OMEGAVEN (fish oil triglycerides)
Omegaven provides a source of calories and fatty acids for pediatric patients who have developed parenteral nutrition-associated cholestasis (PNAC). It helps children who are dependent on intravenous nutrition by supplying essential fats needed for growth and energy. While it is used for patients with existing PNAC, it has not been shown to prevent the condition from occurring.
How OMEGAVEN Works
This drug works by delivering fatty acids that the body uses as a primary substrate for energy production, mainly through a process called beta oxidation. These fatty acids are also essential for maintaining cell membrane structure and function, serving as building blocks for bioactive molecules like prostaglandins, and helping to regulate gene expression.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2018-07-27
- Patent Cliff
- 2026
- Routes
- INTRAVENOUS
- Dosage Forms
- EMULSION
OMEGAVEN Approval History
What OMEGAVEN Treats
1 indicationsOMEGAVEN is approved for 1 conditions since its original approval in 2018. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Parenteral Nutrition-Associated Cholestasis
OMEGAVEN Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to OMEGAVEN
FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
19 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06279793 MODIFY CSX | MODIFY CSX | Ph 2 | recruiting | Intravenous Fish Oil Based Lipid Emulsion to Enhance Recovery in High-Risk Cardiac Surgery Patients |
| NCT02512718 | P00016641 | Ph 1 | completed | Safety and Tolerability of Intravenous Fish Oil Lipid Emulsion in Children Undergoing Hematopoietic Cell Transplantation |
| NCT02140788 results posted | Pro00027822 | Ph 4 | terminated | Effects of Metformin and Fish Oil on Treatment With Clozapine |
| NCT02486042 results posted | 140253 | Ph 2 | completed | Omega-3 Long Chain Polyunsaturated Fatty Acid (LCPUFA) Supplementation in Very Low Birth Weight Infants for The Prevention Retinopathy of Prematurity |
| NCT04697888 results posted | 12010063 | Ph 2, Ph 3 | completed | Use of Omegaven for Treatment With Parenteral Nutrition Associated Liver Disease |
| NCT01601652 results posted | 225576 UCD#225576-3 | Ph 1, Ph 2 | completed | Compassionate Use of an Intravenous Fish Oil Emulsion in Infants With Cholestasis |
| NCT00862446 results posted | 080887 | Ph 4 | completed | Use of Omega-3 Fat Emulsion (Omegaven) in Infants With Parenteral Nutrition Associated Liver Disease |
| NCT01594983 | CLCQ908C2201 2012-000872-40 | Ph 2 | completed | A Pilot Study to Assess the Efficacy and Safety of LCQ908 Alone and in Combination With Fenofibrate or Lovaza® in Patients With Severe Hypertriglyceridemia |
| NCT03662282 results posted | 00033519 | Ph 3 | completed | Omegaven as Alternative Parenteral Fat Nutrition |
| NCT00969332 FO results posted | 09-02-079-02 | Ph 2 | terminated | A Safety and Efficacy Study to Determine if Giving Intravenous Fish Oil Helps Children With Liver Disease |
| NCT02370251 results posted | 5451 | Ph 2, Ph 3 | completed | Compassionate Use of Omegaven in Children |
| NCT03127345 | IRB-P00024279 | Ph 2 | withdrawn | Omega 3 Fatty Acid Treatment for Pediatric Musculoskeletal Health |
| NCT03077724 FORTUNE results posted | 161820 | Ph 2 | completed | Fish Oil to Reduce Tobacco Use iN Expectant Mothers Study |
| NCT01325584 results posted | MRMC 10-06 | Ph 2 | terminated | Compassionate Use of Omegaven® in the Treatment of Parenteral Nutrition Induced Hepatic Injury |
| NCT02231203 EMPIRE | NL46230.029.13 | Ph 4 | completed | Effect of Omega-3 Fatty Acids on the Perioperative Immune Response and Erythrocyte Function |
| NCT01999413 FAMYLY | FAMYLY | Ph 2 | completed | Pilot Study Efficacy and Tolerance Fish Oil Emulsion Daunorubicin and Cytarabine Treatment of AML Younger Patients |
| NCT01933243 TAANA results posted | TAANA-287112 | Ph 2 | completed | Treatment of Anxiety and Anorexia Nervosa in Adolescents |
| NCT00816348 results posted | 08-204 | Ph 2 | terminated | Compassionate Use of Omegaven IV Fat Emulsion |
| NCT01870791 | 11122 2011-003950-24 | Ph 2 | terminated | Study of Additive Omega-3 Fish Oil to Palliative Chemotherapy to Treat Oesophagogastric Cancer |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
OMEGAVEN FDA Label Details
Indications & Usage
FDA Label (PDF)OMEGAVEN is indicated for the treatment of Parenteral Nutrition-Associated Cholestasis.
OMEGAVEN Patents & Exclusivity
Patents (1 active)
Pro Intelligence Preview
Deep insights for OMEGAVEN
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2026
- • 4 active patents
Trial Analysis
- • 17 total trials
- • Stage: Declining
Competitive Landscape
- • 1 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment