SMOFLIPID 20% (fish oil)
Omegaven is an intravenous lipid emulsion indicated as a source of calories and fatty acids in pediatric patients with parenteral nutrition-associated cholestasis (PNAC). It is intended for the treatment of established PNAC; it is not indicated for the prevention of PNAC, and it has not been demonstrated that clinical outcomes are specifically linked to the omega-6:omega-3 fatty acid ratio of the product.
How SMOFLIPID 20% Works
Omegaven provides a biologically utilizable source of calories and essential fatty acids. These fatty acids serve as critical substrates for energy production, primarily via beta-oxidation. Furthermore, they are essential for maintaining cellular membrane structure and function, serving as precursors for bioactive molecules such as prostaglandins and acting as regulators of gene expression.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2016-07-13
- Routes
- INTRAVENOUS
- Dosage Forms
- EMULSION
Companies
SMOFLIPID 20% Approval History
What SMOFLIPID 20% Treats
1 indicationsSMOFLIPID 20% is approved for 1 conditions since its original approval in 2016. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Parenteral Nutrition-Associated Cholestasis
SMOFLIPID 20% 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 SMOFLIPID 20%
FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
13 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 |
| NCT03405870 LIPIDS-P results posted | IRB201800027 - A OCR19642 | Ph 1, Ph 2 | completed | LIPIDS-P Trial Phase I/II Trial |
| NCT02140788 results posted | Pro00027822 | Ph 4 | terminated | Effects of Metformin and Fish Oil on Treatment With Clozapine |
| NCT03563222 results posted | SMOF-028-CP4 | Ph 4 | terminated | Safety and Efficacy Study to Compare Smoflipid and Intralipid 20% in Pediatric Patients of 3 Months to 16 Years of Age |
| NCT04957940 | 17300631 | Ph 3 | completed | Lipid Emulsion Infusion and COVID-19 Patients |
| 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 |
| NCT03077724 FORTUNE results posted | 161820 | Ph 2 | completed | Fish Oil to Reduce Tobacco Use iN Expectant Mothers Study |
| NCT01933243 TAANA results posted | TAANA-287112 | Ph 2 | completed | Treatment of Anxiety and Anorexia Nervosa in Adolescents |
| NCT03054948 | 16-009516 | Ph 4 | withdrawn | SMOFLipid in Patients Who Are Intralipid Intolerant |
| NCT01585935 | MUV-Neo2 2011-005456-33 | Ph 4 | completed | Preventing Cholestasis Using SMOFLipid® |
| NCT02721277 results posted | IRB201600068 | Ph 1, Ph 2 | terminated | SMOFlipid to Lessen the Severity of Neonatal Cholestasis |
| NCT02539316 SMOFPILOT | 15-PP-03 | Ph 4 | completed | Pilot Study: Hepatoprotective Role of SMOFlipid® Used in Short-term Parenteral Nutrition in an Onco-Hematology Pediatric Population |
| NCT02760472 DonnaMega | 2008-000046-31 | Ph 3 | completed | A Fatty Acids Study in Preventing Retinopathy of Prematurity |
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.
SMOFLIPID 20% FDA Label Details
Indications & Usage
FDA Label (PDF)SMOFLIPID 20% is indicated for the treatment of Parenteral Nutrition-Associated Cholestasis.
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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