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Epanova
Epanova is a Small molecule drug developed by AstraZeneca. It is currently in Phase 3 development for Hypertriglyceridemia. Also known as: Omega-3 carboxylic acids, omega-3 free fatty acids.
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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). -
Big-pharma sponsor
+3.0pp
AstraZeneca is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| 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 | Epanova |
|---|---|
| Also known as | Omega-3 carboxylic acids, omega-3 free fatty acids |
| Sponsor | AstraZeneca |
| Modality | Small molecule |
| Therapeutic area | Metabolic |
| Phase | Phase 3 |
Approved indications
- Hypertriglyceridemia
Common side effects
Key clinical trials
- PK Study Comparing Metformin Eicosapentaenoate to a Combined Dose of Metformin Hydrochloride and Ethyl Ester EPA (PHASE1)
- Outcomes Study to Assess STatin Residual Risk Reduction With EpaNova in HiGh CV Risk PatienTs With Hypertriglyceridemia (PHASE3)
- Epanova® for Lowering Very High Triglycerides II (EVOLVE II) (PHASE3)
- AZD0585 Phase III Long-term Study in Japan (PHASE3)
- A Double-blind Randomized Placebo-controlled Study Comparing Epanova and Fenofibrate on Liver Fat in Overweight Subjects. (PHASE2)
- A Ph 1 Study of Epanova® in Healthy Chineses (PHASE1)
- Study in Healthy Subjects to Compare the Concentrations of the Omega-3 Fatty Acids EPA and DHA in Blood When Delivered as Three New Capsules in Relation to the Epanova® Capsule Under Fasting and Fed Conditions (PHASE1)
- A Study to Investigate How Common Pancreatic Exocrine Insufficiency (PEI) is in Patients With Type 2 Diabetes and Also to Investigate the Uptake of a Single Dose of EPANOVA® or OMACOR® in Patients With Different Degrees of PEI (PHASE2)
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:
- Epanova CI brief — competitive landscape report
- Epanova updates RSS · CI watch RSS
- AstraZeneca portfolio CI
Frequently asked questions about Epanova
What is Epanova?
What is Epanova used for?
Who makes Epanova?
Is Epanova also known as anything else?
What development phase is Epanova in?
Related
- Manufacturer: AstraZeneca — full pipeline
- Therapeutic area: All drugs in Metabolic
- Indication: Drugs for Hypertriglyceridemia
- Also known as: Omega-3 carboxylic acids, omega-3 free fatty acids
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing