CLINICAL TRIALS PROFILE FOR LIPOSYN III 30%

All Clinical Trials for LIPOSYN III 30%

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 30%

Condition Name

Condition Name for LIPOSYN III 30%
Intervention	Trials
HIV Infections	2
Insulin Resistance	1
Obesity	1
Diabetes	1

Condition MeSH

Condition MeSH for LIPOSYN III 30%
Intervention	Trials
Immunologic Deficiency Syndromes	2
HIV Infections	2
Acquired Immunodeficiency Syndrome	2
Insulin Resistance	1

Clinical Trial Locations for LIPOSYN III 30%

Trials by Country

Trials by Country for LIPOSYN III 30%
Location	Trials
United States	6

Trials by US State

Trials by US State for LIPOSYN III 30%
Location	Trials
New Jersey	2
Ohio	1
Louisiana	1
Texas	1
Florida	1

Clinical Trial Progress for LIPOSYN III 30%

Clinical Trial Phase

Clinical Trial Phase for LIPOSYN III 30%
Clinical Trial Phase	Trials
N/A	3
Early Phase 1	1

Clinical Trial Status

Clinical Trial Status for LIPOSYN III 30%
Clinical Trial Phase	Trials
Completed	4

Clinical Trial Sponsors for LIPOSYN III 30%

Sponsor Name

Sponsor Name for LIPOSYN III 30%
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 30%
Sponsor	Trials
Other	3
Industry	2
NIH	1

Last updated: May 4, 2026

LIPOSYN III (30%): Clinical-Stage Status, Market Read-Through, and Price/Revenue Projection

What is LIPOSYN III (30%) and who is the regulated product owner?

LIPOSYN III 30% is a soy-derived injectable lipid emulsion indicated for parenteral nutrition. It is an established, marketed product rather than a new molecular entity.

• Product naming
  • “LIPOSYN III” denotes the third-generation soy-based lipid emulsion formulation.
  • “30%” refers to the lipid concentration used in the infusion product.
• Form
  • Injectable lipid emulsion (parenteral nutrition use).
• Regulatory positioning
  • Marketed product; clinical development activity depends on ongoing formulation, manufacturing, labeling, and supply-rail updates rather than first-in-human programs.

Is there an active clinical trial program for LIPOSYN III 30%?

No sufficient, verifiable public evidence is available in the record provided here to map LIPOSYN III 30% to an active, company-sponsored interventional clinical trial (Phase 1-3) with dated enrollment milestones.

What can be stated from a patent analysis perspective for a marketed lipid emulsion:

• Clinical “updates” for established emulsions usually track:
  • label expansions (peds, renal/hepatic subgroups, ICU nutrition protocols),
  • bioequivalence or formulation/mfg comparability studies,
  • stability/compatibility studies with dextrose and amino acids,
  • pharmacovigilance rather than new clinical endpoints.

Because no trial registry identifiers, sponsor names, or dated enrollment/completion milestones are available in the provided context, a trial-by-trial update cannot be produced without fabricating details.

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How does the market for injectable lipid emulsions work for a product like LIPOSYN III 30%?

Injectable lipid emulsions sit inside the parenteral nutrition (PN) segment. Demand is driven by:

• ICU utilization and surgical volumes,
• neonatology and pediatric PN needs,
• oncologic and GI disease burden where enteral access fails,
• hospital formulary adoption and contracting cycles,
• supply reliability and substitution practices.

Key market structure dynamics:

• Hospital purchasing: PN products are tendered at the institutional level; switching requires clinical committee sign-off and compatibility knowledge.
• Formulary stickiness: Once adopted for specific PN regimens, lipid emulsions are typically hard to displace without safety, cost, or supply advantages.
• Clinical substitution: Hospitals may switch between soy-based and mixed-oil or omega-3 containing emulsions depending on nutrition protocols and payer policies.
• Pricing pressure: Mature PN products often face periodic reimbursement pressure and competitive bidding.

Competitive set (directional, not tied to specific current pricing here):

• Other soy-based emulsions (e.g., comparable 20% and 30% concentrated formulations depending on country)
• Mixed-oil emulsions (where available and adopted)
• Fish-oil containing emulsions (where formulary supports them)

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What is the realistic revenue model for LIPOSYN III 30%?

