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Fish oil emulsion
Fish oil emulsion is a Nutritional supplement / Lipid emulsion Small molecule drug developed by Centre Hospitalier Universitaire Vaudois. It is currently in Phase 3 development for Parenteral nutrition support in critically ill patients, Immune modulation in surgical or septic patients. Also known as: Omegaven,Fresenius Kabi AG.
Fish oil emulsion delivers omega-3 polyunsaturated fatty acids (EPA and DHA) that reduce inflammation and modulate immune and metabolic pathways.
Fish oil emulsion is used as an intervention in clinical trials for conditions such as stomach neoplasms and complications related to chemotherapy. It is classified as a supplement, according to ChEMBL, and has been studied in various clinical trials, including those examining its effects on rehabilitation and immune function after surgery and chemotherapy.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Fish oil emulsion |
|---|---|
| Also known as | Omegaven,Fresenius Kabi AG |
| Sponsor | Centre Hospitalier Universitaire Vaudois |
| Drug class | Nutritional supplement / Lipid emulsion |
| Modality | Small molecule |
| Therapeutic area | Nutrition / Critical care / Immunomodulation |
| Phase | Phase 3 |
Mechanism of action
Fish oil emulsion is a lipid-based formulation containing eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), which are incorporated into cell membranes and serve as precursors for anti-inflammatory mediators. These omega-3 fatty acids compete with arachidonic acid metabolism, reducing pro-inflammatory eicosanoid production and promoting resolution of inflammation. They also support endothelial function and may modulate immune cell differentiation.
Approved indications
- Parenteral nutrition support in critically ill patients
- Immune modulation in surgical or septic patients
Common side effects
- Hypertriglyceridemia
- Hepatic steatosis
- Infusion-related reactions
- Gastrointestinal upset (if oral formulation)
Key clinical trials
- Effect of a Parenteral Emulsion With Omega3 on Neonates With PPHN and CDH (PHASE2)
- Preoperative Fish Oil PN and Prognosis After Constipation Surgery
- Intravenous Fish Oil Based Lipid Emulsion to Enhance Recovery in High-Risk Cardiac Surgery Patients (PHASE2)
- Safety Study of SMOFlipid to Evaluate the Risk of Developing EFAD and/or PNAC in Pediatric and Adult Patients (PHASE4)
- Effects of Omega-3 Fatty Acids on Acute Graft-versus-Host Disease After Allogeneic Stem Cell Transplantation. (PHASE1, PHASE2)
- Expanded Access of Omegaven IV Fat Emulsion to Infants and Children With PNALD
- Effect of Parenteral Nutrition With n-3 PUFAs on Patients With Intestinal Failure (NA)
- Safety and Tolerability of Intravenous Fish Oil Lipid Emulsion in Children Undergoing Hematopoietic Cell Transplantation (PHASE1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Fish oil emulsion CI brief — competitive landscape report
- Fish oil emulsion updates RSS · CI watch RSS
- Centre Hospitalier Universitaire Vaudois portfolio CI
Frequently asked questions about Fish oil emulsion
What is Fish oil emulsion?
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Who makes Fish oil emulsion?
Is Fish oil emulsion also known as anything else?
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Related
- Drug class: All Nutritional supplement / Lipid emulsion drugs
- Manufacturer: Centre Hospitalier Universitaire Vaudois — full pipeline
- Therapeutic area: All drugs in Nutrition / Critical care / Immunomodulation
- Indication: Drugs for Parenteral nutrition support in critically ill patients
- Indication: Drugs for Immune modulation in surgical or septic patients
- Also known as: Omegaven,Fresenius Kabi AG
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing