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.
NCT00538616 ↗	Precedex Versus Propofol-Awakening for Reducing Brain Injury Expansion	Completed	Hospira, Inc.	Phase 1/Phase 2	2008-01-01	The purpose of this study is to evaluate brain injury when two different drugs (propofol and precedex) are used to sedate patients who need a neurologic exam.

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
Japan	3

Trials by US State

Trials by US State for DIPRIVAN
Location	Trials
California	9
New York	9
North Carolina	7
Texas	6
Pennsylvania	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, now a wholly owned subsidiary of Pfizer	4
Merck Sharp & Dohme Corp.	4
Hospira, Inc.	4

Sponsor Type

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

Diprivan (propofol): Clinical Trials Update, Market Analysis, and 2025-2035 Projections

Last updated: April 28, 2026

What is Diprivan in the product and regulatory context?

Diprivan is the brand name for propofol, an injectable intravenous anesthetic used for induction and maintenance of anesthesia and for sedation in procedural settings (including ICU sedation in some markets). Propofol is a mature, widely genericized small-molecule product. As a result, the competitive landscape is dominated by originator supply vs. generic penetration, with clinical development centered on formulation, delivery systems, and peri-procedural sedation practice, rather than new molecular entities.

What is the current clinical trial activity for Diprivan (propofol) and how should it be interpreted?

A complete “Diprivan-specific” clinical trials update is not reliably extractable from public trial registries in a way that cleanly maps trials to the branded product versus generic propofol, because most interventional studies list propofol (the active ingredient) rather than brand-level identifiers. Under this constraint, the practical view for business decisions is:

• Most active interventional work is propofol-centric, targeting sedation depth, dosing regimens, infusion strategies, perioperative workflows, and new delivery formats.
• Brand ownership does not generally translate into differentiated clinical claims, unless a trial explicitly evaluates a proprietary formulation, device, or regulated label expansion tied to the originator product.
• Late-stage trials for entirely new propofol indications are uncommon given the long-established clinical use and generic competition.

Implication for R&D

If the commercial strategy is to defend or extend market position, the realistic clinical path is:

• comparative effectiveness and safety in specific procedural contexts,
• label-like claims for sedation protocols or delivery improvements,
• outcomes research that supports perioperative adoption.

Implication for investment

The trial pipeline should be evaluated as “propofol practice evolution,” not “brand-based IP re-leveraging,” because manufacturing and pricing pressure from generics typically dominates market outcomes more than incremental trial results.

What does the market look like today for propofol brands including Diprivan?

Propofol has a large global addressable market driven by:

• high procedure volumes across surgery, endoscopy, and anesthesia,
• ICU sedation demand (in markets where it is guideline-supported),
• rapid onset, predictable recovery profile, and broad clinician familiarity.

Competitive structure

1. Originator vs. generics

   • Diprivan competes against multiple generic propofol presentations.
   • Pricing pressure is structural: propofol is off-patent in many regions and manufactured at scale.

2. Product format competition

   • Sedation and anesthesia settings influence whether competitors differentiate on packaging, concentration, and administration devices.
   • Where delivery systems matter, originators can sometimes retain share through distribution and clinician preference.

3. Hospital procurement dynamics

   • Tender-driven purchasing and formularies heavily affect originator share.
   • Switching costs are low for active ingredient substitutions, making market share sensitive to price and supply reliability.

Key demand drivers

• Procedure growth in ambulatory surgery and GI endoscopy.
• Aging populations increasing surgery and sedation needs.
• Guideline-driven sedation practices that emphasize titratable IV sedation.

What are the pricing and margin dynamics?

Propofol market economics tend to follow:

• downward price trends as generics expand,
• volatility driven by supply shocks and manufacturing capacity constraints,
• margin compression at the originator level unless differentiated on logistics, contracting, or presentation.

For a mature active ingredient, market share gains usually require one of:

• differentiated contracting terms,
• controlled supply and distribution strength,
• presentation differentiation that reduces substitution.

What are the 2025-2035 market projections for Diprivan and what are the assumptions implied by propofol maturity?

Because Diprivan is propofol, projections must be interpreted through an active-ingredient lens. The most decision-relevant scenario set is:

• Total propofol demand grows with procedures and sedation needs.
• Diprivan share faces a ceiling from generic substitution unless a region maintains tighter procurement barriers or originator presentations remain preferred.
• Market value growth is likely lower than volume growth due to ongoing price competition.

Projection framework (scenario-based, market-mechanics view)

Metric	2025 base (directional)	2025-2035 trajectory	Primary driver
Global propofol volume	High	Moderate growth	Procedure volume expansion
Global propofol value	Pressure	Slower growth	Generic price competition
Diprivan unit share	Lower than active-ingredient total share in many markets	Likely stable-to-declining	Substitution and tenders
Diprivan revenue	Mature/pressured	Flat-to-slow growth	Contracting and price erosion

Business takeaway: even if propofol usage rises, branded revenue growth is constrained unless Diprivan gains defensible share through contracting, supply, or differentiated presentation.

What are the likely “clinical update” themes that move adoption in propofol sedation?

Clinical trial activity around propofol tends to cluster into a few practical themes that influence formulary decisions:

1. Sedation quality and safety endpoints

   • Hypotension, respiratory depression, oversedation/undersedation.
   • Recovery time and post-procedure adverse events.

2. Dosing and workflow optimization

   • Target-controlled infusion comparisons vs. manual dosing.
   • Protocolized sedation in procedural suites to standardize outcomes.

3. Device and administration improvements

   • Packaging and infusion handling to reduce dosing errors.
   • Delivery-system trials that aim for consistent concentration and administration.

4. Population-specific protocols

   • Elderly patients, obese patients, pediatrics (where applicable), and ICU sedation protocols.

Where is IP risk and brand defense most likely to fail or succeed?

For Diprivan, the dominant IP reality is that the molecule is mature. Brand defense typically works only when:

• a region maintains strong originator procurement,
• formulation or delivery remains regulated and differentiated,
• there are sustained supply advantages tied to contracting,
• clinical endpoints are used to justify protocol preference.

Brand defense usually fails when:

• procurement is price-led with easy substitution,
• competitors match presentation and concentration,
• supply disruptions shift switching behavior permanently.

Market outlook by geography (decision-useful pattern)

Without region-by-region Diprivan brand-tracking data, the reliable pattern for propofol is:

• High generic penetration markets show slower branded value growth and greater share volatility.
• Markets with originator retention in anesthesia tenders can show more stable originator volumes but still face price pressure.
• Regulated supply and hospital formulary cycles can delay switching, creating temporary hold-up benefits.

Actionable conclusions for R&D and commercial planning

1) How to use clinical trial data

Treat propofol trial results as evidence for protocol and safety optimization, not as brand-differentiating clinical breakthroughs.

2) How to plan for the market

Plan for:

• continued generic substitution,
• procurement-driven contracting,
• supply and distribution as a core competitive lever.

3) Where value can still be captured

Value capture is most feasible through:

• differentiated presentation and administration handling,
• outcomes-driven contracting tied to procedural reliability,
• payer and hospital pathway alignment to reduce adoption friction.

Key Takeaways

• Diprivan is propofol, a mature anesthetic with heavy generic competition, so branded performance depends more on procurement and presentation differentiation than on new molecular clinical claims.
• A “Diprivan-specific” clinical trials update is not cleanly separable from propofol-centric trials, which mainly target sedation protocols, safety endpoints, dosing strategies, and delivery systems.
• Volume growth for propofol is supported by procedure and sedation demand, while branded value growth is constrained by price erosion and substitution dynamics.
• Over 2025-2035, expect flat-to-slow Diprivan branded revenue growth with possible stability in higher-resistance procurement channels, assuming no major differentiated formulation or device-driven label expansion.

FAQs

1. Is Diprivan still growing as a branded product?
   Branded growth is constrained by generic substitution; overall propofol demand can rise while brand value growth is limited by pricing.

2. Do propofol clinical trials translate into branded advantage for Diprivan?
   Usually only if trials evaluate a proprietary formulation, device, or label-relevant differentiation tied to Diprivan; most studies are active-ingredient based.

3. What outcomes matter most in propofol sedation trials for adoption?
   Safety and efficiency endpoints dominate: hypotension, respiratory depression, sedation depth control, and recovery/post-procedure events.

4. What is the biggest commercial risk for Diprivan?
   Continued price compression from generic competition and tender-driven switching.

5. Where can Diprivan defend share despite generics?
   Through stronger contracting, reliable supply, and any sustained differentiation in presentation or administration that affects clinician workflow and outcomes.

References

[1] U.S. National Library of Medicine. ClinicalTrials.gov. (Accessed 2026-04-28). https://clinicaltrials.gov/
[2] U.S. Food and Drug Administration. Drug Trials Snapshots / Drug Labels (propofol and related products). (Accessed 2026-04-28). https://www.fda.gov/