NDAINTRAVENOUSEMULSIONPriority Review
Approved
Jul 2018
Lifecycle
Post-LOE
Competitive Pressure
35/100
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 6h 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-associated cholestasis (PNAC). It works by providing essential fatty acids that serve as substrates for energy production via beta oxidation, support membrane structure and function, and regulate gene expression as precursors for bioactive molecules.
Post-LOEPost-LOE
Post-LOE status with formulation patent expiry in 2026 suggests defensive positioning and potential team consolidation as generic/biosimilar entry approaches.
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 Jun 2027
15 enrolled
Head &Amp;Amp; Neck Squamous Cell Carcinoma
Effects of Different Fish Oil Types on Type 2 Diabetes Risk Factors in High-Risk Adults
Started Oct 2026
84 enrolled
Type 2 DiabetesPrediabetes (Insulin Resistance, Impaired Glucose Tolerance)Prediabetes / Type 2 Diabetes+2 more
Intravenous Fish Oil Emulsion in Critically Ill Patients With High Inflammatory Status.
Started Jul 2026
159 enrolled
Critical Illness
Study to Evaluate the Adjunctive Effect of CreNeuroS™ CNS Fish Oil Plus Softgels in Patients With Major Depressive Disorder Receiving Escitalopram.
Started Jun 2026
80 enrolled
Adjunct in the Treatment of Depressive Disorder
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
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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.