Omegaven (omega-3 long-chain polyunsaturated fatty acids) / Fresenius Kabi - LARVOL DELTA

Omega 3 Fatty Acid Efficiency for Prevention of Atrial Fibrillation After Coronary Artery Bypass Grafting (clinicaltrials.gov) - P3 | N=150 | Suspended | Sponsor: Meshalkin Research Institute of Pathology of Circulation | Recruiting ➔ Suspended

Trial suspension • Atrial Fibrillation • Cardiovascular • Coronary Artery Disease

Omega 3 Fatty Acid Efficiency for Prevention of Atrial Fibrillation After Coronary Artery Bypass Grafting (clinicaltrials.gov) - P3 | N=39 | Terminated | Sponsor: Meshalkin Research Institute of Pathology of Circulation | N=150 ➔ 39 | Suspended ➔ Terminated; Interim analysis did not reveal of anticipated benefits of intervention

Enrollment change • Trial termination • Atrial Fibrillation • Cardiovascular • Coronary Artery Disease

Ischemic Protective Abilities of Omegaven™ in Swine Skeletal Muscle (ACS-CLINCON 2026) - "The trends from the tissue bath studies show that muscle tissue was able to resist fiber death in a hypoxic environment with Omegaven™ administration. Despite not reaching statistical significance, Omegaven™'s anti-inflammatory effects were visible through general trends."

Cardiovascular • Reperfusion Injury

OMEG-054-CP4: Safety Study to Evaluate the Occurrence of EFAD in Pediatric Patients With PNAC Who Require More Than Eight Weeks of Omegaven Treatment (clinicaltrials.gov) - P=N/A | N=40 | Recruiting | Sponsor: Fresenius Kabi | Trial completion date: Mar 2027 ➔ Apr 2028 | Trial primary completion date: Mar 2026 ➔ Apr 2028

Trial completion date • Trial primary completion date • Cholestasis • Hepatology • Pediatrics

Can Omegaven Avoid the Destructive Effect of Procarbazine Over Ovarian Reserve? (PubMed, Reprod Med Biol) - "The AMH levels in the Procarbazine + Omegaven group exhibit a rise significantly in blood serum samples. Omegaven is a promising pharmacological agent for mitigating the deleterious effects of Procarbazine on ovarian reserve."

Journal

High dose fish oil lipid emulsion (FOLE) use in pediatric patients: A case series. (PubMed, Intest Fail) - "We conducted a case series to evaluate safety and efficacy of administering higher dose (2 g/kg/day) Omegaven® (Fresenius Kabi AG, Bad Homburg, Germany), a fish oil-based lipid emulsion (FOLE), in pediatric patients with IFALD...Our findings suggest higher dose FOLE can facilitate PN cycling and promote growth. Further studies are warranted to validate these findings and establish optimal dosing for this patient population."

Journal • Hepatology • Hypoglycemia • Pediatrics

Can omegaven avoid the destructive effect of procarbazine over ovarian reserve? (ISGE 2026) - "Omegaven is a promising drug for prevention of procarbazine's adverse effects on ovarian reserve. Further clinical studies must be conducted to make this experimental preventive treatment to become a routine practice."

CASP3 • IL6 • TNFA

MODIFYCSX: Intravenous Fish Oil Based Lipid Emulsion to Enhance Recovery in High-Risk Cardiac Surgery Patients (clinicaltrials.gov) - P2 | N=550 | Recruiting | Sponsor: GCP-Service International West GmbH | N=120 ➔ 550 | Trial completion date: Feb 2027 ➔ Sep 2030 | Trial primary completion date: Feb 2026 ➔ Mar 2030

Enrollment change • Trial completion date • Trial primary completion date • Cardiovascular • Critical care

Conversion from SMOFlipid® to Omegaven® as a salvage therapy for intestinal failure associated liver disease. (PubMed, Intest Fail) - "Conversion to Omegaven® from SMOFlipid® reversed advanced IFALD in 63.6 % of patients. Response is less likely in children with synthetic liver dysfunction and clinically significant portal hypertension."

Journal • Cardiovascular • Gastroenterology • Hepatology • Hypertension • Liver Failure • Portal Hypertension • Transplantation

Effects of intravenous lipid emulsions on Jurkat cells assessed using label-free deformability cytometry. (PubMed, Sci Rep) - "We investigated the effects of two commonly used ILEs (SMOFlipid and Omegaven) on Jurkat cells, using deformability cytometry (DC)...While cell stiffness remained largely unchanged, DC effectively detected reduced viability and increased lipid droplet accumulation. Seahorse metabolic analysis supported these findings, showing no significant changes in energy metabolism, suggesting that excess lipids were stored rather than metabolized.This study highlights a novel application of DC for high-throughput, label-free characterization of immune cells, providing insights into how ILEs may influence T cell biology and potentially impact the safety and efficacy of immunotherapies."

Journal

Displacement of Bilirubin from Albumin by Omegaven and Intralipid. (PubMed, J Pediatr Surg) - "Omegaven-derived FFAu displaced less bilirubin from albumin than Intralipid-derived FFAu, indicating its potential neuroprotective as well as hepatoprotective advantages."

Journal

Assessment of the association between mixed-oil lipid injectable emulsion use and 30-day mortality or infection persistence from fungal catheter-related bloodstream infections in pediatric patients following receipt of parenteral nutrition: A retrospective cohort study. (PubMed, Pharmacotherapy) - "Use of mixed-oil lipid injectable emulsion compared to other formulations (soybean-oil or fish-oil) demonstrated a non-statistically significant increase in 30-day mortality and/or infection persistence from fungal catheter-related bloodstream infections in pediatric patients receiving parenteral nutrition."

Journal • Retrospective data • Infectious Disease • Pediatrics

MODIFYCSX: Intravenous Fish Oil Based Lipid Emulsion to Enhance Recovery in High-Risk Cardiac Surgery Patients (clinicaltrials.gov) - P2 | N=120 | Recruiting | Sponsor: GCP-Service International West GmbH | Trial completion date: Dec 2025 ➔ Feb 2027 | Trial primary completion date: Dec 2024 ➔ Feb 2026

Trial completion date • Trial primary completion date • Cardiovascular • Critical care

Safety Study to Evaluate the Occurrence of EFAD in Pediatric Patients With PNAC Who Require More Than Eight Weeks of Omegaven Treatment (clinicaltrials.gov) - P=N/A | N=40 | Recruiting | Sponsor: Fresenius Kabi | Not yet recruiting ➔ Recruiting | Initiation date: May 2024 ➔ Dec 2024

Enrollment open • Trial initiation date • Cholestasis • Hepatology • Pediatrics

Intestinal failure-associated liver disease model: a reduced phytosterol intravenous lipid emulsion prevents liver injury. (PubMed, Pediatr Res) - "Half of children receiving long-term parenteral nutrition develop intestinal failure-associated liver disease (IFALD). Standard intravenous lipid emulsions (ILEs) in parenteral nutrition are vegetable oil based and high in phytosterols (plant steroids); no low phytosterol vegetable oil-based ILE is available. Phytosterols in ILEs are associated with IFALD. In this study, a new phytosterol-depleted soybean oil was utilized in a laboratory-generated ILE. Use of the phytosterol-depleted soybean oil ILE prevented liver injury in a murine model of IFALD. Phytosterol-depleted soybean oil may be utilized as a component of less toxic next-generation ILEs."

Journal • Hepatology • Inflammation • Liver Failure

Impact of Omega-3 Fatty Acid Supplementation in Parenteral Nutrition on Inflammatory Markers and Clinical Outcomes in Critically Ill COVID-19 Patients: A Randomized Controlled Trial. (PubMed, Nutrients) - "A total of 69 patients were randomized into three groups: one received standard lipid emulsion, and two received O3FA (Omegaven®) at doses of 0.1 g/kg/day and 0.2 g/kg/day, respectively, in addition to Smoflipid®...Additionally, the higher O3FA dose was associated with a shorter ICU and hospital stay. These findings suggest that O3FA supplementation in PN may reduce inflammation and improve clinical outcomes in critically ill COVID-19 patients."

Biomarker • Clinical • Clinical data • Journal • Critical care • Immunology • Infectious Disease • Inflammation • Novel Coronavirus Disease • Respiratory Diseases • CRP • CXCL10 • IFNG • IL1R1 • IL6 • TNFA

Cholestasis Reversal: Efficacy of IV Fish Oil (clinicaltrials.gov) - P2/3 | N=91 | Completed | Sponsor: Mark Puder | N=290 ➔ 91

Enrollment change • Cholestasis • Gastroenterology • Gastrointestinal Disorder • Hepatology • Short Bowel Syndrome

Omegaven is not cytoprotective after Inflammation-Amplified Hypoxia-Ischemia in a Newborn Piglet Model (PAS 2024) - "Insult severity was no different between groups. Significantly higher Triglyceride levels were observed in the Omegaven group at 65h (p=0.002). No significant group differences in other markers of liver function or physiological parameters were observed."

Cardiovascular • CNS Disorders • Infectious Disease • Inflammation

High Dose Fish Oil Added to Various Lipid Emulsions Normalizes Superoxide Dismutase 1 Activity in Home Parenteral Nutrition Patients. (PubMed, Nutrients) - "(4) An escalated dose of FO normalized SOD1 activity in HPNPs toward that of HCs. Bile acid metabolism was altered in HPNPs without signs of significant cholestasis and not affected by Omegaven."

Journal • Cholestasis • Dyslipidemia • Gastrointestinal Disorder • Hepatology • Short Bowel Syndrome • FGF19 • PON1 • SOD1

MODIFYCSX: Intravenous Fish Oil Based Lipid Emulsion to Enhance Recovery in High-Risk Cardiac Surgery Patients. (clinicaltrials.gov) - P2 | N=120 | Recruiting | Sponsor: GCP-Service International West GmbH

New P2 trial • Cardiovascular • Critical care • IL6

Safety Study to Evaluate the Occurrence of EFAD in Pediatric Patients With PNAC Who Require More Than Eight Weeks of Omegaven Treatment (clinicaltrials.gov) - P4 | N=40 | Not yet recruiting | Sponsor: Fresenius Kabi

New P4 trial • Cholestasis • Hepatology • Pediatrics

Refractory Coagulopathy Associated With Omegaven in an Infant (SCCM 2024) - "This case highlights the potential for coagulopathy resulting from use of Omegaven above the recommended dosing. Further delineation of the mechanism by which Vitamin K factors become deficient is warranted."

Gastrointestinal Disorder • Hematological Disorders • Hepatology • Respiratory Diseases

Crosstalk within peripheral blood mononuclear cells mediates anti-inflammatory effects of n-3 PUFA-rich lipid emulsions in parenteral nutrition. (PubMed, Clin Nutr) - "These results show a mechanism for the beneficial effect of the n-3-rich Omegaven in patients with inflammatory conditions but questions its use in patients with cancer. Hence, our results may assist in choosing the best lipid emulsion for patients who require PN."

Journal • Colorectal Cancer • Gastroenterology • Gastrointestinal Cancer • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Oncology • Solid Tumor • AVEN • CD14 • CD1D • CD8 • CD86 • FOXP3 • IFNG • IL10 • IL4 • TNFA

Safety and Tolerability of Intravenous Fish Oil Lipid Emulsion in Children Undergoing Hematopoietic Cell Transplantation (clinicaltrials.gov) - P1 | N=20 | Completed | Sponsor: Alexandra N. Carey | Active, not recruiting ➔ Completed | Trial completion date: Oct 2023 ➔ May 2023

Trial completion • Trial completion date • Bone Marrow Transplantation • Hematological Malignancies • Myelodysplastic Syndrome • Transplantation • HLA-B • HLA-C • HLA-DRB1

Safety and Tolerability of Intravenous Fish Oil Lipid Emulsion in Children Undergoing Hematopoietic Cell Transplantation (clinicaltrials.gov) - P1 | N=20 | Active, not recruiting | Sponsor: Alexandra N. Carey | Trial completion date: Jun 2023 ➔ Oct 2023

Trial completion date • Bone Marrow Transplantation • Hematological Malignancies • Myelodysplastic Syndrome • Transplantation • HLA-B • HLA-C • HLA-DRB1