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.

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.

Clinical Trial Conditions for INTRALIPID 10%

Condition Name

Condition Name for INTRALIPID 10%
Intervention	Trials
Obesity	6
Parenteral Nutrition	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
Netherlands	3

Trials by US State

Trials by US State for INTRALIPID 10%
Location	Trials
New York	8
Texas	6
Massachusetts	5
Tennessee	5
Ohio	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
Emory University	5
Fresenius Kabi	5
Baxter Healthcare Corporation	4

Sponsor Type

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

Intralipid 10% clinical trials update, market analysis, and 2025–2035 projection

Last updated: July 28, 2026

Executive summary

• Intralipid 10% (soybean oil lipid emulsion; nutrition support for parenteral nutrition) is an established generic-comparable product category with multi-source supply. Clinical activity is largely incremental (new handling/manufacturing validations, stability, packaging, and limited pharmacokinetic or administration-safety studies), not broad, late-stage “new drug” development.
• Market demand tracks hospital utilization of parenteral nutrition, surgery and intensive care lengths of stay, neonatal/parenteral nutrition protocols, and reimbursement coverage for compounded vs commercially supplied lipid emulsions.
• Long-term growth is constrained by substitution toward alternative lipid emulsions (including omega-3 enriched or mixed-oil emulsions where adopted), but remains supported by baseline parenteral nutrition penetration and periodic protocol updates that favor standardized products.
• Near-term (12 to 36 months): unit volumes should be stable to modestly positive across major hospital markets; pricing pressure persists as clinicians and payers balance efficacy, safety, and cost.
• Medium-term (2025–2030): steady growth is most likely in markets with rising ICU and surgical volumes and where standardized lipid emulsions are preferred over compounded alternatives.
• 2030–2035: growth likely normalizes to low single digits in mature markets; higher growth potential in regions expanding hospital infrastructure and parenteral nutrition capacity.

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What is Intralipid 10% (soybean oil lipid emulsion) and what is it used for?

Intralipid 10% is a lipid emulsion used to provide calories and essential fatty acids as part of parenteral nutrition (PN). It is used in adult and pediatric patients who need nutritional support when enteral nutrition is not feasible or insufficient.

How is Intralipid 10% typically administered?

• Administered intravenously as part of PN regimens.
• Dosing is individualized based on caloric needs, weight, lipid clearance, triglyceride monitoring, and clinical status.

What safety monitoring drives clinical workflows?

• Serum triglycerides.
• Liver function tests and signs of PN-associated liver complications in prolonged use.
• Electrolytes and acid-base status depending on the overall PN formulation.
• Infusion-related reactions and lipid overload risk in vulnerable populations.

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What clinical trials exist for Intralipid 10% and what is the latest update?

Intralipid 10% is not widely associated with late-stage, drug-development programs in recent years. Most “updates” reported in public registries tend to fall into one of these buckets:

1. Bioequivalence or formulation equivalence work for generic or re-manufactured emulsions
2. Administration studies (rates, infusion protocols, monitoring strategies)
3. Stability and compatibility studies (with PN admixtures, trace elements, electrolytes)
4. Clinical practice evaluations within PN protocols (often not branded Intralipid-specific)

What do trial patterns indicate about development momentum?

• The product is mature and typically treated as a supply-and-protocol component of PN rather than a novel therapeutic.
• Clinical research emphasis is on safe administration in real-world PN pathways, not on new indications.
• Most “clinical trial activity” is fragmented across geographies and sponsors (manufacturers of branded product, authorized generics, and multi-source suppliers).

Bottom line for R&D planning: treat Intralipid 10% as a mature, supply-led category where incremental clinical evidence is more likely to matter for protocol adoption, switching decisions, and payer formularies than for “new invention” positioning.

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What market is Intralipid 10% in and who buys it?

The buyer is largely institutional: hospitals, long-term acute care facilities, and neonatal/pediatric intensive care units using PN.

Key customer decision drivers

• Product availability and supply reliability for PN compounding workflows
• Safety profile and monitoring guidance usability
• Compatibility with standard PN admixture practices
• Payer reimbursement and formulary placement
• Tendering and contract pricing in hospital procurement

Substitution dynamics

In lipid emulsion PN products, procurement shifts occur when clinicians adopt:

• Alternative oil compositions (eg, mixed-oil emulsions)
• Omega-3 enriched lipid emulsions for specific clinical pathways
• Products marketed with protocol convenience, dosing flexibility, or supplier stability

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How big is the Intralipid 10% market and what portion is tied to PN utilization?

Public, brand-level market sizing for Intralipid 10% specifically is often bundled into “parenteral nutrition” or “lipid emulsion” categories in market reports. Practical sizing typically uses:

• Hospital PN patient counts and PN adoption rates
• Neonatal and ICU PN prevalence
• Average number of lipid emulsion bags per PN patient episode
• Unit conversion across vial/bag sizes and dosing regimes
• Market mix by oil composition where alternative emulsions capture share

Actionable market lens: growth is best modeled as a function of PN volumes in hospitals, multiplied by lipid emulsion utilization per PN episode, then adjusted by share loss to alternative lipid emulsions and generic price erosion.

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What is the competitive landscape for Intralipid 10% (brand vs generic vs alternative lipid emulsions)?

The competitive set is multi-layered:

Layer 1: Direct comparables

• Multi-source soybean oil lipid emulsions comparable to Intralipid 10%
• Authorized generics and region-specific branded equivalents

Layer 2: Alternative lipid compositions

• Mixed-oil emulsions
• Omega-3 enriched or specialty lipid emulsions used selectively by institutions

Layer 3: Procurement structure

• Tender-driven hospital contracts
• Pharmacy and therapeutics committee adoption of PN protocol bundles
• Contract renewal cycles that change supplier share without new clinical trial breakthroughs

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How strong is patent and exclusivity coverage for Intralipid 10% in major markets?

Intralipid 10% is typically treated as off-patent in major jurisdictions, with a market dominated by generics and multi-source suppliers. Patent life cycles for lipid emulsion compositions and manufacturing are usually long ago, replaced by incremental IP around:

• Specific manufacturing methods
• Emulsion composition ratios or physical properties (where claimed)
• Container closure system or process controls (formulation-adjacent claims)

Net effect on competition: IP barriers are generally lower than for newly approved therapies, and supply competition drives market outcomes more than litigation outcomes.

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What regulatory status does Intralipid 10% have with FDA and other agencies?

In the US, Intralipid 10% is regulated as an approved drug product with labeling covering PN indications and administration guidance. The competitive environment is shaped by:

• ANDA approvals for generic equivalents in the same strength/formulation class (where applicable)
• Labeling and interchangeability within PN protocols

In the EU and other markets, approval and substitution similarly depend on marketing authorizations, labeling, and local tender and formulary rules.

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When does Intralipid 10% lose exclusivity and what does that mean for generic entry risk?

For mature lipid emulsion products, exclusivity loss typically occurred years earlier, and generic entry risk is largely realized already. The remaining “risk” is not entry timing for a new competitor but:

• Contract switching to lower-cost supply
• Quality and supply reliability events that shift share
• Institutional protocol moves toward alternative emulsions

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How does Intralipid 10% compare with alternative lipid emulsions used in parenteral nutrition?

Clinicians compare based on:

• Triglyceride response and lipid tolerance in PN patients
• PN-associated complications in long-term therapy settings (protocol-dependent)
• Evidence base used by nutrition support teams
• Supply continuity and procurement economics

Where hospitals prefer omega-3 enriched or mixed-oil emulsions, soybean oil emulsion share can decline even when direct clinical differentiation is modest in the average PN patient.

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What is the commercial forecast for Intralipid 10% through 2035?

Base-case projection (directional)

• Mature markets: low single-digit growth, with periodic declines during aggressive price competition or switching to alternative emulsions.
• Emerging markets: higher growth rates driven by expanding hospital PN capacity, but with fast generic capture once distribution matures.

Forecast framework (how to model volume and value)

1. Volume growth: PN patient volume growth plus PN adoption penetration
2. Share: stable or slight erosion to alternative emulsions
3. Price: contract-driven downward pricing in many regions
4. Mix: more stable dosing protocols and standardization favors commercial products vs compounded alternatives, supporting units but not necessarily revenue

Scenario table (high-level, directional)

Horizon	Base case	Upside	Downside
2025–2030	Low single-digit value growth; modest unit growth	Faster PN adoption, slower switching to alternatives	Accelerated substitution to specialty emulsions; stronger price erosion
2030–2035	Value growth tracks inflation and slight unit expansion	Institutional preference for standardized emulsions offsets substitution	Continued protocol migration to alternative oil compositions; procurement squeezes

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What investment or licensing opportunities exist for Intralipid 10%?

Because Intralipid 10% is mature, the investment angle is mostly operational:

• Supply contracts and manufacturing scale
• Quality systems and regulatory compliance capability
• Tender performance and distribution footprint
• Patent-lite or process-improvement licensing where formulation-manufacturing know-how reduces batch failure risk

“Licensing for molecules” is limited; “licensing for manufacturing/process or distribution” is more relevant.

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Key Takeaways

• Intralipid 10% is a mature parenteral nutrition lipid emulsion. Clinical trial updates are incremental and typically tied to administration, stability, and equivalence rather than new indications.
• Market performance follows institutional PN utilization and tender pricing cycles.
• Forecasts for 2025–2035 are best modeled as modest growth in units with persistent value pressure, partly offset by hospital standardization of commercial lipid emulsion supply.
• Share risk comes primarily from alternative lipid emulsion adoption and aggressive procurement switching, not from new competitive entrants with delayed exclusivity.

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FAQs

1. What triglyceride monitoring thresholds are used in parenteral nutrition when administering lipid emulsions like Intralipid 10%?
2. How do hospitals decide between soybean oil lipid emulsions and omega-3 enriched or mixed-oil lipid emulsions in ICU and neonatal PN protocols?
3. What formulation compatibility issues arise when adding lipid emulsions to multi-component PN admixtures?
4. How do hospital tender contracts typically impact Intralipid 10% pricing and supplier share?
5. What manufacturing and quality requirements are most critical for lipid emulsion product approval and ongoing supply continuity?

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References

No sources were cited because no primary registry/label/market dataset was provided in the request.