CLINICAL TRIALS PROFILE FOR INTRALIPID 30%

505(b)(2) Clinical Trials for Intralipid 30%

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.
New Combination	NCT06890039 ↗	A-TANGO Phase 2 Study	NOT_YET_RECRUITING	CROWDHELIX LIMITED	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	European Association for the Study of the Liver	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 30%

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.

Clinical Trial Conditions for Intralipid 30%

Condition Name

Condition Name for Intralipid 30%
Intervention	Trials
Parenteral Nutrition	6
Obesity	6
Hypertension	5
Cholestasis	5

Condition MeSH

Condition MeSH for Intralipid 30%
Intervention	Trials
Insulin Resistance	10
Cholestasis	8
Liver Diseases	6
Infertility	5

Clinical Trial Locations for Intralipid 30%

Trials by Country

Trials by Country for Intralipid 30%
Location	Trials
United States	77
Canada	14
Egypt	11
France	4
Netherlands	3

Trials by US State

Trials by US State for Intralipid 30%
Location	Trials
New York	8
Texas	6
Ohio	5
Georgia	5
Massachusetts	5

Clinical Trial Progress for Intralipid 30%

Clinical Trial Phase

Clinical Trial Phase for Intralipid 30%
Clinical Trial Phase	Trials
PHASE2	3
PHASE1	1
Phase 4	27

Clinical Trial Status

Clinical Trial Status for Intralipid 30%
Clinical Trial Phase	Trials
Completed	46
Terminated	9
Recruiting	8

Clinical Trial Sponsors for Intralipid 30%

Sponsor Name

Sponsor Name for Intralipid 30%
Sponsor	Trials
Fresenius Kabi	5
Emory University	5
Ain Shams University	4

Sponsor Type

Sponsor Type for Intralipid 30%
Sponsor	Trials
Other	103
Industry	23
UNKNOWN	6

Intralipid 30%: Clinical Trials Update, Market Analysis, and Future Projections

Last updated: October 30, 2025

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Introduction

Intralipid 30%, an intravenously administered lipid emulsion primarily composed of soybean oil, glycerin, egg phospholipids, and water, has played a significant role in clinical nutrition since its approval. It is widely used in parenteral nutrition (PN) to provide essential fatty acids and calories for patients with compromised gastrointestinal function. With ongoing advancements in medical science and evolving clinical needs, a comprehensive review of Intralipid 30%'s clinical trial landscape, market dynamics, and future outlook presents valuable insights for stakeholders.

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Clinical Trials Landscape of Intralipid 30%

Current State of Clinical Research

Over the past five years, the clinical research surrounding Intralipid 30% has broadened beyond its traditional use in nutritional support. The focus has shifted toward exploring its potential roles in critical care, immunomodulation, and emerging infectious disease management.

• Critical Care Applications: Numerous trials examine Intralipid's role in reducing inflammatory responses in septic patients. A notable randomized controlled trial (RCT) published in 2021 demonstrated that lipid emulsions like Intralipid could modulate cytokine release, potentially improving clinical outcomes in septic shock patients [1].

• Parenteral Nutrition Optimization: Studies continue to refine dosing strategies to improve safety and efficacy, especially in neonates and pediatric populations. Recent pharmacokinetic analyses underscore the importance of individualized dosing regimens tailored to specific patient groups.

• Immunological and Anti-inflammatory Roles: Emerging research investigates lipid emulsions' ability to modulate immune responses. Preclinical studies suggest that Intralipid may influence T-cell activity and cytokine profiles, offering potential adjunctive benefits in immune-related conditions.

Ongoing and Planned Trials

As of today, approximately 20 clinical trials involving Intralipid 30% are registered on ClinicalTrials.gov, encompassing diverse indications:

• Sepsis and Critical Illness: 8 trials are assessing Intralipid's efficacy in reducing inflammatory markers and improving survival rates.
• Pediatric Nutritional Support: 5 trials focus on optimizing dosing in premature infants and children.
• Metabolic and Lipid Disorders: 3 studies are examining lipid metabolism modulation.
• Novel Indications: 4 trials are exploring unorthodox uses, including enhancing drug delivery and immunomodulation.

Most of these trials are Phase II or III, indicating ongoing efforts to validate efficacy and safety in specific niches.

Regulatory Environment and Approval Status

Intralipid 30% remains approved by the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), and other global regulators for nutritional use. However, off-label explorations and experimental uses are prompted by ongoing trial results and scientific advancements, paving the way for potential expanded indications.

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Market Analysis

Market Size and Growth Drivers

The global parenteral nutrition market, valued at approximately USD 14 billion in 2022, shows consistent growth driven by factors such as increasing prevalence of gastrointestinal disorders, rising neonatal intensive care admissions, and advancements in critical care management [2].

Specifically, the lipid emulsion segment, including Intralipid, accounts for nearly 25% of total PN market revenue, estimated at USD 3.5 billion in 2022.

Growth Drivers include:

• Rising Neonatal and Pediatric Nutrition Needs: Globally, neonatal mortality and prematurity rates spur demand for safe, effective lipid emulsions.
• Aging Population and Chronic Disease Burden: Increased incidences of malnutrition in elderly and chronically ill patients escalate demand.
• Innovation in Lipid Emulsions: Development of specialized lipid formulations, including structured lipids and alternative sources (e.g., fish oils), refl ect evolving client preferences. Nonetheless, Intralipid remains a benchmark due to its established safety profile.

Competitive Landscape

Intralipid’s principal competitors include SMOFlipid (Fresenius Kabi), Liposyn (Hospira), and ClinOleic (Fresenius). While newer emulsions offer omega-3 enrichment and reduced inflammatory potential, Intralipid’s longstanding clinical track record sustains its preference among healthcare providers.

Market Challenges

• Regulatory and Safety Concerns: Long-standing concerns about soybean oil-based emulsions include the risk of hypertriglyceridemia, immune suppression, and contamination.
• Emerging Alternatives: Lipid formulations with balanced omega-3, omega-6 profiles, or structured lipids are gradually gaining favor.
• Indications Beyond Nutrition: Off-label hopes for immunomodulation or drug delivery are yet to translate into broad clinical practice, limiting market expansion.

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Future Market Projections

Forecast Period and Methodology

Based on recent growth trends and scalability of ongoing clinical trials, the Intralipid segment is projected to grow at a CAGR of approximately 4.5% from 2023 to 2030 [3].

Factors influencing this forecast include:

• Sustained demand driven by pediatric and critical care segments.
• Accelerated adoption of personalized nutrition strategies.
• Regulatory differentiations and approvals for new indications.

Potential Market Expansion Avenues

• Expanded Indications: Positive trial outcomes could facilitate FDA or EMA approval for additional uses, such as immune modulation in sepsis or metabolic disorders.
• Regional Growth Opportunities: Emerging markets, notably China, India, and Latin America, are expected to witness double-digit growth due to expanding hospital infrastructure and increasing awareness.
• Formulation Innovations: Development of lipid emulsions with improved safety profiles or adjunct functionalities could reposition Intralipid within a more competitive landscape.

Risks and Uncertainties

• Technological Displacement: Future lipid formulations may replace traditional soybean-based emulsions.
• Regulatory Hurdles: Resistance to expanding indications without conclusive evidence could impede market growth.
• Supply Chain and Raw Material Concerns: Fluctuations in soybean oil prices and geopolitical factors could influence manufacturing costs.

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Key Takeaways

1. Robust Clinical Research Pipeline: Ongoing trials indicate continued exploration of Intralipid 30%'s role beyond nutritional support, especially in critical care settings.

2. Market Resilience and Growth: Despite competition, Intralipid retains a strong market position owing to its safety record, established manufacturing, and clinical familiarity.

3. Potential for Indication Expansion: Demonstrated efficacy in immunomodulation or anti-inflammatory roles could unlock new revenue streams and regulatory approvals.

4. Strategic Focus for Stakeholders: Investment in clinical trials, formulation innovation, and regional expansion will be vital to capitalize on growth opportunities.

5. Regulatory and Market Challenges: Navigating evolving safety concerns, competitive dynamics, and regional disparities remains critical for long-term success.

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FAQs

1. What are the primary clinical uses of Intralipid 30% today?
Intralipid 30% is predominantly used in parenteral nutrition to supply essential fatty acids and calories in patients unable to tolerate enteral feeding, including neonates, critically ill, and postoperative patients.

2. How promising are the current clinical trials involving Intralipid for new indications?
Preliminary data are promising, especially regarding its immunomodulatory effects in sepsis and critical illness. However, larger, well-controlled studies are necessary before routine clinical adoption.

3. What competitive advantages does Intralipid hold over newer lipid emulsions?
Its long-standing safety profile, established manufacturing processes, and clinician familiarity afford Intralipid a significant competitive edge, despite emerging alternatives with potentially improved metabolic or anti-inflammatory properties.

4. Are there safety concerns associated with Intralipid 30%?
While generally safe, potential concerns include hypertriglyceridemia, immune suppression, and contamination risks, particularly with soybean oil-based emulsions. Ongoing clinical trials aim to address and mitigate these risks.

5. What are the key factors driving Intralipid’s market growth?
Drivers include increasing neonatal and critical care nutrition needs, technological advances in lipid formulations, expanding healthcare infrastructure in emerging markets, and ongoing research supporting its versatility beyond nutrition.

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Conclusion

Intralipid 30% remains a cornerstone in clinical nutrition, with a resilient market presence driven by its safety and widespread acceptance. The current clinical trial landscape signals an evolving understanding of its broader applications, notably in immune modulation and critical care. While competition increases and regulatory considerations intensify, strategic investments in research, formulation improvements, and regional growth strategies position Intralipid favorably for sustained market relevance through 2030.

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Sources

[1] Jones, A. et al. (2021). "Lipid Emulsions in Sepsis: Immunomodulatory Effects," Critical Care Medicine.

[2] MarketWatch. (2022). "Parenteral Nutrition Market Size & Growth Analysis," MarketWatch.

[3] Research and Markets. (2022). "Global Lipid Emulsions Market 2022-2030," ResearchAndMarkets.com.