Triglide (fenofibrate) / Vectura, Shionogi 
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 25 Diseases   1 Trial   1 Trial   1402 News 


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  • ||||||||||  micronized fenofibrate / Generic mfg., fenofibrate / Generic mfg.
    Trial completion date, Trial initiation date, Trial primary completion date:  Fenofibrate in Patients with Cervical Intraepithelial Neoplasia and Invasive Cervical Carcinoma (clinicaltrials.gov) -  Sep 21, 2024   
    P1,  N=24, Not yet recruiting, 
    Not yet recruiting --> Recruiting Trial completion date: May 2025 --> Nov 2026 | Initiation date: Aug 2024 --> Nov 2024 | Trial primary completion date: Jan 2025 --> Jun 2026
  • ||||||||||  micronized fenofibrate / Generic mfg., fenofibrate / Generic mfg.
    Trial initiation date:  Fenofibrate in Patients with Cervical Intraepithelial Neoplasia and Invasive Cervical Carcinoma (clinicaltrials.gov) -  Apr 12, 2024   
    P1,  N=24, Not yet recruiting, 
    Trial completion date: May 2025 --> Nov 2026 | Initiation date: Aug 2024 --> Nov 2024 | Trial primary completion date: Jan 2025 --> Jun 2026 Initiation date: Feb 2024 --> Aug 2024
  • ||||||||||  Triglide (fenofibrate) / Vectura, Shionogi
    Preclinical, Journal:  NPC1L1 and ABCG5/8 induction explain synergistic fecal cholesterol excretion in ob/ob mice co-treated with PPAR-α and LXR agonists. (Pubmed Central) -  Apr 29, 2021   
    Synergistic efficacy on fecal cholesterol excretion following co-treatment with PPAR-α and LXR agonists occurred through a combination of RCT, TICE, and the key enzyme in bile synthesis, cholesterol 7-α hydroxylase (cyp7a1). These results suggest that cholesterol efflux, biliary cholesterol excretion, and TICE collectively contributed to the 12-fold increases in the fecal cholesterol excretion in ob/ob mice co-treated with PPAR-α and LXR agonists.
  • ||||||||||  Triglide (fenofibrate) / Vectura, Shionogi
    Journal:  Toxicity Screens in Human Retinal Organoids for Pharmaceutical Discovery. (Pubmed Central) -  Apr 17, 2021   
    This is a directly actionable finding owing to the highly disease-relevant model tested. This platform can be easily modified to test any number of metabolic stressors and potential pharmacological interventions for future treatment discovery in retinal diseases.
  • ||||||||||  Triglide (fenofibrate) / Vectura, Shionogi
    Clinical, Journal:  Reducing Cardiovascular Disease Risk in Women Beyond Statin Therapy: New Insights 2020. (Pubmed Central) -  Apr 13, 2021   
    CVD risk reduction with icosapent ethyl treatment was comparable between women and men (p for interaction, 0.33). Data from REDUCE-IT suggest women benefit similarly to men with respect to icosapent ethyl, a novel therapy for prevention of CVD.
  • ||||||||||  Triglide (fenofibrate) / Vectura, Shionogi
    Journal:  Modification of the zeta potential of montmorillonite to achieve high active pharmaceutical ingredient nanoparticle loading and stabilization with optimum dissolution properties. (Pubmed Central) -  Apr 7, 2021   
    When examined together, the data for all six APIs suggest a general trend whereby API nanoparticles with zeta potentials more positive than around -25 mV do not require carrier particle surface modification with PA in order to preserve their fast dissolution rates from NP-carrier composites at higher API loadings. Thus, this study offers a potentially effective means of transforming poorly water soluble BCS Class II APIs into fast dissolving solid dosage NP-carrier composites, whereby the surface properties of the carrier particle can be tuned with prior knowledge of the zeta potential of the API nanoparticles.
  • ||||||||||  Triglide (fenofibrate) / Vectura, Shionogi
    Review, Journal:  Evidence and indications for systemic treatment in diabetic retinopathy: a systematic review. (Pubmed Central) -  Apr 1, 2021   
    Systemic intervention appears important in different stages of DR. While IGC seems effective in relation to incident and progressive DR, antihypertensive treatments may be valuable in the early stages of DR, as opposed to fenofibrate, which could benefit at a later stage.
  • ||||||||||  Triglide (fenofibrate) / Vectura, Shionogi
    Preclinical, Journal:  Pharmacological screening of fenofibrate-loaded solid dispersion in fructose-induced diabetic rat. (Pubmed Central) -  Mar 30, 2021   
    While IGC seems effective in relation to incident and progressive DR, antihypertensive treatments may be valuable in the early stages of DR, as opposed to fenofibrate, which could benefit at a later stage. This newly formulated SDF would be a promising alternative for conventional fenofibrate in treating hyperlipidaemia.
  • ||||||||||  Triglide (fenofibrate) / Vectura, Shionogi
    [VIRTUAL] Bone Breaking Triglycerides () -  Mar 27, 2021 - Abstract #ENDO2021ENDO_3225;    
    For oral presentations, the abstracts are embargoed until the session begins. The Endocrine Society reserves the right to lift the embargo on specific abstracts that are selected for promotion prior to or during ENDO 2021.
  • ||||||||||  Triglide (fenofibrate) / Vectura, Shionogi
    [VIRTUAL] Hypertriglyceridemia-Induced Pancreatitis () -  Mar 27, 2021 - Abstract #ENDO2021ENDO_3222;    
    For oral presentations, the abstracts are embargoed until the session begins. The Endocrine Society reserves the right to lift the embargo on specific abstracts that are selected for promotion prior to or during ENDO 2021.
  • ||||||||||  Triglide (fenofibrate) / Vectura, Shionogi
    [VIRTUAL] Statin Intolerance: Prevalence and Management in a Specialized Lipid Clinic () -  Mar 27, 2021 - Abstract #ENDO2021ENDO_3210;    
    Fenofibrate was associated with significantly less frequent adverse effects than statins (p=0.006)...For oral presentations, the abstracts are embargoed until the session begins. The Endocrine Society reserves the right to lift the embargo on specific abstracts that are selected for promotion prior to or during ENDO 2021.
  • ||||||||||  Triglide (fenofibrate) / Vectura, Shionogi
    Journal:  Severe L-asparaginase-induced Hypertriglyceridaemia Treated with Plasmapheresis. (Pubmed Central) -  Mar 27, 2021   
    This response illustrates the strong effectiveness of early treatment with plasmapheresis in severe and symptomatic hypertriglyceridaemia associated with L-asparaginase. Pancreatitis following L-asparaginase-induced hypertriglyceridaemia is a severe and potentially reversible condition in both adults and children treated for acute lymphoblastic leukaemia.Early plasmapheresis is more effective to rapidly decrease serum triglycerides.
  • ||||||||||  Triglide (fenofibrate) / Vectura, Shionogi
    Journal:  Shared PPARα/γ Target Genes Regulate Brown Adipocyte Thermogenic Function. (Pubmed Central) -  Mar 25, 2021   
    Among these, we focused on the lysosomal protease cathepsin Z (CTSZ) and showed it is necessary for mitochondrial respiration in both mouse and human brown adipocytes. Thus, CTSZ is a shared PPARα/γ target gene in BAT and a regulator of brown adipocyte thermogenic function.
  • ||||||||||  Triglide (fenofibrate) / Vectura, Shionogi
    Clinical, Journal:  Fenofibrate decreased microalbuminuria in the type 2 diabetes patients with hypertriglyceridemia. (Pubmed Central) -  Mar 25, 2021   
    P4
    Thus, CTSZ is a shared PPARα/γ target gene in BAT and a regulator of brown adipocyte thermogenic function. In the patients with hypertriglyceridemia and type 2 diabetes mellitus, fenofibrate can improve microalbuminuria and do not increase the deterioration of glomerular filtration rate.
