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Drug

Dexmedetomidine

Established medicine
ResearchActive indication expansion
Also known as Dexased, Dexdomitor, Dexmedesed, Dexmedvet+12 more

Dexased, Dexdomitor, Dexmedesed, Dexmedvet, Igalmi, Precedex, Sedexodine, Sileo, Dexmed-etomidine, Dexmedetomidin, Dexmedetomidina, Dextmedetomidine, dexemedetomidine, (+)-4-((S)-alpha,2,3-Trimethylbenzyl)imidazole, Dexmedetomidine Hydrochloride, Dexmedetomidinum.

RxNorm48937ChEMBLCHEMBL778ATCN05CM18UNII67VB76HONO
10
Research papers
25
Active clinical trials
5
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Neurodevelopmental Outcome After Standard Dose Sevoflurane Versus Low-dose Sevoflurane/Dexmedetomidine/Remifentanil Anaesthesia in Young Children- The TREX Trial

Clinical trial2026-10-31Primary completion · ClinicalTrials.gov

Label change: DEXMEDETOMIDINE (ANDA204843)

Regulatory2026-10-22FDA

Label change: DEXMEDETOMIDINE (ANDA204843)

Regulatory2026-10-22FDA

Label change: DEXMEDETOMIDINE (ANDA204843)

Regulatory2026-10-22FDA

Effect of Perioperative Dexmedetomidine on Postoperative Delirium in Patients With Brain Tumors: a Randomized Placebo-controlled Trial

Clinical trial2026-09-30Primary completion · ClinicalTrials.gov

Par Health Issues Voluntary Nationwide Recall of Two Lots of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection Due to the Presence of Particulate Matter

Regulatory2026-09-21Regulatory news · FDA Drug Approvals

Maximizing Efficacy of Goal-Directed Sedation to Reduce Neurological Dysfunction in Mechanically Ventilated Infants and Children Study

Clinical trial2026-09-11Status changed to Active, not recruiting · ClinicalTrials.gov

Comparison of Combined Dexmedetomidine and Ketamine (Ketodex) Versus Dexmedetomidine Alone in Awake Mapping for Deep Brain Stimulation: A Randomized Controlled Trial

Clinical trial2026-09-03Primary completion · ClinicalTrials.gov

Dexmedetomidine for treatment of hyperactive delirium in non-intubated ICU patients: the 4D randomized clinical trial.

Research2025-10-29Intensive care medicine

Label change: DEXMEDETOMIDINE (ANDA204843)

Regulatory2021-03-25FDA

Optimization of Postoperative Intravenous Patient-Controlled Analgesia with Opioid-Dexmedetomidine Combinations: An Updated Meta-Analysis with Trial Sequential Analysis of Randomized Controlled Trials.

Research2017-11-01Pain physician

Efficacy and Safety of Dexmedetomidine as an Adjuvant in Epidural Analgesia and Anesthesia: A Systematic Review and Meta-analysis of Randomized Controlled Trials.

Research2017-04-01Clinical drug investigation

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Dexmedetomidine
Aliases & brands
DexasedDexdomitorDexmedesedDexmedvetIgalmiPrecedexSedexodineSileoDexmed-etomidineDexmedetomidinDexmedetomidinaDextmedetomidinedexemedetomidine(+)-4-((S)-alpha,2,3-Trimethylbenzyl)imidazoleDexmedetomidine HydrochlorideDexmedetomidinum
RxNorm CUI
48937
ChEMBL ID
CHEMBL778
ATC codes
N05CM18
UNII
67VB76HONO
Regulatory jurisdictions
fda

Regulatory timeline

5 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval on record (generic/biosimilar)
2019-01-18
Latest approval
2019-01-18
Authorities
FDA
Total events
5
fdaU.S. Food and Drug Administration· 5 events
2026-10-22Label change
Label change: DEXMEDETOMIDINE (ANDA204843)
Evidence ↗
2026-10-22Label change
Label change: DEXMEDETOMIDINE (ANDA204843)
Evidence ↗
2026-10-22Label change
Label change: DEXMEDETOMIDINE (ANDA204843)
Evidence ↗

Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).

Clinical trials

188 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
188
registered trials across all phases
LATEST COMPLETION 2026
25
Active studies
20
Recruiting
159
Late-stage (III+)
112
Completed
51
Discontinued
PHASE DISTRIBUTIONn = 188
Early Phase 19Phase 15Phase 1 / 23Phase 212Phase 2 / 37Phase 319Phase 473Phase N / A60

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

The Electroencephalographic Mechanisms of Anesthesia and Human Consciousness

RecruitingPH IVGuangzhou General Hospital of Guangzhou Military Commandn=302027

The Improvement of Low-dose Esketamine on Postoperative Depression in Patients Undergoing Bariatric Surgery With Preoperative Depression:A Prospective Radomized Controlled Trial

Active, not recruitingPH IVThe First Hospital of Jilin Universityn=402026

Comparison of Combined Dexmedetomidine and Ketamine (Ketodex) Versus Dexmedetomidine Alone in Awake Mapping for Deep Brain Stimulation: A Randomized Controlled Trial

Active, not recruitingPH IVAin Shams Universityn=242026

Comparison of Intravenous Dexmedetomidine and Lignocaine in Reducing Hemodynamic Responses During Laryngoscopy and Endotracheal Intubation In Patients Undergoing Cardiac Surgery at Rawalpindi Institute Of Cardiology- A Randomized Controlled Trial

RecruitingPH IVRawalpindi Institute of Cardiologyn=702026

The Addition of Dexmedetomidine to Ropivacaine in Bilateral Erector Spinae Plane Block in Patients Undergoing Coronary Artery Bypass Surgery - A Double-blinded Randomized Clinical Trial

Not yet recruitingPH IVLebanese American Universityn=1102026

Recent completions

Trials that read out recently, adding to the completed evidence base.

The Effects of Intrathecal Morphine in Addition to Serratus Anterior Plane Block and Dexmedetomidine on Postoperative Recovery (QoR-15) and Systemic Inflammation in Video-Assisted Thoracoscopic Surgery: A Randomized Controlled Trial

CompletedN/AAtaturk Universityn=642026

A Randomized Double-Blind Study Comparing the Effects of Preoperative Dexmedetomidine Versus Tramadol on Anxiety, Pain, and Hemodynamics in Patients Undergoing Hemorrhoidectomy

CompletedN/AYuzuncu Yil Universityn=902026

A Comparison of Dexmedetomidine, Nicardipine, and Labetalol to Induce Hypotensive Anesthesia and Their Effects on Surgeon Visibility, Blood Loss, Hemodynamic Parameters, Operation Time, and Adverse Events During Orthognathic Surgery

CompletedPH IVBoston Medical Centern=902026

Comparative Effects of Remimazolam Tosylate and Dexmedetomidine on Postoperative Delirium in Elderly Patients Undergoing Thoracoscopic Surgery: A Randomized Controlled Trial

CompletedN/AFirst Affiliated Hospital of Kunming Medical Universityn=1052026

Effects of Low-dose Dexmedetomidine-esketamine Combined Nasal Administration at Night on Perioperative Sleep Quality in Breast Cancer Patients: a Randomized, Double-blind, Placebo-controlled Trial

CompletedPH IVPeking University First Hospitaln=1802025

Dexmedetomidine Infusion in Either Total Intravenous Anesthesia or Inhalational Anesthesia to Improve Surgical Field Visibility in Endoscopic Sinus Surgery

CompletedPH IVMenoufia Universityn=502025

Research activity

10 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time
2005–2025
Most influential

Is intraoperative dexmedetomidine a new option for postoperative pain treatment? A meta-analysis of randomized controlled trials.

Pain · 2013 · 143 cites

An updated focused review of dexmedetomidine in adults.

The Annals of pharmacotherapy · 2009 · 131 cites

Dexmedetomidine for procedural sedation in children with autism and other behavior disorders.

Pediatric neurology · 2009 · 57 cites

Susceptibility of transcranial electric motor-evoked potentials to varying targeted blood levels of dexmedetomidine during spine surgery.

Anesthesiology · 2010 · 54 cites

Pediatric Procedural Sedation Using Dexmedetomidine: A Report From the Pediatric Sedation Research Consortium.

Hospital pediatrics · 2016 · 53 cites

Preliminary experience with oral dexmedetomidine for procedural and anesthetic premedication.

Paediatric anaesthesia · 2005 · 47 cites
Recent papers

Dexmedetomidine for treatment of hyperactive delirium in non-intubated ICU patients: the 4D randomized clinical trial.

Intensive care medicine · 2025 · 5 cites

Efficacy and Safety of Dexmedetomidine as an Adjuvant in Epidural Analgesia and Anesthesia: A Systematic Review and Meta-analysis of Randomized Controlled Trials.

Clinical drug investigation · 2017 · 41 cites

Optimization of Postoperative Intravenous Patient-Controlled Analgesia with Opioid-Dexmedetomidine Combinations: An Updated Meta-Analysis with Trial Sequential Analysis of Randomized Controlled Trials.

Pain physician · 2017 · 34 cites

Pediatric Procedural Sedation Using Dexmedetomidine: A Report From the Pediatric Sedation Research Consortium.

Hospital pediatrics · 2016 · 53 cites

Electroencephalography for children with autistic spectrum disorder: a sedation protocol.

Paediatric anaesthesia · 2015 · 17 cites

Is intraoperative dexmedetomidine a new option for postoperative pain treatment? A meta-analysis of randomized controlled trials.

Pain · 2013 · 143 cites
Major research themes8
Hypnotics and Sedatives3Dexmedetomidine2Analgesics1Autistic Disorder1Delirium1Evidence-Based Medicine1Mental Disorders1Monitoring, Intraoperative1
Journals, researchers & institutions
Top journals
  • Paediatric anaesthesia2
  • Anesthesiology1
  • Clinical drug investigation1
  • Hospital pediatrics1
  • Intensive care medicine1
  • Pain1
Leading researchers
  • Berkenbosch JW2
  • Ben-Menachem E1
  • Ben-Zeev B1
  • Berkenstadt H1
  • Borao L1
  • Bourguignon N1
  • Chanques G1
  • Constantin JM1
Leading institutions
free-text, unnormalised
  • Baylor College of Medicine1
  • Boston Children's Hospital1
  • Centre Hospitalier d'Aurillac1
  • Centre Hospitalier d'Avignon1
  • Centre Hospitalier de Montluçon1
  • Centre Hospitalier de Moulins Yzeure1
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.