Revenue is typically a function of:

1. Volume (liters of emulsion infused per patient course, or bottles per patient per day)
2. Units per course (driven by PN prescription patterns)
3. Net price (contracted hospital or group purchasing organization pricing after rebates)
4. Market share within PN lipid emulsions
5. Substitution risk (protocol-based and supply-driven)

For projection work, the business-critical variable is net unit volume through:

• inpatient PN incidence,
• proportion of PN patients receiving lipid (nearly universal for longer PN),
• average infusion duration (days on PN),
• product concentration preference (20% vs 30% depending on local regimen),
• institutional share.

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Can a quantified market forecast be produced from the information provided?

No. A defensible, quantified projection (with numbers for TAM/SAM, unit volumes, and price) requires at least one of:

• current market size figures for injectable lipid emulsions by geography,
• current unit volumes or sales for LIPOSYN III 30% (or the owning NDA/ANDA),
• current wholesale acquisition cost (WAC) and typical net discount ranges, and
• competitor mix and adoption rates.

Those inputs are not present in the provided context, so producing numeric projections would require invention.

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What can be delivered as an investment-grade market read-through without fabricating numbers?

This is the actionable, non-numeric decision framework you can use immediately for R&D and licensing screens around LIPOSYN III 30%:

1) Risk map for displacement

• Low displacement risk drivers
  • entrenched formulary status in target hospital networks,
  • proven compatibility with PN admixture workflows,
  • supply continuity and contract coverage.
• Higher displacement risk drivers
  • payer-driven cost controls that favor lower-cost lipid emulsions,
  • safety or tolerability protocol shifts,
  • competitive tendering that compresses margins,
  • supply constraints at manufacturer level.

2) Where “clinical updates” tend to show up

For an established lipid emulsion, “trial-like” evidence often manifests through:

• compatibility and stability data (PN bag admixture workflows),
• retrospective outcomes in nutrition cohorts,
• pharmacovigilance signal reviews,
• label and administration updates.

These updates rarely reset the market unless they unlock:

• new patient subgroups that meaningfully expand eligible patient populations,
• regulatory changes that remove dosing restrictions,
• reimbursement changes that alter economics.

3) Patent and lifecycle implications for business planning

For a mature marketed product:

• The near-term business value typically comes from:
  • patent tail management (formulation, composition, manufacturing process, packaging),
  • manufacturing route improvements that reduce cost of goods,
  • supply-rail resilience.
• The biggest competitive pressure often comes from:
  • generic or biosimilar-like competitive entries (where applicable to emulsions under the regulatory pathway),
  • contract-driven substitutions.

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Key Takeaways

• LIPOSYN III 30% is a marketed parenteral nutrition lipid emulsion; clinical “trial updates” in the interventional Phase 1-3 sense are not supportable from the provided record.
• Quantified market projection cannot be produced without current sales/price/market-size inputs; any numeric forecast would require fabricated inputs.
• The most actionable market view for decision-making is a formulary and contracting framework: displacement risk is driven by institutional stickiness, tender cycles, and product economics rather than new clinical endpoints.

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FAQs

What is LIPOSYN III 30% used for?

It is used as an injectable lipid emulsion in parenteral nutrition.

Are there new Phase 1 to Phase 3 trials for LIPOSYN III 30%?

No verifiable active interventional Phase 1 to Phase 3 trial record is available in the provided context.

What determines hospital adoption of lipid emulsions like LIPOSYN III 30%?

Formulary decisions, PN protocol fit, supply reliability, compatibility with admixture workflows, and contracted net pricing.

What is the biggest driver of revenue change for established PN lipid emulsions?

Net unit volume through institutional contracting and patient PN utilization patterns, not new drug efficacy trials.

What is the likely competitive threat to LIPOSYN III 30%?

Tendering pressure and substitution to alternative lipid emulsions (cost, availability, and protocol-driven preference).

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References

[1] FDA. Drugs@FDA. Product information records for LIPOSYN III (lipid injectable emulsion). https://www.accessdata.fda.gov/scripts/cder/daf/
[2] ClinicalTrials.gov. Search results for “LIPOSYN III” and related terms. https://clinicaltrials.gov/