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
Obesity	6
Parenteral Nutrition	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
Massachusetts	5
Tennessee	5
Ohio	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
Baxter Healthcare Corporation	4

Sponsor Type

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

Last updated: May 22, 2026

INTRALIPID 30% clinical trials update, market analysis, and 2026–2035 projection

INTRALIPID 30% (fat emulsion injectable, soybean oil-based; commonly used for parenteral nutrition) is not a typical “drug development” pipeline asset, because the product is an established parenteral nutrition (PN) formulation. The commercially relevant “trial update” is largely about clinical evidence supporting lipid emulsion use in PN (including safety, triglyceride handling, and PN-associated liver disease risk mitigation) rather than new pivotal registration trials tied to a single product label change.

Market view: demand tracks PN volumes in hospitals, home PN programs, and oncology supportive care, with growth constrained by inpatient utilization cycles, shift toward standardized PN regimens, and product preference dynamics across lipid emulsion classes (soy-based vs MCT/LCT blends vs fish oil-containing emulsions) and reimbursement.

Projection: base-case growth is modest in mature markets with periodic step-ups from protocol changes (e.g., higher PN adoption in complex patient groups) and home-care expansion where approved and reimbursed. Longer-horizon value is most sensitive to (1) substitution pressure from alternative lipid emulsion formulations and (2) pricing dynamics in hospital formularies.

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What clinical trials support Intralipid 30% (soybean oil lipid emulsion) in parenteral nutrition?

What are the highest-signal clinical endpoints for lipid emulsions in PN?

Clinical programs for lipid emulsions used with PN focus on:

• Hypertriglyceridemia control: ability to maintain triglycerides within target ranges while delivering essential fatty acids.
• PN-associated liver disease (PNALD) risk: cholestasis and liver enzyme trends with prolonged PN.
• Inflammation and oxidative stress markers: cytokines and clinical tolerance.
• Safety in special populations: preterm neonates, pediatrics, and patients with critical illness, short bowel syndrome, burns, or GI failure.
• EFA (essential fatty acid) adequacy: linoleic and alpha-linolenic acid status.

Where does Intralipid 30% fit in the evidence base?

Intralipid 30% is used as a standard soy-based lipid emulsion in PN regimens. The evidence base is broad and usually not framed as “Intralipid 30% trials” in isolation because lipid emulsion classes often share mechanistic and dosing principles. In practice, guidelines and comparative trials evaluate lipid emulsions as PN components, with soybean oil emulsions historically forming the comparator arm against newer emulsions (MCT/LCT blends and fish oil-based options).

How to interpret “trial updates” for an established lipid emulsion

For established PN products, the operational “trial update” is:

• new systematic reviews and meta-analyses comparing lipid emulsion types in PN outcomes
• protocol refinements (monitoring frequency, infusion rates, triglyceride thresholds)
• evidence in pediatrics and neonatology about dosing limits and liver outcomes
• observational data from hospital PN programs reflecting protocol adherence and real-world safety

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Are there new pivotal clinical trials or label changes for Intralipid 30%?

What matters for exclusivity-linked commercial impact

For a mature PN lipid emulsion, material commercial changes typically come from:

• label expansion (new populations, dosing frequency, or infusion rate guidance)
• safety communications or revised monitoring recommendations
• substitution-driven guideline updates in hospital PN pathways
• reimbursement changes tied to lipid emulsion categories

Featured insight for buyers and litigators

Commercial impact is less about “new trials for Intralipid 30%” and more about:

• whether alternative lipid emulsion products become preferred in formularies
• whether clinical pathways adopt different emulsion classes for prolonged PN or PNALD risk

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How big is the Intralipid 30% market and what segments drive demand?

Market sizing logic for PN lipid emulsions

INTRALIPID 30% demand is driven by:

• Hospital PN use: ICU, oncology, and surgical services with temporary or supplemental PN
• Chronic PN: home PN for GI failure, short bowel syndrome, and complex malabsorption
• Pediatrics and neonatology: where PN is used early and often, with strict lipid monitoring
• Oncology supportive care: perioperative PN and treatment-related GI dysfunction

Where growth is concentrated

• Home-care PN: expands with infrastructure and reimbursement
• Higher PN adoption in complex care: oncology and GI failure cohorts
• Protocol harmonization: standardized PN orders can increase volume predictability for lipid emulsions

Where growth is constrained

• formulary substitution toward other lipid emulsion classes
• budget compression and drug-buying consolidation in hospital systems
• increased emphasis on minimizing PN duration where enteral nutrition is feasible

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Market forecast for Intralipid 30%: 2026–2035 base case, bull case, bear case

Forecast framework (how the range is formed)

A credible projection for an established PN lipid emulsion uses three drivers:

1. Total PN volumes in inpatient and home settings
2. Market share vs alternative emulsions (MCT/LCT blends, fish oil-containing emulsions, mixed-lipid products)
3. Price and reimbursement (net selling price after contracting, rebates, and tender outcomes)

Base case (most likely)

• Modest volume growth from incremental PN adoption and home-care expansion
• Low-to-mid single digit share pressure depending on region and formulary preference

Result: CAGR likely in the low single digits in mature markets, with higher growth in selected geographies if home PN scales and restrictive substitution rules ease.

Bull case

• PNALD-focused protocols continue to drive lipid emulsions use broadly
• Limited substitution losses due to contracting and supply reliability advantages
• Faster home-care rollouts with stable reimbursement

Result: CAGR can move into mid single digits in markets with strong home PN adoption and broad PN utilization.

Bear case

• Aggressive formulary switch to newer lipid emulsions in PNALD risk cohorts
• Pricing pressure and tender-driven margin compression
• Supply disruptions or product availability constraints

Result: CAGR can fall to near-flat or low single digits, with share loss creating negative net revenue despite flat-to-growing PN volumes.

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How does Intralipid 30% compare with alternative lipid emulsions in parenteral nutrition?

Competitive set to benchmark against

• Soybean oil-based emulsions (Intralipid and similar generic/brand equivalents)
• MCT/LCT blends (designed for different triglyceride handling and tolerance)
• Fish oil-containing emulsions (targeting inflammation modulation and PNALD-related outcomes)

Decision logic used by formularies

Hospitals typically choose based on:

• demonstrated tolerance (triglycerides, infusion rates)
• PNALD outcomes for prolonged PN
• ease of monitoring and standard dosing protocols
• cost per delivered gram of lipid and total PN regimen cost

Practical commercial implication

In mature markets, lipid emulsion competition often shifts “how lipid is delivered” rather than whether lipid is delivered. The procurement outcome is influenced by PN duration cohorts and whether clinicians follow PNALD mitigation pathways.

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Which patents protect Intralipid 30% (soybean oil lipid emulsion) and how does patent expiry affect competition?

Why patent landscape matters less than formulation category for this product

For older lipid emulsion products, core composition or initial formulation patents (if any) are typically long expired. Commercial constraints often derive from:

• manufacturing process know-how
• regulatory exclusivity tied to specific NDA/ANDA or supplements
• brand-specific labeling and packaging configurations
• practical supply agreements and tender frameworks

What is actionable for a competitive threat assessment

• risk of generic/authorized substitution in some markets
• risk of therapeutic substitution toward other lipid emulsion categories

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What is the Orange Book status of Intralipid 30% and what does it imply for generic entry?

How Orange Book status translates into entry risk

For an established parenteral nutrition emulsion:

• If relevant listings are absent or expired, generic entry depends on product-specific regulatory status and manufacturing capabilities.
• If exclusivity or active patents remain, entry may require Paragraph IV challenges or settlement.

Commercial implication

Even if patent listings are minimal, formularies can still switch based on clinical pathways and procurement economics.

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What patent litigation affects the competitive landscape for Intralipid 30%?

Litigation typically shapes entry timing rather than clinical adoption

For lipid emulsion products, litigation outcomes are most relevant to:

• whether a generic enters on schedule
• whether exclusivity stays intact after challenges
• whether supply allocations shift to the challenger or the brand

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Regulatory status for Intralipid 30%: FDA approvals and pathway considerations

What to track

• FDA product type and route: injectable lipid emulsion for PN
• labeling and dosing guidance for infusion rate and triglyceride monitoring
• contraindications and warnings (e.g., disorders of lipid metabolism, severe hypertriglyceridemia)
• compatibility guidance with PN admixtures

Global considerations

In other jurisdictions, regulatory classification and substitution rules influence uptake and tender dynamics similarly:

• whether it is treated as a drug vs a specific PN component
• importation and local manufacturing requirements
• pharmacovigilance expectations and batch release timelines

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What manufacturing and supply risks can disrupt Intralipid 30% demand?

Where supply constraints show up in practice

• soybean oil supply and processing capacity
• sterile production line availability
• batch release testing capacity and lead times
• competition for logistics and packaging formats

Commercial consequence

Even when clinical demand exists, hospitals may divert to alternatives during shortages, shifting share permanently in some procurement cycles.

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Investment and licensing implications: where value is created for lipid emulsion portfolios

Most investable angles

• pipeline adjacent to lipid emulsion categories (e.g., next-gen emulsions targeting PNALD or inflammation)
• development of dosing strategies and monitoring programs that reduce labor cost and adverse events
• market access agreements tied to guideline adoption for prolonged PN

Licensing reality

For mature products, licensing opportunities are more often:

• distribution and tender contracts
• manufacturing rights or authorized generic arrangements
• formulation line expansions rather than new patent estates

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Key Takeaways

• Intralipid 30% demand tracks parenteral nutrition volumes, with the most important clinical decision variables being triglyceride handling and PN-associated liver outcomes.
• “Clinical trial updates” for an established lipid emulsion are mainly about updated evidence syntheses and protocol refinements, not new pivotal registration trials specific to Intralipid 30%.
• Market growth is modest in mature markets, driven by PN adoption and home PN, and constrained by formulary substitution toward alternative lipid emulsion classes.
• A 2026–2035 projection is most consistent with low single-digit CAGR in base case, with bull/bear outcomes driven by formulary switching speed, pricing, and substitution dynamics.

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FAQs

1. What triglyceride monitoring targets are used for soy-based lipid emulsions in PN?
2. Do fish oil-based or MCT/LCT emulsions reduce PN-associated liver disease compared with soybean oil emulsions?
3. How do hospital formularies decide between lipid emulsion classes for prolonged PN?
4. What are the main regulatory labeling elements that affect substitution of lipid emulsions?
5. How do home PN reimbursement and service infrastructure influence market growth for lipid emulsions?

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References

1. American Society for Parenteral and Enteral Nutrition (ASPEN). Clinical nutrition guidance on parenteral nutrition and lipid emulsions.
2. European Society for Clinical Nutrition and Metabolism (ESPEN). Guidelines on clinical nutrition in adults and children.
3. Systematic reviews and meta-analyses comparing lipid emulsion types in parenteral nutrition outcomes (PNALD, triglycerides, safety).