CLINICAL TRIALS PROFILE FOR INTRALIPID 10%

505(b)(2) Clinical Trials for INTRALIPID 10%

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.
New Combination	NCT06890039 ↗	A-TANGO Phase 2 Study	NOT_YET_RECRUITING	European Foundation for Study of Chronic Liver Failure	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 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
Parenteral Nutrition	6
Obesity	6
Hypertension	5
Cholestasis	5

Condition MeSH

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

Clinical Trial Locations for INTRALIPID 10%

Trials by Country

Trials by Country for INTRALIPID 10%
Location	Trials
United States	77
Canada	14
Egypt	11
France	4
China	3

Trials by US State

Trials by US State for INTRALIPID 10%
Location	Trials
New York	8
Texas	6
Tennessee	5
Ohio	5
Georgia	5

Clinical Trial Progress for INTRALIPID 10%

Clinical Trial Phase

Clinical Trial Phase for INTRALIPID 10%
Clinical Trial Phase	Trials
PHASE2	3
PHASE1	1
Phase 4	27

Clinical Trial Status

Clinical Trial Status for INTRALIPID 10%
Clinical Trial Phase	Trials
Completed	46
Terminated	9
Recruiting	8

Clinical Trial Sponsors for INTRALIPID 10%

Sponsor Name

Sponsor Name for INTRALIPID 10%
Sponsor	Trials
Fresenius Kabi	5
Emory University	5
Ain Shams University	4

Sponsor Type

Sponsor Type for INTRALIPID 10%
Sponsor	Trials
Other	103
Industry	23
UNKNOWN	6

Intralipid 10% (Fresenius Kabi and legacy equivalents): Clinical Trials Update and Market Outlook

Last updated: April 28, 2026

What is Intralipid 10% in clinical and market terms?

Intralipid 10% is a soybean oil-based intravenous lipid emulsion used to provide calories and as a vehicle/component of parenteral nutrition (PN). It is also used in clinical settings where intravenous lipid therapy is part of management protocols (notably including certain drug intoxication contexts, where lipid rescue is used off-label depending on jurisdiction and local guidance).

Across markets, “Intralipid 10%” typically refers to 10% w/v fat emulsion products based on soybean oil in aqueous emulsion with emulsifiers (formulation varies by manufacturer and regulatory dossier). The brand landscape includes multiple authorized lipid emulsion products (often with different concentration strengths), and the competitive set is shaped more by hospital formulary access and PN economics than by novel clinical innovation.

Which clinical trial signals matter for Intralipid 10% right now?

No new, brand-specific, pivotal phase 3 programs for Intralipid 10% are evident in standard clinical-trial registries and mainstream clinical literature in a way that would support a near-term “pipeline catalyst” narrative. The clinical evidence base is dominated by:

• Long-standing PN use (nutrition delivery; safety monitoring for lipid metabolism and infusion tolerance).
• Use as a lipid emulsion therapy in established protocols for specific intoxication scenarios (again, typically off-label and protocol-driven rather than brand-unique).
• Comparative nutrition product evaluation that usually centers on lipid composition differences (soy-only vs mixed-oil vs fish-oil-containing emulsions), dose scheduling, and patient subgroups (neonatal and critically ill populations).

Practical read-through for R&D and trials

For market participants, the clinical trial relevance is less about new efficacy endpoints and more about:

• Safety in PN-critical subpopulations (neonates, hepatic impairment, hypertriglyceridemia monitoring).
• Compatibility with PN regimens and infusion workflows.
• Formulation-level differentiation (emulsion stability, droplet size, and emulsifier system) that can influence tolerability rather than core indications.

What is the current commercial structure of the Intralipid 10% market?

The market for Intralipid 10% is structurally a mature hospital product category. Demand tracks with:

• Volume of PN usage in hospitals.
• Neonatal and ICU bed utilization and case mix.
• Formulary contracting and tender cycles for lipid emulsions.
• Substitution among lipid emulsion products (different brands and compositions, including 20% and mixed-lipid products where available).

Brand-level share is driven by:

• Tender wins in hospital networks
• Availability (supply reliability)
• Regulatory status per region
• Clinician switching behavior based on tolerability and institutional protocols

How does competition work versus mixed-oil and alternative lipid emulsions?

In lipid emulsion markets, “10% soy-based emulsion” faces substitution from products that may include:

• Different oil compositions (mixed-oil or fish-oil enriched emulsions in some jurisdictions)
• Different concentrations (commonly 20% products in many formularies)
• Different emulsifier systems that impact tolerability and triglyceride clearance dynamics

As a result, Intralipid 10% competes on contracting and workflow fit more than on headline clinical superiority.

What is the demand base: where does Intralipid 10% get used?

The clinical demand base is primarily:

• Parenteral nutrition for patients unable to meet nutrition needs enterally
• Adjunct lipid provision in PN
• Protocol-based use where lipid emulsion therapy is considered for specific toxicology scenarios (off-label in many settings)

The revenue model depends on:

• Bag/syringe sizes and dosing patterns (10% products are typically used where a specific lipid delivery schedule or institutional PN protocol calls for that strength)
• Hospital inventory cycles and tender pricing

Market projections: what matters and how to forecast?

Without robust, region- and brand-specific sales telemetry embedded in the public record for Intralipid 10% specifically, the most decision-relevant approach is to project from macro PN and lipid emulsion category dynamics and market share survivability under substitution risk.

Key projection drivers that materially move the curve:

1. PN utilization trends
   • Growth in ICU and neonatal care volumes
   • Increased survival of complex patients (expanded PN use)
2. Price and tender pressure
   • Periodic tender re-bids compress unit pricing
   • Multisource competition keeps price growth limited in many countries
3. Substitution by newer lipid compositions
   • Mixed-oil/fish-oil formulations can displace soy-only emulsions where guideline alignment supports them
4. Regulatory and supply stability
   • Shortages or manufacturing disruptions create short spikes but can permanently shift contracts
5. Clinical pathway standardization
   • PN pathway adoption increases predictability of lipid emulsion demand

Base case market outlook (category-driven, brand-retention oriented)

Base case: Intralipid 10% maintains share in the portion of the PN and hospital formulary segment that continues to use 10% soy-based lipid emulsions due to protocol fit, legacy contracting, and availability.

Expected shape:

• Low-to-moderate value growth (driven by volume growth and modest price index effects).
• Tight margin dynamics under tender competition and substitution by alternative emulsions.

Key risks that cap upside:

• Preferential formulary movement to mixed-lipid or different concentration products
• Aggressive tender price undercutting by incumbents and authorized competitors
• Manufacturing discontinuities that trigger contract switching

Upside scenarios (what would increase Intralipid 10% revenue beyond base case)

• Expanded PN penetration in underserved regions due to improved hospital infrastructure
• Contract wins in large hospital groups where purchasing standardization favors current lipid product line-ups
• Protocol confirmation that sustains 10% emulsion usage in neonatal/ICU PN regimens

Downside scenarios (what could reduce share/value)

• Guideline shifts that tilt lipid emulsions toward mixed-oil or alternative strengths in protocols
• Concentration migration within hospital PN lines from 10% to 20% products where clinically equivalent under protocols
• Supply constraints that force temporary substitution and permanently alter tender behavior

Actionable view: what to watch in near-term clinical and regulatory signals

Even without brand-specific late-stage programs, monitoring matters. The leading indicators for near-term commercial change are:

• Formulary updates in major hospital networks (PN order sets)
• Tender award cycles and national procurement policy shifts
• Safety monitoring guidance updates for hypertriglyceridemia and lipid metabolism in PN populations
• Toxicology protocol publications where lipid emulsion therapy is discussed (even off-label), which can shift usage mix

Key Takeaways

• Intralipid 10% is a mature, protocol-driven hospital product centered on parenteral nutrition and established clinical pathways rather than a late-stage R&D pipeline.
• New brand-specific pivotal trial catalysts are not apparent in a way that would justify a near-term “clinical breakthrough” projection.
• Market growth is category-led (PN and critical care volume), with brand value shaped by tender pricing and substitution against mixed-oil and different-strength emulsions.
• Base-case trajectory supports low-to-moderate value growth with limited pricing power and persistent substitution risk.
• Commercial decisions should track contracting and formulary adoption more than clinical-trial headlines for this product.

FAQs

1. Is Intralipid 10% used only for parenteral nutrition?
   It is used primarily for parenteral nutrition, and it can also appear in protocol-driven lipid emulsion therapy contexts in specific clinical settings.

2. Do clinical trials usually drive Intralipid 10% sales?
   Typically no. Sales track more closely to hospital PN protocols, formulary inclusion, and tender outcomes than to new brand-specific efficacy trials.

3. What are the biggest competitive threats to Intralipid 10%?
   Alternative lipid emulsion products, including mixed-oil and other concentration strengths, that can substitute in PN pathways and hospital order sets.

4. What metric best forecasts demand for Intralipid 10%?
   Hospital PN utilization and patient mix in NICUs and ICUs, plus the share of contracts that specify 10% soy-based lipid emulsions.

5. What would change the market outlook quickly?
   Large hospital group formulary switches, aggressive tender price resets, or supply stability disruptions that cause contract reallocation.

---

References

[1] Fresenius Kabi. Intralipid 10% (product information and prescribing information).
[2] European Medicines Agency (EMA). Public assessment and product-related documents for intravenous lipid emulsions (varies by product).
[3] U.S. FDA. Prescribing information and approved labeling for intravenous lipid emulsion products (Intralipid and equivalents where applicable).
[4] Clinical guidance and review literature on parenteral nutrition lipid emulsions and lipid therapy protocols in clinical practice (jurisdiction-dependent).