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Precedex (dexmedetomidine)
Precedex works by activating alpha-2 adrenergic receptors in the brain, which reduces the activity of neurons and produces sedative effects.
Dexmedetomidine (Precedex), marketed by Bioxcel, is a leading agent for conscious sedation with a well-established mechanism of action through alpha-2 adrenergic receptor activation. Its key strength lies in its unique sedative properties, which provide effective patient management during medical procedures. The primary risk to Precedex is the upcoming key composition patent expiry in 2028, which could lead to increased competition from generics.
At a glance
| Generic name | dexmedetomidine |
|---|---|
| Sponsor | Bioxcel |
| Drug class | Central alpha-2 Adrenergic Agonist |
| Target | Alpha-1D adrenergic receptor |
| Therapeutic area | Neuroscience |
| Phase | FDA-approved |
| First approval | 1999 |
Mechanism of action
Precedex is relatively selective alpha2-adrenergic agonist with sedative properties. Alpha2 selectivity is observed in animals following slow intravenous infusion of low and medium doses (10-300 mcg/kg). Both alpha1 and alpha2 activity is observed following slow intravenous infusion of high doses (>=1,000 mcg/kg) or with rapid intravenous administration.
Approved indications
- Conscious sedation
Common side effects
- hypotension
- hypertension
- nausea
- bradycardia
- atrial fibrillation
- pyrexia
- dry mouth
- vomiting
- hypovolemia
- atelectasis
- pleural effusion
- agitation
Drug interactions
- anesthetics
- sedatives
- hypnotics
- opioids
- rocuronium
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)
- The Relationship Between Opioid-Free Anesthesia and Postoperative Agitation-Delirium and Quality of Recovery in Pediatric Ear, Nose, and Throat Cases Monitored With Perioperative Bispectral Index
- Continuous Epidural With Dexmedetomidine Adjuvant in Gynecologic Laparotomy (PHASE4)
- Effect of Dexmedetomidine on Brain Homeostasis and Neurocognitive Outcome (PHASE4)
- Suprainguinal Fascia Iliaca Block With vs Without Dexmedetomidine (PHASE4)
- Dexmedotomidine for Acute Pain Control in Patients With Multiple Rib FracturesRandomized Controlled Trial (PHASE4)
- Dexmedetomidine for Invasive Ventilation In the NEOnate (PHASE2,PHASE3)
- Opioid Free and Opioid Based Anesthesia in Elective Lumbar Spine Surgery
Patents
| Patent | Expiry | Type |
|---|---|---|
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 |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Precedex CI brief — competitive landscape report
- Precedex updates RSS · CI watch RSS
- Bioxcel portfolio CI