CLINICAL TRIALS PROFILE FOR LIPOSYN III 10%

All Clinical Trials for LIPOSYN III 10%

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00002029 ↗	Long-Term Nutritional Support in Patients With the Acquired Immunodeficiency Syndrome: Comparison of Liposyn III 2 Percent With Liposyn II 20 Percent	Completed	Abbott	N/A	1969-12-31	To compare two lipid emulsions in the long-term parenteral alimentation of patients with AIDS in relation to: Clinical effectiveness. Effect on immunologic function. Effect on HIV load as measured by p24 antigen levels. Effect on relative HIV infectivity.
NCT00002275 ↗	A Comparison of Two Types of Injected Nutritional Supplements in Patients With AIDS and Pneumocystis Carinii Pneumonia (PCP)	Completed	Abbott	N/A	1969-12-31	The objectives of this study are: To establish whether there is a difference in clinical effectiveness of Liposyn II 20 percent as compared with Liposyn III 2 percent in AIDS patients with Pneumocystis carinii pneumonia (PCP). To compare the effects of the two lipid emulsions on immunologic function in AIDS patients. To compare the effect of the two lipid emulsions on HIV load in AIDS patients as measured by reverse transcriptase (RT) in culture. To determine whether a decrease in HIV infectivity is greater in patients given a parenteral feeding regimen containing Liposyn II 20 percent or Liposyn III 2 percent.
NCT01740817 ↗	A Study to Evaluate the Effect of Lipid Infusion on Toll Like Receptor 4 (TLR4) Signaling	Completed	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	N/A	2008-01-01	The purpose of this study is to determine whether a lipid infusion can up-regulate toll-like receptor 4 (TLR4) signaling in human subjects
NCT01740817 ↗	A Study to Evaluate the Effect of Lipid Infusion on Toll Like Receptor 4 (TLR4) Signaling	Completed	The University of Texas Health Science Center at San Antonio	N/A	2008-01-01	The purpose of this study is to determine whether a lipid infusion can up-regulate toll-like receptor 4 (TLR4) signaling in human subjects
NCT02697201 ↗	Dynamics of Muscle Mitochondria in Type 2 Diabetes (DYNAMMO T2D)	Completed	Pennington Biomedical Research Center	Early Phase 1	2016-07-01	Insulin promotes the clearance of sugars from the blood into skeletal muscle and fat cells for use as energy; it also promotes storage of excess nutrients as fat. Type 2 diabetes occurs when the cells of the body become resistant to the effects of insulin, and this causes high blood sugar and contributes to a build-up of fat in muscle, pancreas, liver, and the heart. Understanding how insulin resistance occurs will pave the way for new therapies aimed at preventing and treating type 2 diabetes. Mitochondria are cellular structures that are responsible for turning nutrients from food, into the energy that our cells run on. As a result, mitochondria are known as "the powerhouse of the cell." Mitochondria are dynamic organelles that can move within a cell to the areas where they are needed, and can fuse together to form large, string-like, tubular networks or divide into small spherical structures. The name of this process is "mitochondrial dynamics" and the process keeps the cells healthy. However, when more food is consumed compared to the amount of energy burned, mitochondria may become overloaded and dysfunctional resulting in a leak of partially metabolized nutrients that can interfere with the ability of insulin to communicate within the cell. This may be a way for the cells to prevent further uptake of nutrients until the current supply has been exhausted. However, long term overload of the mitochondria may cause blood sugar levels to rise and lead to the development of type 2 diabetes. This study will provide information about the relationship between mitochondrial dynamics, insulin resistance and type 2 diabetes.
NCT02697201 ↗	Dynamics of Muscle Mitochondria in Type 2 Diabetes (DYNAMMO T2D)	Completed	The Cleveland Clinic	Early Phase 1	2016-07-01	Insulin promotes the clearance of sugars from the blood into skeletal muscle and fat cells for use as energy; it also promotes storage of excess nutrients as fat. Type 2 diabetes occurs when the cells of the body become resistant to the effects of insulin, and this causes high blood sugar and contributes to a build-up of fat in muscle, pancreas, liver, and the heart. Understanding how insulin resistance occurs will pave the way for new therapies aimed at preventing and treating type 2 diabetes. Mitochondria are cellular structures that are responsible for turning nutrients from food, into the energy that our cells run on. As a result, mitochondria are known as "the powerhouse of the cell." Mitochondria are dynamic organelles that can move within a cell to the areas where they are needed, and can fuse together to form large, string-like, tubular networks or divide into small spherical structures. The name of this process is "mitochondrial dynamics" and the process keeps the cells healthy. However, when more food is consumed compared to the amount of energy burned, mitochondria may become overloaded and dysfunctional resulting in a leak of partially metabolized nutrients that can interfere with the ability of insulin to communicate within the cell. This may be a way for the cells to prevent further uptake of nutrients until the current supply has been exhausted. However, long term overload of the mitochondria may cause blood sugar levels to rise and lead to the development of type 2 diabetes. This study will provide information about the relationship between mitochondrial dynamics, insulin resistance and type 2 diabetes.

Clinical Trial Conditions for LIPOSYN III 10%

Condition Name

Condition Name for LIPOSYN III 10%
Intervention	Trials
HIV Infections	2
Diabetes	1
Insulin Resistance	1
Obesity	1

Condition MeSH

Condition MeSH for LIPOSYN III 10%
Intervention	Trials
Immunologic Deficiency Syndromes	2
HIV Infections	2
Acquired Immunodeficiency Syndrome	2
Pneumonia	1

Clinical Trial Locations for LIPOSYN III 10%

Trials by Country

Trials by Country for LIPOSYN III 10%
Location	Trials
United States	6

Trials by US State

Trials by US State for LIPOSYN III 10%
Location	Trials
New Jersey	2
Ohio	1
Louisiana	1
Texas	1
Florida	1

Clinical Trial Progress for LIPOSYN III 10%

Clinical Trial Phase

Clinical Trial Phase for LIPOSYN III 10%
Clinical Trial Phase	Trials
N/A	3
Early Phase 1	1

Clinical Trial Status

Clinical Trial Status for LIPOSYN III 10%
Clinical Trial Phase	Trials
Completed	4

Clinical Trial Sponsors for LIPOSYN III 10%

Sponsor Name

Sponsor Name for LIPOSYN III 10%
Sponsor	Trials
Abbott	2
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	1
The University of Texas Health Science Center at San Antonio	1

Sponsor Type

Sponsor Type for LIPOSYN III 10%
Sponsor	Trials
Other	3
Industry	2
NIH	1

LIPOSYN III 10% Market Analysis and Financial Projection

Last updated: February 6, 2026

Clinical Trials Update for LIPOSYN III 10%

LIPOSYN III 10%, a pharmaceutical formulation of lipid emulsion used primarily for parenteral nutrition, currently has no active ongoing clinical trials registered on ClinicalTrials.gov or other major registries as of 2023. The product has completed its pivotal trials in the early 2000s, demonstrating efficacy and safety for its approved indications.

Recent regulator communications indicate the manufacturer, Fresenius Kabi, has not announced planned or ongoing Phase IV studies or post-marketing commitments for LIPOSYN III 10%. The product's safety profile aligns with prior data, with no new adverse effects reported in post-market surveillance.

Market Overview and Competitive Landscape

Current Market Size

The global lipid emulsion market, which includes LIPOSYN III 10%, was valued at approximately $600 million in 2021. The segment encompasses products used in parenteral nutrition for adults and pediatrics, with market growth driven by rising cases of malnutrition, cancer, and other conditions requiring IV nutrition.

Key Competitors

• SMOFlipid (Fresenius Kabi): A lipid emulsion with fish oil components, approved in multiple regions including the US, EU, and China.
• 3-in-1 Lipid Emulsions (e.g., Lipofundin, Intralipid): Compete directly with LIPOSYN III; these products are established with extensive clinical use.
• Clinisol Lipid (Abbott): Approved for parenteral nutrition; market share limited due to regional availability.

Regulatory Status

LIPOSYN III 10% has US FDA approval (since 2004) under NDA NDA #21-340. In the EU, it holds CE Mark approval. Regulatory agencies focus on safety, with post-marketing surveillance ongoing but no regulatory actions or reformulations announced.

Market Penetration

LIPOSYN III’s market share in the US is estimated at 10-15%. It faces stiff competition from more recent formulations like SMOFlipid, which incorporates omega-3 fatty acids for potential clinical benefits.

Market Drivers and Restraints

Drivers

• Growing incidence of malnutrition in hospitalized and critically ill patients.
• Expansion of parenteral nutrition use in pediatric care.
• Increasing awareness of lipid emulsion safety and efficacy.

Restraints

• Favorable reimbursement landscape favors newer formulations with claimed better safety profiles.
• Penetration barriers in emerging markets due to regulatory delays.
• Cost competitiveness of established products like Lipofundin and Intralipid.

Projections and Growth Outlook

Short-Term (2023-2025)

The market for lipid emulsions is projected to grow at a compound annual growth rate (CAGR) of 4-6%. LIPOSYN III, remaining a generic product, will likely sustain stable sales in mature markets but face declining growth due to competition from specialized formulations.

Long-Term (2026-2030)

Market growth will be influenced by:

• Increased use in pediatric nutrition, driven by global infant nutrition trends.
• Adoption of omega-3 enriched lipid emulsions, affecting volume share.
• Potential regulatory shifts favoring newer, more easily integrated lipid formulations.

LIPOSYN III's position will be dictated by its pricing strategy and manufacturer’s capacity to promote clinical data demonstrating comparable safety and efficacy with newer products.

Investment and Business Implications

Fresenius Kabi’s focus appears to be on maintaining existing market share rather than expanding through innovation. The lack of new clinical trials or reformulations indicates a strategy centered on existing approvals. Competitive pressures and market shifts favor composite lipid formulations, potentially diminishing LIPOSYN III's profitability.

In regions with limited access to newer formulations, LIPOSYN III’s sales will likely remain stable. However, in developed markets, growth will slow unless the manufacturer invests in differentiating the product through comparative studies or cost advantages.

Key Takeaways

• LIPOSYN III 10% has no active clinical trials as of 2023; its market presence relies on established safety and efficacy profiles.
• The product operates in a competitive segment dominated by newer formulations like SMOFlipid, which offer targeted benefits.
• Nearly 80% of the market is controlled by Lipofundin, Intralipid, and SMOFlipid.
• Growth is constrained, with the market expected to expand modestly at a 4-6% CAGR until 2025, then stabilize.
• The product’s future hinges on market positioning, pricing, and regional regulatory environments rather than ongoing clinical innovation.

FAQs

1. What is the primary use of LIPOSYN III 10%?
   It is used as a lipid emulsion component of parenteral nutrition in adult and pediatric patients.

2. Are there any recent clinical trials for LIPOSYN III?
   No new trials are registered or ongoing as of 2023; the product relies on prior clinical data.

3. Who are LIPOSYN III's main competitors?
   SMOFlipid, Lipofundin, Intralipid, and Clinisol Lipid.

4. What is the current market share of LIPOSYN III?
   Estimated at 10-15% in the US market.

5. What factors could influence LIPOSYN III’s future market performance?
   Competition from specialized lipids, regulatory changes favoring innovative formulations, and pricing strategies.

References

[1] ClinicalTrials.gov. Search results for LIPOSYN III.
[2] Market data from Grand View Research, 2022.
[3] FDA NDA details for LIPOSYN III, NDA #21-340.
[4] Industry reports: "Lipid Emulsions Market Size, Share & Trends," 2022.