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DHA Omega-3
DHA Omega-3 is a Omega-3 fatty acid / Nutritional supplement Small molecule drug developed by University of Cincinnati. It is currently in Phase 3 development for Hypertriglyceridemia, Cardiovascular disease prevention, Cognitive health / Neurological support. Also known as: Docosahexaenoic acid, Omega 3 Fatty Acids.
DHA (docosahexaenoic acid) omega-3 fatty acid reduces inflammation and supports cardiovascular and neurological health through modulation of lipid metabolism and inflammatory pathways.
DHA (docosahexaenoic acid) omega-3 fatty acid reduces inflammation and supports cardiovascular and neurological health through modulation of lipid metabolism and inflammatory pathways. Used for Hypertriglyceridemia, Cardiovascular disease prevention, Cognitive health / Neurological support.
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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). -
CNS / neurology attrition
-3.0pp
CNS drugs have historically high Phase 3 failure rates (notably in Alzheimer disease + major depression).
| 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 | DHA Omega-3 |
|---|---|
| Also known as | Docosahexaenoic acid, Omega 3 Fatty Acids |
| Sponsor | University of Cincinnati |
| Drug class | Omega-3 fatty acid / Nutritional supplement |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular / Neurology |
| Phase | Phase 3 |
Mechanism of action
DHA is a long-chain polyunsaturated omega-3 fatty acid that incorporates into cell membranes and reduces production of pro-inflammatory eicosanoids and cytokines. It also activates specialized pro-resolving mediators that actively resolve inflammation. DHA has been shown to improve lipid profiles, reduce triglycerides, and support endothelial function and cognitive health.
Approved indications
- Hypertriglyceridemia
- Cardiovascular disease prevention
- Cognitive health / Neurological support
Common side effects
- Gastrointestinal upset
- Fishy aftertaste
- Bleeding risk (at high doses)
Key clinical trials
- Omega-3 Supplementation vs Demodex vs Eyelid Cleanser for Pediatric Chalazia (PHASE2)
- Heart & Health Study (NA)
- Effect of a Parenteral Emulsion With Omega3 on Neonates With PPHN and CDH (PHASE2)
- OMEGA - Dietary Intervention - COPD Trial (NA)
- Targeting Risk Factors for Diabetes in Subjects With Normal Blood Cholesterol Using Omega-3 Fatty Acids (NA)
- Tart Cherry and Omega-3's for Aromatase Inhibitor Musculoskeletal Symptoms (EARLY_PHASE1)
- Long-Term Omega-3 and Omega-3 Index >8%: Effects on Physiological Recovery (NA)
- Observing Metabolism of EPA With Consideration of Genetics And Sex (PHASE4)
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:
- DHA Omega-3 CI brief — competitive landscape report
- DHA Omega-3 updates RSS · CI watch RSS
- University of Cincinnati portfolio CI
Frequently asked questions about DHA Omega-3
What is DHA Omega-3?
How does DHA Omega-3 work?
What is DHA Omega-3 used for?
Who makes DHA Omega-3?
Is DHA Omega-3 also known as anything else?
What drug class is DHA Omega-3 in?
What development phase is DHA Omega-3 in?
What are the side effects of DHA Omega-3?
Related
- Drug class: All Omega-3 fatty acid / Nutritional supplement drugs
- Manufacturer: University of Cincinnati — full pipeline
- Therapeutic area: All drugs in Cardiovascular / Neurology
- Indication: Drugs for Hypertriglyceridemia
- Indication: Drugs for Cardiovascular disease prevention
- Indication: Drugs for Cognitive health / Neurological support
- Also known as: Docosahexaenoic acid, Omega 3 Fatty Acids
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing