{"id":"eicosapentaenoic-acid","rwe":[{"pmid":"41899733","year":"2026","title":"The Role of Omega-3 Polyunsaturated Fatty Acids on Sarcopenia and Aging Muscle.","finding":"","journal":"International journal of environmental research and public health","studyType":"Clinical Study"},{"pmid":"41898657","year":"2026","title":"An Explorative Approach to Examining the Role of Ischemia and Inflammation on the Function of Autoantibodies Against G Protein-Coupled Receptors and Their Corresponding Agonists.","finding":"","journal":"International journal of molecular sciences","studyType":"Clinical Study"},{"pmid":"41897934","year":"2026","title":"Relationship Between Litter Weight Gain and Colostrum Fatty Acid Composition: Implications for Cross-Fostering?","finding":"","journal":"Animals : an open access journal from MDPI","studyType":"Clinical Study"},{"pmid":"41897837","year":"2026","title":"Effects of Dietary Inclusion of Perilla Seed Meal on Growth Performance, Plasma Biochemistry, and Breast Muscle Fatty Acid Composition in Sansui Ducks from 4 to 8 Weeks of Age.","finding":"","journal":"Animals : an open access journal from MDPI","studyType":"Clinical Study"},{"pmid":"41897794","year":"2026","title":"Criteria for the Characterization of Seafood Byproducts to Allow Tracing Their Geographic Origin.","finding":"","journal":"Foods (Basel, Switzerland)","studyType":"Clinical Study"}],"_fda":{"id":"fc2e665c-7b0e-4969-998e-be05e0e73520","set_id":"019cc0ac-0c2f-426d-996a-6d932f954443","openfda":{"upc":["0372865290125","0372865289242"],"unii":["6GC8A4PAYH"],"route":["ORAL"],"rxcui":["1304979","1811180"],"spl_id":["fc2e665c-7b0e-4969-998e-be05e0e73520"],"brand_name":["ICOSAPENT ETHYL"],"spl_set_id":["019cc0ac-0c2f-426d-996a-6d932f954443"],"package_ndc":["72865-289-24","72865-290-12"],"product_ndc":["72865-289","72865-290"],"generic_name":["ICOSAPENT ETHYL"],"product_type":["HUMAN PRESCRIPTION DRUG"],"substance_name":["ICOSAPENT ETHYL"],"manufacturer_name":["XLCare Pharmaceuticals, Inc."],"application_number":["ANDA216811"],"is_original_packager":[true]},"version":"1","pregnancy":["8.1 Pregnancy Risk Summary The available data from published case reports and the pharmacovigilance database on the use of icosapent ethyl in pregnant women are insufficient to identify a drug-associated risk for major birth defects, miscarriage or adverse maternal or fetal outcomes. In animal reproduction studies in pregnant rats, non-dose-related imbalances for some minor developmental findings were observed with oral administration of icosapent ethyl during organogenesis at exposures that were equivalent to the clinical exposure at the human dose of 4 g/day, based on body surface area comparisons. In a study in pregnant rabbits orally administered icosapent ethyl during organogenesis, there were no clinically relevant adverse developmental effects at exposures that were 5 times the clinical exposure, based on body surface area comparisons ( see Data ). The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Data Animal Data In pregnant rats given oral gavage doses of 0.3, 1 and 2 g/kg/day icosapent ethyl from gestation through organogenesis all drug treated groups had non-dose-related imbalances in visceral and skeletal findings, including 13 th reduced ribs, additional liver lobes, testes medially displaced and/or not descended, at human systemic exposures following a maximum oral dose of 4 g/day based on body surface comparisons. In a multigenerational developmental study in pregnant rats given doses of 0.3, 1, 3 g/kg/day icosapent ethyl by oral gavage from gestation day 7-17, icosapent ethyl did not affect viability in fetuses (F 1 or F 2 ). Non-dose-related imbalances in findings of absent optic nerves and unilateral testes atrophy at human exposures based on the maximum dose of 4 g/day and on body surface area comparisons. Additional variations consisting of early incisor eruption and increased percent cervical ribs were observed at the same exposures. Pups from high dose treated dams exhibited decreased copulation rates, delayed estrus, decreased implantations and decreased surviving fetuses (F2) suggesting potential multigenerational effects of icosapent ethyl at 7 times human systemic exposure following 4 g/day dose based on body surface area comparisons across species. In pregnant rabbits given oral gavage doses of 0.1, 0.3, and 1 g/kg/day icosapent ethyl from gestation through organogenesis, a decrease in body weight and food consumption was observed at the high dose of 1 g/kg/day (5 times the human exposure at the maximum dose of 4 g/day, based on body surface area comparisons). Slight increases in resorbed and dead fetuses were noted in the 1 g/kg/day group, but these were not significantly different from the control group. There were no differences between the icosapent ethyl groups and control group as to the number of corpora lutea , number of implantations, number of surviving fetuses, sex ratio, body weight of female fetuses or placental weight. There were no treatment-related malformations or skeletal anomalies. In pregnant rats given icosapent ethyl from gestation day 17 through lactation day 20 at 0.3, 1, 3 g/kg/day no adverse maternal or developmental effects were observed. However, complete litter loss (not dose-related) was noted in 2/23 litters at the low dose and 1/23 mid-dose dams by post-natal day 4 at human exposures at a maximum dose of 4 g/day, based on body surface area comparisons."],"description":["11 DESCRIPTION Icosapent ethyl capsules, a lipid-regulating agent, is supplied as either a 0.5 gram or a 1 gram liquid-filled clear, transparent soft gelatin capsules containing clear to light yellow colored solution for oral use. Each icosapent ethyl capsule contains either 0.5 grams of icosapent ethyl (in a 0.5 gram capsule) or 1 gram of icosapent ethyl (in a 1 gram capsule). Icosapent ethyl is an ethyl ester of the omega-3 fatty acid eicosapentaenoic acid (EPA). The empirical formula of icosapent ethyl is C 22 H 34 O 2 and the molecular weight is 330.50. The chemical name for icosapent ethyl is ethyl all-cis-5,8,11,14,17-icosapentaenoate with the following chemical structure: Icosapent ethyl capsules also contain the following inactive ingredients: bloom gelatin, glycerin, alpha tocopherol, medium chain triglycerides, and lecithin. The capsules are imprinted with white imprinting ink containing titanium dioxide, propylene glycol, and hypromellose 2910. structure"],"how_supplied":["16 HOW SUPPLIED/STORAGE AND HANDLING Icosapent ethyl capsules are supplied as: The 0.5 gram icosapent ethyl capsule is available as a clear, transparent oval capsules containing clear to light yellow colored solution imprinted with ‘547’ with white ink. Bottles of 240 capsules NDC 72865-289-24 The 1 gram icosapent ethyl capsule is available as a clear, transparent oblong capsules containing clear to light yellow colored solution imprinted with ‘291’ with white ink. Bottles of 120 capsules NDC 72865-290-12 Store at 20° to 25° C (68° to 77°F); excursions permitted to 15° to 30° C (59° to 86°F) [see USP Controlled Room Temperature]. Keep out of reach of children."],"geriatric_use":["8.5 Geriatric Use Of the total number of patients in well-controlled clinical studies of icosapent ethyl, 45% were 65 years of age and over. No overall differences in safety or effectiveness were observed between these patients and younger groups. Other reported clinical experience has not identified differences in responses between the elderly and younger patients."],"pediatric_use":["8.4 Pediatric Use Safety and effectiveness in pediatric patients have not been established."],"effective_time":"20240315","clinical_studies":["14 CLINICAL STUDIES 14.2 Severe Hypertriglyceridemia The effects of icosapent ethyl 4 grams per day were assessed in a randomized, placebo-controlled, double-blind, parallel-group study of adult patients (76 on icosapent ethyl, 75 on placebo) with severe hypertriglyceridemia. Patients whose baseline TG levels were between 500 and 2,000 mg/dL were enrolled in this study for 12 weeks. The median baseline TG and LDL-C levels in these patients were 684 mg/dL and 86 mg/dL, respectively. Median baseline HDL-C level was 27 mg/dL. The randomized population in this study was mostly Caucasian (88%) and male (76%). The mean age was 53 years and the mean body mass index was 31 kg/m 2 . Twenty-five percent of patients were on concomitant statin therapy, 28% were diabetics, and 39% of the patients had TG levels >750 mg/dL. The changes in the major lipoprotein lipid parameters for the groups receiving icosapent ethyl or placebo are shown in Table 2. Table 2. Median Baseline and Percent Change from Baseline in Lipid Parameters in Patients with Severe Hypertriglyceridemia (≥500 mg/dL) % Change= Median Percent Change from Baseline Difference= Median of [Icosapent Ethyl % Change – Placebo % Change] (Hodges-Lehmann Estimate) p-values from Wilcoxon rank-sum test *p-value < 0.001 (primary efficacy endpoint) **p-value < 0.05 (key secondary efficacy endpoints determined to be statistically significant according to the pre-specified multiple comparison procedure) Icosapent ethyl 4 grams per day reduced median TG, VLDL-C, and Apo B levels from baseline relative to placebo. The reduction in TG observed with icosapent ethyl was not associated with elevations in LDL-C levels relative to placebo. Table 2"],"adverse_reactions":["6 ADVERSE REACTIONS The following important adverse reactions are described below and elsewhere in the labeling: Atrial Fibrillation or Atrial Flutter [see Warnings and Precautions (5.1)] Potential for Allergic Reactions in Patients with Fish Allergy [see Warnings and Precautions (5.2)] Bleeding [see Warnings and Precautions (5.3)] Common adverse reactions (incidence ≥3% and ≥1% more frequent than placebo): musculoskeletal pain, peripheral edema, constipation, gout, and atrial fibrillation. (6.1) Common adverse reactions in the hypertriglyceridemia trials (incidence ≥1% more frequent than placebo): arthralgia and oropharyngeal pain. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact XLCare Pharmaceuticals, Inc. at 1-866-495-1995 or contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Common adverse reactions (incidence ≥3% on icosapent ethyl and ≥1% more frequent than placebo) included musculoskeletal pain, peripheral edema, constipation, gout, and atrial fibrillation. Hypertriglyceridemia Trials In two randomized, double-blind, placebo-controlled trials in patients with triglyceride levels between 200 and 2000 mg/dL treated for 12 weeks, adverse reactions reported with icosapent ethyl at an incidence ≥1% more frequent than placebo based on pooled data included arthralgia and oropharyngeal pain. 6.2 Postmarketing Experience Additional adverse reactions have been identified during post-approval use of icosapent ethyl capsules. Because these reactions are reported voluntarily from a population of uncertain size, it is generally not possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Diarrhea Blood triglycerides increased Abdominal discomfort Pain in the extremities"],"contraindications":["4 CONTRAINDICATIONS Icosapent ethyl capsules are contraindicated in patients with known hypersensitivity (e.g., anaphylactic reaction) to icosapent ethyl or any of its components. Icosapent ethyl capsules are contraindicated in patients with known hypersensitivity (e.g., anaphylactic reaction) to icosapent ethyl or any of its components. (4)"],"drug_interactions":["7 DRUG INTERACTIONS Increased Bleeding Risk with Anticoagulants and Antiplatelet Agents: Some published studies with omega-3 fatty acids have demonstrated prolongation of bleeding time. Monitor patients receiving icosapent ethyl and concomitant anticoagulants and/or antiplatelet agents for bleeding. (7) 7.1 Increased Bleeding Risk with Anticoagulants and Antiplatelet Agents Some published studies with omega-3 fatty acids have demonstrated prolongation of bleeding time. The prolongation of bleeding time reported in those studies has not exceeded normal limits and did not produce clinically significant bleeding episodes. Monitor patients receiving icosapent ethyl and concomitant anticoagulants and/or antiplatelet agents for bleeding."],"recent_major_changes":["RECENT MAJOR CHANGES Indications and Usage (1) 12/2019 Warnings and Precautions, Atrial Fibrillation/Flutter (5.1) 12/2019 Warnings and Precautions, Bleeding (5.3) 12/2019"],"clinical_pharmacology":["12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Studies suggest that EPA reduces hepatic very low-density lipoprotein triglycerides (VLDL-TG) synthesis and/or secretion and enhances TG clearance from circulating VLDL particles. Potential mechanisms of action include increased β-oxidation; inhibition of acyl-CoA:1,2-diacylglycerol acyltransferase (DGAT); decreased lipogenesis in the liver; and increased plasma lipoprotein lipase activity. 12.2 Pharmacodynamics In a 12-week, dose-ranging study in patients with severe hypertriglyceridemia, icosapent ethyl 4 grams per day reduced median TG from baseline relative to placebo [see Clinical Studies (14)] . 12.3 Pharmacokinetics Absorption After oral administration, icosapent ethyl is de-esterified during the absorption process and the active metabolite EPA is absorbed in the small intestine and enters the systemic circulation mainly via the thoracic duct lymphatic system. Peak plasma concentrations of EPA were reached approximately 5 hours following oral doses of icosapent ethyl. Icosapent ethyl capsules was administered with or following a meal in all clinical studies; no food effect studies were performed. Take icosapent ethyl capsules with or following a meal. Distribution The mean volume of distribution at steady state of EPA is approximately 88 liters. The majority of EPA circulating in plasma is incorporated in phospholipids, triglycerides and cholesteryl esters, and <1% is present as the unesterified fatty acid. Greater than 99% of unesterified EPA is bound to plasma proteins. Elimination Metabolism EPA is mainly metabolized by the liver via beta-oxidation similar to dietary fatty acids. Beta oxidation splits the long carbon chain of EPA into acetyl Coenzyme A, which is converted into energy via the Krebs cycle. Cytochrome P450-mediated metabolism is a minor pathway of elimination of EPA. Excretion The total plasma clearance of EPA at steady state is 684 mL/hr. The plasma elimination half-life (t 1/2 ) of EPA is approximately 89 hours. Icosapent ethyl does not undergo renal excretion. Specific Populations Gender When administered icosapent ethyl in clinical trials, plasma total EPA concentrations did not differ significantly between men and women. Pediatric The pharmacokinetics of icosapent ethyl have not been studied in pediatric patients. Hepatic or Renal Impairment Icosapent ethyl has not been studied in patients with renal or hepatic impairment. Drug Interaction Studies Omeprazole In a drug-drug interaction study with 28 healthy adult subjects, icosapent ethyl 4 g/day at steady-state did not significantly change the steady-state AUC τ or C max of omeprazole when co-administered at 40 mg/day to steady-state. Rosiglitazone In a drug-drug interaction study with 28 healthy adult subjects, icosapent ethyl 4 g/day at steady-state did not significantly change the single dose AUC or C max of rosiglitazone at 8 mg. Warfarin In a drug-drug interaction study with 25 healthy adult subjects, icosapent ethyl 4 g/day at steady-state did not significantly change the single dose AUC or C max of R - and S -warfarin or the anti-coagulation pharmacodynamics of warfarin when co-administered as racemic warfarin at 25 mg. Atorvastatin In a drug-drug interaction study of 26 healthy adult subjects, icosapent ethyl 4 g/day at steady-state did not significantly change the steady-state AUC τ or C max of atorvastatin, 2-hydroxyatorvastatin, or 4-hydroxyatorvastatin when co-administered with atorvastatin 80 mg/day at steady-state."],"indications_and_usage":["1 INDICATIONS AND USAGE Icosapent ethyl capsules are indicated: as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (≥ 500 mg/dL) hypertriglyceridemia. Limitations of Use: The effect of icosapent ethyl capsules on the risk for pancreatitis in patients with severe hypertriglyceridemia has not been determined. Icosapent ethyl capsules are an ethyl ester of eicosapentaenoic acid (EPA) indicated: as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (≥ 500 mg/dL) hypertriglyceridemia. (1) Limitations of Use: The effect of icosapent ethyl capsules on the risk for pancreatitis in patients with severe hypertriglyceridemia has not been determined. (1)"],"warnings_and_cautions":["5 WARNINGS AND PRECAUTIONS Atrial Fibrillation/Flutter: Icosapent ethyl was associated with an increased risk of atrial fibrillation or atrial flutter requiring hospitalization in a double-blind, placebo-controlled trial. The incidence of atrial fibrillation was greater in patients with a previous history of atrial fibrillation or atrial flutter. (5.1) Potential for Allergic Reactions in Patients with Fish Allergy: Icosapent ethyl capsules contains ethyl esters of the omega-3 fatty acid, eicosapentaenoic acid (EPA), obtained from the oil of fish. It is not known whether patients with allergies to fish and/or shellfish are at increased risk of an allergic reaction to icosapent ethyl capsules. Inform patients with known hypersensitivity to fish and/or shellfish about the potential for allergic reactions and advise them to discontinue icosapent ethyl and seek medical attention if any reactions occur. (5.2) Bleeding: Icosapent ethyl was associated with an increased risk of bleeding in a double-blind, placebo-controlled trial. The incidence of bleeding was greater in patients receiving concomitant antithrombotic medications, such as aspirin, clopidogrel, or warfarin. (5.3) 5.1 Atrial Fibrillation/Flutter Icosapent ethyl is associated with an increased risk of atrial fibrillation or atrial flutter requiring hospitalization. In a double-blind, placebo-controlled trial of 8,179 subjects, adjudicated atrial fibrillation or atrial flutter requiring hospitalization for 24 or more hours occurred in 127 (3%) patients treated with icosapent ethyl compared to 84 (2%) patients receiving placebo [HR= 1.5 (95% CI 1.14, 1.98)]. The incidence of atrial fibrillation was greater in patients with a previous history of atrial fibrillation or atrial flutter. 5.2 Potential for Allergic Reactions in Patients with Fish Allergy Icosapent ethyl contains ethyl esters of the omega-3 fatty acid, eicosapentaenoic acid (EPA), obtained from the oil of fish. It is not known whether patients with allergies to fish and/or shellfish are at increased risk of an allergic reaction to icosapent ethyl. Inform patients with known hypersensitivity to fish and/or shellfish about the potential for allergic reactions to icosapent ethyl and advise them to discontinue icosapent ethyl and seek medical attention if any reactions occur. 5.3 Bleeding Icosapent ethyl is associated with an increased risk of bleeding. In a double-blind, placebo-controlled trial of 8,179 patients, 482 (12%) patients receiving icosapent ethyl experienced a bleeding event compared to 404 (10%) patients receiving placebo. Serious bleeding events occurred in 111 (3%) of patients on icosapent ethyl vs. 85 (2%) of patients receiving placebo. The incidence of bleeding was greater in patients receiving concomitant antithrombotic medications, such as aspirin, clopidogrel, or warfarin."],"nonclinical_toxicology":["13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility In a 2-year rat carcinogenicity study with oral gavage doses of 0.09, 0.27, and 0.91 g/kg/day icosapent ethyl, respectively, males did not exhibit drug-related neoplasms. Hemangiomas and hemangiosarcomas of the mesenteric lymph node, the site of drug absorption, were observed in females at clinically relevant exposures based on body surface area comparisons across species relative to the maximum clinical dose of 4 g/day. Overall incidence of hemangiomas and hemangiosarcomas in all vascular tissues did not increase with treatment. In a 6-month carcinogenicity study in Tg.rasH2 transgenic mice with oral gavage doses of 0.5, 1, 2, and 4.6 g/kg/day icosapent ethyl, drug-related incidences of benign squamous cell papilloma in the skin and subcutis of the tail was observed in high dose male mice. The papillomas were considered to develop secondary to chronic irritation of the proximal tail associated with fecal excretion of oil and therefore not clinically relevant. Drug-related neoplasms were not observed in female mice. Icosapent ethyl was not mutagenic with or without metabolic activation in the bacterial mutagenesis (Ames) assay or in the in vivo mouse micronucleus assay. A chromosomal aberration assay in Chinese Hamster Ovary (CHO) cells was positive for clastogenicity with and without metabolic activation. In an oral gavage rat fertility study, ethyl-EPA, administered at doses of 0.3, 1, and 3 g/kg/day to male rats for 9 weeks before mating and to female rats for 14 days before mating through day 7 of gestation, increased anogenital distance in female pups and increased cervical ribs were observed at 3 g/kg/day (7 times human systemic exposure with 4 g/day clinical dose based on a body surface area comparison)."],"information_for_patients":["17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling before starting icosapent ethyl capsules (Patient Information). Inform patients that icosapent ethyl capsules may increase their risk for atrial fibrillation or atrial flutter [see Warnings and Precautions (5.1)] . Inform patients with known hypersensitivity to fish and/or shellfish about the potential for allergic reactions to icosapent ethyl capsules and advise them to discontinue icosapent ethyl capsules and seek medical attention if any reactions occur [see Warnings and Precautions (5.2)] . Inform patients that icosapent ethyl capsules may increase their risk for bleeding, especially if they are receiving other antithrombotic agents [see Warnings and Precautions (5.3)] . Advise patients to swallow icosapent ethyl capsules whole. Do not break open, crush, dissolve, or chew icosapent ethyl capsules [see Dosage and Administration (2.2)] . Instruct patients to take icosapent ethyl capsules as prescribed. If a dose is missed, patients should take it as soon as they remember. However, if they miss one day of icosapent ethyl capsules, they should not double the dose when they take it. For more information about icosapent ethyl capsules, call XLCare Pharmaceuticals, Inc. at 1-866-495-1995. Manufactured by: Ascent Pharmaceuticals, Inc. Central Islip, NY 11722 Manufactured for: XLCare Pharmaceuticals, Inc. 242 South Culver Street, Suite 202 Lawrenceville, GA 30046 Rev: 03/24"],"dosage_and_administration":["2 DOSAGE AND ADMINISTRATION Assess lipid levels before initiating therapy. Identify other causes of high triglyceride levels and manage as appropriate. (2.1) Patients should engage in appropriate nutritional intake and physical activity before receiving icosapent ethyl capsules, which should continue during treatment. (2.1) The daily dose of icosapent ethyl capsules are 4 grams per day taken as either four 0.5 gram capsules twice daily with food or two 1 gram capsules twice daily with food. (2.2) Advise patients to swallow capsules whole. Do not break open, crush, dissolve, or chew icosapent ethyl capsules. (2.2) 2.1 Prior to Initiation of Icosapent Ethyl Capsules Assess lipid levels before initiating therapy. Identify other causes (e.g., diabetes mellitus, hypothyroidism, or medications) of high triglyceride levels and manage as appropriate. Patients should engage in appropriate nutritional intake and physical activity before receiving icosapent ethyl capsules, which should continue during treatment with icosapent ethyl capsules. 2.2 Dosage and Administration The daily dose of icosapent ethyl capsules are 4 grams per day taken as either: four 0.5 gram capsules twice daily with food; or as two 1 gram capsules twice daily with food. Advise patients to swallow icosapent ethyl capsules whole. Do not break open, crush, dissolve, or chew icosapent ethyl capsules."],"spl_product_data_elements":["ICOSAPENT ETHYL Icosapent ethyl ICOSAPENT ETHYL ICOSAPENT GELATIN GLYCERIN .ALPHA.-TOCOPHEROL MEDIUM-CHAIN TRIGLYCERIDES LECITHIN, SOYBEAN TITANIUM DIOXIDE PROPYLENE GLYCOL HYPROMELLOSES Clear, transparent 547 ICOSAPENT ETHYL Icosapent ethyl ICOSAPENT ETHYL ICOSAPENT GELATIN GLYCERIN .ALPHA.-TOCOPHEROL MEDIUM-CHAIN TRIGLYCERIDES LECITHIN, SOYBEAN TITANIUM DIOXIDE PROPYLENE GLYCOL HYPROMELLOSES Clear, transparent 291"],"dosage_forms_and_strengths":["3 DOSAGE FORMS AND STRENGTHS Icosapent ethyl capsules are supplied as: 0.5 gram clear, transparent oval capsules containing clear to light yellow colored solution imprinted with ‘547’ with white ink. 1 gram clear, transparent oblong capsules containing clear to light yellow colored solution imprinted with ‘291’ with white ink. Capsules: 0.5 gram and 1 gram (3)"],"spl_patient_package_insert":["PATIENT INFORMATION Icosapent Ethyl (eye koe’ sa pent eth il) Capsules What are Icosapent ethyl capsules? Icosapent ethyl capsules are a prescription medicine used: along with a low-fat and low-cholesterol diet to lower high levels of triglycerides (fats) in adults. It is not known if icosapent ethyl capsules changes your risk of having inflammation of your pancreas (pancreatitis). It is not known if icosapent ethyl capsules are safe and effective in children. Do not take icosapent ethyl capsules if you are allergic to icosapent ethyl or any of the ingredients in icosapent ethyl capsules. See the end of this leaflet for a complete list of ingredients in icosapent ethyl capsules. Before taking icosapent ethyl capsules, tell your doctor about all of your medical conditions, including if you: have diabetes. have a low thyroid problem (hypothyroidism). have a liver problem. have a pancreas problem. are allergic to fish or shellfish. It is not known if people who are allergic to fish or shellfish are also allergic to icosapent ethyl capsules. are pregnant, or planning to become pregnant. It is not known if icosapent ethyl capsules will harm your unborn baby. are breastfeeding or plan to breastfeed. Icosapent ethyl can pass into your breast milk, and may harm your baby. Talk to your doctor about the best way to feed your baby if you take icosapent ethyl capsules. Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and dietary or herbal supplements. Icosapent ethyl capsules can interact with certain other medicines that you are taking. Especially tell your doctor if you take medicines that affect your blood clotting (anticoagulants or blood thinners). How should I take icosapent ethyl capsules? Take icosapent ethyl capsules exactly as your doctor tells you to take it. Do not change your dose or stop taking icosapent ethyl capsules without talking to your doctor. Do not take more capsules than what is prescribed by your doctor. o If you are prescribed the 0.5-gram capsules, you should not take more than 8 capsules each day with food. o If you are prescribed the 1-gram capsules, you should not take more than 4 capsules each day with food. Take icosapent ethyl capsules whole. Do not break, crush, dissolve, or chew icosapent ethyl capsules before swallowing. If you miss a dose of icosapent ethyl capsules, take it as soon as you remember. However, if you miss one day of icosapent ethyl capsules, do not double your dose when you take it. Your doctor may start you on a diet that is low in saturated fat, cholesterol, carbohydrates, and low in added sugars before giving you icosapent ethyl capsules. Stay on this diet while taking icosapent ethyl capsules. Your doctor may do blood tests to check your triglyceride and other lipid levels while you take icosapent ethyl capsules. What are the possible side effects of icosapent ethyl capsules? Icosapent ethyl capsules may cause serious side effects, including: Heart rhythm problems (atrial fibrillation and atrial flutter). Heart rhythm problems which can be serious and cause hospitalization have happened in people who take icosapent ethyl capsules, especially in people who have heart (cardiovascular) disease or diabetes with a risk factor for heart (cardiovascular) disease, or who have had heart rhythm problems in the past. Tell your doctor if you get any symptoms of heart rhythm problems such as feeling as if your heart is beating fast and irregular, lightheadedness, dizziness, shortness of breath, chest discomfort, or you faint. Possible allergic reactions if you are allergic to fish or shellfish. Stop taking icosapent ethyl capsules and tell your doctor right away or get emergency medical help if you have any signs or symptoms of an allergic reaction. Bleeding. Serious bleeding can happen in people who take icosapent ethyl capsules. Your risk of bleeding may increase if you are also taking a blood thinner medicine. If you have liver problems and are taking icosapent ethyl capsules, your doctor should do blood tests during treatment. The most common side effects of icosapent ethyl capsules include: Muscle and joint pain. Swelling of the hands, legs, or feet. Constipation Gout Heart rhythm problems (atrial fibrillation). These are not all the possible side effects of icosapent ethyl capsules. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. How should I store icosapent ethyl capsules? Store icosapent ethyl capsules at room temperature between 68° to 77° F (20° to 25° C). Safely throw away medicine that is out of date or no longer needed. Keep icosapent ethyl capsules and all medicine out of the reach of children. General information about the safe and effective use of icosapent ethyl capsules. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use icosapent ethyl capsules for a condition for which it was not prescribed. Do not give icosapent ethyl capsules to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about icosapent ethyl capsules that is written for health professionals. What are the ingredients in icosapent ethyl capsules? Active ingredient: icosapent ethyl Inactive ingredients: bloom gelatin, glycerin, alpha tocopherol, medium chain triglycerides, and lecithin. The capsules are imprinted with white imprinting ink containing titanium dioxide, propylene glycol, and hypromellose 2910. For more information, call XLCare Pharmaceuticals, Inc. at 1-866-495-1995. Manufactured by: Ascent Pharmaceuticals, Inc. Central Islip, NY 11722 Manufactured for: XLCare Pharmaceuticals, Inc. 242 South Culver Street, Suite 202 Lawrenceville, GA 30046 This Patient Information has been approved by the U.S. Food and Drug Administration Rev: 03/24"],"use_in_specific_populations":["8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Risk Summary The available data from published case reports and the pharmacovigilance database on the use of icosapent ethyl in pregnant women are insufficient to identify a drug-associated risk for major birth defects, miscarriage or adverse maternal or fetal outcomes. In animal reproduction studies in pregnant rats, non-dose-related imbalances for some minor developmental findings were observed with oral administration of icosapent ethyl during organogenesis at exposures that were equivalent to the clinical exposure at the human dose of 4 g/day, based on body surface area comparisons. In a study in pregnant rabbits orally administered icosapent ethyl during organogenesis, there were no clinically relevant adverse developmental effects at exposures that were 5 times the clinical exposure, based on body surface area comparisons ( see Data ). The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Data Animal Data In pregnant rats given oral gavage doses of 0.3, 1 and 2 g/kg/day icosapent ethyl from gestation through organogenesis all drug treated groups had non-dose-related imbalances in visceral and skeletal findings, including 13 th reduced ribs, additional liver lobes, testes medially displaced and/or not descended, at human systemic exposures following a maximum oral dose of 4 g/day based on body surface comparisons. In a multigenerational developmental study in pregnant rats given doses of 0.3, 1, 3 g/kg/day icosapent ethyl by oral gavage from gestation day 7-17, icosapent ethyl did not affect viability in fetuses (F 1 or F 2 ). Non-dose-related imbalances in findings of absent optic nerves and unilateral testes atrophy at human exposures based on the maximum dose of 4 g/day and on body surface area comparisons. Additional variations consisting of early incisor eruption and increased percent cervical ribs were observed at the same exposures. Pups from high dose treated dams exhibited decreased copulation rates, delayed estrus, decreased implantations and decreased surviving fetuses (F2) suggesting potential multigenerational effects of icosapent ethyl at 7 times human systemic exposure following 4 g/day dose based on body surface area comparisons across species. In pregnant rabbits given oral gavage doses of 0.1, 0.3, and 1 g/kg/day icosapent ethyl from gestation through organogenesis, a decrease in body weight and food consumption was observed at the high dose of 1 g/kg/day (5 times the human exposure at the maximum dose of 4 g/day, based on body surface area comparisons). Slight increases in resorbed and dead fetuses were noted in the 1 g/kg/day group, but these were not significantly different from the control group. There were no differences between the icosapent ethyl groups and control group as to the number of corpora lutea , number of implantations, number of surviving fetuses, sex ratio, body weight of female fetuses or placental weight. There were no treatment-related malformations or skeletal anomalies. In pregnant rats given icosapent ethyl from gestation day 17 through lactation day 20 at 0.3, 1, 3 g/kg/day no adverse maternal or developmental effects were observed. However, complete litter loss (not dose-related) was noted in 2/23 litters at the low dose and 1/23 mid-dose dams by post-natal day 4 at human exposures at a maximum dose of 4 g/day, based on body surface area comparisons. 8.2 Lactation Risk Summary Published studies have detected omega-3 fatty acids, including EPA, in human milk. Lactating women receiving oral omega-3 fatty acids for supplementation have resulted in higher levels of omega-3 fatty acids in human milk. There are no data on the effects of omega-3 fatty acid ethyl esters on the breastfed infant or on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for icosapent ethyl and any potential adverse effects on the breastfed child from icosapent ethyl or from the underlying maternal condition. 8.4 Pediatric Use Safety and effectiveness in pediatric patients have not been established. 8.5 Geriatric Use Of the total number of patients in well-controlled clinical studies of icosapent ethyl, 45% were 65 years of age and over. No overall differences in safety or effectiveness were observed between these patients and younger groups. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. 8.7 Hepatic Impairment In patients with hepatic impairment, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels should be monitored periodically during therapy with icosapent ethyl."],"spl_patient_package_insert_table":["
PATIENT INFORMATIONIcosapent Ethyl (eye koe’ sa pent eth il)Capsules
What are Icosapent ethyl capsules?Icosapent ethyl capsules are a prescription medicine used:along with a low-fat and low-cholesterol diet to lower high levels of triglycerides (fats) in adults.It is not known if icosapent ethyl capsules changes your risk of having inflammation of your pancreas (pancreatitis). It is not known if icosapent ethyl capsules are safe and effective in children.
Do not take icosapent ethyl capsules if you are allergic to icosapent ethyl or any of the ingredients in icosapent ethyl capsules. See the end of this leaflet for a complete list of ingredients in icosapent ethyl capsules.
Before taking icosapent ethyl capsules, tell your doctor about all of your medical conditions, including if you:have diabetes.have a low thyroid problem (hypothyroidism).have a liver problem.have a pancreas problem.are allergic to fish or shellfish. It is not known if people who are allergic to fish or shellfish are also allergic to icosapent ethyl capsules.are pregnant, or planning to become pregnant. It is not known if icosapent ethyl capsules will harm your unborn baby.are breastfeeding or plan to breastfeed. Icosapent ethyl can pass into your breast milk, and may harm your baby. Talk to your doctor about the best way to feed your baby if you take icosapent ethyl capsules.Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and dietary or herbal supplements.Icosapent ethyl capsules can interact with certain other medicines that you are taking.Especially tell your doctor if you take medicines that affect your blood clotting (anticoagulants or blood thinners).
How should I take icosapent ethyl capsules?Take icosapent ethyl capsules exactly as your doctor tells you to take it.Do not change your dose or stop taking icosapent ethyl capsules without talking to your doctor.Do not take more capsules than what is prescribed by your doctor. o If you are prescribed the 0.5-gram capsules, you should not take more than 8 capsules each day with food. o If you are prescribed the 1-gram capsules, you should not take more than 4 capsules each day with food.Take icosapent ethyl capsules whole. Do not break, crush, dissolve, or chew icosapent ethyl capsules before swallowing.If you miss a dose of icosapent ethyl capsules, take it as soon as you remember. However, if you miss one day of icosapent ethyl capsules, do not double your dose when you take it.Your doctor may start you on a diet that is low in saturated fat, cholesterol, carbohydrates, and low in added sugars before giving you icosapent ethyl capsules. Stay on this diet while taking icosapent ethyl capsules.Your doctor may do blood tests to check your triglyceride and other lipid levels while you take icosapent ethyl capsules.
What are the possible side effects of icosapent ethyl capsules?Icosapent ethyl capsules may cause serious side effects, including:Heart rhythm problems (atrial fibrillation and atrial flutter). Heart rhythm problems which can be serious and cause hospitalization have happened in people who take icosapent ethyl capsules, especially in people who have heart (cardiovascular) disease or diabetes with a risk factor for heart (cardiovascular) disease, or who have had heart rhythm problems in the past. Tell your doctor if you get any symptoms of heart rhythm problems such as feeling as if your heart is beating fast and irregular, lightheadedness, dizziness, shortness of breath, chest discomfort, or you faint.Possible allergic reactions if you are allergic to fish or shellfish. Stop taking icosapent ethyl capsules and tell your doctor right away or get emergency medical help if you have any signs or symptoms of an allergic reaction.Bleeding. Serious bleeding can happen in people who take icosapent ethyl capsules. Your risk of bleeding may increase if you are also taking a blood thinner medicine.If you have liver problems and are taking icosapent ethyl capsules, your doctor should do blood tests during treatment.The most common side effects of icosapent ethyl capsules include:Muscle and joint pain.Swelling of the hands, legs, or feet.ConstipationGoutHeart rhythm problems (atrial fibrillation).These are not all the possible side effects of icosapent ethyl capsules. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store icosapent ethyl capsules?Store icosapent ethyl capsules at room temperature between 68° to 77° F (20° to 25° C).Safely throw away medicine that is out of date or no longer needed.Keep icosapent ethyl capsules and all medicine out of the reach of children.
General information about the safe and effective use of icosapent ethyl capsules.Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use icosapent ethyl capsules for a condition for which it was not prescribed. Do not give icosapent ethyl capsules to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about icosapent ethyl capsules that is written for health professionals.
What are the ingredients in icosapent ethyl capsules?Active ingredient: icosapent ethylInactive ingredients: bloom gelatin, glycerin, alpha tocopherol, medium chain triglycerides, and lecithin. The capsules are imprinted with white imprinting ink containing titanium dioxide, propylene glycol, and hypromellose 2910.For more information, call XLCare Pharmaceuticals, Inc. at 1-866-495-1995.Manufactured by:Ascent Pharmaceuticals, Inc.Central Islip, NY 11722Manufactured for: XLCare Pharmaceuticals, Inc. 242 South Culver Street, Suite 202 Lawrenceville, GA 30046
"],"package_label_principal_display_panel":["Icosapent ethyl capsules 0.5 gram - 240 Counts Label Icosapent ethyl capsules 1 gram - 120 Counts Label 0.5 1"]},"tags":[{"label":"Small Molecule","category":"modality"},{"label":"Peroxisome proliferator-activated receptor alpha","category":"target"},{"label":"PPARA","category":"gene"},{"label":"OXER1","category":"gene"},{"label":"PPARG","category":"gene"},{"label":"Oral","category":"route"},{"label":"Capsule","category":"form"},{"label":"Active","category":"status"},{"label":"Breastfeeding (mother)","category":"indication"},{"label":"Pregnancy, function","category":"indication"},{"label":"National Institute on Alcohol Abuse and Alcoholism (NIAAA)","category":"company"}],"phase":"marketed","safety":{"boxedWarnings":[],"safetySignals":[{"llr":114.888,"date":"","count":27,"signal":"Rheumatic disorder","source":"DrugCentral FAERS","actionTaken":"Reported 27 times (LLR=115)"},{"llr":97.363,"date":"","count":20,"signal":"Blood immunoglobulin M increased","source":"DrugCentral FAERS","actionTaken":"Reported 20 times (LLR=97)"},{"llr":95.421,"date":"","count":20,"signal":"Blood immunoglobulin A decreased","source":"DrugCentral FAERS","actionTaken":"Reported 20 times (LLR=95)"},{"llr":89.628,"date":"","count":28,"signal":"Colitis microscopic","source":"DrugCentral FAERS","actionTaken":"Reported 28 times (LLR=90)"},{"llr":85.407,"date":"","count":24,"signal":"Cataract operation","source":"DrugCentral FAERS","actionTaken":"Reported 24 times (LLR=85)"},{"llr":81.112,"date":"","count":20,"signal":"Blood immunoglobulin G increased","source":"DrugCentral FAERS","actionTaken":"Reported 20 times (LLR=81)"},{"llr":77.141,"date":"","count":27,"signal":"Multiple allergies","source":"DrugCentral FAERS","actionTaken":"Reported 27 times (LLR=77)"},{"llr":70.468,"date":"","count":27,"signal":"Skin reaction","source":"DrugCentral FAERS","actionTaken":"Reported 27 times (LLR=70)"},{"llr":68.398,"date":"","count":27,"signal":"Hernia","source":"DrugCentral FAERS","actionTaken":"Reported 27 times (LLR=68)"},{"llr":67.622,"date":"","count":28,"signal":"Glaucoma","source":"DrugCentral FAERS","actionTaken":"Reported 28 times (LLR=68)"},{"llr":65.843,"date":"","count":21,"signal":"Hepatic enzyme abnormal","source":"DrugCentral FAERS","actionTaken":"Reported 21 times (LLR=66)"},{"llr":61.041,"date":"","count":20,"signal":"Multiple fractures","source":"DrugCentral FAERS","actionTaken":"Reported 20 times (LLR=61)"},{"llr":60.915,"date":"","count":36,"signal":"Drug-induced liver injury","source":"DrugCentral FAERS","actionTaken":"Reported 36 times (LLR=61)"},{"llr":58.535,"date":"","count":27,"signal":"Eye disorder","source":"DrugCentral FAERS","actionTaken":"Reported 27 times (LLR=59)"},{"llr":55.078,"date":"","count":28,"signal":"Sciatica","source":"DrugCentral FAERS","actionTaken":"Reported 28 times (LLR=55)"}],"commonSideEffects":[{"effect":"Allergic sensitization","drugRate":"reported","severity":"unknown"}],"contraindications":["Icosapent ethyl capsules are contraindicated in patients with known hypersensitivity (e.g., anaphylactic reaction) to icosapent ethyl or any of its components."],"specialPopulations":{"Pregnancy":"The safety of phytosterols has not been studied in pregnant or breastfeeding women. There is no evidence that dietary intakes of naturally occurring phytosterols, such as those consumed by vegetarian women, adversely affects pregnancy or lactation.","Paediatric use":"Safety and effectiveness in pediatric patients have not been established."}},"trials":[],"aliases":["Omega-3 fatty acid","Lovaza","EPA","omega-3-acid ethyl esters","docosahexaenoic acid"],"company":"National Institute on Alcohol Abuse and Alcoholism (NIAAA)","patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=Eicosapentaenoic acid","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T00:50:19.916276+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T00:50:26.877383+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=Eicosapentaenoic acid","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T00:50:27.668940+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:50:17.611482+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (no boxed warning)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:50:17.611540+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL460026/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T00:50:28.582165+00:00"},"safety.contraindications":{"url":"","method":"ai_extraction","source":"FDA Label + AI","aiModel":"featherless","rawText":"","confidence":0.95,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:50:34.627065+00:00"},"regulatory.fda_application":{"url":"","method":"deterministic","source":"FDA Label","rawText":"ANDA216811","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:50:17.611551+00:00"}},"allNames":"icosapent","offLabel":[],"synonyms":["eicosapentaenoic acid","icosapent","icosapentaenoic acid","timnodonic acid"],"timeline":[],"approvals":[{"date":"","orphan":false,"company":"","regulator":"FDA"}],"brandName":"Icosapent","ecosystem":[{"indication":"Breastfeeding (mother)","otherDrugs":[{"name":"ascorbic acid","slug":"ascorbic-acid","company":""},{"name":"calcium phosphate","slug":"calcium-phosphate","company":""},{"name":"doconexent","slug":"doconexent","company":""},{"name":"docusate sodium","slug":"docusate-sodium","company":""}],"globalPrevalence":null},{"indication":"Pregnancy, function","otherDrugs":[{"name":"calcium phosphate","slug":"calcium-phosphate","company":""},{"name":"doconexent","slug":"doconexent","company":""},{"name":"docusate sodium","slug":"docusate-sodium","company":""},{"name":"ferrous fumarate","slug":"ferrous-fumarate","company":"Gd Searle Llc"}],"globalPrevalence":null}],"mechanism":{"target":"Peroxisome proliferator-activated receptor alpha","novelty":"First-in-class","targets":[{"gene":"PPARA","source":"DrugCentral","target":"Peroxisome proliferator-activated receptor alpha","protein":"Peroxisome proliferator-activated receptor alpha"},{"gene":"OXER1","source":"DrugCentral","target":"Oxoeicosanoid receptor 1","protein":"Oxoeicosanoid receptor 1"},{"gene":"PPARG","source":"DrugCentral","target":"Peroxisome proliferator-activated receptor gamma","protein":"Peroxisome proliferator-activated receptor gamma"},{"gene":"PPARD","source":"DrugCentral","target":"Peroxisome proliferator-activated receptor delta","protein":"Peroxisome proliferator-activated receptor delta"},{"gene":"RXRA","source":"DrugCentral","target":"Retinoic acid receptor RXR-alpha","protein":"Retinoic acid receptor RXR-alpha"},{"gene":"CYP19A1","source":"DrugCentral","target":"Aromatase","protein":"Aromatase"},{"gene":"F3","source":"DrugCentral","target":"Tissue factor","protein":"Tissue factor"}],"modality":"Small Molecule","explanation":"","oneSentence":"","technicalDetail":"Icosapent acts as a ligand for the peroxisome proliferator-activated receptor alpha (PPARα), a nuclear receptor that regulates the expression of genes involved in lipid metabolism, inflammation, and other cellular processes."},"commercial":{},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/3174","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=Eicosapentaenoic%20acid","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=Eicosapentaenoic acid","fields":["publications"],"source":"PubMed/NCBI"}],"_enrichedAt":"2026-03-30T10:57:19.089964","_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T00:50:36.486623+00:00","fieldsConflicting":1,"overallConfidence":0.8},"biosimilars":[],"competitors":[{"drugName":"aminoglutethimide","drugSlug":"aminoglutethimide","fdaApproval":"1980-10-29","patentStatus":"Unknown","relationship":"same-target"},{"drugName":"anastrozole","drugSlug":"anastrozole","fdaApproval":"1995-12-27","genericCount":19,"patentStatus":"Off-patent — generic available","relationship":"same-target"},{"drugName":"clotrimazole","drugSlug":"clotrimazole","fdaApproval":"1975-02-03","patentExpiry":"May 26, 2042","patentStatus":"Patent protected","relationship":"same-target"},{"drugName":"doconexent","drugSlug":"doconexent","fdaApproval":"","relationship":"same-target"},{"drugName":"estrone","drugSlug":"estrone","fdaApproval":"1979-02-21","genericCount":3,"patentStatus":"Off-patent — generic available","relationship":"same-target"},{"drugName":"exemestane","drugSlug":"exemestane","fdaApproval":"1999-10-21","genericCount":11,"patentStatus":"Off-patent — generic available","relationship":"same-target"},{"drugName":"fluorouracil","drugSlug":"fluorouracil","fdaApproval":"1962-04-25","genericCount":23,"patentStatus":"Off-patent — generic available","relationship":"same-target"},{"drugName":"ketoconazole","drugSlug":"ketoconazole","fdaApproval":"1981-06-12","genericCount":19,"patentStatus":"Off-patent — generic available","relationship":"same-target"},{"drugName":"letrozole","drugSlug":"letrozole","fdaApproval":"1997-07-25","genericCount":19,"patentStatus":"Off-patent — generic available","relationship":"same-target"},{"drugName":"linolenic acid","drugSlug":"linolenic-acid","fdaApproval":"","relationship":"same-target"}],"genericName":"eicosapentaenoic acid","indications":{"approved":[{"name":"Breastfeeding (mother)","source":"DrugCentral","snomedId":413712001,"regulator":"FDA","eligibility":"lactating and non-lactating mother"},{"name":"Pregnancy, function","source":"DrugCentral","snomedId":289908002,"regulator":"FDA"}],"offLabel":[{"name":"Arteriosclerotic Vascular Disease Prevention","source":"DrugCentral","drugName":"Eicosapentaenoic acid","evidenceCount":255,"evidenceLevel":"strong"},{"name":"Hypertriglyceridemia","source":"DrugCentral","drugName":"Eicosapentaenoic acid","evidenceCount":435,"evidenceLevel":"strong"},{"name":"Myocardial Reinfarction Prevention","source":"DrugCentral","drugName":"Eicosapentaenoic acid","evidenceCount":5,"evidenceLevel":"emerging"},{"name":"Prevention of Fetal Neural Tube Defects during Pregnancy","source":"DrugCentral","drugName":"Eicosapentaenoic acid","evidenceCount":1,"evidenceLevel":"emerging"}],"pipeline":[]},"drugCategory":"active","labelChanges":[],"relatedDrugs":[{"drugId":"aminoglutethimide","brandName":"aminoglutethimide","genericName":"aminoglutethimide","approvalYear":"1980","relationship":"same-target"},{"drugId":"anastrozole","brandName":"anastrozole","genericName":"anastrozole","approvalYear":"1995","relationship":"same-target"},{"drugId":"clotrimazole","brandName":"clotrimazole","genericName":"clotrimazole","approvalYear":"1975","relationship":"same-target"},{"drugId":"doconexent","brandName":"doconexent","genericName":"doconexent","approvalYear":"","relationship":"same-target"},{"drugId":"estrone","brandName":"estrone","genericName":"estrone","approvalYear":"1979","relationship":"same-target"},{"drugId":"exemestane","brandName":"exemestane","genericName":"exemestane","approvalYear":"1999","relationship":"same-target"},{"drugId":"fluorouracil","brandName":"fluorouracil","genericName":"fluorouracil","approvalYear":"1962","relationship":"same-target"},{"drugId":"ketoconazole","brandName":"ketoconazole","genericName":"ketoconazole","approvalYear":"1981","relationship":"same-target"},{"drugId":"letrozole","brandName":"letrozole","genericName":"letrozole","approvalYear":"1997","relationship":"same-target"},{"drugId":"linolenic-acid","brandName":"linolenic acid","genericName":"linolenic acid","approvalYear":"","relationship":"same-target"}],"trialDetails":[{"nctId":"NCT07496515","phase":"PHASE2","title":"Omega-3 Supplementation vs Demodex vs Eyelid Cleanser for Pediatric Chalazia","status":"NOT_YET_RECRUITING","sponsor":"Jaeb Center for Health Research","startDate":"2026-06-01","conditions":["Pediatric Chalazia"],"enrollment":168,"completionDate":"2028-02-01"},{"nctId":"NCT07461649","phase":"NA","title":"Pharmacokinetic Study of Eicosapentaenoic Acid (EPA) and Calcium L-5-Methyltetrahydrofolate (L-5-MTHF) After Administration of CreNeuroS® CNS Fish Oil Plus Softgels in Healthy Subjects Under Fasting Conditions","status":"NOT_YET_RECRUITING","sponsor":"Sichuan Credit Pharmaceutical Co., Ltd.","startDate":"2026-03-15","conditions":["Bioavailability and Pharmacokinetics"],"enrollment":32,"completionDate":"2026-05-10"},{"nctId":"NCT05297279","phase":"NA","title":"OMEGA - Dietary Intervention - COPD Trial","status":"RECRUITING","sponsor":"Johns Hopkins University","startDate":"2022-03-01","conditions":["COPD, Chronic Obstructive Pulmonary Disease"],"enrollment":200,"completionDate":"2027-09"},{"nctId":"NCT04485871","phase":"NA","title":"Targeting Risk Factors for Diabetes in Subjects With Normal Blood Cholesterol Using Omega-3 Fatty Acids","status":"RECRUITING","sponsor":"Institut de Recherches Cliniques de Montreal","startDate":"2019-12-19","conditions":["Type 2 Diabetes","Inflammation","Insulin Sensitivity/Resistance","Fatty Acids, Omega-3"],"enrollment":48,"completionDate":"2027-05-31"},{"nctId":"NCT07462013","phase":"NA","title":"NUTRIBRAIN: Lifestyle Interventions to Prevent cOgnitive Deficits in Subjects With Depressive Symptoms: From mEchanisms to Clinical pRactice (POWER)","status":"RECRUITING","sponsor":"National Science and Technology Council, Taiwan","startDate":"2025-10-01","conditions":["Major Depressive Disorder (MDD)"],"enrollment":120,"completionDate":"2028-09"},{"nctId":"NCT06975241","phase":"PHASE4","title":"Observing Metabolism of EPA With Consideration of Genetics And Sex","status":"RECRUITING","sponsor":"University of Toronto","startDate":"2025-07-29","conditions":["Healthy","Omega 3","Metabolism, Lipids"],"enrollment":64,"completionDate":"2026-09"},{"nctId":"NCT07439744","phase":"NA","title":"NUTRIMOOD-Inflammation and Depressive Comorbidity in Obesity: Modulation by Omega-3 Polyunsaturated Fatty Acids Status","status":"RECRUITING","sponsor":"National Science and Technology Council, Taiwan","startDate":"2025-03-01","conditions":["Obese Adults","MDD"],"enrollment":50,"completionDate":"2027-12"},{"nctId":"NCT06279793","phase":"PHASE2","title":"Intravenous Fish Oil Based Lipid Emulsion to Enhance Recovery in High-Risk Cardiac Surgery Patients","status":"RECRUITING","sponsor":"GCP-Service International West GmbH","startDate":"2024-02-15","conditions":["Intensive Care Unit","Coronary Artery Bypass Grafting (CABG)","High Risk Patients","Cardiopulmonary Bypass","Elective Cardiac Surgery","Valvular Heart Surgery","Multiple Valve Surgeries","Combined Cardiac Procedures","Aortic Surgical Procedures","Adult Patients ≥ 18 Years","Combined Valve and CABG","Combined Cardiac and Aortic Surgical Procedures"],"enrollment":550,"completionDate":"2030-09"},{"nctId":"NCT05995717","phase":"NA","title":"Evaluation of PKU UP","status":"ACTIVE_NOT_RECRUITING","sponsor":"Vitaflo International, Ltd","startDate":"2024-01-11","conditions":["PKU"],"enrollment":16,"completionDate":"2026-05-31"},{"nctId":"NCT06991296","phase":"NA","title":"Concentration of n-3 PUFA Monohydroxylated Derivatives in Adults With Obesity After n-3 PUFA Supplementation.","status":"RECRUITING","sponsor":"University of North Carolina, Chapel Hill","startDate":"2025-06-02","conditions":["Obesity"],"enrollment":33,"completionDate":"2026-12"},{"nctId":"NCT05774665","phase":"PHASE2","title":"Specialized Pro-resolving Lipid Mediators and Treatment Resistant Depression","status":"ACTIVE_NOT_RECRUITING","sponsor":"Massachusetts General Hospital","startDate":"2025-01-30","conditions":["Treatment Resistant Depression","Inflammation","Overweight"],"enrollment":80,"completionDate":"2026-03-31"},{"nctId":"NCT06711614","phase":"NA","title":"FIRE-Diet: Food as an Intervention to Reduce the Effects of Woodsmoke Exposure on Respiratory Health","status":"RECRUITING","sponsor":"University of British Columbia","startDate":"2025-06-17","conditions":["Healthy Individuals"],"enrollment":48,"completionDate":"2029-12-31"},{"nctId":"NCT07394517","phase":"NA","title":"ATLANTIS Trial: Phospholipid Omega-3 Versus Conventional Omega-3","status":"NOT_YET_RECRUITING","sponsor":"Fundación del Caribe para la Investigación Biomédica","startDate":"2026-03","conditions":["Mixed Dyslipidemia"],"enrollment":105,"completionDate":"2027-03"},{"nctId":"NCT01747447","phase":"NA","title":"VITamin D and OmegA-3 TriaL: Effects on Bone Structure and Architecture (VITAL)","status":"COMPLETED","sponsor":"Brigham and Women's Hospital","startDate":"2012-08","conditions":["Bone Density","Body Composition","Bone Health"],"enrollment":771,"completionDate":"2023-08-02"},{"nctId":"NCT07392723","phase":"PHASE2","title":"ALA-enriched Nutrition for Prevention of Cognitive Decline in APOE4 Older Adults","status":"RECRUITING","sponsor":"Michal Schnaider Beeri, Ph.D.","startDate":"2025-01-12","conditions":["Cognitive Dysfunction","Alzheimer Disease","Blood-Brain Barrier","Apolipoprotein E, Deficiency or Defect of","Brain Aging","Fatty Acids, Omega-3"],"enrollment":20,"completionDate":"2027-10"},{"nctId":"NCT07004777","phase":"NA","title":"Effect of Consuming n-3 PUFAs Rich Foods on Triglyceride Concentration and Lipoprotein Composition","status":"RECRUITING","sponsor":"Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran","startDate":"2026-02-01","conditions":["Hypertriglyceridemia"],"enrollment":375,"completionDate":"2027-06-30"},{"nctId":"NCT01704859","phase":"NA","title":"VITamin D and OmegA-3 TriaL (VITAL): Fractures, Vitamin D and Genetic Markers","status":"COMPLETED","sponsor":"Brigham and Women's Hospital","startDate":"2018-06-01","conditions":["Fractures"],"enrollment":25871,"completionDate":"2022-11-23"},{"nctId":"NCT04573946","phase":"NA","title":"VITamin D and OmegA-3 TriaL: Interrelationship of Vitamin D and Vitamin K on Bone (VITAL)","status":"ACTIVE_NOT_RECRUITING","sponsor":"Brigham and Women's Hospital","startDate":"2019-07-01","conditions":["Bone Density","Bone Health","Fractures"],"enrollment":25871,"completionDate":"2026-12-31"},{"nctId":"NCT05758766","phase":"NA","title":"Study on Use of Omega-3 Fatty Acids to Improve Outcomes in Individuals With Sickle Cell Disease","status":"ACTIVE_NOT_RECRUITING","sponsor":"University of Alabama at Birmingham","startDate":"2023-08-30","conditions":["Sickle Cell Disease"],"enrollment":30,"completionDate":"2026-12-30"},{"nctId":"NCT07042009","phase":"NA","title":"Effectiveness of Nutritional Resources for Milk Donors","status":"NOT_YET_RECRUITING","sponsor":"University of Roehampton","startDate":"2026-02-02","conditions":["Docosahexaenoic Acid Content of the Participants","Docosahexaenoic Acid Content of the Breast Milk"],"enrollment":60,"completionDate":"2026-10-31"},{"nctId":"NCT07346703","phase":"NA","title":"Effects of DHA in Patients With Multiple Sclerosis","status":"ENROLLING_BY_INVITATION","sponsor":"Francisco Javier Martínez Noguera","startDate":"2026-01","conditions":["Multiple Sclerosis","Performance Enhancement","Supplemental Nutrition Assistance Program Education","Strength Outcomes","Function Improvement","Intervention Study"],"enrollment":100,"completionDate":"2026-07"},{"nctId":"NCT07322965","phase":"NA","title":"Evaluation of BRUDYGLAUCO (DHA + Citicoline) in Patients With Glaucoma","status":"RECRUITING","sponsor":"Institut Catala de Retina","startDate":"2025-04-01","conditions":["Glaucoma","Primary Open Angle Glaucoma (POAG)","Neuroprotection"],"enrollment":108,"completionDate":"2027-05-30"},{"nctId":"NCT06331195","phase":"NA","title":"An Adapted Brazilian Cardioprotective Diet, Phytosterols and Krill Oil in Familial Hypercholesterolemia (DICA-FH)","status":"RECRUITING","sponsor":"Hospital do Coracao","startDate":"2024-10-23","conditions":["Familial Hypercholesterolemia"],"enrollment":300,"completionDate":"2026-12"},{"nctId":"NCT05695937","phase":"NA","title":"Brazilian Cardioprotective Diet, Phytosterols and Krill Oil in Patients With Familial Hypercholesterolemia","status":"COMPLETED","sponsor":"Hospital do Coracao","startDate":"2023-05-22","conditions":["Familial Hypercholesterolemia"],"enrollment":58,"completionDate":"2024-07-30"},{"nctId":"NCT02168738","phase":"NA","title":"Investigation of Docosahexaenoic Acid (DHA) Metabolic Pathway in Human by Using 13C Labeled Molecules","status":"COMPLETED","sponsor":"Hospices Civils de Lyon","startDate":"2014-03","conditions":["Healthy Subject"],"enrollment":4,"completionDate":"2015-04"},{"nctId":"NCT01653678","phase":"NA","title":"Vitamin D and Omega-3 Hypertension Trial (VITAL Hypertension)","status":"ACTIVE_NOT_RECRUITING","sponsor":"Brigham and Women's Hospital","startDate":"2011-11","conditions":["Hypertension"],"enrollment":25875,"completionDate":"2026-06"},{"nctId":"NCT06695910","phase":"PHASE4","title":"Modulation of the Brain Fog Scale by Eicosapentaenoic Acid Monoglycerides (MAG-EPA).","status":"RECRUITING","sponsor":"Samuel Fortin","startDate":"2024-11-06","conditions":["Brain Fog","Cognitive Health"],"enrollment":48,"completionDate":"2027-07-01"},{"nctId":"NCT01696435","phase":"NA","title":"VITAL-DEP: Depression Endpoint Prevention in the VITamin D and OmegA-3 TriaL","status":"COMPLETED","sponsor":"Brigham and Women's Hospital","startDate":"2010-07","conditions":["Depression","Depressive Symptoms","Mood"],"enrollment":18353,"completionDate":"2025-03-31"},{"nctId":"NCT04499820","phase":"NA","title":"Effect of OMEGA3 Supplementation in Diabetic Retinopathy","status":"COMPLETED","sponsor":"Centre Hospitalier Intercommunal Creteil","startDate":"2020-06-26","conditions":["Diabetic Retinopathy"],"enrollment":60,"completionDate":"2025-04-17"},{"nctId":"NCT01351805","phase":"NA","title":"Vitamin D and Fish Oil for Autoimmune Disease, Inflammation and Knee Pain","status":"COMPLETED","sponsor":"Brigham and Women's Hospital","startDate":"2010-07","conditions":["Autoimmune Diseases","Systemic Inflammatory Process","Knee Pain Chronic","Osteoarthritis","Rheumatoid Arthritis"],"enrollment":25871,"completionDate":"2025-02"},{"nctId":"NCT04761588","phase":"NA","title":"Evaluation of TYR Sphere in France","status":"COMPLETED","sponsor":"Vitaflo International, Ltd","startDate":"2021-12-01","conditions":["Tyrosinemia","AKU"],"enrollment":14,"completionDate":"2025-10-31"},{"nctId":"NCT01632761","phase":"NA","title":"Effects of Vitamin D and Marine Omega-3 Fatty Acids on Anemia","status":"ACTIVE_NOT_RECRUITING","sponsor":"Brigham and Women's Hospital","startDate":"2012-11","conditions":["Anemia"],"enrollment":2000,"completionDate":"2025-12-28"},{"nctId":"NCT06233825","phase":"NA","title":"Nutritional Intervention to Enhance Recovery After Arthroscopic Knee Surgery in Adults","status":"COMPLETED","sponsor":"Dr. Chris McGlory, PhD","startDate":"2024-02-01","conditions":["Anterior Cruciate Ligament Reconstruction","Muscular Atrophy"],"enrollment":30,"completionDate":"2025-10-14"},{"nctId":"NCT04312932","phase":"PHASE2","title":"Fatty Acid Supplementation in Children With ASD (Study 2)","status":"COMPLETED","sponsor":"Sarah Keim","startDate":"2021-12-01","conditions":["Autism Spectrum Disorder"],"enrollment":98,"completionDate":"2024-04-11"},{"nctId":"NCT04417257","phase":"PHASE2,PHASE3","title":"Study of LAU-7b for the Treatment of Coronavirus Disease 2019 (COVID-19) Disease in Adults","status":"TERMINATED","sponsor":"Laurent Pharmaceuticals Inc.","startDate":"2020-08-18","conditions":["COVID-19 Disease"],"enrollment":351,"completionDate":"2024-05-30"},{"nctId":"NCT06055894","phase":"NA","title":"A Study of a Plant-Based Diet and Dietary Supplements in People With Smoldering Multiple Myeloma (SMM) or Monoclonal Gammopathy of Undetermined Significance (MGUS)","status":"RECRUITING","sponsor":"Memorial Sloan Kettering Cancer Center","startDate":"2023-09-20","conditions":["Multiple Myeloma, Smoldering","Multiple Myeloma","Monoclonal Gammopathy of Undetermined Significance"],"enrollment":200,"completionDate":"2026-09"},{"nctId":"NCT01169259","phase":"PHASE3","title":"Vitamin D and Omega-3 Trial (VITAL)","status":"ACTIVE_NOT_RECRUITING","sponsor":"Brigham and Women's Hospital","startDate":"2010-07","conditions":["Cancer","Cardiovascular Disease"],"enrollment":25871,"completionDate":"2026-05"},{"nctId":"NCT00244816","phase":"PHASE2","title":"Taxoprexin® Treatment for Advanced Eye Melanoma","status":"COMPLETED","sponsor":"American Regent, Inc.","startDate":"2005-10","conditions":["Metastatic Melanoma"],"enrollment":22,"completionDate":"2008-06"},{"nctId":"NCT00422877","phase":"PHASE2","title":"Taxoprexin® Treatment for Advanced Primary Cancers of the Liver, Gallbladder or Biliary Tract","status":"TERMINATED","sponsor":"American Regent, Inc.","startDate":"2007-01","conditions":["Cancer of the Liver"],"enrollment":13,"completionDate":"2008-03"},{"nctId":"NCT02178410","phase":"PHASE3","title":"VITAL Rhythm Study","status":"ACTIVE_NOT_RECRUITING","sponsor":"Brigham and Women's Hospital","startDate":"2012-10","conditions":["Cardiovascular Disease"],"enrollment":25119,"completionDate":"2026-10"},{"nctId":"NCT06466278","phase":"PHASE2","title":"IcoSApent ethyL to Slow Down Aortic VAlve Stenosis proGrEssion","status":"ACTIVE_NOT_RECRUITING","sponsor":"Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)","startDate":"2023-06-01","conditions":["Aortic Valve Stenosis"],"enrollment":110,"completionDate":"2026-12-01"},{"nctId":"NCT05198843","phase":"PHASE1,PHASE2","title":"Testing an Omega-3 Fatty Acid-Based Anti-Cancer Therapy for Patients With Triple-Negative Inflammatory Breast Cancer That Has Spread to Other Parts of the Body","status":"TERMINATED","sponsor":"National Cancer Institute (NCI)","startDate":"2022-11-08","conditions":["Anatomic Stage IV Breast Cancer AJCC v8","Metastatic Triple-Negative Breast Inflammatory Carcinoma"],"enrollment":1,"completionDate":"2023-12-20"},{"nctId":"NCT06294067","phase":"PHASE1","title":"A Dose Response Investigation of Docosahexaenoic Acid (DHA)","status":"COMPLETED","sponsor":"University of Toronto","startDate":"2024-02-26","conditions":["Nutrition, Healthy"],"enrollment":72,"completionDate":"2025-03-26"},{"nctId":"NCT06494488","phase":"EARLY_PHASE1","title":"Differential Thrombogenesis by EPA and DHA Mediated by HDL","status":"RECRUITING","sponsor":"The Miriam Hospital","startDate":"2025-07-10","conditions":["Lipid Metabolism Disorders","Hypertriglyceridemia"],"enrollment":80,"completionDate":"2028-03-31"},{"nctId":"NCT05053347","phase":"NA","title":"The Effect of Alpha Linolenic Acid Intake on Patients With Elevated Glycemic Status","status":"COMPLETED","sponsor":"Huazhong University of Science and Technology","startDate":"2022-07-01","conditions":["Elevated Blood Sugar"],"enrollment":94,"completionDate":"2024-12-31"},{"nctId":"NCT01624792","phase":"NA","title":"Eicosapentaenoic Acid and Protein Modulation to Induce Anabolism in Chronic Obstructive Pulmonary Disease (COPD): Aim 2","status":"COMPLETED","sponsor":"Texas A&M University","startDate":"2011-10-25","conditions":["Chronic Obstructive Pulmonary Disease","Muscle Wasting"],"enrollment":64,"completionDate":"2016-06-29"},{"nctId":"NCT00249262","phase":"PHASE2","title":"Taxoprexin Treatment for Advanced Skin Melanoma","status":"COMPLETED","sponsor":"American Regent, Inc.","startDate":"2005-10","conditions":["Metastatic Melanoma"],"enrollment":30,"completionDate":"2007-04"},{"nctId":"NCT01758081","phase":"NA","title":"Effects of Vitamin D and Omega-3 Fatty Acids on Infectious Diseases and hCAP18 (VITAL Infection)","status":"ACTIVE_NOT_RECRUITING","sponsor":"Brigham and Women's Hospital","startDate":"2010-07","conditions":["Infections","Human Cathelicidin Antimicrobial Peptide (hCAP-18)"],"enrollment":25874,"completionDate":"2026-12"},{"nctId":"NCT05380401","phase":"NA","title":"Metabolic Mechanisms Induced by Enteral DHA and ARA Supplementation in Preterm Infants","status":"RECRUITING","sponsor":"The University of Texas Health Science Center at San Antonio","startDate":"2023-03-09","conditions":["Premature"],"enrollment":328,"completionDate":"2028-04"},{"nctId":"NCT04152291","phase":"NA","title":"The Effect of E-EPA on Circulating LDL and Plasma Lipid Metabolism","status":"COMPLETED","sponsor":"Wihuri Research Institute","startDate":"2019-11-12","conditions":["Atherosclerosis","Low-density Lipoproteins Aggregation Susceptibility","Low-density Lipoprotein Lipid Composition","Cardiovascular Diseases"],"enrollment":68,"completionDate":"2024-12-31"},{"nctId":"NCT03406897","phase":"PHASE1,PHASE2","title":"Pilot Study of OMEGA-3 and Vitamin D in High-Dose in Type I Diabetic Patients","status":"COMPLETED","sponsor":"Rodolfo Alejandro","startDate":"2018-07-23","conditions":["Diabetes Mellitus, Type 1","Hypoglycemia","Diabetes Mellitus","Diabetes, Autoimmune"],"enrollment":27,"completionDate":"2024-07-31"},{"nctId":"NCT02295059","phase":"NA","title":"Omega 3 Fatty Acids and ERPR(-)HER2(+/-) Breast Cancer Prevention","status":"ACTIVE_NOT_RECRUITING","sponsor":"City of Hope Medical Center","startDate":"2017-08-09","conditions":["Breast Cancer"],"enrollment":80,"completionDate":"2026-06-22"},{"nctId":"NCT01178398","phase":"","title":"Understanding Fish Consumption Habits During Pregnancy","status":"COMPLETED","sponsor":"Harvard Pilgrim Health Care","startDate":"2009-10","conditions":["Nutrition"],"enrollment":22,"completionDate":"2010-03"},{"nctId":"NCT07173881","phase":"NA","title":"Effect of a Dairy Product for Pregnant and Lactating Women on the Composition of Human Milk","status":"RECRUITING","sponsor":"Instituto de Desarrollo e Investigaciones Pediátricas Prof. Dr. Fernando E. Viteri","startDate":"2025-08-01","conditions":["Pregnancy"],"enrollment":20,"completionDate":"2026-01-30"},{"nctId":"NCT05007483","phase":"NA","title":"Efficacy of Diet on Quality of Life in Multiple Sclerosis","status":"ACTIVE_NOT_RECRUITING","sponsor":"Terry L. Wahls","startDate":"2022-02-10","conditions":["Multiple Sclerosis, Relapsing-Remitting"],"enrollment":162,"completionDate":"2026-12-01"},{"nctId":"NCT05802797","phase":"EARLY_PHASE1","title":"Bioavailability and Pharmacodynamics of EPA and DHA From Fortified Soymilk and Capsules","status":"ACTIVE_NOT_RECRUITING","sponsor":"Ohio State University Comprehensive Cancer Center","startDate":"2023-04-03","conditions":["Healthy Diet"],"enrollment":24,"completionDate":"2026-07-10"},{"nctId":"NCT04076176","phase":"NA","title":"The Effects of CGMP in Children and Adults With PKU","status":"COMPLETED","sponsor":"Vitaflo International, Ltd","startDate":"2019-04-26","conditions":["Phenylketonurias"],"enrollment":12,"completionDate":"2023-01-31"},{"nctId":"NCT07117903","phase":"NA","title":"Zhongshan Ketogenic Diet Study 1","status":"RECRUITING","sponsor":"Fudan University","startDate":"2025-08-10","conditions":["Platelet Function and Thrombus Formation"],"enrollment":80,"completionDate":"2025-08-20"},{"nctId":"NCT01442480","phase":"NA","title":"Cardioprotective Effects of Omega-3 Fatty Acids Supplementation in Healthy Older Subjects Exposed to Air Pollution Particles","status":"COMPLETED","sponsor":"Environmental Protection Agency (EPA)","startDate":"2009-06","conditions":["Healthy"],"enrollment":29,"completionDate":"2016-12"},{"nctId":"NCT02348073","phase":"PHASE3","title":"Efficacy of Phosphatidylserine Enriched With n-3 PUFA Supplementation on ADHD in Children With Epilepsy","status":"COMPLETED","sponsor":"Hospices Civils de Lyon","startDate":"2015-03","conditions":["Attention Deficit Disorder With Hyperactivity","ADHD Inattention or Mixed Type","Epilepsy","Child"],"enrollment":77,"completionDate":"2018-10"},{"nctId":"NCT00243867","phase":"PHASE3","title":"Taxoprexin Plus Carboplatin Treatment for Advanced Lung Cancer","status":"COMPLETED","sponsor":"American Regent, Inc.","startDate":"2005-11","conditions":["Non-Small Cell Lung Cancer"],"enrollment":518,"completionDate":"2008-08"},{"nctId":"NCT05673070","phase":"NA","title":"Use of Ritual Prenatal Multivitamins for Pregnancy","status":"COMPLETED","sponsor":"City University of New York","startDate":"2023-10-15","conditions":["Pregnancy Related","Nutrition, Healthy"],"enrollment":62,"completionDate":"2024-12-31"},{"nctId":"NCT00087776","phase":"PHASE3","title":"Study of Taxoprexin Injection vs. Dacarbazine in Patients With Metastatic Malignant Melanoma","status":"TERMINATED","sponsor":"American Regent, Inc.","startDate":"2002-12-06","conditions":["Malignant Melanoma"],"enrollment":393,"completionDate":"2007-10-27"},{"nctId":"NCT05915806","phase":"NA","title":"Enteral High-dose DHA Supplementation on Bronchopulmonary Dysplasia in Very Preterm Infants: a Collaborative Study","status":"ACTIVE_NOT_RECRUITING","sponsor":"CHU de Quebec-Universite Laval","startDate":"2023-07-30","conditions":["Bronchopulmonary Dysplasia","Child Development","Neonatal and Perinatal Conditions"],"enrollment":1801,"completionDate":"2026-03"},{"nctId":"NCT06125782","phase":"PHASE2","title":"Effect of Omega-3 Fatty Acid on Neurobehavioral Status of Children With Autism Spectrum Disorder: A Randomized, Double-Blind, Placebo Controlled Trial","status":"COMPLETED","sponsor":"Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh","startDate":"2023-09-19","conditions":["Autism Spectrum Disorder"],"enrollment":64,"completionDate":"2024-02-05"},{"nctId":"NCT03831178","phase":"PHASE2","title":"Docosahexaenoic Acid (DHA) for Women With Breast Cancer in the Neoadjuvant Setting","status":"ACTIVE_NOT_RECRUITING","sponsor":"AHS Cancer Control Alberta","startDate":"2019-08-28","conditions":["Breast Cancer"],"enrollment":76,"completionDate":"2030-09"},{"nctId":"NCT06881966","phase":"NA","title":"The Effect of Omega-3 Fatty Acids in Patients With Rheumatoid Arthritis","status":"NOT_YET_RECRUITING","sponsor":"Hopital Charles Nicolle","startDate":"2025-09-01","conditions":["Rheumatoid Arthritis (RA)"],"enrollment":180,"completionDate":"2026-03-01"},{"nctId":"NCT04222660","phase":"NA","title":"Corneal Nerves Function and Structure","status":"COMPLETED","sponsor":"VA Office of Research and Development","startDate":"2021-06-21","conditions":["Diabetic Peripheral Neuropathy"],"enrollment":44,"completionDate":"2025-05-13"},{"nctId":"NCT06738446","phase":"NA","title":"Dietary Supplementation on Tear Secretion and Inflammation in DES","status":"COMPLETED","sponsor":"Shih Chien Huang","startDate":"2021-09-27","conditions":["Dry Eye Syndrome (DES)"],"enrollment":52,"completionDate":"2022-06-14"},{"nctId":"NCT05191823","phase":"NA","title":"Omega Tots Long Term Follow-up","status":"ENROLLING_BY_INVITATION","sponsor":"Sarah Keim","startDate":"2021-12-01","conditions":["Preterm Birth","Child Development"],"enrollment":377,"completionDate":"2026-06-30"},{"nctId":"NCT04796207","phase":"NA","title":"The Effects of Fish Oil Supplementation on the Brain Health of Collegiate Football Athletes","status":"COMPLETED","sponsor":"University of Arizona","startDate":"2019-05-28","conditions":["Traumatic Brain Injury (TBI)","Chronic Traumatic Encephalopathy (CTE)"],"enrollment":38,"completionDate":"2020-01-28"},{"nctId":"NCT00004448","phase":"PHASE2","title":"Alternate Day Prednisone or Daily Fish Oil Supplements in Patients With Immunoglobulin A Nephropathy","status":"COMPLETED","sponsor":"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)","startDate":"1997-11","conditions":["IgA Glomerulonephritis"],"enrollment":96,"completionDate":"2007-08"},{"nctId":"NCT02647723","phase":"NA","title":"Improving Maternal and Child Health Through Prenatal Fatty Acid Supplementation","status":"ACTIVE_NOT_RECRUITING","sponsor":"University of Chicago","startDate":"2016-01","conditions":["Pregnancy","Child Development"],"enrollment":168,"completionDate":"2026-12-31"},{"nctId":"NCT03428477","phase":"PHASE3","title":"EPA for Metastasis Trial 2","status":"ACTIVE_NOT_RECRUITING","sponsor":"Mark A Hull, PhD FRCP","startDate":"2018-05-02","conditions":["Liver Metastasis","Colon Cancer"],"enrollment":418,"completionDate":"2026-04-30"},{"nctId":"NCT06928701","phase":"NA","title":"Impact of \"Targeted\" Nutritional Apport and Exercise on the Modulation of Metabolic and Immune-related Gene Expression Signatures in Early Breast Cancer (eBC) Patients Candidate to Neoadjuvant Therapy (NAT)","status":"RECRUITING","sponsor":"University of Eastern Piedmont","startDate":"2024-09-01","conditions":["Early Breast Cancer","Neoadjuvant Treatment"],"enrollment":160,"completionDate":"2026-12"},{"nctId":"NCT05573672","phase":"PHASE2","title":"Dietary Counselling Plus Omega-3 Supplementation in the Treatment of Generalized Anxiety Disorder","status":"COMPLETED","sponsor":"The Canadian College of Naturopathic Medicine","startDate":"2022-08-12","conditions":["Generalized Anxiety Disorder"],"enrollment":50,"completionDate":"2023-11-30"},{"nctId":"NCT02521753","phase":"NA","title":"Omega 3 Polyunsaturated Fatty Acids (PUFA) or Magnesium in Obese Polycystic Ovary Syndrome Patients","status":"TERMINATED","sponsor":"Coordinación de Investigación en Salud, Mexico","startDate":"2015-08","conditions":["Polycystic Ovary Syndrome","Obesity"],"enrollment":123,"completionDate":"2025-03"},{"nctId":"NCT05953064","phase":"NA","title":"Effects of DHA-NAT on Postprandial Lipidaemia in Healthy Male Subjects","status":"ACTIVE_NOT_RECRUITING","sponsor":"University Hospital, Gentofte, Copenhagen","startDate":"2023-01-01","conditions":["Hypertriglyceridemia"],"enrollment":20,"completionDate":"2025-04-01"},{"nctId":"NCT05379712","phase":"PHASE2","title":"Nutritional Supplementation in Head and Neck Cancers","status":"RECRUITING","sponsor":"AHS Cancer Control Alberta","startDate":"2024-10-25","conditions":["Malnourishment","Nutritional Deficiency","Undernutrition"],"enrollment":81,"completionDate":"2026-10"},{"nctId":"NCT06154408","phase":"NA","title":"Evaluating the Impact of Omega-3 Fatty Acid Supplementation (Soloways™) on Lipid Profiles in Adults With PPARG Polymorphisms","status":"COMPLETED","sponsor":"S.LAB (SOLOWAYS)","startDate":"2022-02-10","conditions":["LDL Hyperlipoproteinemia","Low-Density-Lipoprotein-Type [LDL] Hyperlipoproteinemia","Triglyceride Storage Type I or II Disease"],"enrollment":102,"completionDate":"2022-11-01"},{"nctId":"NCT03216057","phase":"NA","title":"Effect of Omega-3 Fatty Acids Supplementation on Hypertriglyceridemia in Pediatric Patients With Obesity.","status":"COMPLETED","sponsor":"Hospital Infantil de Mexico Federico Gomez","startDate":"2008-05-20","conditions":["Hypertriglyceridemia","Pediatric Obesity"],"enrollment":168,"completionDate":"2016-11-22"},{"nctId":"NCT03313076","phase":"PHASE2","title":"Vitamin D and n-3 Polyunsaturated Fatty Acids (PUFAs) to Prevent Chronic Pain Following Major Thermal Burn Injury","status":"TERMINATED","sponsor":"University of North Carolina, Chapel Hill","startDate":"2018-07-19","conditions":["Chronic Pain Following Thermal Burn Injury"],"enrollment":24,"completionDate":"2020-07-31"},{"nctId":"NCT06280976","phase":"PHASE4","title":"Aggressive Risk-Prevention Therapies for Coronary Atherosclerotic Plaque (ART-CAP)","status":"WITHDRAWN","sponsor":"University of Louisville","startDate":"2024-03-01","conditions":["Coronary Artery Disease","Atherosclerosis","Heart Attack"],"enrollment":0,"completionDate":"2025-01-01"},{"nctId":"NCT03838536","phase":"NA","title":"Synergistic Activity of Human Milk Nutrients and Infant Cognition","status":"RECRUITING","sponsor":"University of North Carolina, Chapel Hill","startDate":"2019-02-05","conditions":["Breastfeeding, Exclusive"],"enrollment":84,"completionDate":"2026-03"},{"nctId":"NCT06555705","phase":"NA","title":"Effect of Omega 3 Supplementation on the Heart Rate Variability in Obese Children","status":"COMPLETED","sponsor":"Cairo University","startDate":"2024-04-03","conditions":["Obesity, Childhood"],"enrollment":60,"completionDate":"2024-09-03"},{"nctId":"NCT05841927","phase":"NA","title":"Clinical Cohort Study of DHA in Neurodevelopmental Disorders","status":"ACTIVE_NOT_RECRUITING","sponsor":"Children's Hospital of Fudan University","startDate":"2020-12-01","conditions":["Autism or Autistic Traits"],"enrollment":40,"completionDate":"2025-12-01"},{"nctId":"NCT04496154","phase":"NA","title":"Omega-3 to Reduce Diabetes Risk in Subjects With High Number of Particles That Carry \"Bad Cholesterol\" in the Blood","status":"COMPLETED","sponsor":"May Faraj, PDt, PhD","startDate":"2013-09-05","conditions":["Type 2 Diabetes","Insulin Sensitivity/Resistance","Inflammatory Response","Fatty Acids, Omega-3"],"enrollment":41,"completionDate":"2020-02-24"},{"nctId":"NCT01728571","phase":"NA","title":"LungVITamin D and OmegA-3 Trial (lungVITAL)","status":"ACTIVE_NOT_RECRUITING","sponsor":"Brigham and Women's Hospital","startDate":"2010-07","conditions":["COPD","Asthma","Pulmonary Function","Pneumonia"],"enrollment":25871,"completionDate":"2025-02"},{"nctId":"NCT05971147","phase":"NA","title":"Time Course Change in Skeletal Muscle and Blood Phospholipid Composition With Omega-3 Fatty Acid Supplementation","status":"COMPLETED","sponsor":"Dr. Chris McGlory, PhD","startDate":"2023-08-01","conditions":["Skeletal Muscle Fatty Acid Metabolism"],"enrollment":29,"completionDate":"2025-01-13"},{"nctId":"NCT06758778","phase":"NA","title":"CreNeuroS™️CNS Fish Oil Plus Softgels Compared to Vascepa® Capsules and Deplin® Capsules in a Pharmacokinetic, Single Dose Evaluation on Healthy Adult Human Subjects Under Fasting Conditions","status":"ENROLLING_BY_INVITATION","sponsor":"Sichuan Credit Pharmaceutical Co., Ltd.","startDate":"2025-01-03","conditions":["Bioavailability"],"enrollment":14,"completionDate":"2025-03"},{"nctId":"NCT06781918","phase":"PHASE3","title":"Severe Acute Malnutrition and Child Development Clinical Trial in Mwanza","status":"NOT_YET_RECRUITING","sponsor":"National Institute for Medical Research, Tanzania","startDate":"2025-02-03","conditions":["Severe Acute Malnutrition in Childhood"],"enrollment":800,"completionDate":"2026-05-14"},{"nctId":"NCT03576989","phase":"NA","title":"Impact of Omega-3 Fatty Acid Oral Therapy on Healing of Chronic Venous Leg Ulcers in Older Adults","status":"COMPLETED","sponsor":"Ohio State University","startDate":"2019-04-15","conditions":["Chronic Venous Leg Ulcers"],"enrollment":296,"completionDate":"2024-12-18"},{"nctId":"NCT06720662","phase":"NA","title":"Effect of Icosapent-ethyl Ester (IPE) to Reduce the Residual Risk Cardiovascular Disease.","status":"NOT_YET_RECRUITING","sponsor":"University of Sao Paulo","startDate":"2025-04-01","conditions":["Atherosclerosis Cardiovascular Disease"],"enrollment":294,"completionDate":"2026-01-30"},{"nctId":"NCT06302023","phase":"PHASE2","title":"Docosahexaenoic Acid (DHA) Supplementation During Pregnancy Reduces the Risk of Preterm Birth in Threatened Preterm Labor","status":"COMPLETED","sponsor":"Khon Kaen University","startDate":"2024-04-01","conditions":["Pregnant Women Diagnosed With Threatened Preterm Labor"],"enrollment":60,"completionDate":"2024-10-07"},{"nctId":"NCT06710080","phase":"PHASE3","title":"Targeting Vascular INflammation in Patients with Community-Acquired Pneumonia","status":"NOT_YET_RECRUITING","sponsor":"Ottawa Heart Institute Research Corporation","startDate":"2024-12-15","conditions":["Inflammation","Community Acquired Pneumonia (CAP)","Inflammation Plaque, Atherosclerotic"],"enrollment":168,"completionDate":"2027-06"},{"nctId":"NCT04682665","phase":"","title":"Prebiotic Effect of Eicosapentaenoic Acid Treatment for Colorectal Cancer Liver Metastases","status":"COMPLETED","sponsor":"University of Leeds","startDate":"2021-09-16","conditions":["Colon Cancer Liver Metastasis"],"enrollment":81,"completionDate":"2024-07-31"},{"nctId":"NCT02719327","phase":"PHASE2,PHASE3","title":"Brain Amyloid and Vascular Effects of Eicosapentaenoic Acid","status":"COMPLETED","sponsor":"VA Office of Research and Development","startDate":"2017-06-08","conditions":["Alzheimer's Disease"],"enrollment":131,"completionDate":"2023-09-29"},{"nctId":"NCT04531410","phase":"NA","title":"NETwork of Linoleic Acid Supplementation in Cystic Fibrosis","status":"COMPLETED","sponsor":"Karolinska Institutet","startDate":"2021-10-25","conditions":["Cystic Fibrosis"],"enrollment":50,"completionDate":"2024-11-05"},{"nctId":"NCT05207059","phase":"NA","title":"Healthy Early Life Moments in Singapore","status":"RECRUITING","sponsor":"KK Women's and Children's Hospital","startDate":"2022-03-18","conditions":["Metabolic Disease","Mental Health Wellness 1","Lifestyle Risk Reduction","Maternal Obesity"],"enrollment":500,"completionDate":"2028-12"},{"nctId":"NCT03265288","phase":"PHASE2","title":"Study of LAU-7b in the Treatment of Cystic Fibrosis in Adults","status":"COMPLETED","sponsor":"Laurent Pharmaceuticals Inc.","startDate":"2018-11-05","conditions":["Cystic Fibrosis"],"enrollment":166,"completionDate":"2021-09-15"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"administration":{"route":"Oral","formulation":"Capsule","formulations":[{"form":"CAPSULE","route":"ORAL","productName":"Animi-3"},{"form":"CAPSULE","route":"ORAL","productName":"Animi-3 with Vitamin D"},{"form":"CAPSULE, GELATIN COATED","route":"ORAL","productName":"PNV-Omega"},{"form":"CAPSULE, GELATIN COATED","route":"ORAL","productName":"Prenate Essential"},{"form":"CAPSULE, GELATIN COATED","route":"ORAL","productName":"TRICARE PRENATAL DHA ONE"},{"form":"CAPSULE, LIQUID FILLED","route":"ORAL","productName":"TriStart DHA"}]},"crossReferences":{"NUI":"N0000148114","MMSL":"d07891","NDDF":"002052","UNII":"AAN7QOV9EA","VUID":"4020139","CHEBI":"CHEBI:36006","VANDF":"4020139","INN_ID":"6328","RXNORM":"90","UMLSCUI":"C0000545","chemblId":"CHEMBL460026","ChEMBL_ID":"CHEMBL460026","KEGG_DRUG":"D08061","DRUGBANK_ID":"DB00159","PDB_CHEM_ID":"EPA","PUBCHEM_CID":"446284","SNOMEDCT_US":"226367006","IUPHAR_LIGAND_ID":"7441","MESH_DESCRIPTOR_UI":"D015118"},"formularyStatus":[],"_enricherVersion":"v2","_offLabelChecked":true,"developmentCodes":[],"ownershipHistory":[{"period":"present","companyName":"National Institute on Alcohol Abuse and Alcoholism (NIAAA)","relationship":"Current Owner"}],"publicationCount":12109,"therapeuticAreas":["Metabolic"],"biosimilarFilings":[],"recentPublications":[{"date":"2026 Mar 11","pmid":"41899733","title":"The Role of Omega-3 Polyunsaturated Fatty Acids on Sarcopenia and Aging Muscle.","journal":"International journal of environmental research and public health"},{"date":"2026 Mar 19","pmid":"41898657","title":"An Explorative Approach to Examining the Role of Ischemia and Inflammation on the Function of Autoantibodies Against G Protein-Coupled Receptors and Their Corresponding Agonists.","journal":"International journal of molecular sciences"},{"date":"2026 Mar 19","pmid":"41897934","title":"Relationship Between Litter Weight Gain and Colostrum Fatty Acid Composition: Implications for Cross-Fostering?","journal":"Animals : an open access journal from MDPI"},{"date":"2026 Mar 10","pmid":"41897837","title":"Effects of Dietary Inclusion of Perilla Seed Meal on Growth Performance, Plasma Biochemistry, and Breast Muscle Fatty Acid Composition in Sansui Ducks from 4 to 8 Weeks of Age.","journal":"Animals : an open access journal from MDPI"},{"date":"2026 Mar 18","pmid":"41897794","title":"Criteria for the Characterization of Seafood Byproducts to Allow Tracing Their Geographic Origin.","journal":"Foods (Basel, Switzerland)"}],"companionDiagnostics":[],"genericManufacturerList":[],"status":"active","companyName":"National Institute on Alcohol Abuse and Alcoholism (NIAAA)","companyId":"national-institute-on-alcohol-abuse-and-alcoholism-niaaa","modality":"Small molecule","firstApprovalDate":"","aiSummary":"","enrichmentLevel":3,"visitCount":0,"regulatoryByCountry":[{"country_code":"US","regulator":"FDA","status":"approved","approval_date":null,"mah":"","brand_name_local":null,"application_number":""},{"country_code":"CA","regulator":"Health Canada","status":"approved","approval_date":null,"mah":"","brand_name_local":"","application_number":""},{"country_code":"BR","regulator":"ANVISA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"MX","regulator":"COFEPRIS","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AR","regulator":"ANMAT","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"TR","regulator":"TITCK","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"IN","regulator":"CDSCO","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"TH","regulator":"FDA-TH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"MY","regulator":"NPRA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"PH","regulator":"FDA-PH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"CO","regulator":"INVIMA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"ZA","regulator":"SAHPRA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"TW","regulator":"TFDA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"HK","regulator":"DH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"IL","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"SG","regulator":"HSA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AE","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"KR","regulator":"MFDS","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AU","regulator":"TGA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"GB","regulator":"MHRA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null}],"trialStats":{"total":6,"withResults":0},"validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T00:50:36.486623+00:00","fieldsConflicting":1,"overallConfidence":0.8},"verificationStatus":"verified","dataCompleteness":{"mechanism":false,"indications":true,"safety":true,"trials":true,"score":3}}