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.
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 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.
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 20%

Condition Name

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

Condition MeSH

Condition MeSH for INTRALIPID 20%
Intervention	Trials
Insulin Resistance	10
Cholestasis	8
Liver Diseases	6
Infertility	5

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
Tennessee	5
Ohio	5
Georgia	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
University Health Network, Toronto	4

Sponsor Type

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

INTRALIPID 20%: Clinical Trials Update, Market Analysis, and 2025-2035 Projection

Last updated: April 24, 2026

What is INTRALIPID 20% and how is it positioned commercially?

INTRALIPID 20% is a soybean oil-based parenteral lipid emulsion indicated for nutritional support. As a lipid emulsion product, its clinical development path and market dynamics differ from small-molecule or biologic drug franchises because the active ingredient is an excipient-grade formulation category (lipid emulsion) with established clinical utility in parenteral nutrition (PN). That positioning drives: (i) incremental label updates rather than new MOA expansion, (ii) competitive pressure from generics and alternative lipid emulsions, and (iii) procurement-oriented pricing decisions tied to hospital formularies and reimbursement mechanics.

Where is the clinical evidence base concentrated?

For INTRALIPID 20% specifically, the clinical evidence base largely sits within historical parenteral nutrition practice and guidance-based use, with periodic updates tied to nutritional safety endpoints (for example, triglyceride tolerance, hepatic fat accumulation risk, and infusion-related complications). Public, product-specific, late-stage “new trials” updates are typically sparse for established lipid emulsion brands, while new research more often targets:

• Comparative outcomes versus other lipid emulsion compositions (for example, different fatty-acid profiles)
• Safety in specific populations (neonates, pediatric PN, critically ill patients)
• Traceability and quality attributes
• Protocol-driven endpoints (lipid clearance, liver-associated biomarkers, infection rates when applicable)

Clinical-trial transparency note (market-relevant): For established marketed nutritional emulsions, the most decision-relevant “updates” often appear in label revisions, guideline incorporation, and hospital protocol adoption rather than large randomized phase 3 programs.

Are there currently active product-specific late-stage trials for INTRALIPID 20%?

No complete, verifiable public record set is provided here that establishes an active INTRALIPID 20% late-stage clinical trial program by registration, sponsor, or NCT identifier with endpoints that would materially shift the market outlook for the branded product.

How does the market buy INTRALIPID 20% (demand drivers)?

Demand for INTRALIPID 20% is driven by persistent PN need in hospitals and long-term care:

• Inpatient PN use in surgery, oncology, GI failure, ICU care, and selected chronic conditions
• Pediatric and neonatal PN protocols where lipid emulsions are used to prevent essential fatty acid deficiency
• Step-down and home-PN pathways where permitted by product stability, compounding rules, and reimbursement

Procurement is also shaped by:

• Budget impact of lipid emulsions (choice influenced by price per gram of lipid and waste)
• Safety monitoring costs (hypertriglyceridemia surveillance protocols)
• Formulary preference and substitution policies for alternative lipid emulsions

What is the competitive landscape (substitutable lipid emulsions)?

INTRALIPID 20% competes primarily in a “therapeutic class substitution” environment:

• Other soybean oil-based emulsions
• Mixed lipid emulsions (different fatty-acid compositions)
• Multicomponent PN formulations (where lipid emulsion choice is bundled)
• Generic equivalents where market access and interchangeability exist

Competitive advantage typically comes from:

• Contract pricing and distribution reach
• Product availability and shelf-life logistics
• Institutional familiarity and protocol compatibility
• Pharmacovigilance history and ease of monitoring

Market analysis: sizing logic for lipid emulsion utilization

Because INTRALIPID 20% is used as part of PN, the market is best modeled using healthcare delivery volumes (hospitals, ICU bed-days, surgery volumes), then scaled to PN utilization rates and lipid emulsion penetration. For an investment decision, the critical question is not “how many patients take lipids,” but:

• How many PN courses require a lipid emulsion
• How often the institution prefers a particular brand due to procurement cycles
• How much substitution pressure exists from competing compositions

Market value mechanics (what sets revenue)

Revenue for INTRALIPID 20% is primarily a function of:

• Volume of emulsion units administered (per patient-day or per PN course)
• Net price after tenders, rebates, and hospital contracts
• Packaging format and dosing size (units per carton)
• Regulatory and reimbursement status in each geography

Projection framework for 2025-2035

For established lipid emulsions, projection typically reflects:

1. Volume growth from baseline PN demand growth tied to healthcare utilization.
2. Price erosion from tender cycles, generics, and substitution to alternative lipid emulsions.
3. Mix shift toward preferred lipid profiles in some segments (ICU, pediatrics, long-stay PN) where protocols evolve.

Base case projection (directional, not numeric)

• Volume: Low-to-mid single digit growth annually driven by ongoing PN demand and population aging.
• Net price: Gradual downward pressure due to procurement and substitution.
• Net revenue: Likely flat-to-slight growth in mature markets if volume growth offsets price erosion.

Upside / downside levers (transaction-level impact)

Upside

• Contract wins in large hospital systems
• Reduced stockouts and improved supply reliability
• Guideline-driven preference in specific patient segments that align with the branded formulation

Downside

• Intensified tender-based switching to lower-priced alternatives
• More restrictive formulary criteria for soybean oil-based emulsions in favor of alternative compositions
• Supply disruptions that shift institutions to substitution options

Clinical trials update: what matters for investment

For nutritional emulsions, the most actionable “trial updates” are those that change:

• Label indications or dosing restrictions
• Safety monitoring requirements (for example, triglyceride thresholds or infusion rates)
• Comparative efficacy or safety conclusions that influence formularies

Without a confirmed, product-specific active trial dataset in the public domain in this response, the appropriate investment interpretation is that near-term commercial movement will rely more on:

• Tender cycles and contract renewals
• Pharmacy and therapeutics committee decisions
• Guideline updates and protocol adoption

Key market risks specific to INTRALIPID 20%

• Formulary substitution risk: alternative lipid emulsions may be selected for protocol differentiation.
• Price compression: hospital procurement favors lowest net cost per delivered lipid dose.
• Utilization variability: PN utilization may shift with care pathway changes (enhanced recovery, enteral nutrition preference, ICU management protocols).

What outcomes will drive next-year purchasing behavior?

Purchasing behavior is most sensitive to:

• Safety outcomes tracked institutionally (lipid tolerance, liver-related monitoring)
• Operational reliability (availability, lead times)
• Contracting terms (rebates and guaranteed supply)
• Protocol alignment (product infusion rate compatibility with institutional ordersets)

Key Takeaways

• INTRALIPID 20% is a marketed parenteral lipid emulsion where demand is anchored in parenteral nutrition practice and hospital procurement cycles rather than novel drug development milestones.
• Public, product-specific active late-stage clinical trial information that would materially change near-term market outlook is not established in this response.
• Market growth is expected to follow PN utilization trends with ongoing net price pressure from tenders, generics, and substitution among lipid emulsion compositions.
• 2025-2035 revenue direction is likely flat-to-slightly positive in mature markets if volume growth offsets price erosion; upside depends on contract wins and protocol alignment.

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FAQs

1) What clinical endpoints would most influence INTRALIPID 20% formulary adoption?

Endpoints tied to infusion tolerance and safety in PN: triglyceride handling, hepatic tolerance markers used in PN monitoring, and infusion-related adverse events that map to institutional protocols.

2) Are clinical trials the main driver of INTRALIPID 20% market growth?

For an established lipid emulsion, market movement is more often driven by contracts, formulary decisions, and substitution dynamics than by large new efficacy trials.

3) What determines the net price performance of INTRALIPID 20%?

Tender outcomes, rebate structures, and substitution to competing lipid emulsions with different fatty-acid compositions or lower priced equivalents.

4) Where is substitution risk typically highest?

Hospitals with active tender renegotiations, systems standardizing on lipid profiles based on protocol updates, and formularies that treat lipid emulsions as interchangeable.

5) What is the most realistic projection shape for 2025-2035?

A slow-growth-to-flat revenue profile in mature markets due to volume growth being offset by price erosion, with upside in segments where protocols favor the specific formulation’s compatibility.

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Sources

[1] No external sources were provided or verified within this response.