CLINICAL TRIALS PROFILE FOR PROPOFOL

505(b)(2) Clinical Trials for Propofol

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
OTC	NCT01691690 ↗	Analgesic Effect of IV Acetaminophen in Tonsillectomies	Completed	Nationwide Children's Hospital	Phase 2	2012-10-01	Acetaminophen (paracetamol) is a first-line antipyretic and analgesic for mild and moderate pain for pediatric patients. Its common use (particularly in oral form) is underscored by its wide therapeutic window, safety profile, over the counter accessibility, lack of adverse systemic effects (as compared with NSAIDS and opioids) when given in appropriate doses. Although the exact anti-nociceptive mechanisms of acetaminophen continue to be elucidated, these mechanisms appear to be multi-factorial and include central inhibition of the cyclo-oxygenase (COX) enzyme leading to decreased production of prostaglandins from arachidonic acid, interference with serotonergic descending pain pathways, indirect activation of cannabinoid 1 (CB1) receptors and inhibition of nitric oxide pathways through N-methyl-D-aspartate (NMDA) or substance P. Of the above mechanisms, the most commonly known is that of central inhibition of COX enzymes by which the decreased production of prostaglandins diminish the release of excitatory transmitters of substance P and glutamate which are both involved in nociceptive transmission (Anderson, 2008; Smith, 2011). To date, several studies have shown acetaminophen's opioid sparing effect in the pediatric population when given by the rectal or intravenous routes (Korpela et al, 1999; Dashti et al, 2009; Hong et al, 2010).
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.

All Clinical Trials for Propofol

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00004424 ↗	Randomized Study of Propofol Versus Fentanyl and Midazolam in Pediatric Patients Requiring Mechanical Ventilation and Sedation Therapy	Completed	Case Western Reserve University	N/A	1996-07-01	OBJECTIVES: I. Assess the degree of amnesia afforded by study sedatives relative to the patient's intensive care unit experiences. II. Evaluate the efficacy and safety of propofol monotherapy compared to a conventional sedative regimen consisting of continuous infusion fentanyl and midazolam. III. Perform a detailed pharmacoeconomic evaluation of propofol sedation compared to combination drug therapy in acutely ill, mechanically ventilated pediatric patients.
NCT00004424 ↗	Randomized Study of Propofol Versus Fentanyl and Midazolam in Pediatric Patients Requiring Mechanical Ventilation and Sedation Therapy	Completed	FDA Office of Orphan Products Development	N/A	1996-07-01	OBJECTIVES: I. Assess the degree of amnesia afforded by study sedatives relative to the patient's intensive care unit experiences. II. Evaluate the efficacy and safety of propofol monotherapy compared to a conventional sedative regimen consisting of continuous infusion fentanyl and midazolam. III. Perform a detailed pharmacoeconomic evaluation of propofol sedation compared to combination drug therapy in acutely ill, mechanically ventilated pediatric patients.
NCT00095251 ↗	MENDS Study: Trial in Ventilated ICU Patients Comparing an Alpha2 Agonist Versus a Gamma Aminobutyric Acid (GABA)-Agonist to Determine Delirium Rates, Efficacy of Sedation, Analgesia and Discharge Cognitive Status	Completed	Vanderbilt University	Phase 2	2004-08-01	Delirium has recently been shown as a predictor of death, increased cost, and longer length of stay in ventilated patients. Sedative and analgesic medications relieve anxiety and pain, but may contribute to patients' transitioning into delirium. It is possible that modifying the paradigm for sedation using novel therapies targeted at different receptors, such as dexmedetomidine targeting alpha2 receptors and sparing the GABA receptors, could provide efficacious sedation yet reduce the development, duration, and severity of acute brain dysfunction (delirium).

Clinical Trial Conditions for Propofol

Condition Name

Condition Name for Propofol
Intervention	Trials
Anesthesia	212
Postoperative Pain	79
Pain	70

Condition MeSH

Condition MeSH for Propofol
Intervention	Trials
Pain, Postoperative	184
Delirium	78
Postoperative Nausea and Vomiting	49

Clinical Trial Locations for Propofol

Trials by Country

Trials by Country for Propofol
Location	Trials
United States	481
China	371
Egypt	247
Korea, Republic of	164
France	88

Trials by US State

Trials by US State for Propofol
Location	Trials
New York	42
California	39
Texas	38
Ohio	29
Illinois	28

Clinical Trial Progress for Propofol

Clinical Trial Phase

Clinical Trial Phase for Propofol
Clinical Trial Phase	Trials
PHASE4	95
PHASE3	23
PHASE2	20

Clinical Trial Status

Clinical Trial Status for Propofol
Clinical Trial Phase	Trials
COMPLETED	1085
Recruiting	400
Unknown status	229

Clinical Trial Sponsors for Propofol

Sponsor Name

Sponsor Name for Propofol
Sponsor	Trials
Yonsei University	59
Assiut University	42
Ain Shams University	38

Sponsor Type

Sponsor Type for Propofol
Sponsor	Trials
Other	2721
Industry	187
UNKNOWN	29

Clinical Trials Update, Market Analysis, and Projection for Propofol

Last updated: October 28, 2025

Introduction

Propofol, a short-acting sedative-hypnotic agent, remains central in anesthesia practice worldwide. Its rapid onset, favorable recovery profile, and versatility have cemented its status in both surgical anesthesia and intensive care. Given ongoing clinical developments, evolving regulatory landscapes, and market dynamics, this analysis provides a comprehensive update on clinical trials, current market conditions, and future projections for Propofol.

Clinical Trials and Research Developments

Ongoing Clinical Trials and Innovations

Despite its long-standing clinical use, recent research endeavors focus on optimizing Propofol administration and expanding its therapeutic scope. The majority of current trials aim to mitigate associated adverse effects, such as hypotension and respiratory depression, and explore novel delivery systems.

1. Enhanced Safety Profiles and Dosing Strategies

Several phase II and III trials investigate tailored dosing algorithms through advanced pharmacokinetic/pharmacodynamic (PK/PD) modeling. The goal: improving intraoperative hemodynamic stability, especially in vulnerable populations like pediatrics and the elderly. For example, a recent trial (NCT04812345) evaluated individualized Propofol dosing guided by real-time blood pressure monitoring, showing promising results in reducing hypotensive episodes.

2. Extended Applications and Combination Therapies

Research into combining Propofol with other agents aims to improve sedation quality and safety. Trials are examining adjunct agents such as ketamine or dexmedetomidine to lower Propofol doses, thereby reducing its cardiovascular effects. Additionally, exploratory studies are assessing Propofol's efficacy in procedural sedation beyond anesthesia, including ER and ICU settings.

3. Alternative Delivery Systems

Nanoparticle-based and controlled-release formulations of Propofol are in early testing phases. These innovations could extend Sedation duration, require fewer administrations, and improve patient outcomes, especially in resource-limited settings. For instance, a recent preclinical study demonstrated sustained release of Propofol from biodegradable nanoparticles, potentiating safer outpatient procedures.

Regulatory and Safety Monitoring

The FDA and EMA continue rigorous post-market surveillance, with some recent updates highlighting rare but serious adverse events such as Propofol infusion syndrome (PRIS). Towards this, clinical trials increasingly stratify patient populations and monitor biomarkers to refine safety profiles. As of 2023, no significant regulatory shifts have emerged, but ongoing research could influence labeling and usage guidelines.

Market Analysis

Current Market Landscape

Propofol remains a dominant product in anesthesia, with an estimated global market valuation exceeding USD 1.4 billion in 2022. Major manufacturers include Pfizer (Diprivan), Fresenius Kabi (Propofol-Lipuro), and Maruishi (Mundipharma). The drug’s widespread adoption is driven by its pharmacological profile supporting fast induction and recovery, critical in outpatient surgeries and ICU sedation.

Regional Market Dynamics

• North America: Dominates the market owing to high surgical volumes, advanced healthcare infrastructure, and favorable reimbursement policies.
• Europe: Significant usage, with growing interest in safer dosing protocols.
• Asia-Pacific: Rapidly expanding due to rising procedural volumes, expanding access, and government emphasis on healthcare infrastructure development.

Market Drivers and Constraints

Drivers:

• Growing volume of minimally invasive surgeries.
• Increased adoption of outpatient and same-day surgeries.
• Rising ICU admissions, particularly in COVID-19 post-pandemic recovery.
• The demand for rapid recovery agents facilitating faster patient turnover.

Constraints:

• Safety concerns, especially PRIS, impact prescribing practices.
• Alternative agents like dexmedetomidine gaining popularity.
• Stringent regulatory scrutiny on infusion-related adverse events.

Market Segmentation and Pricing Trends

Propofol formulations vary according to packaging, concentration, and adjunct compositions. Premium brands with enhanced safety profiles command higher prices. The emergence of generic formulations has intensified market competition, exerting downward price pressure, particularly in emerging markets.

Competitive Landscape & Innovation Trends

Innovation revolves around formulation improvements, such as lipid emulsion modifications reducing allergy risks, and safer infusion systems. Maruishi and other regional players focus on niche markets with modified formulations catering to specific patient populations (pediatric, geriatric). The pipeline indicates prospective new entrants focusing on bespoke sedation protocols and combination therapies.

Market Projection (2023–2030)

Growth Forecast and Trends

The global Propofol market is projected to grow at a CAGR of approximately 4.5% between 2023 and 2030, reaching USD 2.2 billion by 2030. This growth hinges on expanding surgical volume, technological innovations, and increasing procedural sedation demands.

Scenario 1: Optimistic

• Advances in safety profile and novel formulations lead to wider acceptance.
• Regulatory bodies endorse expanded indications, such as outpatient procedural sedation.
• Institutional adoption of smarter infusion systems reduces adverse events.

Scenario 2: Conservative

• Regulatory restrictions tighten, especially concerning infusion safety.
• The development of targeted alternatives, such as inhalational agents, diverts market share.
• Safety concerns limit Propofol use in certain vulnerable populations.

Key Growth Areas

• Outpatient and ambulatory surgery settings.
• ICU sedation, especially with evolving guidelines emphasizing early extubation.
• Emerging markets experiencing healthcare infrastructure growth.

Challenges and Opportunities

While clinical innovation offers opportunities to improve safety, regulatory hurdles could impede market penetration. Additionally, the growing role of non-Propofol sedatives—particularly dexmedetomidine—presents competitive challenges. However, ongoing research into enhanced formulations and delivery systems may carve new niche markets.

Conclusions

Propofol’s clinical utility remains unmatched, but safety concerns and emerging alternatives shape its market evolution. Continuous innovation, rigorous clinical research, and regulatory adaptation are vital to sustain growth. Manufacturers and healthcare providers must navigate safety profiles, emerging technologies, and regional market variations.

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Key Takeaways

• Recent clinical trials focus on personalized dosing, safety improvements, and alternative delivery routes.
• The Propofol market remains robust, driven by procedural volume growth, with potential expansion into outpatient and ICU settings.
• Innovations in formulations and infusion systems may enhance safety, expanding clinical applications.
• Market growth is projected at approximately 4.5% CAGR through 2030, with emerging markets playing an increasing role.
• Safety concerns, particularly related to PRIS, and competition from alternative sedatives are critical factors influencing future trends.

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FAQs

1. How are new clinical trials impacting Propofol’s safety and efficacy?
Recent trials aim to optimize dosing, introduce safer formulations, and reduce adverse events like hypotension and PRIS. These advancements could lead to broader, safer use across patient populations.

2. What are the main factors influencing Propofol market growth?
Growth factors include rising surgical volumes, increased ICU admissions, innovation in delivery systems, and expanding outpatient procedures. Regulatory and safety concerns remain challenges.

3. How do regional differences affect Propofol’s market adoption?
North America and Europe are primary markets due to advanced healthcare infrastructure. Asia-Pacific offers high growth potential owing to expanding healthcare access, though price sensitivity limits premium formulations.

4. Are there new formulations or delivery methods for Propofol in development?
Yes, nanoparticle formulations, controlled-release systems, and lipid emulsion modifications are under investigation to improve safety and convenience.

5. What competitive threats could impact Propofol’s future market share?
The rise of alternative sedatives such as dexmedetomidine, safety concerns, and regulatory restrictions on infusion methods could affect Propofol's dominance.

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References

1. ClinicalTrials.gov: Database entries detailing ongoing Propofol studies.
2. Market research reports (e.g., Grand View Research, 2022).
3. Regulatory agency updates (FDA and EMA safety advisories).
4. Peer-reviewed journal articles on recent Propofol innovations and safety profiles.