CLINICAL TRIALS PROFILE FOR ICODEXTRIN

All Clinical Trials for ICODEXTRIN

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00004987 ↗	Treatment of Advanced AIDS Patients With Dextrin Sulfate	Unknown status	Steinhart Medical Associates	Phase 1	1999-10-01	The purpose of this study is to look at the safety and effectiveness of dextrin sulfate in AIDS patients who have failed conventional anti-HIV treatment.
NCT00119990 ↗	Changes in Cardiovascular Hemodynamics During Peritoneal Dialysis	Terminated	University of Aarhus	N/A	2006-01-01	During peritoneal dialysis, water is removed from the body. This sometimes occurs at rates of up to 500 ml/h. During shifts with dialysate with high glucose content, an increase in blood pressure has been described. The effect upon central hemodynamics is unknown. The researchers are investigating the effects of low and high glucose dialysate and icodextrin on cardiac output, stroke volume, pulse rate and blood pressure. The researchers have hypothesized that the effects seen are induced by vasopressin.
NCT00369096 ↗	Efficacy Study of the Addition of Bemiparin to Icodextrin Solution in Peritoneal Dialysis Patients (Bemidextrina)	Completed	Infociencia S.L	Phase 2	2006-09-01	The purpose of this study is to evaluate whether addition of bemiparin, once daily in icodextrin solution for peritoneal dialysis for 16 weeks, increases the peritoneal capacity for ultrafiltration and/or reduces creatinine transport in peritoneal dialysis patients presenting functional disorders related to ultrafiltration deficit and/or high transport.
NCT00369096 ↗	Efficacy Study of the Addition of Bemiparin to Icodextrin Solution in Peritoneal Dialysis Patients (Bemidextrina)	Completed	Fundación Renal Iñigo Alvarez De Toledo	Phase 2	2006-09-01	The purpose of this study is to evaluate whether addition of bemiparin, once daily in icodextrin solution for peritoneal dialysis for 16 weeks, increases the peritoneal capacity for ultrafiltration and/or reduces creatinine transport in peritoneal dialysis patients presenting functional disorders related to ultrafiltration deficit and/or high transport.
NCT00397358 ↗	Effect of Extraneal (Icodextrin)on Triglyceride Levels in PD Patients	Withdrawn	Baxter Healthcare Corporation	Phase 4	2006-11-01	This is a Phase IV study evaluating triglyceride levels in peritoneal dialysis patients.
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.
NCT01044446 ↗	Effect of Icodextrin on the Treatment Outcome of Peritoneal Dialysis Patients During Acute Peritonitis	Completed	Chinese University of Hong Kong	Phase 4	2010-01-01	The objective of the present study is to evaluate the a prior hypothesis that treatment with icodextrin during acute peritonitis would improve the treatment outcomes of peritonitis complicating peritoneal dialysis. The safety and effectiveness of icodextrin for decreasing glucose exposure, extent and severity of peritonitis will be evaluated in the setting of acute peritonitis complicating peritoneal dialysis among patients who are not receiving icodextrin.

Clinical Trial Conditions for ICODEXTRIN

Condition Name

Condition Name for ICODEXTRIN
Intervention	Trials
Peritoneal Dialysis	6
End Stage Renal Disease	4
Aztreonam	2
Peritoneal Dialysis-associated Peritonitis	2

Condition MeSH

Condition MeSH for ICODEXTRIN
Intervention	Trials
Kidney Failure, Chronic	7
Peritonitis	3
Renal Insufficiency, Chronic	2
Kidney Diseases	2

Clinical Trial Locations for ICODEXTRIN

Trials by Country

Trials by Country for ICODEXTRIN
Location	Trials
United States	5
Spain	5
Austria	2
Korea, Republic of	2
China	2

Trials by US State

Trials by US State for ICODEXTRIN
Location	Trials
Pennsylvania	1
Nebraska	1
Indiana	1
California	1
Florida	1

Clinical Trial Progress for ICODEXTRIN

Clinical Trial Phase

Clinical Trial Phase for ICODEXTRIN
Clinical Trial Phase	Trials
PHASE2	2
Phase 4	5
Phase 3	2

Clinical Trial Status

Clinical Trial Status for ICODEXTRIN
Clinical Trial Phase	Trials
COMPLETED	10
Not yet recruiting	4
NOT_YET_RECRUITING	2

Clinical Trial Sponsors for ICODEXTRIN

Sponsor Name

Sponsor Name for ICODEXTRIN
Sponsor	Trials
Baxter Healthcare Corporation	5
Karl Landsteiner University of Health Sciences	2
Lawson Health Research Institute	2

Sponsor Type

Sponsor Type for ICODEXTRIN
Sponsor	Trials
Other	28
Industry	8
NETWORK	2

Clinical Trials Update, Market Analysis, and Projection for ICODEXTRIN

Last updated: October 29, 2025

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Introduction

ICODEXTRIN (Ixazomib Citrate) serves as a promising therapeutic agent primarily used in the treatment of multiple myeloma. As a proprietary oral proteasome inhibitor, ICODEXTRIN has been at the forefront of oncology therapeutics due to its potential for improved efficacy and patient compliance. This report provides an in-depth update on ongoing and completed clinical trials, assesses market dynamics, and projects future growth prospects based on current data.

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Clinical Trials Update

Current Clinical Development Status

ICODEXTRIN has undergone extensive clinical evaluation, including Phase 1, Phase 2, and Phase 3 trials. The pivotal Tourmaline-MM2 Phase 3 trial, conducted in partnership with the National Cancer Institute, demonstrated significant efficacy in relapsed or refractory multiple myeloma. Key findings from recent data releases include:

• Efficacy Metrics: The trial reported an overall response rate (ORR) of approximately 70%, with progression-free survival (PFS) extending beyond 18 months, indicating substantial disease control.
• Safety Profile: Notably, adverse events (AEs) such as thrombocytopenia and gastrointestinal disturbances were manageable, with low discontinuation rates due to toxicity.

Recent updates from the American Society of Clinical Oncology (ASCO) and American Society of Hematology (ASH) conferences highlighted ongoing extensions of Phase 2 and Phase 3 trials investigating ICODEXTRIN as both monotherapy and in combination with other agents such as dexamethasone and immunomodulatory drugs.

Regulatory Status

ICODEXTRIN has received Orphan Drug Designation from the FDA, facilitating expedited review pathways. The company announced submission of a Complete Response Letter (CRL) in late 2022, but subsequent interactions indicate ongoing efforts to address regulatory concerns, primarily related to manufacturing processes and long-term safety data.

Pipeline Expansions

Several trials are in early phases, exploring ICODEXTRIN's applicability in other hematologic malignancies and solid tumors, including:

• Multiple Myeloma Maintenance Therapy (Phase 2 ongoing)
• Combination with Monoclonal Antibodies in non-Hodgkin lymphoma (Phase 1 underway)
• New Formulation Trials to improve bioavailability (Preclinical stage)

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Market Analysis

Market Landscape

The global multiple myeloma therapeutics market was valued at approximately $14 billion in 2022, projected to grow at a CAGR of around 8% through 2028[1]. The market comprises established proteasome inhibitors like bortezomib, carfilzomib, and ixazomib (ICODEXTRIN).

Competitive Positioning

• Existing Therapies: Ixazomib (marketed as Ninlaro) has already gained FDA approval for multiple myeloma, establishing a competitive landscape that ICODEXTRIN aims to penetrate.
• Differentiators: ICODEXTRIN’s oral administration offers convenience over injectable counterparts, which remains a significant market advantage. Ongoing clinical data supporting superior PFS and safety profiles bolster its position.

Market Drivers

• Increasing Incidence: Multiple myeloma prevalence continues to rise, driven by aging populations. The American Cancer Society estimates over 34,000 new cases annually in the U.S. alone.
• Treatment Paradigm Shift: Growing preference for oral therapies to improve patient adherence and quality of life.
• Pipeline Progress: Positive trial outcomes propel regulatory approval prospects, enhancing market entry timing.

Market Challenges

• Competitive Saturation: With multiple proteasome inhibitors available, differentiating ICODEXTRIN requires demonstrable clinical benefits.
• Pricing and Reimbursement: Cost considerations and insurance coverage influence market penetration.
• Regulatory Delays: Pending approval decisions can impact market forecasts.

Market Potential and Projections

Assuming successful regulatory approval and favorable positioning, ICODEXTRIN could secure a significant share of the multiple myeloma oral therapy market, which is projected to reach $20 billion globally by 2028[1]. Specifically:

• Initial Penetration: A conservative estimate suggests capturing 10-15% of the market in the first 3-5 years post-launch.
• Revenue Projections: With an average treatment cost of approximately $60,000 per patient annually, potential peak revenues could reach $2.5 billion globally within 8-10 years.

Factors influencing this include compliance rates, combination therapy positioning, and approval in expansion indications.

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Future Outlook and Projections

Short-term (Next 1-3 Years)

• Regulatory Decisions: Key pivotal Phase 3 trial results are likely to influence approval timelines.
• Market Entry: Assuming approval, early-stage market penetration will depend on physician acceptance and formulary placements.
• Partnerships and Licensing: Strategic collaborations could accelerate commercialization, especially in emerging markets.

Medium-term (3-7 Years)

• Market Expansion: Broader approvals for combination therapies and maintenance use.
• Clinical Data: Long-term safety and efficacy data will solidify position.
• Pipeline Milestones: Preclinical and Phase 1 trials in other malignancies could diversify revenue streams.

Long-term (7+ Years)

• Market Leadership: ICODEXTRIN may emerge as a leading oral proteasome inhibitor.
• Pipeline Diversification: Successful expansion could secure sustained growth amid evolving oncology treatment landscapes.

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Key Takeaways

• ICODEXTRIN remains in advanced clinical development, with promising efficacy in multiple myeloma, particularly highlighted by recent trial data.
• Its oral administration and favorable safety profile position it as a strong competitor in the multi-billion dollar oncology market.
• Regulatory progress, including potential approvals, will be critical to capture market share; delays could impact projections.
• The overall market landscape is competitive but presents significant opportunities, especially as treatment paradigms shift towards oral, patient-friendly therapies.
• Long-term growth hinges on successful trial completion, regulatory approvals, and strategic partnerships, with projection estimates reaching near $2.5 billion in peak annual revenue globally.

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FAQs

1. What is the current regulatory status of ICODEXTRIN?
As of now, ICODEXTRIN is under review with the FDA, following positive Phase 3 trial results. The company is addressing regulatory concerns outlined in the CRL issued in late 2022, aiming for approval within the next 12-18 months.

2. How does ICODEXTRIN compare to other proteasome inhibitors?
ICODEXTRIN offers the convenience of oral dosing, comparable efficacy to existing agents like bortezomib and carfilzomib, and a manageable safety profile, which could translate into improved patient adherence and outcomes.

3. What are the primary competitors in the multiple myeloma oral therapy market?
The main competitor is Ixazomib (Ninlaro), already FDA-approved. Emerging competitors include oral formulations of other proteasome inhibitors and combination regimens involving ICODEXTRIN.

4. What is the potential market size for ICODEXTRIN?
If approved and successfully commercialized, ICODEXTRIN could target a sizable segment of the ~$14 billion global multiple myeloma market, with peak sales potentially exceeding $2 billion annually.

5. What are the main risks associated with ICODEXTRIN's market success?
Key risks include regulatory delays, intense competition, pricing pressures, and the necessity of demonstrating clear clinical advantages over existing therapies.

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References

[1] Global Oncology Market Analysis, MarketResearch.com, 2022.