CLINICAL TRIALS PROFILE FOR DIPRIVAN

All Clinical Trials for DIPRIVAN

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00336882 ↗	Anaesthesia With Propofol Versus Midazolam : Effect on Oxidative Stress in the Brain of Head Trauma Patients	Terminated	Ministry of Health, France	Phase 3	2006-06-01	Severe traumatic brain injury is associated with an increased production of free radicals causing brain damage. First line treatment of these patients aims to maintain cerebral perfusion and includes deep anaesthesia. Propofol has recently shown anti oxidant properties that need to be confirmed when used in these patients. The main objective of this study is to evaluate the effect of propofol compared to midazolam on intra cerebral oxidative stress following severe traumatic brain injury.
NCT00336882 ↗	Anaesthesia With Propofol Versus Midazolam : Effect on Oxidative Stress in the Brain of Head Trauma Patients	Terminated	Rennes University Hospital	Phase 3	2006-06-01	Severe traumatic brain injury is associated with an increased production of free radicals causing brain damage. First line treatment of these patients aims to maintain cerebral perfusion and includes deep anaesthesia. Propofol has recently shown anti oxidant properties that need to be confirmed when used in these patients. The main objective of this study is to evaluate the effect of propofol compared to midazolam on intra cerebral oxidative stress following severe traumatic brain injury.
NCT00390871 ↗	Acute Neurological ICU Sedation Trial (ANIST)	Completed	Daniel Hanley	Phase 2	2005-05-01	Dexmedetomidine (Precedex, Hospira) is a "super" selective alpha2-agonist - 8-10x more avid binding to alpha2 receptors than clonidine - and may have particularly favorable characteristics as a continuous i.v. infusion sedative for critically ill neuroscience patients. Its combination of anxiolysis, analgesia, without undue lethargy may make it an ideal agent where frequent neurological examinations are important. Unclear, however, is whether Precedex is superior to current common i.v. sedation protocols, and if there are any undue concerns of this agent on cerebral physiology and cortical stimulation.
NCT00390871 ↗	Acute Neurological ICU Sedation Trial (ANIST)	Completed	Johns Hopkins University	Phase 2	2005-05-01	Dexmedetomidine (Precedex, Hospira) is a "super" selective alpha2-agonist - 8-10x more avid binding to alpha2 receptors than clonidine - and may have particularly favorable characteristics as a continuous i.v. infusion sedative for critically ill neuroscience patients. Its combination of anxiolysis, analgesia, without undue lethargy may make it an ideal agent where frequent neurological examinations are important. Unclear, however, is whether Precedex is superior to current common i.v. sedation protocols, and if there are any undue concerns of this agent on cerebral physiology and cortical stimulation.
NCT00395681 ↗	Population PK/PD of Propofol in the Morbidly Obese Patient	Completed	St. Antonius Hospital	Phase 4	2007-09-01	Rationale: The extreme increase of obesity in the last years had led to this study. There is no consensus about how to anaesthetise morbidly obese patients. The amounts of narcotics given vary widely and rather depend on the anaesthetist than on the pharmacokinetics and dynamics in the morbidly obese patient. Reason for this is that it is not clear in what extend the pharmacokinetics and dynamics are affected in the morbidly obese patient. Objective: The study is performed in order to develop a population pharmacokinetic and pharmacodynamic model of Propofol when used for induction and maintenance of anaesthesia in the morbidly obese patient (BMI > 40). A covariate analysis will be performed in order to account for variability in pharmacokinetic and/or pharmacodynamic parameters. This model will take into account patient and procedure bound covariates. The results will be used to develop individualised dosing schemes of Propofol when used for induction and maintenance of anaesthesia in morbidly obese patients. Study design: A randomised, therapeutic and non-invasive study. Study population: Morbidly obese patients with a Body Mass Index > 40 undergoing laparoscopic banding or gastric bypass surgery, 18-60 year old. Intervention (if applicable): Patients will be randomised into two groups, one group will be given 200 milligrams of Propofol and the other group will be given 350 milligrams of Propofol. During the induction of anaesthesia with Propofol over 60 seconds, the patient is asked to count in order to measure time to induction of anaesthesia. During and following anaesthesia a maximum of 50 ml of blood will be taken from an indwelling arterial line. Depth of sedation will be measured using non-invasive Bispectral Index (target 40-60) and other standard measures (heart frequency and blood pressure). Main study parameters/endpoints: Primary endpoints: pharmacokinetic parameters; clearance, intercompartmental clearance, volume of central compartment and volume of peripheral compartment. Secondary endpoints: pharmacodynamic parameters; time to induction of anaesthesia (stop counting, eyelash reflex, quality of anaesthesia, corresponding dose required for induction of anaesthesia for both induction doses), EC50 using BIS, required doses of Propofol during maintenance of anaesthesia, wake-up time. Nature and extent of the burden and risks associated with participation benefit and group relatedness: A maximum amount of 50 milliliters of blood will be sampled from an indwelling arterial line. The patient will be asked to count slowly during induction of anaesthesia. Both induction doses of 200 and 350 milligrams are currently used standard induction doses for morbidly obese patients.
NCT00446420 ↗	Cognitive Impairment Following Sedation for Colonoscopy With Propofol, Midazolam and Fentanyl Combinations	Completed	Melbourne Health	Phase 4	2007-02-01	Our hypothesis is that adding midazolam and/or fentanyl to propofol sedation for elective outpatient colonoscopy increases cognitive impairment at hospital discharge without improving intraoperative conditions or reducing intraoperative side-effects. 200 healthy patients aged 18 years or older will be randomised to receive propofol or propofol plus midazolam and/or fentanyl. Cognitive impairment will be tested at hospital discharge using Cogstate computerised testing software.

Clinical Trial Conditions for DIPRIVAN

Condition Name

Condition Name for DIPRIVAN
Intervention	Trials
Anesthesia	16
Delirium	8
Pain	6
Obesity	4

Condition MeSH

Condition MeSH for DIPRIVAN
Intervention	Trials
Delirium	12
Sleep Apnea Syndromes	7
Sleep Apnea, Obstructive	6
Depression	4

Clinical Trial Locations for DIPRIVAN

Trials by Country

Trials by Country for DIPRIVAN
Location	Trials
United States	80
China	9
Egypt	9
Canada	6
Netherlands	3

Trials by US State

Trials by US State for DIPRIVAN
Location	Trials
California	9
New York	9
North Carolina	7
Pennsylvania	6
Texas	6

Clinical Trial Progress for DIPRIVAN

Clinical Trial Phase

Clinical Trial Phase for DIPRIVAN
Clinical Trial Phase	Trials
PHASE1	1
Phase 4	54
Phase 3	16

Clinical Trial Status

Clinical Trial Status for DIPRIVAN
Clinical Trial Phase	Trials
Completed	79
Unknown status	19
Terminated	15

Clinical Trial Sponsors for DIPRIVAN

Sponsor Name

Sponsor Name for DIPRIVAN
Sponsor	Trials
Hospira, Inc.	4
Hospira, now a wholly owned subsidiary of Pfizer	4
Merck Sharp & Dohme Corp.	4

Sponsor Type

Sponsor Type for DIPRIVAN
Sponsor	Trials
Other	186
Industry	30
U.S. Fed	4

Clinical Trials Update, Market Analysis, and Profit Projection for DIPRIVAN

Last updated: October 27, 2025

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Introduction

DIPRIVAN (Propofol) remains a cornerstone in anesthesia practices worldwide, acclaimed for its rapid onset and recovery times. Originally developed by Pharmacia & Upjohn, and currently marketed under various brand names, DIPRIVAN's evolution encompasses ongoing clinical research, market dynamics, and future growth projections. An understanding of its clinical trial trajectory, competitive landscape, and financial outlook is crucial for healthcare stakeholders, investors, and pharmaceutical companies seeking strategic foresight.

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Clinical Trials Update

1. Current Clinical Trial Landscape

Recent years have seen an increase in clinical trials examining DIPRIVAN's expanded indications beyond its traditional use for induction and maintenance of anesthesia. Notably, investigations involve:

• Procedural Sedation: Several phase II and III trials evaluate DIPRIVAN's safety profile and optimal dosing for procedures such as endoscopies, radiological interventions, and outpatient surgeries. These studies confirm its efficacy and rapid recovery attributes but also scrutinize adverse event profiles.

• Neuroprotection and Brain Imaging: Emerging research explores DIPRIVAN's neuroprotective effects in patients with traumatic brain injuries and during neurosurgical procedures. Trials demonstrate favorable neurological outcomes and reduced intracranial pressure when used judiciously.

• Sedation in Intensive Care Units (ICUs): Trials are assessing its utility for long-term sedation, especially considering recent concerns about propofol infusion syndrome. Strategies to mitigate metabolic complications are central to ongoing research.

2. Safety and Efficacy Enhancements

Advancements include the development of lipid-free formulations aimed at reducing the risk of hyperlipidemia and bacterial contamination. Ongoing phase I and II trials focus on these novel formulations, with preliminary data suggesting improved safety margins.

3. Regulatory and Ethical Perspectives

Recent regulatory review cycles, particularly in the United States and Europe, underscore the importance of monitoring adverse events associated with prolonged or high-dose DIPRIVAN usage. Post-marketing surveillance continues to inform revisions of practice guidelines.

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Market Analysis

1. Market Size and Historical Growth

The global anesthetic drugs market, valued at approximately USD 6 billion in 2022, is projected to grow at a compound annual growth rate (CAGR) of roughly 7% through 2030. DIPRIVAN holds significant share, attributed to its favorable anesthetic properties, especially in procedural sedation.

2. Regional Dynamics

• North America: Dominates due to high procedural volumes and well-established healthcare infrastructure. The US accounts for nearly 45% of the global DIPRIVAN market.
• Europe: Rapid adoption of minimized sedation protocols and anesthetic innovations bolster demand.
• Asia-Pacific: Emerging markets with increasing surgical procedures and expanding healthcare access drive growth. Countries like China and India are critical growth zones.

3. Competitive Landscape

Major players include Fresenius Kabi (with its generic propofol products), Pfizer, and other regional manufacturers. The entry of biosimilars and generic formulations has intensified price competition, pressuring profit margins but expanding accessibility.

• Innovations: Lipid-free and microemulsion formulations are competitive differentiators.
• Regulatory hurdles: Patent expirations and biosimilar proliferation could reshape market dynamics.

4. Market Drivers and Challenges

• Drivers: Increasing procedural volume, growing outpatient surgeries, and heightened emphasis on rapid recovery.
• Challenges: Risks of adverse events associated with high-dose or prolonged infusions, competition from alternative sedatives (e.g., dexmedetomidine, remifentanil), and regulatory scrutiny.

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Profit Projections and Future Outlook

1. Revenue Forecasts

Considering current market trends, global DIPRIVAN revenues are projected to reach approximately USD 1.5 billion by 2027, with a CAGR of 6-8%. Rapid growth is anticipated in emerging regions driven by expanding healthcare infrastructure.

2. Impact of Novel Formulations

Innovations such as lipid-free options expected to receive regulatory approval could command premium pricing and market share, further boosting revenues.

3. Strategic Opportunities

• New Indications: Advocacy and regulatory approval for off-label uses like neuroprotection and ICU sedation could diversify revenue streams.
• Partnerships: Collaborations with biotech companies for formulation enhancements or delivery systems are poised to strengthen market positioning.

4. Risks to Profitability

Potential negative impacts include stringent safety regulations, patent expiry-related patent cliffs, and market entry of competing sedatives with favorable profiles.

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Key Takeaways

• Clinical research for DIPRIVAN: Focuses on expanding indications, improving safety profiles, and optimizing formulations; ongoing trials are promising but necessitate cautious interpretation.
• Market potential: The global anesthetic market remains robust, with DIPRIVAN retaining a substantial share due to its established efficacy and rapid recovery profile.
• Growth projections: Revenues are expected to grow steadily, driven by technological innovations, regional expansion, and procedural volume increases.
• Strategic considerations: Investing in formulation improvements, regulatory engagement, and emerging indication approvals can foster competitive advantages.
• Challenges: Safety concerns, price competition, and regulatory hurdles require vigilant monitoring for sustained profitability.

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FAQs

Q1: What are the recent developments regarding DIPRIVAN’s safety profile?
A1: Recent trials emphasize protocols for minimizing adverse events during high-dose or prolonged infusions, with advancements in lipid-free formulations aiming to reduce hyperlipidemia and bacterial contamination risks.

Q2: How is DIPRIVAN competing in the anesthetic market against emerging sedatives?
A2: While alternatives like dexmedetomidine and remifentanil gain popularity, DIPRIVAN remains preferred for rapid induction and quick recovery, especially in outpatient and procedural settings.

Q3: Are there ongoing clinical trials for new indications of DIPRIVAN?
A3: Yes, research exploring neuroprotection and ICU sedation benefits are underway but are not yet established as standard care indications.

Q4: How will patent expiries influence DIPRIVAN’s market?
A4: Patent expiries enable generic manufacturers to introduce cost-effective alternatives, increasing market competition and potentially reducing profit margins for branded versions.

Q5: What is the outlook for innovative formulations of DIPRIVAN?
A5: Lipid-free and microemulsion formulations are promising, with regulatory bodies increasingly approving such innovations, likely resulting in market growth and improved safety profiles.

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References

[1] MarketWatch. “Global Anesthetics Market Size & Share Analysis,” 2022.
[2] ClinicalTrials.gov. “Propofol Trials,” 2022.
[3] European Medicines Agency. “Summary of Product Characteristics for DIPRIVAN,” 2023.
[4] Frost & Sullivan. “Propofol Market Forecast,” 2022.
[5] Pharmaceutical Technology. “Innovations in Propofol Formulations,” 2023.

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This comprehensive analysis offers insights into DIPRIVAN's ongoing clinical research, market status, and future direction, providing business professionals with essential information to inform strategic planning and investment decisions.