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local dexmedetomidine
local dexmedetomidine is a Alpha-2 adrenergic receptor agonist Small molecule drug developed by The University of Hong Kong. It is currently in Phase 3 development for Sedation for patients undergoing mechanical ventilation. Also known as: Precedex.
Local dexmedetomidine acts as an alpha-2 adrenergic receptor agonist to induce sedation and analgesia.
Local dexmedetomidine acts as an alpha-2 adrenergic receptor agonist to induce sedation and analgesia. Used for Sedation for patients undergoing mechanical ventilation.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | local dexmedetomidine |
|---|---|
| Also known as | Precedex |
| Sponsor | The University of Hong Kong |
| Drug class | Alpha-2 adrenergic receptor agonist |
| Target | Alpha-2 adrenergic receptor |
| Modality | Small molecule |
| Therapeutic area | Anesthesiology |
| Phase | Phase 3 |
Mechanism of action
By activating alpha-2 adrenergic receptors in the brain, local dexmedetomidine reduces the release of norepinephrine, leading to decreased sympathetic nervous system activity and subsequent sedative and analgesic effects.
Approved indications
- Sedation for patients undergoing mechanical ventilation
Common side effects
- Hypotension
- Bradycardia
- Dry mouth
Key clinical trials
- Effect of Lidocaine Infusion Versus Dexmedemidine Infusion on the Neurocognitive Function of Elderly Patients Undergoing Endoscopic Retrograde Cholangiopancreatography(ERCP): a Randomized, Controlled Trial. (NA)
- Opioid Free and Opioid Based Anesthesia in Elective Lumbar Spine Surgery
- Awareness Neuraxial Versus General Anesthesia in Frail Patients Undergoing Laparoscopic or Robotic Abdominopelvic Surgery. (NA)
- Dexmedetomidine Use in SZMN Blocks for Pediatric T&A Pain Control (NA)
- Analgesic Efficacy of Adding Different Doses of Dexmedetomidine as Adjuvants With Bupivacaine vs.Bupivacaine Only in Ultrasound-guided Erector Spinae Plane Block in Morbidly Obese Patients Undergoing Laparoscopic Bariatric Surgery. A Randomized Controlled Double Blinded Study.
- PENG Block With Dexmedetomidine in Older Adults (NA)
- Ultrasound Guided Quadratus Lumborum Block, Thoracolumbar Interfascial Plane Block, and Local Anesthetic Infiltration for Lumbar Spine Fixation (NA)
- Perioperative Multimodal Analgesia for Supratentorial Craniotomy (NA)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- local dexmedetomidine CI brief — competitive landscape report
- local dexmedetomidine updates RSS · CI watch RSS
- The University of Hong Kong portfolio CI
Frequently asked questions about local dexmedetomidine
What is local dexmedetomidine?
How does local dexmedetomidine work?
What is local dexmedetomidine used for?
Who makes local dexmedetomidine?
Is local dexmedetomidine also known as anything else?
What drug class is local dexmedetomidine in?
What development phase is local dexmedetomidine in?
What are the side effects of local dexmedetomidine?
What does local dexmedetomidine target?
Related
- Drug class: All Alpha-2 adrenergic receptor agonist drugs
- Target: All drugs targeting Alpha-2 adrenergic receptor
- Manufacturer: The University of Hong Kong — full pipeline
- Therapeutic area: All drugs in Anesthesiology
- Indication: Drugs for Sedation for patients undergoing mechanical ventilation
- Also known as: Precedex
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing