DEXMEDETOMIDINE HYDROCHLORIDE
Dexmedetomidine hydrochloride is a sedative indicated for use in two primary adult populations. First, it is used for initially intubated and mechanically ventilated patients in an intensive care unit (ICU) setting, administered by continuous infusion for no more than 24 hours. It may be continued through the extubation process. Second, it is indicated for the sedation of non-intubated patients prior to and/or during surgical and other medical procedures.
How DEXMEDETOMIDINE HYDROCHLORIDE Works
Dexmedetomidine is a relatively selective, centrally acting alpha-2 adrenergic receptor agonist. It induces sedation by stimulating alpha-2 receptors in the brainstem, which inhibits the release of norepinephrine. While it is selective for alpha-2 receptors at low to medium doses, alpha-1 activity may be observed at very high doses or during rapid intravenous administration.
Details
- Status
- Prescription
- First Approved
- 2014-08-18
- Patent Cliff
- 2036
- Routes
- INJECTION, INTRAVENOUS
- Dosage Forms
- INJECTABLE, SOLUTION
Companies
DEXMEDETOMIDINE HYDROCHLORIDE Approval History
What DEXMEDETOMIDINE HYDROCHLORIDE Treats
1 indicationsDEXMEDETOMIDINE HYDROCHLORIDE is approved for 1 conditions since its original approval in 2014. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Sedation
DEXMEDETOMIDINE HYDROCHLORIDE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to DEXMEDETOMIDINE HYDROCHLORIDE
FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
21 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04772222 DICE results posted | 136561 | Ph 2 | completed | Dexmedetomidine Use in Infants Undergoing Cooling Due to Neonatal Encephalopathy (DICE Trial) |
| NCT05793060 | DTH: 23001 | Ph 4 | recruiting | Dexmedetomidine Versus Dexamethasone as Adjuvants to Bupivacaine for Intermediate Cervical Plexus Block |
| NCT06575530 | IIT2024-001-002 | Ph 4 | recruiting | Sedation Efficacy and Safety of Remazolam Besylate in Ventilated Surgical Critically Ill Patients |
| NCT06417125 | K2024-01-006 | Ph 4 | completed | Intranasal Dexmedetomidine Versus Oral Midazolam Premedication for Postoperative Negative Behavior Changes in Children |
| NCT03708315 DEX | 2000023998 | Ph 1 | completed | BXCL501 for Agitation in Schizophrenia |
| NCT06720220 | Airway topicalization | Ph 3 | completed | Role of Airway Topicalization in Awake Fiberoptic Intubation |
| NCT04824144 | 339633386643463 | Ph 1, Ph 2 | recruiting | Effects of Dexmedetomidine in Patients With Agitated Delirium in Palliative Care |
| NCT06808295 DCR | 24-11-17-6-5 | Ph 1 | recruiting | Dexmedetomidine an Effective Drug in Reducing Anesthetic Requirements in External Dacrocystorhinostomy (DCR) Patients |
| NCT04042727 C-RAD results posted | IRB2019-00250 | Ph 2, Ph 3 | terminated | Controlling Rapid Atrial Fibrillation With Dexmedetomidine |
| NCT05552391 | N-88-2022 | Ph 4 | completed | Dexametomedine Versus Ketamine as an Adjuvant in Erector Spinae Block for Perioperative Thoracotomy Pain Control |
| NCT05993975 | SAbbas | Ph 4 | completed | Effects of Intrathecal Dexmedetomidine as an Adjuvant to Low Dose Hyperbaric 0.5% Bupivacaine |
| NCT03078946 results posted | 1775 | Ph 4 | completed | Dexmedetomidine Versus Morphine and Midazolam in Prevention and Treatment of Delirium After Adult Cardiac Surgery |
| NCT03530371 | 17-HPNCL-02 | Ph 3 | completed | Intranasal Dexmedetomidine for Sedated Hearing Testing |
| NCT04971759 | 17300618 | Ph 2, Ph 3 | completed | Dexmedetomidine to Levobupivacaine for Transversus Abdominis Plane Block in Elderly Patients Undergoing Inguinal Hernia Repair Surgery |
| NCT04968392 | 17300626 | Ph 2, Ph 3 | completed | Single-shot Adductor Canal Block With Levobupivacaine and Dexmedetomidine in Total Knee Arthroplasty |
| NCT01438957 results posted | DEX-303 | Ph 3 | completed | 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 |
| NCT03290625 | PV0939-2017 | Ph 4 | completed | Intranasal Sedation With Dexmedetomidine and Ketamine in Pediatric Dentistry (NASO II) |
| NCT04027829 | 1905-188-1037 | Ph 2 | completed | Pharmacokinetics-pharmacodynamics and Safety of Dexmedetomidine in Children |
| NCT03940469 IBBB | Interscalene Dexmedetomidine | Ph 4 | completed | Dexmedetomidine Versus Dexamethasone With Levobupivacaine in Interscalene Block |
| NCT02757625 results posted | C0801017 ZIN-DEX-1506 | Ph 3 | completed | Study of DA-9501 In Pediatric Subjects In The Intensive Care Unit |
| NCT00691886 | 2008-011 | Ph 4 | withdrawn | Safety and Efficacy of Intravenous (IV) Dexmedetomidine During Flexible Bronchoscopy and Endobronchial Ultrasound |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
DEXMEDETOMIDINE HYDROCHLORIDE FDA Label Details
Indications & Usage
FDA Label (PDF)DEXMEDETOMIDINE HYDROCHLORIDE is indicated for the treatment of Sedation.
Pro Intelligence Preview
Deep insights for DEXMEDETOMIDINE HYDROCHLORIDE
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2036
- • 16 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • 3 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.