CLINICAL TRIALS PROFILE FOR SMOFLIPID 20%

All Clinical Trials for Smoflipid 20%

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00451646 ↗	Study Comparing the Safety and Tolerance of SMOFlipid 20% in Long-term Treatment With Parenteral Nutrition	Completed	Fresenius Kabi	Phase 3	2007-10-01	The aim of this study is to evaluate the safety and tolerance of SMOFlipid 20% in comparison to a standard lipid emulsion Intralipid 20% in patients requiring long-term parenteral nutrition. The safety and tolerance will be evaluated by biochemistry, hematology and coagulation variables, vital signs and adverse events. Further objectives to evaluate are the influence of SMOFlipid 20% on inflammation processes, the efficacy of anti-oxidative properties of vitamin E supplemented to SMOFlipid 20%, and the fatty acid pattern in red blood cells and serum.
NCT00793195 ↗	Can SMOFlipid®, A Composite Parenteral Nutrition Lipid Emulsion, Prevent Progression Of Parenteral Nutrition Associated Liver Disease In Infants?	Unknown status	Fresenius Kabi	Phase 2	2009-01-01	The aim of this study is to determine the feasibility of conducting a trial to examine the efficacy of an ω3FA (Omega-3 fatty acid) containing balanced lipid emulsion in the prevention of progression of PNALD in infants with Intestinal Failure/Short Bowel Syndrome (SBS) and early liver dysfunction.
NCT00793195 ↗	Can SMOFlipid®, A Composite Parenteral Nutrition Lipid Emulsion, Prevent Progression Of Parenteral Nutrition Associated Liver Disease In Infants?	Unknown status	The Hospital for Sick Children	Phase 2	2009-01-01	The aim of this study is to determine the feasibility of conducting a trial to examine the efficacy of an ω3FA (Omega-3 fatty acid) containing balanced lipid emulsion in the prevention of progression of PNALD in infants with Intestinal Failure/Short Bowel Syndrome (SBS) and early liver dysfunction.
NCT00885781 ↗	Efficacy and Safety Comparison Between SMOFlipid and Lipovenoes MCT	Completed	National Taiwan University Hospital	Phase 4	2008-11-01	Comparison of efficacy and safety of two lipid emulsion products will be performed on gastrectomy patients postsurgically.
NCT01585935 ↗	Preventing Cholestasis Using SMOFLipid®	Completed	Medical University of Vienna	Phase 4	2012-06-01	Preterm infants of extreme low birth weight (ELBW, < 1000 gram birth weight) cannot immediately be nourished with mother´s or formula milk and are typically dependent on parenteral nutrition (PN) for a prolonged period of time. This puts them at risk for liver complications of PN, namely parenteral nutrition associated cholestasis (PNAC). Intravenous lipid emulsions (ILE) based on soy bean oil are standard of care for provision of energy and essential fatty acids in preterm infants. However, they might be implicated in the pathogenesis of PNAC. ILEs based on pure fish oil are proposed for therapy of PNAC. Recently a lipid emulsion containing 15 % fish oil together with soy bean, olive and MCT oil has become available in Europe (SMOFLIPID®). Such a balanced lipid emulsion might be more favourable than the standard soy bean oil emulsion (Intralipid®) concerning the development of PNAC. Furthermore ILEs containing fish oil might exert a positive effect on neurodevelopment. However, there are no data so far. The study aims to evaluate the fish oil containing ILE "SMOFlipid®" for its protective effect against PNAC in ELBW infants compared to standard treatment with the soy bean based ILE "Intralipid®". Furthermore neurodevelopment at 12 and 24 months of corrected gestational age will be investigated.
NCT02412566 ↗	SMOF Lipid for Children With Parenteral Nutrition Induced Liver Injury	Available	Fresenius Kabi		1969-12-31	While fish-oil lipid emulsions have shown a benefit to the treatment of parenteral nutrition (PN)-associated cholestasis, the dose is limited to 1 g/kg/day. Similarly, in early PN-associated cholestasis the dose of soy-based lipid is limited to 1 g/kg/day. Often the calories that are lost from this relative decreased dose of lipids can be provided by adjusting the dextrose content of the PN solution and providing a higher glucose infusion rate. In some cases, this is not tolerated or even with maximizing this strategy, growth is inadequate. Inadequate growth is a direct cause of poor outcomes including poorer neurological outcome, failure to be able to stop mechanical ventilation and poorer growth of their often already damaged intestine. These outcomes can lead to severe disability and death. Therefore, infants receiving only 1 g/kg/day of lipids who are not adequately growing must have a greater intake of lipids to meet their needs for weight, length, and head circumference growth. SMOFlipid (Fresenius Kabi, Bad Homburg, Germany) contains a mixture of 4 different lipid sources: soybean oil providing essential fatty acids, olive oil rich in monounsaturated fatty acids which are less susceptible to lipid peroxidation than polyunsaturated fatty acids, medium-chain triglycerides showing a faster metabolic clearance than long-chain triglycerides, and fish oil for the supply of omega-3 fatty acids. It is safe to give in what is the usual dose for lipid therapy in neonates of 3 g/kg/day, rather than being limited to 1 g/kg/day as we do with cholestatic infants receiving Omegaven or soy lipids. Because this product includes both omega-6 and omega-3 lipids, it provides the benefits of the omega-3s for the liver and provides more than enough omega-6s to meet essential fatty acid requirements. Its use in situations in which growth is inadequate in babies who must be restricted to 1 g/kg/day can be expected to improve their growth and likely markedly increase their chances of both a good neurological outcome and survival. Purpose: We want to find out if this new intravenous fat mixture (SMOFlipid) will help promote good growth while reducing the severity (or seriousness) of liver disease or help put an end to liver disease in infants.
NCT02412566 ↗	SMOF Lipid for Children With Parenteral Nutrition Induced Liver Injury	Available	Baylor College of Medicine		1969-12-31	While fish-oil lipid emulsions have shown a benefit to the treatment of parenteral nutrition (PN)-associated cholestasis, the dose is limited to 1 g/kg/day. Similarly, in early PN-associated cholestasis the dose of soy-based lipid is limited to 1 g/kg/day. Often the calories that are lost from this relative decreased dose of lipids can be provided by adjusting the dextrose content of the PN solution and providing a higher glucose infusion rate. In some cases, this is not tolerated or even with maximizing this strategy, growth is inadequate. Inadequate growth is a direct cause of poor outcomes including poorer neurological outcome, failure to be able to stop mechanical ventilation and poorer growth of their often already damaged intestine. These outcomes can lead to severe disability and death. Therefore, infants receiving only 1 g/kg/day of lipids who are not adequately growing must have a greater intake of lipids to meet their needs for weight, length, and head circumference growth. SMOFlipid (Fresenius Kabi, Bad Homburg, Germany) contains a mixture of 4 different lipid sources: soybean oil providing essential fatty acids, olive oil rich in monounsaturated fatty acids which are less susceptible to lipid peroxidation than polyunsaturated fatty acids, medium-chain triglycerides showing a faster metabolic clearance than long-chain triglycerides, and fish oil for the supply of omega-3 fatty acids. It is safe to give in what is the usual dose for lipid therapy in neonates of 3 g/kg/day, rather than being limited to 1 g/kg/day as we do with cholestatic infants receiving Omegaven or soy lipids. Because this product includes both omega-6 and omega-3 lipids, it provides the benefits of the omega-3s for the liver and provides more than enough omega-6s to meet essential fatty acid requirements. Its use in situations in which growth is inadequate in babies who must be restricted to 1 g/kg/day can be expected to improve their growth and likely markedly increase their chances of both a good neurological outcome and survival. Purpose: We want to find out if this new intravenous fat mixture (SMOFlipid) will help promote good growth while reducing the severity (or seriousness) of liver disease or help put an end to liver disease in infants.

Clinical Trial Conditions for Smoflipid 20%

Condition Name

Condition Name for Smoflipid 20%
Intervention	Trials
Cholestasis	3
Malnutrition	2
Short Bowel Syndrome	2
Malnutrition, Child	2

Condition MeSH

Condition MeSH for Smoflipid 20%
Intervention	Trials
Cholestasis	4
Malnutrition	3
Child Nutrition Disorders	2
Premature Birth	2

Clinical Trial Locations for Smoflipid 20%

Trials by Country

Trials by Country for Smoflipid 20%
Location	Trials
United States	21
Egypt	2
France	2
Canada	2
Australia	2

Trials by US State

Trials by US State for Smoflipid 20%
Location	Trials
Pennsylvania	3
Indiana	2
Florida	2
Illinois	2
Texas	2

Clinical Trial Progress for Smoflipid 20%

Clinical Trial Phase

Clinical Trial Phase for Smoflipid 20%
Clinical Trial Phase	Trials
PHASE4	1
Phase 4	8
Phase 3	6

Clinical Trial Status

Clinical Trial Status for Smoflipid 20%
Clinical Trial Phase	Trials
Completed	8
Recruiting	5
Not yet recruiting	2

Clinical Trial Sponsors for Smoflipid 20%

Sponsor Name

Sponsor Name for Smoflipid 20%
Sponsor	Trials
Fresenius Kabi	7
Assiut University	2
University of Florida	2

Sponsor Type

Sponsor Type for Smoflipid 20%
Sponsor	Trials
Other	18
Industry	7

Smoflipid 20% Market Analysis and Financial Projection

Last updated: April 26, 2026

SMOFLIPID 20% Clinical Trials Update, Market Analysis, and 2026-2030 Projection

SMOFLIPID 20% (soya-bean oil, medium-chain triglycerides, olive oil, fish oil emulsion) is a parenteral nutrition (PN) lipid emulsion used to prevent or treat essential fatty acid deficiency and to deliver calories in patients requiring intravenous nutrition. Its market outlook is tied to hospital PN adoption, surgical throughput, oncology and critical care caseloads, neonatal intensive care unit (NICU) utilization, and payer pressure on lipid emulsion costs. Growth is incremental rather than disruptive, with competition concentrated around other PN lipid emulsions (soy-based, MCT-based mixtures, fish oil-containing emulsions, and third-generation or “new generation” PN products where authorized).

What clinical trial activity exists for SMOFLIPID 20%?

No new, product-specific late-stage registration program for SMOFLIPID 20% is evidenced in the public clinical trial record as a distinct “SMOFLIPID 20%” brand with recent phase milestones. Publicly available clinical evidence for this class (fish oil-containing and mixed lipid emulsions) is typically brand-agnostic or focuses on PN outcomes, fatty acid profiles, liver parameters, and tolerance endpoints rather than generating a new mechanism-of-action label expansion.

How to interpret the clinical trial signal for business use

• Evidence base is mature. SMOFLIPID is an established PN lipid emulsion with a long history of clinical use; label expansions tend to be incremental (e.g., population coverage, dosing routes, or safety/tolerability in specific subgroups).
• Trial endpoints are supportive, not transformative. The most common endpoints in PN lipid emulsion studies are triglyceride handling, liver enzymes/bilirubin changes, essential fatty acid status, infection and inflammatory markers, and infusion tolerance.

Operational implication For R&D and commercial planning, the practical “clinical update” for SMOFLIPID 20% is less about new mechanism validation and more about ongoing safety surveillance, formulation consistency, and evidence used in hospital formularies and tender documents.

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Where is SMOFLIPID 20% used and what label constraints matter commercially?

SMOFLIPID 20% is positioned for PN in settings where lipid emulsions are required as energy sources and essential fatty acids. Commercially relevant constraints generally include:

• Indication scope: PN support in patients who require intravenous nutrition.
• Administration constraints: prescribed infusion rate limits and monitoring needs (notably triglycerides).
• Population considerations: pediatric and neonatal use is common for PN products, but any exact subgroup positioning is jurisdiction-specific in labeling.

The market access dynamic is therefore driven by hospital nutrition protocols and procurement rather than physician preference for a novel therapy class.

Key regulatory anchor

• SMOFLIPID is manufactured and marketed under a licensed lipid emulsion format; dosing and use are governed by the local Summary of Product Characteristics (SmPC) and labeling. Public packaging and labeling references support the product’s composition and standard PN role. (See sources [1], [2].)

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How big is the opportunity for SMOFLIPID-style PN lipid emulsions?

Market drivers

1. Hospital PN demand

   • Surgical volumes, oncology supportive care, and ICU stays drive ongoing lipid emulsion consumption.
   • PN utilization rises with perioperative complications, GI dysfunction, and prolonged hospitalization.

2. Improved outcomes narrative in PN

   • Fish oil-containing lipid emulsions are used to address PN-related complications, including markers of inflammation and liver dysfunction in some populations.
   • These outcomes matter in procurement committees because nutrition-associated morbidity affects length of stay and discharge readiness.

3. NICU and pediatric PN

   • PN in neonates is highly protocol-driven.
   • Products that satisfy lipid and essential fatty acid requirements with acceptable tolerance often secure formularies.

4. Cost containment

   • Economic pressure favors predictable dosing and tender pricing.
   • Competitive bids can compress margins, especially where payers or hospital groups standardize PN product catalogs.

What limits growth

• Formulary switching friction: PN lipid emulsion adoption is conservative. Switching is justified only by protocol updates, safety events, or demonstrable cost-effectiveness.
• Supply chain and manufacturing: lipid emulsions are sensitive to manufacturing consistency and shelf-life logistics.
• Regulatory substitution: some markets permit multiple “authorized” lipid options; others enforce tighter controls on which emulsions are preferred.

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Who competes with SMOFLIPID 20% and how does the competitive set shape pricing?

Competitive substitute categories

• Soybean oil-based lipid emulsions
• MCT/soy mixtures
• Fish oil-containing emulsions (where authorized)
• Third-generation PN lipid emulsions (composition differs by jurisdiction)

In tenders, committees typically choose based on:

• Patient population coverage (peds, ICU)
• Safety monitoring requirements
• Compatibility and administration protocols
• Total cost per PN day (unit price plus wastage patterns plus administration time constraints)

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Market projection: 2026 to 2030

SMOFLIPID 20% itself is a branded product, but the projection below is framed as a commercially actionable band for the SMOFLIPID segment (fish oil-containing and mixed lipid emulsions for PN) rather than a single-country estimate.

Base-case growth profile

• Growth character: steady, low-to-mid single digit, driven by PN case volumes and incremental formulary updates.
• No major inflection expected: absent a new mechanism claim, new pediatric expansion, or a disruptive clinical results package that forces guideline change.

Projection ranges (segment-level)

Use these as planning bands for revenue forecasting and capacity planning in the SMOFLIPID-style PN lipid emulsion space.

Year	Expected segment expansion (range)	Primary demand driver
2026	3% to 5%	Ongoing PN utilization and hospital procurement cycles
2027	3% to 6%	Pediatric/NICU protocol continuity, tender normalization
2028	3% to 6%	Oncology and ICU throughput support
2029	2% to 5%	Competitive bid pressure and cost controls
2030	2% to 5%	Mature market dynamics, incremental share shifts

Share-change scenario (what moves SMOFLIPID specifically)

SMOFLIPID’s share changes are more likely to come from:

• Formulary wins through hospital group renewals
• Tender pricing improvements
• Supply reliability during competitor shortages
• Payer and protocol updates driven by outcomes and safety monitoring experience

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Commercial checklist: what to validate for forecast accuracy

These are the variables that most often cause variance between a generic PN lipid emulsion forecast and the realized brand trajectory.

1) Contracting cycle visibility

• Hospital group tender timing
• Distributor coverage and inventory depth at contract start

2) Dosing economics

• Unit price versus per-patient PN day utilization
• Wastage rate by bag size and infusion schedule

3) Clinical governance

• Monitoring requirements for triglycerides and infusion tolerance
• Protocol compatibility with ICU and surgical pathways

4) Supply continuity

• Manufacturing allocation during periods of high demand
• Shelf-life duration and distribution latency

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Key Takeaways

• SMOFLIPID 20% is an established PN lipid emulsion with a mature clinical evidence base; public clinical activity does not show a clear, recent late-stage brand-specific registration pathway.
• Demand growth is governed by stable PN case volumes, NICU and pediatric PN, and outcomes-driven procurement rather than breakthrough clinical shifts.
• 2026 to 2030 growth for SMOFLIPID-style lipid emulsions is best modeled as steady low-to-mid single digit segment expansion, with SMOFLIPID brand performance driven by tender wins, pricing, and supply continuity.
• The most material forecast drivers are contracting cycle timing, total cost per PN day, and hospital protocol adoption friction.

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FAQs

1. Is SMOFLIPID 20% a cancer therapy?
   No. It is a parenteral nutrition lipid emulsion used as an energy source and to prevent essential fatty acid deficiency in patients requiring intravenous nutrition.

2. What outcomes matter most in PN lipid emulsion adoption?
   In practice, committees focus on safety tolerance (including infusion-related parameters), essential fatty acid adequacy, and PN-related liver or inflammatory markers where supported by local evidence.

3. Why do PN lipid emulsions show slow growth compared with novel drugs?
   Adoption requires protocol and formulary changes, and switching is conservative due to established clinical handling and monitoring workflows.

4. What is the main lever for SMOFLIPID share gains?
   Tender pricing, contract renewal timing, and supply reliability tied to distribution performance.

5. What range should be used for 2026 to 2030 segment modeling?
   A planning band of roughly 2% to 6% annual growth for PN lipid emulsions, with the higher end tied to faster formulary uptake and the lower end to competitive bid pressure.

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References

[1] SMOFLIPID 20% product information (composition and PN lipid emulsion format).
[2] Summary of Product Characteristics / labeling reference for SMOFLIPID (administration and clinical use in parenteral nutrition).

(Note: The provided sources are limited to publicly accessible product-labeling records for composition and indication framing.)