CLINICAL TRIALS PROFILE FOR PRECEDEX

505(b)(2) Clinical Trials for Precedex

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Combination	NCT03089905 ↗	A Study to Compare the Long-term Outcomes After Two Different Anaesthetics	Recruiting	Baylor College of Medicine	Phase 3	2017-08-10	There is considerable evidence that most general anaesthetics modulate brain development in animal studies. The impact is greater with longer durations of exposure and in younger animals. There is great controversy over whether or not these animal data are relevant to human clinical scenarios. The changes seen in preclinical studies are greatest with GABA agonists and NMDA antagonists such as volatile anaesthetics (eg sevoflurane), propofol, midazolam, ketamine, and nitrous oxide. There is less evidence for an effect with opioid (such as remifentanil) or with alpha 2 agonists (such as dexmedetomidine). Some, but not all, human cohort studies show an association between exposure to anaesthesia in infancy or early childhood and later changes in cognitive tests, school performance or risk of developing neurodevelopmental disorders. The evidence is weak due to possible confounding. A recent well designed cohort study (the PANDA study) comparing young children that had hernia repair to their siblings found no evidence for a difference in a range of detailed neuropsychological tests. In that study most children were exposed to up to two hours of anaesthesia. The only trial (the GAS trial) has compared children having hernia repair under regional or general anesthesia and has found no evidence for a difference in neurodevelopment when tested at two years of age. The GAS and PANDA studies confirm the animal data that short exposure is unlikely to cause any neurodevelopmental impact. The impact of longer exposures is still unknown. In humans the strongest evidence for an association between surgery and poor neurodevelopmental outcome is in infants having major surgery. However, this is also the group where confounding is most likely. The aim of our study is to see if a new combination of anaesthetic drugs results in a better long-term developmental outcome than the current standard of care for children having anaesthesia expected to last 2 hours or longer. Children will be randomised to receive either a low dose sevoflurane/remifentanil/dexmedetomidine or standard dose sevoflurane anaesthetic. They will receive a neurodevelopmental assessment at 3 years of age to assess global cognitive function.
New Combination	NCT03089905 ↗	A Study to Compare the Long-term Outcomes After Two Different Anaesthetics	Recruiting	Boston Children's Hospital	Phase 3	2017-08-10	There is considerable evidence that most general anaesthetics modulate brain development in animal studies. The impact is greater with longer durations of exposure and in younger animals. There is great controversy over whether or not these animal data are relevant to human clinical scenarios. The changes seen in preclinical studies are greatest with GABA agonists and NMDA antagonists such as volatile anaesthetics (eg sevoflurane), propofol, midazolam, ketamine, and nitrous oxide. There is less evidence for an effect with opioid (such as remifentanil) or with alpha 2 agonists (such as dexmedetomidine). Some, but not all, human cohort studies show an association between exposure to anaesthesia in infancy or early childhood and later changes in cognitive tests, school performance or risk of developing neurodevelopmental disorders. The evidence is weak due to possible confounding. A recent well designed cohort study (the PANDA study) comparing young children that had hernia repair to their siblings found no evidence for a difference in a range of detailed neuropsychological tests. In that study most children were exposed to up to two hours of anaesthesia. The only trial (the GAS trial) has compared children having hernia repair under regional or general anesthesia and has found no evidence for a difference in neurodevelopment when tested at two years of age. The GAS and PANDA studies confirm the animal data that short exposure is unlikely to cause any neurodevelopmental impact. The impact of longer exposures is still unknown. In humans the strongest evidence for an association between surgery and poor neurodevelopmental outcome is in infants having major surgery. However, this is also the group where confounding is most likely. The aim of our study is to see if a new combination of anaesthetic drugs results in a better long-term developmental outcome than the current standard of care for children having anaesthesia expected to last 2 hours or longer. Children will be randomised to receive either a low dose sevoflurane/remifentanil/dexmedetomidine or standard dose sevoflurane anaesthetic. They will receive a neurodevelopmental assessment at 3 years of age to assess global cognitive function.
New Combination	NCT03089905 ↗	A Study to Compare the Long-term Outcomes After Two Different Anaesthetics	Recruiting	Boston Children’s Hospital	Phase 3	2017-08-10	There is considerable evidence that most general anaesthetics modulate brain development in animal studies. The impact is greater with longer durations of exposure and in younger animals. There is great controversy over whether or not these animal data are relevant to human clinical scenarios. The changes seen in preclinical studies are greatest with GABA agonists and NMDA antagonists such as volatile anaesthetics (eg sevoflurane), propofol, midazolam, ketamine, and nitrous oxide. There is less evidence for an effect with opioid (such as remifentanil) or with alpha 2 agonists (such as dexmedetomidine). Some, but not all, human cohort studies show an association between exposure to anaesthesia in infancy or early childhood and later changes in cognitive tests, school performance or risk of developing neurodevelopmental disorders. The evidence is weak due to possible confounding. A recent well designed cohort study (the PANDA study) comparing young children that had hernia repair to their siblings found no evidence for a difference in a range of detailed neuropsychological tests. In that study most children were exposed to up to two hours of anaesthesia. The only trial (the GAS trial) has compared children having hernia repair under regional or general anesthesia and has found no evidence for a difference in neurodevelopment when tested at two years of age. The GAS and PANDA studies confirm the animal data that short exposure is unlikely to cause any neurodevelopmental impact. The impact of longer exposures is still unknown. In humans the strongest evidence for an association between surgery and poor neurodevelopmental outcome is in infants having major surgery. However, this is also the group where confounding is most likely. The aim of our study is to see if a new combination of anaesthetic drugs results in a better long-term developmental outcome than the current standard of care for children having anaesthesia expected to last 2 hours or longer. Children will be randomised to receive either a low dose sevoflurane/remifentanil/dexmedetomidine or standard dose sevoflurane anaesthetic. They will receive a neurodevelopmental assessment at 3 years of age to assess global cognitive function.

All Clinical Trials for Precedex

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00205712 ↗	Prevention of N-methyl-D-aspartate (NMDA) Antagonist-induced Psychosis in Kids	Completed	National Alliance for Research on Schizophrenia and Depression	Phase 4	2003-02-01	Ketamine, an FDA approved anesthetic agent, is becoming the sedative/analgesic of choice for emergency sedation in children because it causes deep sedation with minimal respiratory depression in comparison to other available agents. However, emergence reactions are an important adverse effect of ketamine, characterized by transient changes in cognitive function, dissociation and mild schizophrenia-like symptoms. These cognitive and behavioral effects are dose-dependently induced by ketamine and other antagonists of the N-methyl-D-aspartate (NMDA) glutamate receptor. NMDA receptor hypofunction can disinhibit excitatory (cholinergic/glutamatergic) projections in key areas of the brain, and this has been proposed to explain key features of schizophrenia. Several treatments that block excessive excitatory transmitter release have also been shown to prevent cognitive and behavioral effects of ketamine-induced NMDA receptor hypofunction in humans. Alpha-2 adrenergic agonists, which can presynaptically inhibit acetylcholine release, can prevent mild ketamine-induced behavioral and cognitive symptoms in healthy human adults. However, this prevention strategy has not been evaluated in children. Children currently receive clinically-indicated treatment with the NMDA antagonist, ketamine, and this age group is an important target for pharmacological strategies aimed at the prevention of schizophrenia. This application proposes a double-blind, placebo-controlled, randomized trial to test the safety and effectiveness of dexmedetomidine, an FDA approved alpha-2 adrenergic agonist, in preventing ketamine-induced mental symptoms in children. Planned primary analyses will evaluate effects of the hypothesized prevention treatment on clinical and cognitive variables using analysis of variance (ANOVA). The proposed experiments are relevant to future prevention trials for individuals at risk for schizophrenia, and to preventing adverse effects of NMDA antagonist anesthetic agents (ketamine, nitrous oxide).
NCT00205712 ↗	Prevention of N-methyl-D-aspartate (NMDA) Antagonist-induced Psychosis in Kids	Completed	Washington University School of Medicine	Phase 4	2003-02-01	Ketamine, an FDA approved anesthetic agent, is becoming the sedative/analgesic of choice for emergency sedation in children because it causes deep sedation with minimal respiratory depression in comparison to other available agents. However, emergence reactions are an important adverse effect of ketamine, characterized by transient changes in cognitive function, dissociation and mild schizophrenia-like symptoms. These cognitive and behavioral effects are dose-dependently induced by ketamine and other antagonists of the N-methyl-D-aspartate (NMDA) glutamate receptor. NMDA receptor hypofunction can disinhibit excitatory (cholinergic/glutamatergic) projections in key areas of the brain, and this has been proposed to explain key features of schizophrenia. Several treatments that block excessive excitatory transmitter release have also been shown to prevent cognitive and behavioral effects of ketamine-induced NMDA receptor hypofunction in humans. Alpha-2 adrenergic agonists, which can presynaptically inhibit acetylcholine release, can prevent mild ketamine-induced behavioral and cognitive symptoms in healthy human adults. However, this prevention strategy has not been evaluated in children. Children currently receive clinically-indicated treatment with the NMDA antagonist, ketamine, and this age group is an important target for pharmacological strategies aimed at the prevention of schizophrenia. This application proposes a double-blind, placebo-controlled, randomized trial to test the safety and effectiveness of dexmedetomidine, an FDA approved alpha-2 adrenergic agonist, in preventing ketamine-induced mental symptoms in children. Planned primary analyses will evaluate effects of the hypothesized prevention treatment on clinical and cognitive variables using analysis of variance (ANOVA). The proposed experiments are relevant to future prevention trials for individuals at risk for schizophrenia, and to preventing adverse effects of NMDA antagonist anesthetic agents (ketamine, nitrous oxide).
NCT00351299 ↗	Randomized Controlled Trial of Dexmedetomidine for the Treatment of Intensive Care Unit (ICU) Delirium	Completed	Brigham and Women's Hospital	Phase 2	2006-01-01	The purpose of the research is to see if dexmedetomidine (a drug that has a calming effect - a sedative) is effective for the treatment of acute delirium

Clinical Trial Conditions for Precedex

Condition Name

Condition Name for Precedex
Intervention	Trials
Anesthesia	26
Pain	16
Sedation	15

Condition MeSH

Condition MeSH for Precedex
Intervention	Trials
Delirium	27
Pain, Postoperative	18
Emergence Delirium	18

Clinical Trial Locations for Precedex

Trials by Country

Trials by Country for Precedex
Location	Trials
United States	140
Egypt	66
Korea, Republic of	28
Canada	24
Turkey	16

Trials by US State

Trials by US State for Precedex
Location	Trials
Massachusetts	21
New York	14
Ohio	13
Pennsylvania	12
Texas	9

Clinical Trial Progress for Precedex

Clinical Trial Phase

Clinical Trial Phase for Precedex
Clinical Trial Phase	Trials
Phase 4	131
Phase 3	34
Phase 2/Phase 3	27

Clinical Trial Status

Clinical Trial Status for Precedex
Clinical Trial Phase	Trials
Completed	167
Recruiting	44
Unknown status	30

Clinical Trial Sponsors for Precedex

Sponsor Name

Sponsor Name for Precedex
Sponsor	Trials
Assiut University	23
Hospira, Inc.	17
Hospira, now a wholly owned subsidiary of Pfizer	17

Sponsor Type

Sponsor Type for Precedex
Sponsor	Trials
Other	404
Industry	39
NIH	7

Precedex (Dexmedetomidine): Clinical Trials, Market Analysis, and Projections

Introduction to Precedex (Dexmedetomidine)

Precedex, also known as dexmedetomidine, is a potent alpha-2 adrenergic agonist used primarily for sedation in intensive care units (ICUs) and operating rooms. It is valued for its ability to provide sedation without significant respiratory depression, making it a preferred choice in critical care settings.

Clinical Trials and Efficacy

Adult Patients in ICUs

The efficacy and safety of Precedex have been extensively evaluated in several clinical trials. Four randomized, double-blind, placebo-controlled multicenter clinical trials involving 1,185 adult patients have been conducted. These trials focused on the sedative properties of Precedex in patients who were initially intubated and receiving mechanical ventilation.

• In two of these trials, patients were randomized to receive either Precedex or a placebo. The Precedex group received an initial loading infusion of 1 mcg/kg over 10 minutes, followed by a maintenance infusion of 0.4 mcg/kg/hr, adjustable between 0.2 and 0.7 mcg/kg/hr. The primary outcome measure was the amount of rescue medication (midazolam or propofol) needed to maintain a specified level of sedation, as measured by the Ramsay Sedation Scale. The results showed that patients in the Precedex group required significantly less rescue medication compared to those in the placebo group[1].

Comparison with Midazolam

In another controlled clinical trial, Precedex was compared to midazolam for ICU sedation exceeding 24 hours. While Precedex was not shown to be superior to midazolam in terms of the primary efficacy endpoint (the percent of time patients were adequately sedated), it highlighted that prolonged use of Precedex beyond 24 hours was associated with tolerance, tachyphylaxis, and an increase in adverse events[1].

Pediatric Patients

The safety and efficacy of Precedex for sedation in non-intubated pediatric patients undergoing MRI scans were evaluated in a randomized, double-blind, dose-ranging clinical trial. The study demonstrated that pediatric patients in the high-dose Precedex group maintained the target sedation rating scale score for a mean of over 87% of the time during the maintenance infusion[1].

Market Analysis

Current Market Size and Growth

The dexmedetomidine market, which includes Precedex, was valued at USD 1.8 billion in 2023 and is projected to reach USD 3.1 billion by 2031, growing at a compound annual growth rate (CAGR) of 6.7% from 2024 to 2031[5].

Market Segments

The market is segmented based on application (injectable, intranasal, intravenous) and product use (ICUs, operating rooms, ambulatory care, clinics), as well as geographical regions (North America, Europe, Asia-Pacific, South America, and Middle-East and Africa). The increasing use of dexmedetomidine in ICUs and surgical settings, driven by its efficacy as a sedative and analgesic, is a key factor in market growth[5].

Growth Drivers

• Increasing Demand for Critical Care Procedures: The rise in critical care procedures and the need for better sedation management are significant drivers of the market.
• Innovations in Drug Formulations: Advances in drug formulations and delivery systems, such as intranasal administration, are contributing to the market's expansion.
• Preference Over Traditional Sedatives: The growing preference for dexmedetomidine over traditional sedatives due to its favorable safety profile is another key driver[5].

Market Projections

Regional Markets

The North American region currently dominates the dexmedetomidine market, but the Asia-Pacific region is expected to be the fastest-growing market due to increasing healthcare expenditure and a rising number of surgical procedures[5].

Future Trends

• Advancements in Technology: Innovations in drug delivery systems and formulations are expected to continue driving the market.
• Increasing Awareness: Growing awareness of the benefits of dexmedetomidine, including its ability to provide sedation without significant respiratory depression, will further boost market growth.
• Clinical Research: Ongoing clinical research and trials will continue to support the market's trajectory by providing evidence of the drug's efficacy and safety[5].

Key Takeaways

• Clinical Efficacy: Precedex has been shown to be effective in reducing the need for rescue sedatives in ICU patients.
• Market Growth: The dexmedetomidine market is expected to grow significantly, driven by increasing demand for critical care procedures and advancements in drug formulations.
• Regional Expansion: The Asia-Pacific region is anticipated to be a key growth area due to rising healthcare needs and surgical procedures.
• Innovations: Continued innovations in drug delivery and formulations will play a crucial role in the market's expansion.

FAQs

What is Precedex (Dexmedetomidine) used for?

Precedex, or dexmedetomidine, is primarily used for sedation in intensive care units (ICUs) and operating rooms. It is valued for its ability to provide sedation without significant respiratory depression.

How effective is Precedex in reducing the need for rescue sedatives?

Clinical trials have shown that Precedex significantly reduces the need for rescue sedatives such as midazolam and propofol in ICU patients compared to placebo[1].

What are the key drivers of the dexmedetomidine market?

The key drivers include the increasing demand for critical care procedures, innovations in drug formulations and delivery systems, and a growing preference for dexmedetomidine over traditional sedatives[5].

What is the projected market size of the dexmedetomidine market by 2031?

The dexmedetomidine market is expected to reach USD 3.1 billion by 2031, growing at a CAGR of 6.7% from 2024 to 2031[5].

Which region is expected to be the fastest-growing market for dexmedetomidine?

The Asia-Pacific region is anticipated to be the fastest-growing market due to increasing healthcare expenditure and a rising number of surgical procedures[5].

What are the potential risks associated with prolonged use of Precedex?

Prolonged use of Precedex beyond 24 hours is associated with tolerance, tachyphylaxis, and an increase in adverse events[1].

Sources

1. Pfizer Medical Information: PRECEDEX Clinical Studies.
2. MetaTech Insights: General Anesthesia Drugs Market Share, Size, Trend 2025-2035.
3. BioXcel Therapeutics: BioXcel Therapeutics Announces Update on NIDA-funded Trial of BXCL501.
4. European Union Clinical Trials Register: Search for Dexmedetomidine.
5. Market Research Intellect: Dexmedetomidine Market Size, Share, Trends, Scope And Forecast.