sedation During ERCP

Completed·SSeoul National University Hospital·Phase 4·NCT01404689·110 enrolled

Comparison of Remimazolam and Dexmedetomidine for Intraoperative Sedation

Completed·SSeoul National University Hospital·Phase 4·NCT05447507·104 enrolled

The Effects of Mild Sedation on Motor Function Networks in Patients With Brian Gliomas

Completed·—·N/A·NCT03984240·38 enrolled

Goal Directed Propofol Sedation With Magnesium Sulphate Versus Dexmedetomidine for ERCP Procedure

Completed·TTheodor Bilharz Research Institute·Phase 3·NCT02684019·60 enrolled

Sedation Using Intranasal Dexmedetomidine in Upper Gastrointestinal Endoscopy

Completed·TThe University of Hong Kong·Phase 3·NCT01887184·50 enrolled

Dexmedetomidine Sedation and Cardiopulmonary Bypass

Completed·—·Phase 2·NCT02727621·100 enrolled

Dexmedetomidine-Propofol and Ketamine-Propofol During Upper Gastrointestinal System Sedation

Completed·YYuzuncu Yil University··NCT04399226·60 enrolled

Sedation With Dexmedetomidine Versus Remifentanil in Urogynecological Surgery Under Spinal Anaesthesia

Unknown status·UUniversity of Athens·Phase 3·NCT03883347·50 enrolled

Effects of Two Different Sedation Regimes on Auditory Evoked Potentials and Electroencephalogram (EEG)

Completed·IInsel Gruppe AG, University Hospital Bern·N/A·NCT00641563·10 enrolled

Intranasal Dexmedetomidine vs. Standard of Care for Emergency Department (ED) Procedural Sedation in the Older Adult

Not yet recruiting·SState University of New York - Upstate Medical University·Phase 3·NCT06370442·60 enrolled

The Effect of Dexmedetomidine Analgesia and Sedation in Minimally Invasive Spine Surgery Under Local Anesthesia

Unknown status·TTang-Du Hospital·Phase 4·NCT02535273·212 enrolled

Dexmedetomidine vs Midazolam for Intraoperative Sedation

Completed·IInstituto de Assistencia Medica ao Servidor Publico Estadual, Sao Paulo·Phase 4·NCT02878837·120 enrolled

Testing the Feasibility of Patient Controlled Sedation for Ventilated ICU Patients

Completed·UUniversity of Minnesota·Phase 1/2·NCT01606852·15 enrolled

Dexmedetomidine-based Sedation in Neurocritical Care Patients

Unknown status·UUniversity Hospital, Clermont-Ferrand·Phase 2·NCT02252523·66 enrolled

Delirium11 trials

Dexmedetomidine Alleviates Postoperative Delirium After Brain Tumor Resections

Completed·—·N/A·NCT04674241·260 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

Show 8 more trials

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

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

Completed·SStanford University··NCT00417664·90 enrolled

Pregabalin Versus Dexmedetomidine for Delirium Prevention After Cardiac Surgery

Completed·TTanta University·Phase 4·NCT05640479·60 enrolled

Ketofol for Preventing Postoperative Delirium in Elderly Patients

Completed·ZZagazig University·Phase 4·NCT04816162·120 enrolled

Efficacy of Dexmedetomidine Versus Clonidine to Control Delirium in Patients Undergoing CABG

Completed·—·N/A·NCT03477994·147 enrolled

Dexmedetomidine Reduces Emergence Delirium in Children Undergoing Tonsillectomy With Propofol Anesthesia

Completed·—·Phase 2/3·NCT03131375·60 enrolled

Study Using Dexmedetomidine to Decreases Emergence Delirium in Pediatric Patients

Terminated·OOchsner Health System·N/A·NCT00778063·40 enrolled

Agitation6 trials

ED50 of Dexmedetomidine to Prevent Emergence Agitation in Children

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

Dexmedetomidine Versus Gabapentin Premedication on the Emergence Agitation After Rhinoplasty

Completed·—·Phase 4·NCT05626998·153 enrolled

Dexmedetomidine Versus Nalbuphine in Prevention of Emergence Agitation Following Adenotonsillectomy in Pediatrics

Unknown status·—·Phase 1/2·NCT04058899·120 enrolled

Show 3 more trials

Dexmedetomidine to Lessen Intensive Care Unit (ICU) Agitation

Completed·AAustin Health·Phase 2/3·NCT01151865·96 enrolled

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

Completed·MMedipol University··NCT06097169·80 enrolled

Prevention of Emergence Agitation in Rhinoplasty With Subanesthetic Propofol and Single-Dose Dexmedetomidine: A Prospective Double-Blind Clinical Study

Recruiting·YYuzuncu Yil University·N/A·NCT07144007·80 enrolled

Hemodynamic Response3 trials

Hemodynamic Response to Intubation

Unknown status·UUfuk University·Phase 4·NCT02844894·60 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

Attenuation of Hemodynamic Response to Laryngoscopy and Endotracheal Intubation With Single Dose of Dexmedetomidine in Hypertensive Patients.

Completed·—·N/A·NCT03204006·70 enrolled

87 more indications

Cataract3 trials

Conscious Sedation for Cataract Operations Under Topical Anaesthesia

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

Controlled Sedation for Cataract Surgery

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

Efficacy of Dexmedetomidine for Postoperative Analgesia in Infantile Cataract Surgery

Unknown status·—·Phase 2/3·NCT02495220·80 enrolled

Post Operative Cognitive Dysfunction3 trials

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

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

Whether Dexmedetomidine Can Improve the Prognosis of Elderly Patients With Postoperative Cognitive Dysfunction

Completed·ZZhejiang Cancer Hospital·Phase 4·NCT02923128·240 enrolled

Effect of Intraoperative Dexmedetomidine on Early Postoperative Cognitive Dysfunction

Completed·TTata Main Hospital·Phase 4·NCT03793751·120 enrolled

Brain Injury3 trials

Precedex Versus Propofol-Awakening for Reducing Brain Injury Expansion

Completed·UUnknown Sponsor·Phase 1/2·NCT00538616·8 enrolled

Comparison of C-Reactive Protein Levels in Traumatic Brain Injury Patients Undergoing Craniotomy With and Without Dexmedetomidine

Completed·UUniversitas Jenderal Soedirman·Phase 4·NCT07406555·25 enrolled

Study on Cerebral Protection of Dexmedetomidine for Patients With Traumatic Brain Injury

Unknown status·XXiangya Hospital of Central South University·Phase 4·NCT04006054·82 enrolled

Postoperative Analgesia3 trials

Intraperitoneal Dexmedetomidine Versus Ketamine With Bupivacaine For Postoperative Analgesia

Completed·ZZagazig University·N/A·NCT04525274·60 enrolled

Caudal Dexmedetomidine vs Ketamine for Postoperative Analgesia in Pediatric DDH Surgery

Not yet recruiting·—·N/A·NCT07385352·54 enrolled

Adjuvants With Intrathecal Bupivacaine for Postoperative Analgesia

Unknown status·—·Phase 4·NCT06082232·90 enrolled

Sepsis3 trials

Dexmedetomidine for Sepsis in ICU Randomized Evaluation Trial

Completed·WWakayama Medical University·Phase 4·NCT01760967·203 enrolled

The Effect of Dexmedetomidine on Microcirculation in Severe Sepsis

Terminated·NNational Taiwan University Hospital·Phase 4·NCT02109965·12 enrolled

Effects of Dexmedetomidine vs Propofol in Patients With Intra-abdominal Sepsis

Completed·—·Phase 4·NCT04718714·60 enrolled

Intensive Care Unit3 trials

Study to Evaluate Hemodynamic Effect of Different Loading Doses of Precedex in Post-surgical Intensive Care Unit (ICU) Patients

Completed· Pfizer logo

Pfizer··NCT01169571·373 enrolled

Study Evaluating Safety and Efficacy of Dexmedetomidine (DEX) in Intubated and Mechanically Ventilated Pediatric Intensive Care Unit (PICU) Subjects

Completed· Pfizer logo

Pfizer·Phase 3·NCT00875550·175 enrolled

Evaluation of Renal Protection Of Dexmedetomidine Versus Midazolam As a Sedative For Septic Patients In Intensive Care Unit

Unknown status·MMinia University·Phase 1·NCT05903963·40 enrolled

Total Knee Arthroplasty2 trials

Postoperative Delirium After Total Knee Arthroplasty Under Regional Anesthesia

Unknown status·MMahidol University·N/A·NCT03120442·600 enrolled

Premedication with Intranasal Dexmedetomidine in Sedation of Patients Undergoing Total Knee Arthroplasty

Completed·TTurku University Hospital·Phase 4·NCT04859283·100 enrolled

Hyperbaric Bupivacaine2 trials

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

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

Dexmedetomidine and Fentanyl As Adjuvants to Hyperbaric Bupivacaine for the Prevention of Post-spinal Shivering in Hip Arthroplasty Surgeries

Unknown status·—·N/A·NCT06834841·100 enrolled

Cesarean Section2 trials

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

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

Intrathecal Dexmedetomidine Versus Transversus Abdominus Plane Block (TAP) for Postoperative Analgesia After Cesarean Section.

Completed·SSohag University·N/A·NCT04969705·60 enrolled

Invasive Mechanical Ventilation2 trials

Dexmedetomidine Versus Standard Clinical Practice During Non Invasive Mechanical Ventilation

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

Evaluation of Remifentanil and Dexmedetomidine in Patients With Noninvasive Mechanical Ventilation Intolerance

Unknown status·SShanghai Zhongshan Hospital·N/A·NCT04734418·178 enrolled

General Anesthesia2 trials

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

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

Perioperative Multimodal General AnesTHesia Focusing on Specific CNS Targets in Patients Undergoing carDiac surgERies

Completed·—·N/A·NCT05279898·70 enrolled

Anxiety2 trials

Evaluating Stress Response and Anxiety Score in Paediatric Patients

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

Intranasal Dexmedetomidine for Severe Dental Anxiety: a Randomized Trial

Unknown status·SSun Yat-Sen Memorial Hospital of Sun Yat-Sen University·N/A·NCT05500261·30 enrolled

Laparoscopic Surgery2 trials

Dexmedetomidine and Laparoscopic Surgery

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

Dexmedetomidine to Improve Outcomes During Emergence From Retroperitoneal Laparoscopic Surgery

Completed·—·N/A·NCT02316236·66 enrolled

Cardiac Surgery2 trials

Sevoflurane and Dexmedetomidine's Contrasting Renal Impacts After Non-Cardiac Surgery

Completed·TTanta University·N/A·NCT06835010·90 enrolled

Effect of Perioperative Dexmedetomidine Administration on Outcome in Cardiac Surgery Patients

Completed·MMoscow Regional Research and Clinical Institute (MONIKI)·Phase 4·NCT03091166·169 enrolled

Laparoscopic Cholecystectomy2 trials

Hemodynamic Responses of Dexmedetomidine, Lidocaine or Propofol Infusions During Laparoscopic Cholecystectomy

Unknown status·MMenoufia University·Phase 4·NCT05937282·80 enrolled

Dexmedetomidine Infusion as an Analgesic Adjuvant During Laparoscopic Cholecystectomy

Unknown status·—·Phase 3·NCT03211871·60 enrolled

Inflammatory Response2 trials

A Comparative Study Between Dexmedetomidine Versus Methylprednisolone on Induced Inflammatory Response in Patients Undergoing On-pump CABG

Not yet recruiting·—·Phase 1/2·NCT07101367·60 enrolled

Effect of Dexmedetomidine on the Inflammatory Response After One-lung Ventilation

Completed·SSeoul St. Mary's Hospital·N/A·NCT04007341·40 enrolled

Hypospadias2 trials

Intravenous Dexmedetomidin on Postoperative Pain After Hypospadias Repair in Children

Unknown status·—·Phase 2/3·NCT05194904·60 enrolled

Comparison of the Efficacy of Bupivacaine with and Without Dexmedetomidine As an Adjuvant on Penile Block for Postoperative Pain Relief in Pediatrics Undergoing Hypospadias Repair Surgery

Not yet recruiting·—·Phase 3·NCT06789393·80 enrolled

Bariatric Surgery2 trials

The Improvement of Low-dose Esketamine on Postoperative Depression in Patients Undergoing Bariatric Surgery With Preoperative Depression

Not yet recruiting·TThe First Hospital of Jilin University·Phase 4·NCT07179913·40 enrolled

Analgesia Management in Bariatric Surgery

Completed·OOndokuz Mayıs University·N/A·NCT04836819·78 enrolled

Septic Shock1 trial

Hemodynamic Effects of Dexmedetomidine in Septic Shock

Completed·UUniversity of Roma La Sapienza·Phase 3·NCT02638545·37 enrolled

Autism Spectrum Disorder1 trial

Procedure Sedation With Dexmedetomidine in Children With Autism Spectrum Disorders During Magnetic Resonance Imaging

Completed·GGuangzhou Women and Children's Medical Center··NCT03597477·136 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

Sleep Disorder1 trial

DISE in Pediatric Sleep Disordered Breathing

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

Tobacco Use Disorder1 trial

The Effects of Sedatives on Tobacco Use Disorder Version 2

Completed·WWake Forest University Health Sciences·Phase 1·NCT05505630·20 enrolled

Lumbar Fusion Surgery1 trial

Ultrasound vs. Surgical ESP Block With Bupivacaine-Dexmedetomidine in Lumbar Fusion Surgery

Completed·FFayoum University Hospital·Phase 4·NCT06958718·52 enrolled

Interstitial Cystitis1 trial

Usefulness of Dexmedetomidine on Post-operative Pain Management in Patients With Interstitial Cystitis

Completed·UUniversity of Rochester·Phase 4·NCT01195116·41 enrolled

Drug1 trial

The Effects of the Drugs Used in Hypotensive Anaesthesia on Cochlea

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

After Cardiac Surgery1 trial

Stress Response and Neurodevelopmental Outcome After Cardiac Surgery Utilizing CPB in Children: A Prospective, Double Blinded and Randomized Study

Completed·AAymen N Naguib·Phase 2·NCT02492269·30 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

Alcohol Withdrawal1 trial

Ketamine vs. Placebo as Adjunctive Therapies for Severe Alcohol Withdrawal

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

Functional Endoscopic Sinus Surgery1 trial

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

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

Analgesia1 trial

Transverse Abdominal Block for Analgesia in Casarean Section

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

Safety and Efficacy1 trial

Safety and Efficacy of Intranasal Dexmedetomidine

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

Epilepsy1 trial

Conscious Sedation for Epilepsy Surgery

Completed·MMenoufia University·N/A·NCT02988050·60 enrolled

Local Anesthetic1 trial

Ketamine Versus Dexmedetomidine With Local Anesthetic in TAP Block

Completed·—·Phase 2/3·NCT03060070·90 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

Idiopathic Scoliosis1 trial

Dexmedetomidine for ESPB in Pain Management After Pediatric Idiopathic Scoliosis Surgery

Not yet recruiting·PPoznan University of Medical Sciences·Phase 4·NCT06789016·60 enrolled

Myocardial Protection1 trial

Myocardial Protection and Anesthetic Agents

Completed·—·Phase 4·NCT02405689·60 enrolled

General Anaesthesia1 trial

Effect of Dexmedetomidine Supplementation to General Anaesthesia in Paediatric Transcatheter Closure of Atrial Septal Defect

