Hypertriglyceridemia
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CLINICAL_TRIALS trial_result · 2022-04-25Clinical Trial Update: Efficacy and Safety of AMR101 (Ethyl Icosapentate) in Patients With Fasting Triglyceride (Tg) Levels ≥ 500 and ≤ 2000 mg/dL [Phase 3]
Phase 3 trial results for AMR101 (ethyl esters of eicosapentaenoic acid) in patients with fasting triglycerides 500–2000 mg/dL; study comple…
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CLINICAL_TRIALS trial_result · 2022-04-13Clinical Trial Update: The COMPASS Study: A Study of Volanesorsen (Formally ISIS-APOCIIIRx) in Patients With Hypertriglyceridemia [Phase 3]
A Phase 3 trial in hypertriglyceridemia assessing volanesorsen (ISIS-APOCIIIRx) has completed; results were posted in 2022.
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FDA approval · 2022-04-05FDA Approved: FENOFIBRATE — Supplemental Application (Alembic Pharmaceuticals Inc.)
The FDA approved Alembic Pharmaceuticals' supplemental application for fenofibrate, enabling a generic fenofibrate product.
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FDA approval · 2022-04-05FDA Approved: FENOFIBRATE — Supplemental Application (AvKARE)
FDA approved a supplemental application for fenofibrate from AvKARE, granting approval for a change under the ANDA for this generic product.…
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CLINICAL_TRIALS trial_result · 2022-03-04Clinical Trial Update: Pharmacodynamic Effects of a Free-Fatty Acid Formulation of Omega-3 Pentaenoic Acid in Adults With Hypertriglyceridemia [Phase 2]
Phase 2 trial evaluating pharmacodynamic effects of a free-fatty acid formulation of omega-3 pentaenoic acid in adults with hypertriglycerid…
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CLINICAL_TRIALS trial_result · 2022-01-27Clinical Trial Update: Safety, Tolerability, and Pharmacokinetic Study of ISIS ApoC-III Rx in Hypertriglyceridemia [Phase 2]
Phase 2 safety, tolerability, and pharmacokinetic study of ISIS ApoC-III Rx in hypertriglyceridemia has completed.
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FDA approval · 2022-01-04FDA Approved: FENOFIBRATE — Supplemental Application (Mylan Pharmaceuticals Inc.)
FDA approved a supplemental application for fenofibrate from Mylan Pharmaceuticals, updating an approved generic product.
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CLINICAL_TRIALS trial_result · 2022-01-04Clinical Trial Update: Setmelanotide in a Single Patient With Partial Lipodystrophy [Phase 2]
Phase 2 clinical trial update reporting on a single patient treated with setmelanotide for partial lipodystrophy.
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CLINICAL_TRIALS trial_result · 2021-12-22Clinical Trial Update: A Study to Evaluate the Effect of GFA-918 on Serum Triglyceride Levels in Individuals With Elevated Serum Triglyceride [Phase 2]
A Phase 2 clinical trial evaluating the effect of GFA-918 on serum triglyceride levels in individuals with elevated triglycerides has comple…
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FDA approval · 2021-12-10FDA Approved: GEMFIBROZIL — Supplemental Application (Cadila Pharmaceuticals Limited)
The FDA approved a supplemental application from Cadila Pharmaceuticals Limited for Gemfibrozil, finalizing approval of a generic version un…
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CLINICAL_TRIALS trial_result · 2021-12-10Clinical Trial Update: Evaluation of Common Bean Baked Snack Consumption on Blood Lipids in Overweight People With Altered Blood Lipid Levels [Phase 2]
Phase 2 clinical trial evaluating common bean baked snack consumption on blood lipid levels in overweight individuals with dyslipidemia; stu…
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FDA approval · 2021-12-10FDA Approved: GEMFIBROZIL — Supplemental Application (Zydus Lifesciences Limited)
The FDA approved a supplemental application for Gemfibrozil from Zydus Lifesciences Limited. This approval updates the existing ANDA for Gem…
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FDA approval · 2021-11-29FDA Approved: FENOFIBRIC ACID — Supplemental Application (Lupin Pharmaceuticals, Inc.)
FDA approved the supplemental application for Fenofibric Acid submitted by Lupin Pharmaceuticals, Inc. This action approves a supplemental s…
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FDA label_change · 2021-11-16FDA Approved: FENOFIBRATE — Supplemental Application (Apotex Corp.)
FDA approved a supplemental application for fenofibrate from Apotex Corp., resulting in a label change for the generic product.
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FDA approval · 2021-11-15FDA Approved: OMEGA-3-ACID ETHYL ESTERS — Original Application (Lifestar Pharma LLC)
FDA approved the original application for Omega-3-acid ethyl esters by Lifestar Pharma LLC.
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CLINICAL_TRIALS trial_result · 2021-11-02Clinical Trial Update: Effect of Vascepa on Improving Coronary Atherosclerosis in People With High Triglycerides Taking Statin Therapy [Phase 4]
Phase 4 trial updating on the effect of Vascepa (icosapent ethyl) on improving coronary atherosclerosis in people with high triglycerides on…
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CLINICAL_TRIALS trial_result · 2021-11-01Clinical Trial Update: The Effect of Fish Oil Plus Fenofibrate on Triglyceride Levels in People Taking Highly Active Antiretroviral Therapy (HAART) [Phase 2]
Phase 2 trial evaluating the effect of fish oil plus fenofibrate on triglyceride levels in people on HAART.
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CLINICAL_TRIALS trial_result · 2021-10-26Clinical Trial Update: Niacin, N-3 Fatty Acids and Insulin Resistance [Phase 4]
Phase 4 clinical trial evaluating effects of niacin and n-3 fatty acids on insulin resistance in metabolic syndrome and hypertriglyceridemia…
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CLINICAL_TRIALS trial_result · 2021-10-20Clinical Trial Update: Effects of Lovaza on Lipoprotein Composition and Function in Mild Hypertriglyceridemia [Phase 1, Phase 2]
Clinical trial update on the effects of Lovaza on lipoprotein composition and function in mild hypertriglyceridemia (Phase 1/Phase 2).
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FDA approval · 2021-09-20FDA Approved: FENOFIBRATE — Original Application (Aurobindo Pharma Limited)
FDA approves the original application for generic fenofibrate by Aurobindo Pharma Limited.
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CLINICAL_TRIALS withdrawal · 2021-09-16Clinical Trial Update: Safety and Efficacy of MAT9001(Omega-3-pentaenoic Acid) in Subjects With Triglycerides ≥500 mg/dL and <2000 mg/dL [Phase 3]
Phase 3 trial of MAT9001 (Omega-3-pentaenoic Acid) in severe hypertriglyceridemia was withdrawn.
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CLINICAL_TRIALS trial_result · 2021-08-23Clinical Trial Update: Long-term Safety and Efficacy Study of MND-2119 in Patients With Hypertriglyceridemia [Phase 3]
Phase 3 trial update reporting long-term safety and efficacy of MND-2119 in patients with hypertriglyceridemia.
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CLINICAL_TRIALS trial_result · 2021-07-28Clinical Trial Update: Outcomes Study to Assess STatin Residual Risk Reduction With EpaNova in HiGh CV Risk PatienTs With Hypertriglyceridemia [Phase 3]
Phase 3 outcomes study completed; FocaSThStatin residual risk reduction with EPA in high cardiovascular risk patients with hypertriglyceride…
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FDA approval · 2021-06-30FDA Approved: ICOSAPENT ETHYL — Original Application (Apotex Corp)
FDA approved Apotex Corp's original ANDA for a generic icospent ethyl product. The approval covers icosapent ethyl for the treatment of adul…
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CLINICAL_TRIALS trial_result · 2021-06-15Clinical Trial Update: Fructose Consumption and Metabolic Dysregulation [NA]
Completed clinical trial studying fructose consumption and metabolic dysregulation in adults with central obesity and hypertriglyceridemia; …