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n-3 PUFAs
n-3 PUFAs is a Fatty acid Small molecule drug developed by Università degli Studi di Brescia. It is currently in Phase 3 development for Hypertriglyceridemia, Cardiovascular disease prevention. Also known as: OMACOR, Pronova Biopharma, Lysaker, Norway, OMACOR.
n-3 PUFAs are a class of fatty acids that exert anti-inflammatory effects and improve cardiovascular health.
N-3 polyunsaturated fatty acids (PUFAs) have been studied for their potential benefits in treating or preventing various conditions, including cardiovascular diseases, hypertension, lipid metabolism disorders, alcohol use disorder, and chronic pain following thermal burn injury. Clinical trials have investigated the efficacy of n-3 PUFAs in comparison to placebo interventions, such as olive oil and flaxseed oil, in subjects at high cardiovascular risk.
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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). -
Cardiovascular Phase 3 risk
-2.0pp
Modern cardiovascular outcome trials are large + long; many fail to beat aggressive standard-of-care.
| 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 | n-3 PUFAs |
|---|---|
| Also known as | OMACOR, Pronova Biopharma, Lysaker, Norway, OMACOR |
| Sponsor | Università degli Studi di Brescia |
| Drug class | Fatty acid |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular |
| Phase | Phase 3 |
Mechanism of action
They do this by inhibiting the production of pro-inflammatory eicosanoids and reducing inflammation in the body. Additionally, they have been shown to improve lipid profiles and reduce triglyceride levels.
Approved indications
- Hypertriglyceridemia
- Cardiovascular disease prevention
Common side effects
- Fishy aftertaste
- Gastrointestinal upset
Key clinical trials
- n-3 Polyunsaturated Fatty Acids to Prevent and Treat Diabetic Neuropathy (NA)
- NUTRIMOOD-Inflammation and Depressive Comorbidity in Obesity: Modulation by Omega-3 Polyunsaturated Fatty Acids Status (NA)
- Effects of Fish Oil and Red Wine on Oxidative Stress Biomarkers (NA)
- Effect of Consuming n-3 PUFAs Rich Foods on Triglyceride Concentration and Lipoprotein Composition (NA)
- Window of Opportunity Study Targeting the Inflammatory Milieu (EARLY_PHASE1)
- Therapeutic Efficacy of Nutritional Supplementation in Cachexia Associated With Chronic Pulmonary Disease (NA)
- Changes in Muscle Strength, Inflammatory Markers, and Body Composition in Response to Alternate Day Fasting Combined With Krill Oil Supplementation in Adults With Overweight and Obesity (NA)
- Effect of Parenteral Nutrition With n-3 PUFAs on Patients With Intestinal Failure (NA)
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:
- n-3 PUFAs CI brief — competitive landscape report
- n-3 PUFAs updates RSS · CI watch RSS
- Università degli Studi di Brescia portfolio CI
Frequently asked questions about n-3 PUFAs
What is n-3 PUFAs?
How does n-3 PUFAs work?
What is n-3 PUFAs used for?
Who makes n-3 PUFAs?
Is n-3 PUFAs also known as anything else?
What drug class is n-3 PUFAs in?
What development phase is n-3 PUFAs in?
What are the side effects of n-3 PUFAs?
Related
- Drug class: All Fatty acid drugs
- Manufacturer: Università degli Studi di Brescia — full pipeline
- Therapeutic area: All drugs in Cardiovascular
- Indication: Drugs for Hypertriglyceridemia
- Indication: Drugs for Cardiovascular disease prevention
- Also known as: OMACOR, Pronova Biopharma, Lysaker, Norway, OMACOR
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing