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Omega-3 supplements
Omega-3 supplements is a Dietary supplement / Omega-3 polyunsaturated fatty acid Small molecule drug developed by University of Pennsylvania. It is currently in Phase 3 development for Cardiovascular disease prevention and management, Hypertriglyceridemia, Inflammatory conditions.
Omega-3 fatty acids reduce inflammation and modulate lipid metabolism to improve cardiovascular and metabolic health.
Omega-3 supplements have been studied in clinical trials for conditions such as cardiovascular diseases, coronary disease, and diabetes mellitus. These supplements have been tested as part of interventions including dietary supplements and fatty acids, but the specific effects and outcomes of these studies are not specified in the provided facts.
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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 | Omega-3 supplements |
|---|---|
| Sponsor | University of Pennsylvania |
| Drug class | Dietary supplement / Omega-3 polyunsaturated fatty acid |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular |
| Phase | Phase 3 |
Mechanism of action
Omega-3 polyunsaturated fatty acids (EPA and DHA) are incorporated into cell membranes and serve as precursors for anti-inflammatory mediators. They reduce triglyceride levels, lower blood pressure, decrease platelet aggregation, and modulate immune and inflammatory responses through effects on eicosanoid production and gene expression.
Approved indications
- Cardiovascular disease prevention and management
- Hypertriglyceridemia
- Inflammatory conditions
Common side effects
- Gastrointestinal upset (nausea, dyspepsia, diarrhea)
- Fishy aftertaste or odor
- Bleeding or bruising (at high doses)
- Headache
Key clinical trials
- FAST for DM - Fatty Acid Supplementation Trial (FAST) for Dermatomyositis (DM) (PHASE2)
- Heart & Health Study (NA)
- Preoperative Fish Oil PN and Prognosis After Constipation Surgery
- Tart Cherry and Omega-3's for Aromatase Inhibitor Musculoskeletal Symptoms (EARLY_PHASE1)
- A Study of a Dietary Supplement on Serum Biomarkers in Children (NA)
- Effects of DHA in Patients With Multiple Sclerosis (NA)
- Therapeutic Efficacy of Nutritional Supplementation in Cachexia Associated With Chronic Pulmonary Disease (NA)
- A Study Comparing a Plant-Based Diet With Supplements and Placebo in People With Monoclonal Gammopathy of Undetermined Significance (MGUS) or Smoldering Multiple Myeloma (SMM) (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:
- Omega-3 supplements CI brief — competitive landscape report
- Omega-3 supplements updates RSS · CI watch RSS
- University of Pennsylvania portfolio CI
Frequently asked questions about Omega-3 supplements
What is Omega-3 supplements?
How does Omega-3 supplements work?
What is Omega-3 supplements used for?
Who makes Omega-3 supplements?
What drug class is Omega-3 supplements in?
What development phase is Omega-3 supplements in?
What are the side effects of Omega-3 supplements?
Related
- Drug class: All Dietary supplement / Omega-3 polyunsaturated fatty acid drugs
- Manufacturer: University of Pennsylvania — full pipeline
- Therapeutic area: All drugs in Cardiovascular
- Indication: Drugs for Cardiovascular disease prevention and management
- Indication: Drugs for Hypertriglyceridemia
- Indication: Drugs for Inflammatory conditions
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing