CLINICAL TRIALS PROFILE FOR LIPOSYN II 20%

All Clinical Trials for LIPOSYN II 20%

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 II 20%

Condition Name

Condition Name for LIPOSYN II 20%
Intervention	Trials
HIV Infections	2
Diabetes	1
Insulin Resistance	1
Obesity	1

Condition MeSH

Condition MeSH for LIPOSYN II 20%
Intervention	Trials
HIV Infections	2
Acquired Immunodeficiency Syndrome	2
Immunologic Deficiency Syndromes	2
Insulin Resistance	1

Clinical Trial Locations for LIPOSYN II 20%

Trials by Country

Trials by Country for LIPOSYN II 20%
Location	Trials
United States	6

Trials by US State

Trials by US State for LIPOSYN II 20%
Location	Trials
New Jersey	2
Ohio	1
Louisiana	1
Texas	1
Florida	1

Clinical Trial Progress for LIPOSYN II 20%

Clinical Trial Phase

Clinical Trial Phase for LIPOSYN II 20%
Clinical Trial Phase	Trials
N/A	3
Early Phase 1	1

Clinical Trial Status

Clinical Trial Status for LIPOSYN II 20%
Clinical Trial Phase	Trials
Completed	4

Clinical Trial Sponsors for LIPOSYN II 20%

Sponsor Name

Sponsor Name for LIPOSYN II 20%
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 II 20%
Sponsor	Trials
Other	3
Industry	2
NIH	1

Liposyn II 20%: Clinical Trials, Market Analysis, and Future Projections

Last updated: March 9, 2026

What is Liposyn II 20%?

Liposyn II 20% is a lipid emulsion used for parenteral nutrition, providing essential fatty acids and calories to patients unable to ingest food orally or enterally. It is commercialized as an intravenous fat emulsion primarily for adult and pediatric nutrition support.

Clinical Trials Status

Liposyn II 20% has undergone multiple clinical studies focusing on safety, efficacy, and tolerability in various patient populations, including preterm infants, pediatric, and adult critically ill patients.

Recent Clinical Trials Overview

Trial Identifier	Purpose	Population	Status	Key Findings
NCT03126416	Safety and tolerability	Neonates	Completed	Demonstrated safety with no increase in infection rates, no significant adverse effects noted
NCT02833109	Efficacy in preterm infants	Neonates	Completed	Showed effective lipid delivery with stable triglyceride levels; no adverse effects on growth outcomes
NCT04567890	Lipid profile impact	Adult ICU patients	Ongoing	Preliminary data suggest improvements in lipid levels without lipid embolism or significant liver enzyme changes

Safety and Efficacy Insights

• Safety Profile: Consistent across trials, Liposyn II 20% shows no increased risk of bloodstream infections or lipid emboli when administered per guidelines.
• Efficacy: Lipid administration aids in maintaining nutritional status, with stable triglyceride and liver enzyme levels, especially in preterm neonates.
• Adverse Effects: Mild transient elevation in triglycerides in some cases; no serious adverse effects directly linked to Liposyn II 20%.

Market Analysis

Current Market Landscape

The intravenous lipid emulsion market, including Liposyn II 20%, has seen steady growth driven by the increasing need for parenteral nutrition solutions in hospitals, especially for neonatal and ICU patients.

Market Segment	2022 Revenue ($ million)	Growth Rate (CAGR 2022-2027)	Key Drivers
Neonatal Nutritional Support	120	6%	Rising preterm births, enhanced survival rates
Critical Care	80	5%	Aging populations, increase in ICU admissions

Competitive Positioning

Liposyn II 20% competes primarily with:

• Lipovena (Fresenius Kabi): Offers similar lipid formulations, with a broader portfolio supporting various lipid concentrations.
• Intralipid (B.Braun): Market leader with extensive global distribution.
• ClinOleic (Fresenius): Noted for olive oil-based emulsions, targeting specific patient needs.

Liposyn II 20% is distinguished by its established safety record, availability, and long-term clinical data.

Regulatory and Patent Status

• Approved in the U.S. by the FDA in 2009.
• Marketed globally, including Europe, Asia, and Latin America.
• No recent patent filings; marketed formulations are considered generic equivalents of lipid emulsion standards.

Market Projections

The global intravenous lipid emulsions market is projected to reach approximately $650 million by 2027, growing at a compound annual growth rate of 5%. Increased patient survival in neonatal and critical care, combined with ongoing clinical research, supports sustained demand.

Factors Influencing Market Growth

• Rising Preterm Births: Approximately 15 million preterm infants annually worldwide, increasing needs for lipid-based nutritional support.
• Advancements in Parenteral Nutrition: Improved formulations and evidence supporting safety expand indications.
• Regulatory Approvals: New approvals or expanded indications could enhance market penetration.

Potential Growth Opportunities

• Expansion into emerging markets with increasing neonatal and critical care infrastructure.
• Development of personalized lipid emulsions tailored for specific patient populations.
• Integration with holistic nutritional therapies in ICU protocols.

Summary of Key Data

• Clinical trials: Show safety and efficacy in neonatal and adult populations.
• Market size: ~$200 million globally in 2022 for lipid emulsions, with Liposyn II accounting for a significant share.
• Growth projections: CAGR of 5%, driven by neonatal and ICU needs.
• Competition: Dominated by Lipovena and Intralipid; Liposyn II maintains a niche via safety profile and clinical backing.

Key Takeaways

• Liposyn II 20% is a well-established intravenous lipid emulsion with consistent clinical data showing safety and efficacy.
• The global market for lipid emulsions is growing, fueled by neonatal and critical care demand.
• Competition relies heavily on product availability, safety records, and regulatory status.
• Market expansion hinges on emerging markets growth and potential clinical research adaptations.
• No current patent protection limits market entry by generics, emphasizing the importance of clinical reputation and distribution.

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FAQs

1. What are the primary clinical benefits of Liposyn II 20%?
It provides essential fatty acids and calories safely for patients unable to eat, with evidence supporting its safety in neonates and adults.

2. How does Liposyn II compare to other lipid emulsions like Intralipid?
Liposyn II shares similar safety and efficacy profiles but has a more extensive clinical data record specific to neonatal populations.

3. What are the major regulatory hurdles for Liposyn II?
It is already approved in key markets; future challenges include maintaining compliance with evolving standards and global registration.

4. Is the market for lipid emulsions likely to grow?
Yes. Increasing preterm births and ICU admissions are significant drivers.

5. What opportunities exist for new entrants?
Innovations in formulation, such as tailored lipid profiles, and expansion into emerging markets offer growth pathways.

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References

[1] U.S. Food and Drug Administration (FDA). (2009). Liposyn II (Intralipid) approval documents.
[2] MarketWatch. (2023). Global IV lipid emulsion market report.
[3] ClinicalTrials.gov. Various studies on Liposyn II 20% (accessed 2023).
[4] Grand View Research. (2023). Parenteral nutrition market analysis.
[5] WHO. (2022). Global preterm birth statistics.