Recruiting·—·Phase 4·NCT06631534·30 enrolled

Bradycardia1 trial

Bradycardia Following Intraoperative Administration of Dexmedetomidine

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

Extracorporeal Membrane Oxygenation1 trial

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

Recruiting·—··NCT03593408·20 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

Microcirculation1 trial

Effect Of Dexmedetomidine On Sublingual Microcirculation In Patients Undergoing On Pump CABG Surgery

Unknown status·—·Phase 4·NCT02714725·70 enrolled

Post Operative Pain1 trial

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

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

Hypotension1 trial

Comparisons Between Dexmedetomidine and Magnesium Sulfate in Controlled Hypotension During Rhinoplasty Surgeries

Completed·Mmohamed·Phase 1·NCT05880693·56 enrolled

Seizure1 trial

Dexmedetomidine in Seizure Patients

Completed·UUniversity of California, San Francisco·Phase 1·NCT01116700·16 enrolled

Carpal Tunnel Syndrome1 trial

Dexmedetomidine, Ozone and Dexamethasone Local Injection in Carpal Tunnel Syndrome for Pain Relief

Recruiting·TTanta University·N/A·NCT06133712·135 enrolled

Caesarean Section1 trial

COMPARISON OF INTRAVENOUS DEXMEDETOMEDINE AND TRAMADOL FOR POST OPERATIVE SHIVERING AFTER SPINAL ANESTHESIA FOR CAESAREAN SECTION

Completed·LLiaquat National Hospital & Medical College·Phase 4·NCT07332572·100 enrolled

Complication1 trial

The Effect of Dexmedetomidine on Airway Complications After Deep or Awake Extubation

Terminated·MMassachusetts Eye and Ear Infirmary·Phase 4·NCT02162433·92 enrolled

Cognitive Dysfunction1 trial

Dexmedetomidine and Magnesium Sulfate in the Reduction Cognitive Dysfunction in Geriatrics

Recruiting·FFayoum University·Phase 1·NCT06702488·58 enrolled

Dexamethasone1 trial

Dexmedetomine vs Dexamethasone in TAB Block for Abdominal Surgries

Unknown status·—·Phase 4·NCT05323565·45 enrolled

Thoracoscopic Surgery1 trial

Effects of Esketamine on Oxygenation and Quality of Recovery in Patients Undergoing Thoracoscopic Surgery

Not yet recruiting·JJinqiao Qian·Phase 4·NCT06822088·126 enrolled

Supraclavicular Brachial Plexus Block1 trial

Effect of the Addition of Dexmedetomidine to Bupivacaine During Supraclavicular Brachial Plexus Blockade

Completed·TTC Erciyes University·Phase 4·NCT02049970·44 enrolled

Abdominal Surgeries1 trial

Analgesic and Sedative Effect of Fentanyl Versus Dexmedetomidine Infusion in Post-Operative Mechanically Ventilated Children After Open Abdominal Surgeries

Completed·TTanta University·N/A·NCT06994273·54 enrolled

Arteriovenous Fistula1 trial

Dexmedetomidine and Propofol As Sole Sedative Agent for Patients Undergoing Arteriovenous Fistula Surgery

Unknown status·—·Phase 4·NCT02447796·48 enrolled

Adolescent Idiopathic Scoliosis1 trial

Opioid-Free Anesthesia Versus Opioid Based Anesthesia For Adolescent Idiopathic Scoliosis

Recruiting·NNashwa Ahmed·Phase 4·NCT07389096·30 enrolled

Ischemia1 trial

Mechanism of Cardiac and Cerebral Function Injury Caused by Intraoperative Limb Ischemia-reperfusion

Unknown status·HHebei Medical University Third Hospital·N/A·NCT05661227·120 enrolled

Mechanical Ventilation1 trial

Medical Records Investigation of Whether Perioperative Dexmedetomidine Will Reduce the Duration of Mechanical Ventilation or Hospital Length of Stay in Patients Undergoing Minimally Invasive Cardiac Surgery

