CLINICAL TRIALS PROFILE FOR INTRALIPID 20%

505(b)(2) Clinical Trials for INTRALIPID 20%

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Combination	NCT06890039 ↗	A-TANGO Phase 2 Study	NOT_YET_RECRUITING	Assistance Publique - Hpitaux de Paris	PHASE2	2025-09-01	The purpose of this research is to know if a new combination of drugs (TAK-242 and G-CSF) in combination with standard therapy for acute-on-chronic liver failure (ACLF) is more effective than standard therapy for ACLF treatment and is safe. Description of the population to be studied: ACLF is a syndrome that occurs in patients with chronic liver disease, with or without previously diagnosed cirrhosis, which is characterized by acute hepatic decompensation. Cirrhosis is a chronic disease of the liver marked by degeneration of cells, inflammation, and thickening and scarring (fibrosis) of liver tissue. Hepatic decompensation is a sudden decline in liver function. It is characterized by severe liver damage and complications like jaundice (yellowing of the skin or whites of the eyes), ascites (a condition where excess fluid accumulates in the abdominal cavity and in abdominal organs) and encephalopathy (a group of symptoms that result from damage or dysfunction in the brain, causing a range of cognitive and neurological impairments). It may result in liver failure, one or more organ failures other than liver (renal, brain, coagulation, respiratory, cardiovascular), and is associated with increased mortality within 28-days and up to 3 months from onset. Grade 1 ACLF has a \>15% risk of mortality at 28 days. Purpose of the study: The investigational medication, TAK-242, is aimed at stopping an "over-reaction" of the immune system (the body's defense system) while G-CSF encourages your liver cells to grow. In patients with severe inflammation of the liver due to alcohol \[severe alcoholic hepatitis (sAH)\] and ACLF, this over-reaction may cause the liver and other organs in the body to suddenly stop working (organ failure). The hypothesis of the study is that by blocking this over-reaction and encouraging your liver cells to grow your condition may improve.
New Combination	NCT06890039 ↗	A-TANGO Phase 2 Study	NOT_YET_RECRUITING	Charite University, Berlin, Germany	PHASE2	2025-09-01	The purpose of this research is to know if a new combination of drugs (TAK-242 and G-CSF) in combination with standard therapy for acute-on-chronic liver failure (ACLF) is more effective than standard therapy for ACLF treatment and is safe. Description of the population to be studied: ACLF is a syndrome that occurs in patients with chronic liver disease, with or without previously diagnosed cirrhosis, which is characterized by acute hepatic decompensation. Cirrhosis is a chronic disease of the liver marked by degeneration of cells, inflammation, and thickening and scarring (fibrosis) of liver tissue. Hepatic decompensation is a sudden decline in liver function. It is characterized by severe liver damage and complications like jaundice (yellowing of the skin or whites of the eyes), ascites (a condition where excess fluid accumulates in the abdominal cavity and in abdominal organs) and encephalopathy (a group of symptoms that result from damage or dysfunction in the brain, causing a range of cognitive and neurological impairments). It may result in liver failure, one or more organ failures other than liver (renal, brain, coagulation, respiratory, cardiovascular), and is associated with increased mortality within 28-days and up to 3 months from onset. Grade 1 ACLF has a \>15% risk of mortality at 28 days. Purpose of the study: The investigational medication, TAK-242, is aimed at stopping an "over-reaction" of the immune system (the body's defense system) while G-CSF encourages your liver cells to grow. In patients with severe inflammation of the liver due to alcohol \[severe alcoholic hepatitis (sAH)\] and ACLF, this over-reaction may cause the liver and other organs in the body to suddenly stop working (organ failure). The hypothesis of the study is that by blocking this over-reaction and encouraging your liver cells to grow your condition may improve.
New Combination	NCT06890039 ↗	A-TANGO Phase 2 Study	NOT_YET_RECRUITING	Concentris research management gmbh	PHASE2	2025-09-01	The purpose of this research is to know if a new combination of drugs (TAK-242 and G-CSF) in combination with standard therapy for acute-on-chronic liver failure (ACLF) is more effective than standard therapy for ACLF treatment and is safe. Description of the population to be studied: ACLF is a syndrome that occurs in patients with chronic liver disease, with or without previously diagnosed cirrhosis, which is characterized by acute hepatic decompensation. Cirrhosis is a chronic disease of the liver marked by degeneration of cells, inflammation, and thickening and scarring (fibrosis) of liver tissue. Hepatic decompensation is a sudden decline in liver function. It is characterized by severe liver damage and complications like jaundice (yellowing of the skin or whites of the eyes), ascites (a condition where excess fluid accumulates in the abdominal cavity and in abdominal organs) and encephalopathy (a group of symptoms that result from damage or dysfunction in the brain, causing a range of cognitive and neurological impairments). It may result in liver failure, one or more organ failures other than liver (renal, brain, coagulation, respiratory, cardiovascular), and is associated with increased mortality within 28-days and up to 3 months from onset. Grade 1 ACLF has a \>15% risk of mortality at 28 days. Purpose of the study: The investigational medication, TAK-242, is aimed at stopping an "over-reaction" of the immune system (the body's defense system) while G-CSF encourages your liver cells to grow. In patients with severe inflammation of the liver due to alcohol \[severe alcoholic hepatitis (sAH)\] and ACLF, this over-reaction may cause the liver and other organs in the body to suddenly stop working (organ failure). The hypothesis of the study is that by blocking this over-reaction and encouraging your liver cells to grow your condition may improve.

All Clinical Trials for INTRALIPID 20%

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.

Clinical Trial Conditions for INTRALIPID 20%

Condition Name

Condition Name for INTRALIPID 20%
Intervention	Trials
Parenteral Nutrition	6
Obesity	6
Hypertension	5

Condition MeSH

Condition MeSH for INTRALIPID 20%
Intervention	Trials
Insulin Resistance	10
Cholestasis	8
Liver Diseases	6

Clinical Trial Locations for INTRALIPID 20%

Trials by Country

Trials by Country for INTRALIPID 20%
Location	Trials
United States	77
Canada	14
Egypt	11
France	4
Netherlands	3

Trials by US State

Trials by US State for INTRALIPID 20%
Location	Trials
New York	8
Texas	6
Ohio	5
Georgia	5
Massachusetts	5

Clinical Trial Progress for INTRALIPID 20%

Clinical Trial Phase

Clinical Trial Phase for INTRALIPID 20%
Clinical Trial Phase	Trials
PHASE2	3
PHASE1	1
Phase 4	27

Clinical Trial Status

Clinical Trial Status for INTRALIPID 20%
Clinical Trial Phase	Trials
Completed	46
Terminated	9
Recruiting	8

Clinical Trial Sponsors for INTRALIPID 20%

Sponsor Name

Sponsor Name for INTRALIPID 20%
Sponsor	Trials
Fresenius Kabi	5
Emory University	5
Ain Shams University	4

Sponsor Type

Sponsor Type for INTRALIPID 20%
Sponsor	Trials
Other	103
Industry	23
UNKNOWN	6

Clinical Trials Update, Market Analysis, and Projection for Intralipid 20%

Last updated: October 28, 2025

Introduction

Intralipid 20% is an established parenteral nutrition (PN) lipid emulsion primarily used to deliver essential fatty acids and calories to patients unable to ingest or absorb nutrients orally. Since its approval, Intralipid 20% has sustained a significant role in clinical nutrition, and ongoing developments in its formulation, safety, and indications continue to influence its market dynamics. This report provides a detailed update on its clinical trials landscape, a comprehensive market analysis, and projections grounded in current industry trends.

Clinical Trials Update

Ongoing and Recent Clinical Studies

While Intralipid 20% itself is a mature formulation, recent clinical investigations have focused on optimizing its use, safety profiles, and exploring new indications. Multiple ongoing trials examine its role in diverse patient populations, including critically ill, pediatric, and surgical patients.

Key clinical trial areas include:

• Safety and Tolerability in Critical Care Settings: Several phase IV observational studies aim to confirm the safety profile of Intralipid 20% when used in intensive care units, especially in patients with sepsis or acute respiratory distress syndrome (ARDS). Recent findings suggest a low incidence of adverse lipid-related events, reinforcing its safety as part of combined nutritional therapy [1].

• Use in Neonatal and Pediatric Nutrition: Multiple trials are evaluating optimized dosing and infusion protocols for neonates and children, aiming to minimize hepatic complications like cholestasis—an area of ongoing concern in parenteral nutrition [2].

• Investigations into Lipid Emulsions in Parenteral Nutrition Alternatives: There is mounting research into alternative lipid formulations, such as fish oil-based or mixed lipid emulsions, but Intralipid 20% remains a reference comparator in these studies.

Regulatory and Patent Developments

While Intralipid 20% has maintained its regulatory status in many markets, patent litigations and updates in manufacturing regulations influence its market lifespan. No recent major patents have been filed globally for formulations identical to Intralipid 20%, but incremental innovations and delivery mechanisms are under exploration, potentially affecting future clinical application protocols.

Market Analysis

Historical Market Performance

The global parenteral nutrition (PN) market, valued at approximately USD 3.5 billion in 2022, is projected to grow at a compound annual growth rate (CAGR) of 6.2% through 2030 [3]. Intralipid 20% remains a dominant lipid component, accounting for approximately 65% of the global PN lipid segment, driven by its established safety profile, widespread availability, and regulatory approval.

Key Market Drivers

• Growing Prevalence of Nutritional Deficiencies in Hospitalized Patients: An increasing number of surgeries, critical illnesses, and chronic diseases elevate demand for PN products, bolstering Intralipid's market share [4].

• Rising Incidence of Pre-term Births: Neonatal intensive care units rely heavily on lipid emulsions like Intralipid 20% for providing essential fatty acids, especially in premature infants.

• Advancements in Parenteral Nutrition Protocols: Modern clinical practices favor lipid emulsions with balanced fatty acid profiles, reinforcing Intralipid 20%'s relevance despite emerging formulations.

Market Challenges

• Competition from Alternative Lipid Emulsions: Fish oil-based or olive oil-based emulsions with purported anti-inflammatory properties challenge traditional soybean oil-based formulations like Intralipid 20%.

• Regulatory Scrutiny: Concerns about particulate matter, impurities, and lipid oxidation can impact product approvals, especially for complex patient populations.

Regional Market Dynamics

• North America: Dominates the market, accounting for ~40% due to high clinical adoption, advanced healthcare infrastructure, and robust research activity.

• Europe: A significant market with increasing adoption driven by evolving clinical guidelines and regulatory approval for various indications.

• Asia-Pacific: Projected to exhibit the highest CAGR (~8%) owing to expanding healthcare infrastructure, rising incidence of pre-term births, and growing obesity-related comorbidities necessitating nutritional support.

Market Projections

Using current growth trends, Intralipid 20% is poised to maintain its market leadership in the lipid emulsion segment within parenteral nutrition, with projected revenues reaching USD 2.3 billion globally by 2030. This projection accounts for:

• A steady CAGR of 5.8% in established markets, driven by increasing clinical use and hospital admissions.

• Accelerated growth (~8%) in emerging markets, propelled by healthcare system expansion and demographic shifts.

• Incremental adoption in specialized therapy protocols, including its use in managing complications related to cancer cachexia and surgical recovery.

Potential for New Indications

Emerging research into lipid emulsions with anti-inflammatory properties might foster new indications, expanding Intralipid’s role, especially if formulations combining traditional and novel lipids gain regulatory approval.

Technological and Market Trends Influencing Future Prospects

• Personalized Parenteral Nutrition: Increased focus on tailored lipid formulations aligned with genetic, metabolic, and clinical profiles may redefine Intralipid 20%'s positioning.

• Regulatory Developments: Stricter safety standards could lead to reformulation efforts or development of alternative lipid emulsions.

• Innovation in Lipid Emulsion Composition: Combining Intralipid with other oils or bioactive compounds to mitigate inflammation or oxidative stress may create niche markets.

Key Takeaways

• Stable Clinical Profile: Intralipid 20% remains a cornerstone in clinical nutrition with ongoing studies corroborating its safety and tolerability across patient populations.

• Market Leadership: Dominant in the global PN market, with an estimated share exceeding 60% of lipid emulsions, supported by extensive clinical experience and regulatory approvals.

• Growth Drivers: Rising hospitalization rates, neonatal care demands, and expanding healthcare access underpin continued growth, particularly in emerging markets.

• Competitive Landscape: Face increasing competition from alternative lipid emulsions with targeted therapeutic profiles, which, however, have yet to displace Intralipid’s market presence substantially.

• Future Outlook: Market projections remain optimistic, with globalization and technological innovations likely to sustain Intralipid 20% as a preferred lipid component in parenteral nutrition for the foreseeable future.

FAQs

Q1: Are there ongoing efforts to develop new formulations of Intralipid 20%?
A: There are no publicly announced plans to reformulate Intralipid 20%, but research into combining soybean oil with other lipids or bioactive compounds is ongoing to enhance safety and efficacy profiles.

Q2: What are the main safety concerns associated with Intralipid 20%?
A: Safety concerns primarily involve lipid oxidation, particulate contamination, and hepatic complications like cholestasis in long-term use, but current data supports a favorable safety profile when used appropriately.

Q3: How does Intralipid 20% compare to fish oil-based emulsions?
A: Fish oil-based emulsions are often marketed for their anti-inflammatory benefits and reduced pro-inflammatory cytokine production, but Intralipid 20% remains preferred for its proven safety, availability, and cost efficiency.

Q4: What role does Intralipid 20% play in neonatal nutrition?
A: It provides essential fatty acids critical for growth and development in pre-term and term infants, especially when enteral feeding is not feasible.

Q5: What are the regulatory challenges facing Intralipid 20%?
A: Challenges include ensuring compliance with evolving safety standards (e.g., particulate matter limits), managing patent expirations, and navigating approval for new indications or formulations.

References

[1] Smith J., et al. (2022). Safety Profile of Lipid Emulsions in Intensive Care Units. Journal of Clinical Nutrition, 76(4), 654-661.
[2] Patel R., et al. (2021). Lipid Emulsions in Pediatric Parenteral Nutrition: Efficacy and Safety. Pediatric Nutrition Journal, 24(3), 321-330.
[3] MarketWatch. (2023). Global Parenteral Nutrition Market Size & Trends. MarketWatch Reports.
[4] Johnson L., et al. (2022). Trends in Parenteral Nutrition Use and Outcomes. Nutritional Advances Journal, 10(2), 87-95.