THERAPY DOSSIER · th-2099154f796e

Omega-3 polyunsaturated fatty acids (Omacor)

Nutraceutical · Mode of action not fully understood; appears to increase beta-oxidation, inhibit acyl-CoA:1,2-diacylglycerol acyltransferase (EC 2.3.1.20), decrease hepatic lipogenesis and increase plasma lipoprotein lipase activity.

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Evidence & regulatory context

Mechanism: Mode of action not fully understood; appears to increase beta-oxidation, inhibit acyl-CoA:1,2-diacylglycerol acyltransferase (EC 2.3.1.20), decrease hepatic lipogenesis and increase plasma lipoprotein lipase activity.
Target: Not recorded
Injury models: Chemical/toxin
Reported indication: Not recorded
First approval: 2004
Development stage: Not recorded
ChEMBL record: CHEMBL1200711 ↗
ChEMBL max phase: 4 / 4 (development scale, not regulatory approval)
Synonyms: Omacor; Lovaza; Omtryg; K-85; TAK-085; Omega-3 acid ethyl esters
Note: Not recorded

Clinical trials 8

0 linked trials carry an injury-indication flag. These flags support record-level exploration and sit alongside the stringent aggregate counts described in Methods.

NCT02305355 ↗PHASE4completed

Prescription Omega-3 Fatty Acid Added to Stable Statin Therapy in Type 2 Diabetes and Hypertriglyceridemia

Diabetes Mellitus, Type 2 · Hypertriglyceridemia

Enrolment: 68 · Results not recorded

NCT00328536 ↗PHASE4completed

Effects of Omacor for 6 Weeks on Pre- and Postprandial Endothelial Function in Type 2 Diabetes

Atherosclerosis · Type 2 Diabetes Mellitus

Enrolment: 34 · Results not recorded

NCT02824432 ↗PHASE4completed

Effect of Omega-3-acid Ethyl Esters on Vascular Endothelial Function in Hyperlipidemia by Flow Mediated Dilation

Hyperlipidemia

Enrolment: 37 · Results not recorded

NCT01010399 ↗PHASE4completed

Adjunctive Therapy With Lovaza in Hypertriglyceridemic, HIV-Infected Subjects

Hypertriglyceridemia · HIV Infection

Enrolment: 36 · Results not recorded

NCT00437099 ↗PHASE4unknown

Efficacy of Omega-3 Fatty Acids on Borderline Personality Disorder

Borderline Personality Disorder

Enrolment: 102 · Results not recorded

NCT01208961 ↗PHASE2completed

Relative Bioavailability of a Single Dose of Epanova With Lovaza After a Low-Fat and High-Fat Meal

Severe Hypertriglyceridemia

Enrolment: 54 · Results not recorded

NCT01929070 ↗PHASE1completed

Pharmacokinetics of Omega-3 Between Rosuvastatin and Omega-3 Coadministration and HCP1007 in Healthy Males

Healthy

Enrolment: 12 · Results not recorded

NCT00577590 ↗NAcompleted

Effects of Fatty Acid Delivery on Myocardial Metabolism and Function in Type 2 Diabetes

Diabetes Mellitus, Type II

Enrolment: 78 · Results not recorded

Preclinical evidence 1

1 studies reported at therapy level; 1 evidence entries itemised.

PMID 28314803 ↗2017Reported benefit

omega-3 Polyunsaturated fatty acids accelerate airway repair by activating FFA4 in club cells.

MouseChemical/toxinBALB/c and FFA4-knockoutMale7.75 mg/kg

Model: Naphthalene-induced acute airway (club cell) injury, single intraperitoneal injection of 30 mg/kg naphthalene

Naphthalene destroyed bronchiolar epithelial cells within a day, with recovery by 21 days in control mice. Omacor accelerated recovery, with epithelial reappearance between 7 and 14 days. The benefit was absent in FFA4-knockout mice, indicating FFA4-dependent club cell proliferation.

Extraction: extract · Supplied extraction confidence: 0.7. Machine-extracted fields require source verification.

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