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.
New Combination	NCT03089905 ↗	A Study to Compare the Long-term Outcomes After Two Different Anaesthetics	Recruiting	Children's Hospital of Philadelphia	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
NCT00363935 ↗	Bariatric Dose-ranging Study With Dexmedetomidine	Withdrawn	University of Texas Southwestern Medical Center	Phase 4	2007-01-01	After obtaining informed consent,80 morbidly obese ASA II-III patients undergoing laparoscopic bariatric surgery procedures would be randomly assigned to one of four study groups at UTSWMC at Dallas.Hemodynamic paarameters, recovery times, postoperative pain scores, the need for rescue analgesics and side effects will be recorded.The purpose of this study is to determine the optimal linfusion rate of dexmedetomidine for maintaining cardiovscular stability during general anesthesia.

Clinical Trial Conditions for PRECEDEX

Condition Name

Condition Name for PRECEDEX
Intervention	Trials
Anesthesia	26
Pain	16
Sedation	15
Delirium	14

Condition MeSH

Condition MeSH for PRECEDEX
Intervention	Trials
Delirium	27
Emergence Delirium	18
Pain, Postoperative	18
Psychomotor Agitation	17

Clinical Trial Locations for PRECEDEX

Trials by Country

Trials by Country for PRECEDEX
Location	Trials
United States	140
Egypt	70
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
PHASE4	1
PHASE2	1
PHASE1	2

Clinical Trial Status

Clinical Trial Status for PRECEDEX
Clinical Trial Phase	Trials
Completed	169
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	409
Industry	39
NIH	7

Clinical Trials Update, Market Analysis, and Projection for Precedex (Dexmedetomidine)

Last updated: October 30, 2025

Introduction

Precedex, the brand name for dexmedetomidine, is a selective alpha-2 adrenergic receptor agonist primarily used for sedation in intensive care units (ICUs) and anesthesia settings. Since its approval, Precedex has revolutionized sedation protocols by offering favorable sedation profiles, including minimal respiratory depression and easy titratability. As demand for effective sedation options rises amidst expanding critical care needs, an understanding of current clinical research, market dynamics, and future projections for Precedex becomes crucial for industry stakeholders.

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Clinical Trials Landscape for Precedex

Ongoing and Recent Clinical Studies

Precedex's clinical research has focused on its safety, efficacy, and expanding indications. Recent trials emphasize its benefits over traditional sedatives like benzodiazepines and opioids, especially regarding delirium, respiratory function, and hemodynamics.

• Sedation in Critical Care: Multiple phase IV studies examine dexmedetomidine's role in ICU sedation protocols. For example, a recent large-scale trial assessed its use in mechanically ventilated patients, demonstrating reduced ventilator days and delirium incidence compared to lorazepam (e.g., the SEDCOM trial, published in Critical Care Medicine).

• Postoperative Applications: Trials targeting surgical settings, e.g., cardiac and neurological surgeries, investigate dexmedetomidine’s neuroprotective effects, analgesic-sparing properties, and its role in improving postoperative recovery profiles.

• Delirium Prevention: Several studies explore dexmedetomidine's ability to prevent ICU delirium, with findings suggesting significant benefits, which are crucial given the morbidity associated with ICU delirium.

• Exploratory Investigations: Emerging studies are examining off-label uses such as in procedural sedation outside the ICU, treating agitation in neurocritical care, and potential psychiatric indications.

Regulatory and Clinical Guidelines Influence

Recent updates from societies such as the Society of Critical Care Medicine (SCCM) support the use of dexmedetomidine for ICU sedation, emphasizing its safety profile and delirium reduction, spurring further research and adoption. However, ongoing trials continue to investigate optimal dosing and long-term safety, especially concerning cardiovascular side effects.

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Market Analysis

Market Size and Growth Trajectory

The global dexmedetomidine market has experienced rapid expansion, driven by increased ICU admissions, rising prevalence of surgeries requiring sedation, and shifting preferences toward sedatives with fewer adverse effects than traditional options.

• Current Market Size: Estimates place the market at approximately USD 800 million in 2022, with projections reaching USD 1.2 billion by 2028, reflecting a Compound Annual Growth Rate (CAGR) of around 7-8% (source: MarketWatch, 2022).

• Geographical Drivers: North America dominates due to high ICU utilization and established clinical guidelines. Asia-Pacific exhibits the fastest growth, fueled by expanding healthcare infrastructure and a surge in surgical procedures, particularly in China and India.

Competitive Landscape

Precedex’s primary competitors include other sedatives like midazolam, lorazepam, fentanyl, and newer agents under investigation. Abbott’s strong patent protections and global market presence facilitate Precedex’s leadership position.

• Patents and Exclusivity: Dexmedetomidine’s exclusivity in multiple markets sustains premium pricing. However, patent expirations in certain regions could introduce generic versions, intensifying competition and pressuring margins.

• Pricing Dynamics: Precedex commands a premium due to its clinical benefits. Price sensitivity varies across regions, influenced by healthcare policies and reimbursement frameworks.

Regulatory Environment

In the U.S., the drug holds a New Drug Application (NDA) approval from the FDA since 2007, with subsequent expansions for ICU sedation. Other regulatory agencies, such as the European Medicines Agency (EMA), have also approved Precedex.

Continued regulatory attention focuses on additional indications, optimal dosing protocols, and post-market safety surveillance, impacting market access and branding strategies.

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Market Drivers and Challenges

Drivers

• Growing ICU and Surgical Populations: The COVID-19 pandemic underscored the importance of effective sedation in critical care, causing a surge in demand for dexmedetomidine.

• Shift Toward Sedation with Less Respiratory Depression: Increasing awareness of complications associated with benzodiazepines and opioids boosts demand for dexmedetomidine’s favorable safety profile.

• Clinical Evidence Supporting Use: Robust scientific data validating efficacy and safety encourage guideline endorsements and clinician adoption.

• Emerging Applications: Investigations into non-traditional uses (e.g., procedural sedation, delirium management) expand potential markets.

Challenges

• Cost: Precedex’s higher price point compared to traditional sedatives limits usage in resource-constrained settings.

• Adverse Effects: Cardiovascular side effects, such as bradycardia and hypotension, necessitate cautious use, which could restrict widespread application.

• Generic Competition & Patent Expiry: Future patent cliffs may facilitate generic manufacturing, reducing prices and profit margins.

• Variability in Practice Guidelines: Differences across countries and institutions in sedation protocols influence adoption rates.

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Future Market Projections

Growth Outlook (2023-2030)

The market for dexmedetomidine is expected to sustain a CAGR of approximately 7-8%, predominantly driven by the expanding critical care landscape, technological advancements, and clinical validation of new indications.

• Expansion into New Indications: Anticipated approvals for uses such as agitation in neurocritical care, adjunct in procedural sedation, and potentially psychiatric applications could substantially increase market size.

• Geopolitical Expansion: Increased penetration in emerging markets with improving healthcare infrastructure, especially in Asia-Pacific and Latin America, will further propel growth.

• Formulation Innovations: Development of sustained-release formulations and alternative delivery methods can enhance patient convenience and safety, opening additional markets.

• Regulatory and Reimbursement Trends: Positive guideline updates and favorable reimbursement policies will be pivotal in determining penetration rates.

Potential Risks

• Market saturation in developed regions may limit growth.
• The emergence of new, safer, or more cost-effective sedatives could displace Precedex.
• Regulatory hurdles related to off-label uses or safety concerns could impact future approval pathways.

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Key Takeaways

• Clinical Validation: Precedex remains backed by robust clinical data, especially in ICU sedation and delirium prevention, reinforcing its growing clinical role.

• Market Growth: The global dexmedetomidine market is projected to grow at a CAGR of approximately 7-8% through 2030, driven by increasing critical care needs, procedural sedation, and expanding indications.

• Competitive Edge: Its safety profile and guideline endorsements position Precedex favorably, though price and safety concerns necessitate strategic positioning.

• Innovation & Expansion: The future lies in developing new formulations, expanding indications, and penetrating emerging markets, which will further cement Precedex's market dominance.

• Regulatory & Economic Factors: Evolving policies, patent expiries, and healthcare economics will play critical roles in shaping its long-term market trajectory.

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FAQs

1. What are the primary clinical benefits of Precedex over traditional sedatives?
Precedex offers effective sedation with minimal respiratory depression, facilitates easy titration, and reduces delirium incidence, making it favorable over benzodiazepines and opioids in critical care settings.

2. Are there ongoing trials investigating new indications for dexmedetomidine?
Yes. Current research explores its application in neurocritical care, agitation management, procedural sedation, and psychiatric treatment, which may expand its market in coming years.

3. How might patent expirations affect Precedex’s market?
Patent expirations could lead to generic versions, increasing competition and reducing prices, potentially lowering profit margins but expanding access globally.

4. What are the main safety concerns associated with dexmedetomidine?
Cardiovascular effects, such as bradycardia and hypotension, are notable safety considerations requiring careful patient monitoring and dosage adjustments.

5. Will emerging competitors threaten Precedex’s market share?
Potentially. Development of alternative agents with comparable efficacy and safety profiles or lower costs could challenge Precedex's dominance if they gain regulatory approval and clinician acceptance.

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References

1. [1] Critical Care Medicine, "Sedative Efficacy of Dexmedetomidine Versus Lorazepam," 2021.
2. [2] MarketWatch, "Global Dexmedetomidine Market Forecast," 2022.
3. [3] Society of Critical Care Medicine, Guidelines for Sedation Practices, 2020.
4. [4] Drug patent and regulatory filings, Food and Drug Administration (FDA), 2023.
5. [5] ReportLinker, "Expanded Indications and Future Trends in Sedative Market," 2022.