Completed·FFar Eastern Memorial Hospital··NCT05038111·81 enrolled

Kidney Transplant1 trial

Dexmedetomidine and Kidney Transplantation

Not yet recruiting·EEduardo Schiffer·Phase 4·NCT05935293·206 enrolled

Nephropathy1 trial

Efficacy of Dexmedetomidine in Preventing Contrast Induced Nephropathy

Completed·TTC Erciyes University·Phase 4·NCT02137863·60 enrolled

Regional Anaesthesia1 trial

Regional Anaesthesia

Completed·RReham Ali Abdelhaleem Abdelrahman·N/A·NCT06055101·54 enrolled

Video-Assisted Thoracoscopic Surgery1 trial

Effects of Dexmedetomidine on Quality of Recovery and Analgesia After Video-assisted Thoracoscopic Surgery

Completed·YYonsei University·N/A·NCT02537249·111 enrolled

Shoulder Arthroscopy1 trial

Effect of Dexmedetomidine on Postoperative Cognitive Function in Patients Undergoing Shoulder Arthroscopy With Beach Chair Position Under Desflurane Anesthesia

Completed·YYonsei University·N/A·NCT02643017·80 enrolled

Mastectomy1 trial

Paravertebral Morphine Versus Dexmedetomidine on Acute and Chronic Postmastectomy Pain

Unknown status·—·Phase 1/2·NCT02935933·90 enrolled

Valvular Heart Surgery1 trial

The Effects of Dexmedetomidine on Postoperative Renal Function in Valvular Heart Surgery

Unknown status·YYonsei University·Phase 4·NCT01886079·200 enrolled

Knee Arthroscopic Surgery1 trial

Analgesia in Knee Arthroscopic Surgery

Completed·—·Phase 2·NCT02818985·60 enrolled

Thoracic Paravertebral Block1 trial

Thoracic Paravertebral Blocks Using a Combination of Ropivacaine and Dexmedetomidine

Withdrawn·—·Phase 4·NCT03677115

Interaction1 trial

Pharmacodynamic Interaction of REMI and DMED

Completed·UUniversity Medical Center Groningen·Phase 4·NCT03143972·30 enrolled

Breast Cancer1 trial

The Effect of Intraoperative Dexmedetomidine on Postoperative Morphine Requirements After Breast Cancer Surgery

Unknown status·NNational Taiwan University Hospital·N/A·NCT04454515·60 enrolled

Erector Spinae Block1 trial

Adding Dexmedetomidine to Bupivacaine for Bilateral Erector Spinae Block

Unknown status·—·Phase 4·NCT06231979·48 enrolled

Intraperitoneal Chemotherapy1 trial

The Influence of Perioperative Administration of Dexmedetomidine on Inflammation Response and Postoperative Outcomes in Patients Undergoing Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Cytoreductive Surgery; Double Blind Randomized Controlled Trial

Completed·YYonsei University·N/A·NCT03370588·56 enrolled

Quadratus Lumborum Block1 trial

Impact of Adding Dexmedetomidine as an Adjuvant to The Local Anesthetic in Quadratus Lumborum Block in Patient Undergoing Caesarean Section

Completed·MMajid Fakhir Mutar Alhamaaidah·Phase 1·NCT07072650·80 enrolled

Cerebral Oxygen Saturation1 trial

Mg Sulfate Versus Dexmedetomidine on Cerebral Oxygen Saturation

Not yet recruiting·TTanta University·Phase 3·NCT06848595·90 enrolled

Adjuvant1 trial

Three Variants of the PENG Block With and Without Perineural Adjuvants in Older Adults

Recruiting·PPoznan University of Medical Sciences·N/A·NCT07330999·120 enrolled

Oxidative Stress1 trial

The Effect of Dexmedetomidine Infusion on Post-operative Cognitive Function and Oxidative Stress in Cardiac Surgery

Completed·—·Phase 4·NCT03054857·100 enrolled

Interscalene Brachial Plexus Block1 trial

The Effect of Dexamedetomidine for Interscalene Brachial Plexus Block on Plasma Biomarkers After Rotator Cuff Repair

Completed·—·N/A·NCT02766556·50 enrolled

Opioid Free Anesthesia1 trial

Opioid Free Anesthesia in ENT Surgery

Unknown status·UUniversity of Thessaly·N/A·NCT04105946·200 enrolled

Bupivacaine1 trial

Dexmeditomedine as an Adjuvant to Levobupivacaine in Transversus Thoracis Plane Block on the Management of Post-sternotomy Pain in Open-heart Surgeries

Not yet recruiting·—·N/A·NCT06410404·60 enrolled

Hysterectomy1 trial

Dexmedetomidine Adjuvant to General Anesthesia of Abdominal Hysterectomy

Unknown status·SSuez Canal University·N/A·NCT03600506·52 enrolled

Laryngeal Mask Airway1 trial

Dexmedetomidine for Laryngeal Mask Airway Insertion

Completed·—·Phase 4·NCT01852539·22 enrolled

Cleft Palate1 trial

Suprazygomatic Block in Cleft Palate Surgery in Children

Completed·—·Phase 2·NCT03412474·80 enrolled

Tachycardia1 trial

Dexmedetomidine and Magnesium Sulfate in Preventing Junctional Ectopic Tachycardia After Pediatric Cardiac Surgery

Completed·KKasr El Aini Hospital·Phase 4·NCT05554848·120 enrolled

Intrathecal Dexmedetomidine1 trial

Effect of Different Doses Of Intrathecal Dexmedetomidine In Combination With Bupivacaine On Spinal Anesthesia

Completed·TTanta University·Phase 1·NCT07051512·90 enrolled

Coronary Artery Bypass1 trial

Effect of Dexmedetomidine on Left Ventricular Function in Coronary Artery Bypass Graft Surgery Outcome

Completed·—·Phase 1·NCT05778305·50 enrolled

Renal Protection1 trial

Renal Protection of Intravenous Dexmedetomidine During Radical Cystectomy

Completed·MMansoura University·N/A·NCT03265470·100 enrolled

Regulatory

FDA Approval Timeline[5]

Dec 17, 1999

PRECEDEX

NDA NDA021038

May 8, 2001

PRECEDEX

NDA NDA021038

Oct 17, 2008

PRECEDEX

NDA NDA021038

Oct 13, 2010

PRECEDEX

NDA NDA021038

Mar 13, 2013

PRECEDEX

NDA NDA021038

Jun 17, 2013

PRECEDEX

NDA NDA021038

Jun 17, 2013

PRECEDEX

NDA NDA021038

Sep 28, 2013

PRECEDEX

NDA NDA021038

Jan 16, 2014

PRECEDEX

NDA NDA021038

Apr 18, 2014

PRECEDEX

NDA NDA021038

Nov 14, 2014

PRECEDEX

NDA NDA021038

Nov 14, 2014

PRECEDEX

NDA NDA021038

Nov 14, 2014

PRECEDEX

NDA NDA021038

Oct 21, 2015

DEXMEDETOMIDINE HYDROCHLORIDE

NDA NDA206628

Apr 11, 2016

PRECEDEX

NDA NDA021038

Jan 31, 2020

PRECEDEX

NDA NDA021038

Jan 31, 2020

PRECEDEX

NDA NDA021038

Apr 5, 2022

IGALMI

NDA NDA215390

Aug 12, 2022

PRECEDEX

NDA NDA021038

Aug 12, 2022

PRECEDEX

NDA NDA021038

Dec 16, 2022

PRECEDEX

NDA NDA021038

Oct 11, 2024

PRECEDEX

NDA NDA021038

May 1, 2026

PRECEDEX

NDA NDA021038

Sources

References

[1]
ClinicalTrials.gov — 1192 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 NDA021038). 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

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