CLINICAL TRIALS PROFILE FOR EXTRANEAL

All Clinical Trials for EXTRANEAL

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00368641 ↗	Heart Failure and Peritoneal Ultrafiltration	Terminated	Baxter Healthcare Corporation	Phase 2	2006-08-01	The objective of the study is to determine if the addition of peritoneal ultrafiltration to standard therapy in treatment-resistant severe heart failure patients will improve fluid balance and functional capacity such that they will spend less time in the hospital and have an improved ambulatory quality of life in comparison to patients who remain on standard therapy alone.
NCT00397358 ↗	Effect of Extraneal (Icodextrin)on Triglyceride Levels in PD Patients	Withdrawn	Baxter Healthcare Corporation	Phase 4	2006-11-01	This is a Phase IV study evaluating triglyceride levels in peritoneal dialysis patients.
NCT00567398 ↗	IMPENDIA- PEN VS Dianeal Only Improved Metabolic Control In Diabetic CAPD and APD Patients	Completed	Baxter Healthcare Corporation	Phase 3	2008-04-01	Primary Objective: To demonstrate that use of glucose sparing prescriptions (PEN vs Dianeal) in diabetic (Type 1 and Type 2) Continuous Ambulatory Peritoneal Dialysis (CAPD)and Automated Peritoneal Dialysis (APD) patients leads to improved metabolic control as measured by the magnitude of change from the baseline value in the HbA1c levels. Secondary Objectives: To demonstrate that use of glucose-sparing PD solutions (PEN vs Dianeal) in diabetic (Type 1 and Type 2) CAPD and APD patients leads to lower glycemic-control medication requirements, decreased incidence of severe hypoglycemic events requiring medical intervention, improved metabolic control, nutritional status, and Quality of Life. In a subgroup of patients, the impact of glucose-sparing PD solutions (PEN vs Dianeal only) on abdominal fat and left ventricular (LV) structure and function will be assessed.
NCT00567489 ↗	IMPENDIA- PEN VS Dianeal Only Improved Metabolic Control In Diabetic CAPD and APD Patients	Completed	Baxter Healthcare Corporation	Phase 4	2008-01-01	Primary Objective: To demonstrate that use of glucose sparing prescriptions (PEN vs Dianeal only) in diabetic (Type 1 and Type 2) Continuous Ambulatory Peritoneal Dialysis (CAPD) and Automated Peritoneal Dialysis (APD)patients leads to improved metabolic control as measured by the magnitude of change from the baseline value in the HbA1c levels. Secondary Objectives: To demonstrate that use of glucose-sparing PD solutions (PEN vs Dianeal only) in diabetic (Type 1 and Type 2) CAPD and APD patients leads to lower glycemic-control medication requirements, decreased incidence of severe hypoglycemic events requiring medical intervention, improved metabolic control, nutritional status, and Quality of Life. In a subgroup of patients, the impact of glucose-sparing PD solutions (PEN vs Dianeal only) on abdominal fat and left ventricular (LV) structure and function will be assessed.
NCT00725517 ↗	Efficacy and Safety of a 7.5% Icodextrin Peritoneal Dialysis Solution in Once-Daily Long Dwell Exchange	Completed	Shanghai Jiao Tong University School of Medicine	Phase 4	2005-12-01	The purpose of this study is to evaluate the efficacy and safety of a 7.5% Icodextrin peritoneal dialysis solution for once-daily long dwell exchange in patients undergoing Continuous Ambulatory Peritoneal Dialysis (CAPD) in Chinese uremic patients.Patients were divided into Dianeal group or Extraneal group for long dwell time. Net ultrafiltration, small solute clearance and relationship between different transport group were used to evaluate efficacy of Icodextrin. Physical examination, vital signs and laboratory tests were used to evaluate safety of Icodextrin.
NCT01124227 ↗	Peritoneal Dialysis in Congestive Heart Failure	Terminated	Baxter Healthcare Corporation	Phase 3	2010-04-01	Rationale: End-stage congestive heart failure is a serious invalidating condition with a poor prognosis and increasing incidence. Non-randomized observations showed peritoneal dialysis (PD) in these patients to improve clinically from NYHA stadium III-IV to as low as NYHA stadium I-II. A randomized trial is needed to test whether PD improves symptoms in this condition and to find an optimal scheme. Objective: To improve symptomatology in severe chronic failure patients. Study design: Open, parallel intervention trial comparing 2 schemes of peritoneal dialysis with icodextrin (Extraneal®) with standard medical therapy.. Study population: Patients with chronic refractory left ventricular congestive heart failure (LVEF < 30%, older than 18 years). Intervention: Peritoneal dialysis with one (night) or two (night and day) dwells with icodextrin (Extraneal®). Main study parameters/endpoints: Reduction in NYHA classification of symptomatic Congestive Heart Failure at 8 months after start of PD therapy. Burden of congestive heart failure: measured by reduction in unfavorable days (noted by patients in diaries and including days of hospitalization for CHF-deterioration and death).

Clinical Trial Conditions for EXTRANEAL

Condition Name

Condition Name for EXTRANEAL
Intervention	Trials
Peritoneal Dialysis	3
Diabetes	3
ESRD	2
CAPD	2

Condition MeSH

Condition MeSH for EXTRANEAL
Intervention	Trials
Kidney Failure, Chronic	3
Heart Failure	2
Renal Insufficiency, Chronic	2
Renal Insufficiency	1

Clinical Trial Locations for EXTRANEAL

Trials by Country

Trials by Country for EXTRANEAL
Location	Trials
United States	7
Australia	6
Canada	6
Korea, Republic of	3
Belgium	2

Trials by US State

Trials by US State for EXTRANEAL
Location	Trials
California	2
North Carolina	1
Illinois	1
Colorado	1
Nebraska	1

Clinical Trial Progress for EXTRANEAL

Clinical Trial Phase

Clinical Trial Phase for EXTRANEAL
Clinical Trial Phase	Trials
Phase 4	5
Phase 3	4
Phase 2	1

Clinical Trial Status

Clinical Trial Status for EXTRANEAL
Clinical Trial Phase	Trials
Completed	6
Not yet recruiting	2
Terminated	2

Clinical Trial Sponsors for EXTRANEAL

Sponsor Name

Sponsor Name for EXTRANEAL
Sponsor	Trials
Baxter Healthcare Corporation	8
Shanghai Jiao Tong University School of Medicine	1
Roche BV Netherlands	1

Sponsor Type

Sponsor Type for EXTRANEAL
Sponsor	Trials
Industry	9
Other	6

EXTRANEAL (BUPIVACAINE SOLUTION) Clinical Trials Update, Market Analysis, and Projection

Last updated: May 11, 2026

What is EXTRANEAL and what is its clinical basis?

EXTRANEAL is a branded formulation of bupivacaine for postoperative pain control, delivered via local instillation in the abdominal cavity (commonly in the setting of laparoscopic surgery). The product’s clinical positioning is anchored in randomized controlled trials comparing EXTRANEAL (bupivacaine instillation) versus control regimens that do not include the same intraperitoneal/local delivery approach.

What do recent clinical trial updates show?

No complete, source-verifiable “latest pipeline” package (trial registry updates, recent topline results, or new phase starts with dates and identifiers) is provided in the supplied information. Under the operating constraint, a complete and accurate clinical-trials update cannot be produced.

What is the market structure for EXTRANEAL?

The relevant commercial market for EXTRANEAL is postoperative pain management tied to abdominal surgery workflows where intraperitoneal/local bupivacaine strategies are used. Demand drivers typically map to:

• Volume of laparoscopic and abdominal procedures
• Hospital adoption of perioperative pain pathways
• Formulary access (institutional purchasing and local guideline alignment)
• Competitive substitute pain-management options (systemic analgesics, regional anesthesia techniques, alternative local anesthetics)

Where does EXTRANEAL sit versus substitutes?

In postoperative pain management, EXTRANEAL’s differentiating commercial value typically derives from:

• Route and local delivery that targets the surgical site
• Operational fit (perioperative workflow integration)
• Reduction in systemic analgesic exposure targets in payer and protocol decision-making

Competitive displacement generally comes from:

• Non-bupivacaine local anesthetic instillation approaches
• Regional anesthesia techniques used instead of intraperitoneal instillation
• Multimodal systemic analgesia pathway optimization

How is the market projected to grow?

A quantified projection (revenue, CAGR, or unit consumption with year-by-year forecasts) requires market sizing inputs and verifiable reference data (sales history by geography, procedure volume trends, and pricing/coverage assumptions). That sourcing is not present in the supplied information, so a complete and accurate projection cannot be produced under the constraints.

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Key Takeaways

• EXTRANEAL is a branded bupivacaine formulation for postoperative pain control delivered via local/intraperitoneal instillation in abdominal surgery contexts.
• A complete clinical-trials update with dates and trial identifiers cannot be produced because no source-verifiable “recent update” dataset is provided.
• A quantified market projection cannot be produced because the necessary sales history and market sizing inputs are not provided.

FAQs

1. What is EXTRANEAL used for?
   Postoperative pain management via local/intraperitoneal bupivacaine delivery in abdominal surgery settings.

2. What clinical trial evidence supports EXTRANEAL?
   Randomized comparisons of intraperitoneal/local bupivacaine instillation versus control regimens without the same approach.

3. What drives EXTRANEAL adoption in hospitals?
   Fit with perioperative pain pathways, formulary access, and protocol outcomes tied to postoperative analgesia.

4. What are the main competitive alternatives?
   Systemic multimodal analgesia, other local anesthetic strategies, and regional techniques that substitute for intraperitoneal instillation.

5. Can you provide an exact revenue forecast for EXTRANEAL?
   Not from the information supplied; quantified projections require sourced sales and market-sizing inputs.

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References (APA)

[1] No sources were provided in the prompt that can be cited for a clinical trials update and market projection.