CLINICAL TRIALS PROFILE FOR INTRALIPID 10%

All Clinical Trials for Intralipid 10%

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00005889 ↗	Gluconeogenesis in Very Low Birth Weight Infants Who Are Receiving Nutrition By Intravenous Infusion	Unknown status	Baylor College of Medicine	N/A	1999-10-01	RATIONALE: Very low birth weight infants have problems maintaining normal blood sugar levels. Gluconeogenesis is the production of sugar from amino acids and fats. The best combination of amino acids, fat, and sugar to help very low birth weigh infants maintain normal blood sugar levels is not yet known. PURPOSE: Clinical trial to study how very low birth weight infants break down amino acids, fat, and sugar given by intravenous infusion, and the effect of different combinations of nutrients on the infants' ability to maintain normal blood sugar levels.
NCT00005889 ↗	Gluconeogenesis in Very Low Birth Weight Infants Who Are Receiving Nutrition By Intravenous Infusion	Unknown status	National Center for Research Resources (NCRR)	N/A	1999-10-01	RATIONALE: Very low birth weight infants have problems maintaining normal blood sugar levels. Gluconeogenesis is the production of sugar from amino acids and fats. The best combination of amino acids, fat, and sugar to help very low birth weigh infants maintain normal blood sugar levels is not yet known. PURPOSE: Clinical trial to study how very low birth weight infants break down amino acids, fat, and sugar given by intravenous infusion, and the effect of different combinations of nutrients on the infants' ability to maintain normal blood sugar levels.
NCT00048646 ↗	Progesterone Treatment of Blunt Traumatic Brain Injury	Completed	National Institute of Neurological Disorders and Stroke (NINDS)	Phase 1/Phase 2	2002-05-01	The purpose of this study is to determine if progesterone treatment safely reduces brain swelling and damage after injury.
NCT00048646 ↗	Progesterone Treatment of Blunt Traumatic Brain Injury	Completed	David Wright	Phase 1/Phase 2	2002-05-01	The purpose of this study is to determine if progesterone treatment safely reduces brain swelling and damage after injury.
NCT00074477 ↗	Safety and Efficacy of an Anti-Psychotic in Patients With Schizophrenia	Completed	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	Phase 2	2003-10-01	The purpose of this study is to determine the efficacy (how well the drug works), safety, and side effects of paliperidone palmitate injection compared to placebo in the treatment of the symptoms of schizophrenia in adults. The placebo used in this study was a nutritional substance known as 20% Intralipid emulsion given to patients requiring intravenous feedings.
NCT00088647 ↗	Study Evaluating MST-997 in Advanced Malignant Solid Tumors	Terminated	Wyeth is now a wholly owned subsidiary of Pfizer	Phase 1	1969-12-31	The primary objective of this clinical research study is to evaluate the safety, tolerability, and maximum tolerated dose (MTD) of intravenous (IV) MST-997 formulated in Intralipid 20% administered on a weekly schedule to subjects with advanced malignant solid tumors.

Clinical Trial Conditions for Intralipid 10%

Condition Name

Condition Name for Intralipid 10%
Intervention	Trials
Obesity	6
Parenteral Nutrition	6
Hypertension	5
Cholestasis	5

Condition MeSH

Condition MeSH for Intralipid 10%
Intervention	Trials
Insulin Resistance	10
Cholestasis	8
Infertility	5
Liver Diseases	5

Clinical Trial Locations for Intralipid 10%

Trials by Country

Trials by Country for Intralipid 10%
Location	Trials
United States	76
Canada	14
Egypt	9
France	4
Netherlands	3

Trials by US State

Trials by US State for Intralipid 10%
Location	Trials
New York	7
Texas	6
Georgia	5
Massachusetts	5
Tennessee	5

Clinical Trial Progress for Intralipid 10%

Clinical Trial Phase

Clinical Trial Phase for Intralipid 10%
Clinical Trial Phase	Trials
Phase 4	27
Phase 3	11
Phase 2/Phase 3	7

Clinical Trial Status

Clinical Trial Status for Intralipid 10%
Clinical Trial Phase	Trials
Completed	45
Terminated	9
Recruiting	8

Clinical Trial Sponsors for Intralipid 10%

Sponsor Name

Sponsor Name for Intralipid 10%
Sponsor	Trials
Emory University	5
Fresenius Kabi	5
Baxter Healthcare Corporation	4

Sponsor Type

Sponsor Type for Intralipid 10%
Sponsor	Trials
Other	94
Industry	21
NIH	3

Intralipid 10%: Clinical Trials, Market Analysis, and Projections

Introduction

Intralipid 10% is a sterile, non-pyrogenic fat emulsion used intravenously to provide calories and essential fatty acids, particularly for patients requiring parenteral nutrition. Here, we will delve into the current clinical trials, market analysis, and future projections for this drug.

Clinical Trials and Usage

Indications and Administration

Intralipid 10% is indicated for preventing and treating essential fatty acid deficiency (EFAD) and for providing a source of calories and essential fatty acids in patients requiring parenteral nutrition for extended periods[1][4][5].

Dosage and Administration

The dosage varies between adults and children. For adults, the initial infusion rate is 1 mL/min for the first 15-30 minutes, which can be increased to 2 mL/min if tolerated. The maximum dose is 25 mL/kg/day. For children, the initial rate is lower, and the maximum dose is 30 mL/kg/day[1][4].

Contraindications and Warnings

Intralipid 10% is contraindicated in patients with known hypersensitivity to egg, soybean, or peanut, and in those with severe disorders of lipid metabolism. It also carries warnings for risks such as parenteral nutrition-associated liver disease, fat overload syndrome, and the need for close monitoring of serum triglycerides and liver function[1][5].

Current Clinical Trials

While Intralipid 10% itself is not currently involved in new clinical trials, its use is often part of broader parenteral nutrition regimens. There are no specific ongoing clinical trials focused solely on Intralipid 10%. However, studies on parenteral nutrition and lipid emulsions continue to evolve, providing insights into optimal usage and safety profiles.

Market Analysis

Market Segmentation

The lipid injectable drugs market, which includes Intralipid 10%, is segmented by type (Intralipid, Liposyn III, Smoflipid, Clinolipid) and application (Pain Reduction, Toxicity Reduction, Targeted Drug Delivery)[2].

Market Growth and Projections

The global lipid injectable drugs market is expected to register a Compound Annual Growth Rate (CAGR) of 8.8% from 2023 to 2031. This growth is driven by increasing demand for parenteral nutrition, advancements in lipid emulsion technology, and the expanding need for targeted drug delivery systems[2].

Key Players and Market Dynamics

The market is influenced by several key players, including manufacturers of lipid emulsions. The dynamics include technological advancements, regulatory oversight, and the need for high-quality, safe products. The market evaluation is presented in terms of regional analysis and major countries, providing insights into global trends and opportunities[2].

Market Trends and Opportunities

Increasing Demand for Parenteral Nutrition

The growing need for parenteral nutrition, especially in critically ill patients and those with intestinal failure, drives the demand for lipid emulsions like Intralipid 10%. This trend is expected to continue as healthcare systems improve and more patients require extended nutritional support[2].

Technological Advancements

Advancements in lipid emulsion technology, such as the development of new formulations and delivery systems, are expected to enhance the market. For instance, newer emulsions like Smoflipid offer different fatty acid profiles that may provide additional benefits over traditional formulations like Intralipid 10%[2].

Regulatory Environment

Regulatory bodies play a crucial role in ensuring the safety and efficacy of lipid injectable drugs. Compliance with regulatory standards and ongoing monitoring of safety profiles are essential for market growth and consumer trust[2].

Challenges and Considerations

Safety and Efficacy Concerns

Despite its benefits, Intralipid 10% carries risks such as parenteral nutrition-associated liver disease, fat overload syndrome, and hypersensitivity reactions. Close monitoring and adherence to guidelines are critical to mitigate these risks[1][5].

Cost and Accessibility

The cost of lipid emulsions can be a barrier to access, especially in resource-limited settings. Efforts to make these products more affordable and widely available are necessary to ensure equitable healthcare[2].

Key Takeaways

• Clinical Usage: Intralipid 10% is crucial for preventing EFAD and providing essential fatty acids in parenteral nutrition.
• Market Growth: The lipid injectable drugs market is expected to grow at a CAGR of 8.8% from 2023 to 2031.
• Technological Advancements: New formulations and delivery systems are enhancing the market.
• Regulatory Oversight: Compliance with safety and efficacy standards is essential.
• Challenges: Safety concerns, cost, and accessibility remain key challenges.

FAQs

What is Intralipid 10% used for?

Intralipid 10% is used to provide a source of calories and essential fatty acids for patients requiring parenteral nutrition and to prevent essential fatty acid deficiency (EFAD)[1][4][5].

What are the contraindications for Intralipid 10%?

Intralipid 10% is contraindicated in patients with known hypersensitivity to egg, soybean, or peanut, and in those with severe disorders of lipid metabolism[1][5].

How is Intralipid 10% administered?

Intralipid 10% is administered by IV infusion via a peripheral or central vein, with initial rates and maximum doses specified for adults and children[1][4].

What is the expected market growth for lipid injectable drugs?

The lipid injectable drugs market is expected to register a CAGR of 8.8% from 2023 to 2031[2].

What are the potential risks associated with Intralipid 10%?

Potential risks include parenteral nutrition-associated liver disease, fat overload syndrome, and hypersensitivity reactions. Close monitoring of serum triglycerides and liver function is necessary[1][5].

Are there any new clinical trials involving Intralipid 10%?

There are no specific ongoing clinical trials focused solely on Intralipid 10%, but studies on parenteral nutrition and lipid emulsions continue to provide valuable insights[1][4].

Sources

1. eMPR.com: Intralipid 10% Prescription & Dosage Information.
2. The Insight Partners: Lipid Injectable Drugs Market Insights and Growth by 2031.
3. NewAmsterdam Pharma: NewAmsterdam Pharma Announces 2024 Strategic Priorities.
4. RxList: Intralipid 10% (10% I.V Fat Emulsion): Side Effects, Uses.
5. FDA: Intralipid® 10% (A 10% IV Fat Emulsion) - Label.

Last updated: 2025-01-07