NDAINTRAVENOUSEMULSIONPriority Review
Approved
Jul 2018
Lifecycle
LOE Approaching
Competitive Pressure
25/100
Clinical Trials
20
Data completeness
5/8 — Partial
Priority Review
OMEGAVEN (fish oil) by Fresenius Kabi is acids. Approved for pnac. First approved in 2018.
Drug data last refreshed 18h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
OMEGAVEN is an intravenous fish oil emulsion containing omega-3 fatty acids approved for parenteral nutrition in adult and pediatric patients. It functions through beta-oxidation of fatty acids for energy production while supporting membrane structure, prostaglandin synthesis, and gene regulation. The drug treats patients dependent on parenteral nutrition and unable to tolerate lipid emulsions derived from soybean or safflower oil.
LOE Approaching3mo to LOE
Product approaching loss of exclusivity (LOE July 2026) with minimal linked career opportunities, indicating a contracting commercial footprint and likely team consolidation.
Mechanism of Action
acids. Fatty acids serve as an important substrate for energy production. The most common mechanism of action for energy production derived from fatty acid metabolism is beta oxidation. Fatty acids are also important for membrane structure and function, as precursors for bioactive molecules (such…
Indications (1)
Clinical Trials (20)
The FORCE Trial Pilot: Fish Oil-enriched Nutrition for Radiotherapy in Cancer of the hEad and Neck
Started Jan 2026
15 enrolled
Head &Amp;Amp; Neck Squamous Cell Carcinoma
Safety Study to Evaluate the Occurrence of EFAD in Pediatric Patients With PNAC Who Require More Than Eight Weeks of Omegaven Treatment
Started Dec 2024
40 enrolled
Parenteral Nutrition Associated Liver Disease (PNALD)Essential Fatty Acid DeficiencyMalnutrition+1 more
Intravenous Fish Oil Based Lipid Emulsion to Enhance Recovery in High-Risk Cardiac Surgery Patients
Started Feb 2024
550 enrolled
Intensive Care UnitCoronary Artery Bypass Grafting (CABG)High Risk Patients+9 more
Safety of Omegaven in Pediatric Patients With Parenteral Nutrition-Associated Cholestasis (PNAC)
Started Apr 2022
0Parenteral Nutrition Associated Liver DiseaseEssential Fatty Acid DeficiencyNeurocognitive Deficit+2 more
NEM® + KD PUR® Fish Oil Versus Placebo in Exercised-induced Joint Pain, Stiffness, & Cartilage Turnover in Healthy Men & Women
Started Sep 2018
85 enrolled
Exercise-induced Joint PainExercise-induced Joint StiffnessExercise-induced Joint Cartilage Turnover
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.