PRECEDEX (dexmedetomidine hydrochloride)
Precedex is a sedative used to help adult patients who are intubated and mechanically ventilated in an intensive care setting. It can be administered for up to 24 hours and is often used as patients transition through the process of having their breathing tubes removed. This medication also provides sedation for non-intubated adults during surgical procedures and for pediatric patients as young as one month old undergoing non-invasive procedures.
How PRECEDEX Works
This medication works by acting as a selective alpha 2-adrenergic agonist within the central nervous system to produce sedative effects. While it primarily targets alpha 2 receptors at low to medium doses, it can also activate alpha 1 receptors if it is administered too rapidly or at very high doses.
Development Insights
Details
- Status
- Prescription
- First Approved
- 1999-12-17
- Patent Cliff
- 2032
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
PRECEDEX Approval History
What PRECEDEX Treats
1 indicationsPRECEDEX is approved for 1 conditions since its original approval in 1999. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Sedation
PRECEDEX 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 PRECEDEX
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Clinical Trial Registry
28 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 |
| NCT01007773 | HP-00042821 PRE-08-019 | Ph 2 | withdrawn | Safety of Dexmedetomidine in Severe Traumatic Brain Injury |
| 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) |
| NCT03357718 | 2017/18 | Ph 4 | completed | Oral Dexmedetomidine vs Midazoam For Premedication |
| NCT04027829 | 1905-188-1037 | Ph 2 | completed | Pharmacokinetics-pharmacodynamics and Safety of Dexmedetomidine in Children |
| NCT02245256 | 1407-114-596 | Ph 4 | completed | Efficacy of Low-dose Dexmedetomidine to Prevent Delirium in Liver Transplant Patients |
| 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 |
| NCT03479216 results posted | U1111-1211-1791 | Ph 4 | completed | Comparison of Intra-articular Dexmedetomidine and Magnesium in Postoperative Pain |
| NCT02734940 results posted | HM20004692 | Ph 4 | terminated | Multimodal Analgesia in Cardiac Surgery (Pilot Study) |
| NCT01070680 | a004c 2009-014862-25 | Ph 4 | completed | Dexmedetomidine Versus Placebo in Endoscopic Retrograde Cholangiopancreatography (ERCP) Sedation |
| NCT00691886 | 2008-011 | Ph 4 | withdrawn | Safety and Efficacy of Intravenous (IV) Dexmedetomidine During Flexible Bronchoscopy and Endobronchial Ultrasound |
| NCT00848991 | 01 | Ph 3 | completed | Comparison of Propofol to Precedex With Propofol for Emergence and Recovery in Patients Having Craniotomy Surgery |
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.
PRECEDEX FDA Label Details
Indications & Usage
FDA Label (PDF)PRECEDEX is indicated for the treatment of Sedation.
PRECEDEX Patents & Exclusivity
Patents (13 active)
Pro Intelligence Preview
Deep insights for PRECEDEX
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2032
- • 190 active patents
Trial Analysis
- • 7 total trials
- • Stage: Mature
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.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment