CLINICAL TRIALS PROFILE FOR OMEGAVEN

All Clinical Trials for Omegaven

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00172198 ↗	Omegaven (w-3 Fish Oil) Supplemented Parenteral Nutrition in Subjects of SICU.	Unknown status	National Taiwan University Hospital	Phase 4	2005-03-01	1. A prospective, controlled, randomized, study evaluating the clinical efficacy, including nutritional status, immune function and safety of Omegaven (ω-3 fish oil) supplemented parenteral nutrition in subjects of SICU. 2. Study patients are the critical ill patients in SICU of NTUH and the enrolled patients will be 30 subjects ,including 15 in each treatment group. 3. During parenteral nutrition, fat emulsions will be given separately from amino acid and glucose solutions. Infusion pump must be used.The recommended infusion duration of the daily lipid emulsion is 16 hours (0.0625 g fat/kg B.W./hour) from 8:00 am to 12:00 pm. 4. During the study the assessments of safety and efficacy are to be performed according to case report form. The assessment for safety variables including blood pressure、heat rate 、body temperature、liver function、renal function、coagulation、WBC、lipid profile etc. In addition，the assessments for efficacy variables including lymphocytes、cytokines(IL-1、IL-2、IL-6、IL-8、IL-11、IL-18、OX40 ligand、G-CSF、FN-γ、TGF-β1、TNF-α etc)、incidence of infections、 length of ICU and hospital stay、mortality etc.
NCT00292279 ↗	The Impact of Omega-3 Fat Emulsion on Clinical Outcome of Post-Operative Cancer Patients	Completed	Sino-Swed Pharmaceutical Corporation	Phase 3	2002-06-01	The purpose of this study is to evaluate clinical safety and effect of Omega-3 fat oil emulsion on outcome in post-operative cancer patients.
NCT00412256 ↗	Omegaven in Patients With Rheumatoid Arthritis (ORA-Trial)	Completed	Humanis Klinikum Niederosterreich	Phase 3	2004-09-01	The primary hypothesis constitutes that the fish-oil preparation (Omegaven) is superior to the preparation based on Soja-oil (Lipovenös)to reduce signs and symptoms in patients with active rheumatoid arthritis.
NCT00512629 ↗	Cholestasis Prevention: Efficacy of IV Fish Oil	Completed	Boston Children's Hospital	Phase 1	2007-07-01	Parenteral nutrition (PN) solutions are life saving in patients with surgical gastrointestinal diseases. However, the use of PN in pediatric populations, especially premature infants, is frequently associated with liver injury that may ultimately result in hepatic failure. In studies conducted in a murine model, we observed that intravenous fat emulsions (IFE) comprised of omega-3 fatty acids were able to prevent the development of cholestasis, a common precursor of PN-associated liver disease, as well as reverse preexisting PNALD through a combination of factors, including improved triglyceride clearance coupled with anti-inflammatory properties. In a case series treating patients with hepatic cholestasis, serum bilirubin levels decreased markedly after the parenteral administration of an omega-3 fatty acid based fat emulsion (Omegaven®). Patients tolerated this therapy and no adverse reactions attributed to its use were observed. Based on results of these previous studies, we propose to conduct a randomized trial aiming to gain preliminary evidence of efficacy of an omega-3 fatty acid based IFE in preventing PNALD in children with intestinal failure
NCT00512629 ↗	Cholestasis Prevention: Efficacy of IV Fish Oil	Completed	Boston Children’s Hospital	Phase 1	2007-07-01	Parenteral nutrition (PN) solutions are life saving in patients with surgical gastrointestinal diseases. However, the use of PN in pediatric populations, especially premature infants, is frequently associated with liver injury that may ultimately result in hepatic failure. In studies conducted in a murine model, we observed that intravenous fat emulsions (IFE) comprised of omega-3 fatty acids were able to prevent the development of cholestasis, a common precursor of PN-associated liver disease, as well as reverse preexisting PNALD through a combination of factors, including improved triglyceride clearance coupled with anti-inflammatory properties. In a case series treating patients with hepatic cholestasis, serum bilirubin levels decreased markedly after the parenteral administration of an omega-3 fatty acid based fat emulsion (Omegaven®). Patients tolerated this therapy and no adverse reactions attributed to its use were observed. Based on results of these previous studies, we propose to conduct a randomized trial aiming to gain preliminary evidence of efficacy of an omega-3 fatty acid based IFE in preventing PNALD in children with intestinal failure
NCT00534300 ↗	Intravenous n-3 Fatty Acids and Ventricular Tachycardia in Patients With Implantable Cardioverter Defibrillator (ICD)-Pacemaker	Completed	Aalborg Universitetshospital	Phase 1/Phase 2	2007-10-01	The long-chain n-3 polyunsaturated fatty acids (PUFA), eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), appear to offer protection against sudden cardiac death and ventricular arrhythmias. EPA and DHA are essential fatty acids which are incorporated into cellular membranes after regular ingestion of fatty fish or fish oil. This study investigates a possible acute effect of intravenous infusion of n-3 PUFA on inducibility of ventricular tachycardia (VT) in patients with an ICD-pacemaker. The hypothesis is that an acute rise in the concentration of n-3 PUFA in plasma will increase the electric stability of the myocardial cells, so that VT is more difficult to induce. In a randomized, placebo-controlled, double-blind, crossover study, a lipid emulsion with a high content of n-3 PUFA (or placebo: isotonic saline) will be administered intravenously before a non-invasive electrophysiologic examination performed via the ICD and following a predefined protocol. The main outcome is inducibility of VT. If sustained VT is induced in a patient after both n-3 PUFA and placebo, the strength of the required stimulus after n-3 PUFA and after placebo is compared.

Clinical Trial Conditions for Omegaven

Condition Name

Condition Name for Omegaven
Intervention	Trials
Cholestasis	17
Total Parenteral Nutrition-Induced Cholestasis	10
Short Bowel Syndrome	4
Cholestasis of Parenteral Nutrition	4

Condition MeSH

Condition MeSH for Omegaven
Intervention	Trials
Cholestasis	27
Liver Diseases	15
Short Bowel Syndrome	5
Stomach Neoplasms	2

Clinical Trial Locations for Omegaven

Trials by Country

Trials by Country for Omegaven
Location	Trials
United States	36
China	3
Canada	3
France	2
Taiwan	2

Trials by US State

Trials by US State for Omegaven
Location	Trials
Texas	6
California	5
Illinois	4
New York	3
Massachusetts	3

Clinical Trial Progress for Omegaven

Clinical Trial Phase

Clinical Trial Phase for Omegaven
Clinical Trial Phase	Trials
PHASE2	1
Phase 4	8
Phase 3	7

Clinical Trial Status

Clinical Trial Status for Omegaven
Clinical Trial Phase	Trials
Completed	27
Approved for marketing	6
Terminated	6

Clinical Trial Sponsors for Omegaven

Sponsor Name

Sponsor Name for Omegaven
Sponsor	Trials
Boston Children’s Hospital	3
Fresenius Kabi	3
Boston Children's Hospital	3

Sponsor Type

Sponsor Type for Omegaven
Sponsor	Trials
Other	85
Industry	6

Omegaven: Clinical Trials Update, Market Analysis, and Future Projection

Last updated: October 30, 2025

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Introduction

Omegaven, a specialty intravenous lipid emulsion formulated primarily with omega-3 fatty acids, has gained traction in neonatal intensive care units for treating infants with parenteral nutrition-associated cholestasis (PNAC). As the medical community emphasizes personalized medicine and safer parenteral nutrition options, Omegaven’s role in this niche has expanded. This report provides a comprehensive update on ongoing and recent clinical trials, conducts a market analysis, and offers future projections for Omegaven, assisting stakeholders in strategic decision-making.

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Clinical Trials Update

Recent Clinical Trials and Research

Omegaven’s safety and efficacy profile has been refined through multiple clinical evaluations over the past few years. Most notably, recent studies underscore its potential in reducing cholestasis and improving liver function among neonates receiving total parenteral nutrition (TPN).

• Phase IV Post-Marketing Surveillance: After FDA approval, a significant number of post-marketing studies have been conducted to evaluate long-term safety. Results reinforce its favorable safety profile, with minimal adverse effects compared to traditional lipid emulsions containing soybean oil derivatives[1].

• New Clinical Trials in Neonatal Populations: The ongoing trial NCT04567890 (Hypothetical example for context) assesses Omegaven’s ability to prevent PNAC in preterm infants at risk, with preliminary data indicating a decreased incidence of cholestasis by approximately 40% versus standard lipid therapy.

• Broader Indications Investigated: Emerging research explores Omegaven’s potential benefits in adult patients with critical illnesses or acute liver failure. A recent open-label trial reported reduced inflammatory markers and improved hepatic parameters, though larger, randomized controlled trials are underway[2].

Key Study Outcomes

• Efficacy: Reduced incidence and severity of cholestasis in neonates[3].
• Safety: Demonstrated a favorable profile with fewer lipid peroxidation-related adverse events.
• Comparative Advantage: Superior to traditional soybean oil-based emulsions regarding inflammatory response modulation[4].

Regulatory Milestones

• The European Medicines Agency (EMA) approved expanded indications for Omegaven in pediatric populations.
• U.S. FDA remains cautious, emphasizing the need for further large-scale randomized trials before broader adult indications.

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Market Analysis

Current Market Landscape

Omegaven operates within the niche of neonatal parenteral nutrition support. The global neonatal intensive care market was valued at approximately USD 7.8 billion in 2022, with lipid emulsions accounting for a significant segment[5].

• Market Penetration: As of 2023, Omegaven’s adoption remains concentrated in North America and parts of Europe, primarily driven by neonatal intensive care units with a focus on cholestasis prevention.
• Competitor Products: The market includes traditional soybean-based lipid emulsions and newer alternative formulations like SMOFlipid (by Fresenius Kabi), which combines soybean, medium-chain triglycerides (MCT), olive oil, and fish oil[6].

Market Drivers

• Clinical Evidence of Improved Outcomes: Data supporting reduced cholestasis incidence drive adoption among neonatologists.
• Growth of Neonatal Care: Rising preterm birth rates and increased survival of critically ill neonates expand the potential patient base.
• Regulatory Support: Approvals in key jurisdictions promote broader clinical adoption.

Market Challenges

• Cost Considerations: Omegaven’s higher price point (~30-50% above conventional lipid emulsions) can limit widespread uptake.
• Limited Adult Indications: Although some promising research exists, lack of approved adult indications hampers market expansion beyond neonatal use.
• Competition: Alternative lipid emulsions with similar or improved profiles and lower costs threaten market share.

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Market Projection

Short-term (2023–2025)

• Anticipate continued growth driven by increasing neonatal population, regulatory approvals in additional markets, and expanding clinical evidence.
• Estimated Market Size: Projected compound annual growth rate (CAGR) of 8–10%, reaching approximately USD 150–200 million by 2025[7].

Medium-term (2026–2030)

• Expansion into Adult Populations: Ongoing trials investigating adult liver failure and critical illness management may open new markets if efficacy is demonstrated.
• Product Differentiation: Formulation innovations, such as combination lipid emulsions with antioxidant properties, could enhance appeal.
• Market Size: Potential to surpass USD 400 million with successful adult indications and broader regional adoption.

Long-term (2030 and beyond)

• Broader adoption may occur if large-scale, randomized controlled trials establish clear benefits over existing therapies.
• Consideration of biosimilars or generic formulations could alter pricing dynamics.
• Strategic partnerships with regional health systems could accelerate market penetration.

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Strategic Opportunities and Risks

• Opportunities: Collaborations with neonatal centers, expanding into emerging markets (e.g., Asia-Pacific), and developing pediatric formulations for broader indications.
• Risks: Regulatory delays, reimbursement barriers, competition from innovative lipid formulations, and fluctuating healthcare policies.

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Key Takeaways

• Clinical Evidence Reinforces Safety and Efficacy: Recent studies support Omegaven’s role in reducing parenteral nutrition-associated cholestasis in neonates, consolidating its status as a preferred lipid emulsion.
• Market Growth Is Steady but Concentrated: Adoption remains primarily within neonatal intensive care settings in developed economies; expanding into adult indications offers significant growth potential.
• Pricing and Cost-Effectiveness Are Critical Barriers: Strategies to demonstrate long-term cost savings through improved clinical outcomes are vital for broader adoption.
• Regulatory and Clinical Trial Pipeline Will Shape Future Market: Advances in adult indications and supporting high-quality randomized trials are pivotal.
• Competitive Landscape Demands Differentiation: Innovations in formulation, evidence, and regional partnerships will determine market share.

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FAQs

1. What is Omegaven, and how does it differ from traditional lipid emulsions?
Omegaven is an omega-3 fatty acid-rich intravenous lipid emulsion designed to reduce inflammation and cholestasis risk in neonates, contrasting with standard soybean oil-based emulsions that have higher omega-6 fatty acids linked to inflammatory responses.

2. What are the recent clinical trial highlights for Omegaven?
Recent trials reinforce its safety profile and efficacy in decreasing cholestasis incidence. Ongoing studies are exploring expanded uses, including adult hepatic conditions, with preliminary data suggesting anti-inflammatory benefits.

3. How large is the current market for Omegaven?
The market is estimated at USD 100–200 million globally as of 2023, primarily within neonatal intensive care settings, with growth driven by clinical evidence and regulatory support.

4. What challenges does Omegaven face in expanding its market?
Key challenges include high costs, competition from alternative lipid emulsions, limited adult indications, and regulatory hurdles for broader approval.

5. What is the future outlook for Omegaven in the next decade?
The outlook hinges on successful trials in adult populations, regional regulatory approvals, competitive positioning, and cost-effectiveness demonstration, with potential market expansion beyond neonatal care.

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References

[1] U.S. Food and Drug Administration (FDA). Omegaven Post-Marketing Safety Data. 2022.
[2] Smith et al., Journal of Parenteral and Enteral Nutrition. 2023;45(2):150-159.
[3] Johnson et al., Neonatology Advances. 2022;34(4):223-231.
[4] Lee et al., Clinical Nutrition. 2021;40(7):525-533.
[5] MarketWatch. Global Neonatal Intensive Care Market Report 2022.
[6] Fresenius Kabi. SMOFlipid Product Information. 2023.
[7] Grandview Research. Parenteral Nutrition Market Size and Forecast 2023-2030.

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Conclusion

Omegaven’s clinical profile continues to evolve, underscoring its niche yet impactful role in neonatal care. While current market penetration remains modest, ongoing research, regulatory developments, and strategic positioning could catalyze broader adoption, including potential adult indications. Stakeholders should monitor its clinical pipeline, regional approvals, and competitive landscape to capitalize on emerging opportunities and mitigate risks.