CLINICAL TRIALS PROFILE FOR LIPOSYN 20%

All Clinical Trials for LIPOSYN 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 20%

Condition Name

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

Condition MeSH

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

Clinical Trial Locations for LIPOSYN 20%

Trials by Country

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

Trials by US State

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

Clinical Trial Progress for LIPOSYN 20%

Clinical Trial Phase

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

Clinical Trial Status

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

Clinical Trial Sponsors for LIPOSYN 20%

Sponsor Name

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

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

Last updated: March 11, 2026

What is the current status of clinical trials for Liposyn 20%?

Liposyn 20% remains an intravenous lipid emulsion used primarily for parenteral nutrition in clinical settings. As of 2023, there are no publicly registered or ongoing clinical trials specifically evaluating Liposyn 20%. The drug has completed its initial safety and efficacy assessments in early-phase studies conducted decades ago. No recent updates indicate new trials or modifications in its clinical development status.

How does Liposyn 20% compare to similar lipid emulsions in clinical efficacy and safety?

Existing comparative data suggest Liposyn 20% is well-tolerated with a safety profile comparable to other lipid emulsions such as Intralipid and SMOFlipid. It offers a 20% lipid concentration, which allows for reduced infusion volumes.

• Safety profile: No significant adverse effects beyond mild, transient reactions typical of lipid infusions.
• Efficacy: Supports nutrient delivery with proven efficacy in adult and pediatric patients requiring parenteral nutrition.

What is the market landscape for Liposyn 20%?

Liposyn 20% is marketed by Fresenius Kabi, which holds significant market share in the intravenous lipid emulsion segment. The global market for injectable lipid emulsions was valued at approximately $950 million in 2022. It is expected to grow at a compound annual growth rate (CAGR) of 7% from 2023 to 2030, driven by increasing adoption of parenteral nutrition in hospitals and intensive care units.

Market segmentation indicates:

• By application: Parenteral nutrition (85%), specific therapeutic indications (15%).
• By geography: North America dominates with around 45% market share; Europe accounts for 30%, Asia-Pacific for 20%, and Rest of World for 5%.

Competitive landscape:

• Major competitors include Fresenius Kabi (Liposyn 20%), Baxter (Intralipid), and weyValley (SMOFlipid).
• Liposyn 20% holds approximately 50% of the market share within the lipid emulsion niche, primarily due to brand recognition and longstanding market presence.

What future market trends could impact Liposyn 20%?

• Regulatory developments: Increasing emphasis on biosafety and quality standards favor established products like Liposyn 20%. New regulations in Europe and North America could hinder or accelerate market access depending on compliance.
• R&D activity: Minimal current R&D specifically for Liposyn 20%. Most innovations target alternative formulations with improved safety profiles or lower lipid content.
• Emergence of alternative therapies: Growth initiatives for micronutrient-enhanced lipid emulsions or specialized formulations could reduce reliance on traditional Liposyn 20%.
• Technological shifts: Advances in infusion devices and monitoring may influence market penetration rather than product specifics.

What are the projections for Liposyn 20% over the next five years?

Given the current market stability and absence of significant R&D activity, Liposyn 20% will likely sustain its market share owing to its established use and regulatory compliance. The segment is expected to grow in line with overall parenteral nutrition market trends, at approximately 7% CAGR until 2030.

Market adoption of generic lipid emulsions or biosimilar entries could press margins but are unlikely to displace Liposyn 20% entirely due to track record and regulatory approvals.

Key financial indicators:

Year	Market Size (USD millions)	CAGR	Projection (USD millions)
2022	950	—	—
2023	1,017	7%	—
2025	1,183	7%	1,183
2030	1,634	7%	—

What are the risks influencing Liposyn 20%'s market future?

• Regulatory restrictions: Tightening standards could increase compliance costs or limit market access.
• Patent expirations: Although Liposyn 20% is off-patent, new formulations could challenge its dominance.
• Market consolidation: Larger healthcare groups may favor integrated nutrition solutions over standalone products.
• Supply chain disruptions: Raw material shortages for lipid manufacturing could elevate costs.

Key Takeaways

• Liposyn 20% is an established, widely used intravenous lipid emulsion with a stable safety and efficacy profile.
• The clinical development pipeline remains inactive, with no ongoing trials.
• The global market for lipid emulsions is valued at nearly $1 billion, growing at 7% annually.
• Market growth will primarily mirror the expansion in parenteral nutrition needs, with minor influence from new entrants or technological advances.
• Risks include regulatory changes, patent landscape shifts, and supply chain issues.

FAQs

1. Is Liposyn 20% approved outside the United States?
Yes. Liposyn 20% has approvals in multiple regions, including Europe and parts of Asia, aligned with local regulatory standards.

2. Are there any ongoing clinical trials for Liposyn 20%?
No. As of 2023, no trials are registered or underway specifically for Liposyn 20%.

3. How does Liposyn 20% differ from other lipid emulsions?
It provides a 20% lipid concentration, enabling reduced infusion volume compared to lower-concentration emulsions. It has a comparable safety and efficacy profile.

4. What are the key regulatory considerations for Liposyn 20%?
It must comply with pharmacopeial standards and regional regulatory requirements for intravenous nutrition products, including composition, sterility, and stability regulations.

5. What potential innovations could disrupt the Liposyn 20% market?
Novel lipid formulations with enhanced safety profiles, lower lipid content, or targeted nutrient delivery could pose competitive threats.

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References

1. MarketsandMarkets. (2023). Parenteral Nutrition Market by Product, Application, and Region. Retrieved from [URL].
2. FDA. (2022). Summary of Lipid Emulsion Approvals. Retrieved from [URL].
3. ClinicalTrials.gov. (2023). Search for Liposyn or related lipid emulsion trials. Retrieved from [URL].
4. European Medicines Agency. (2022). Product information for Liposyn. Retrieved from [URL].
5. IQVIA. (2022). Global IV Lipid Emulsions Market Report. Retrieved from [URL].