  • ||||||||||  Triglide (fenofibrate) / Vectura, Shionogi
    Clinical, Journal, Real-world evidence:  No Time to Waste: Real-World Repurposing of Generic Drugs as a Multifaceted Strategy Against COVID-19. (Pubmed Central) -  Mar 17, 2021   
    Having previously fast-tracked this paper to publication in summary form, we now expand on why cimetidine/famotidine (histamine type-2 receptor antagonists), dipyridamole (antiplatelet agent), fenofibrate/bezafibrate (cholesterol/triglyceride-lowering agents), and sildenafil (phosphodiesterase-5 inhibitor) are worth considering for patients with COVID-19 based on their antiviral, anti-inflammatory, renoprotective, cardioprotective, and anticoagulation properties. These examples also reveal the unlimited opportunity to future-proof public health by proactively mining, synthesizing, and cataloging the off-label treatment opportunities of thousands of safe, well-established, and affordable generic drugs.
  • ||||||||||  Triglide (fenofibrate) / Vectura, Shionogi
    Preclinical, Journal:  Effects of low and high doses of fenofibrate on protein, amino acid, and energy metabolism in rat. (Pubmed Central) -  Feb 24, 2021   
    HFFD causes signs of hepatotoxicity, impairs energy and protein balance in muscles, and decreases BCAA, methionine, and lysine. It is suggested that increased glycine and decreased lysine and methionine levels are due to activated carnitine synthesis; decreased BCAA and BCKA levels are due to increased BCAA oxidation.
  • ||||||||||  micronized fenofibrate / Generic mfg., fenofibrate / Generic mfg.
    Biomarker, Trial completion, Enrollment change, Trial completion date, Trial primary completion date:  Fenofibrate in Type 2 Diabetes (clinicaltrials.gov) -  Feb 23, 2021   
    P4,  N=11, Completed, 
    It is suggested that increased glycine and decreased lysine and methionine levels are due to activated carnitine synthesis; decreased BCAA and BCKA levels are due to increased BCAA oxidation. Recruiting --> Completed | N=40 --> 11 | Trial completion date: Mar 2021 --> Mar 2020 | Trial primary completion date: Dec 2020 --> Mar 2020
  • ||||||||||  Triglide (fenofibrate) / Vectura, Shionogi
    Journal:  Transfer of Lipophilic Drugs from Nanoemulsions into Lipid-Containing Alginate Microspheres. (Pubmed Central) -  Feb 3, 2021   
    Lipophilicity, estimated according to the calculated logP value of the respective drug, was a major factor influencing the transfer performance: the higher the logP value, the slower the transfer. This experimental setup is a promising technique to investigate the release of poorly water-soluble drugs from various types of nanocarriers under closer to physiological conditions than with many other methods currently applied.
  • ||||||||||  Triglide (fenofibrate) / Vectura, Shionogi
    [VIRTUAL] The Troublesome Triad: Hypertriglyceridemia-Induced Acute Pancreatitis in Diabetic Ketoacidosis (On-Demand) -  Feb 2, 2021 - Abstract #ENDO2021ENDO_1077;    
    CT abdomen showed hepatic steatosis andperipancreatic inflammation, confirming the diagnosis.Hewas admitted to the ICU, received aggressive IV fluid resuscitation with 5%dextrose in half normal saline while on an insulin infusion, with morphine andondansetron to control his pain and nausea...He was transitioned to an oraldiet with subcutaneous insulin prior to discharge on insulin and fenofibrate.At 1 month follow up, he reported medication compliance and denied anyrecurrence. Conclusion :While DKA rarely triggers HTGAP in 1000 mg/dL is required for diagnosis of HTGAP, and thedegree of elevation is associated with the severity of pancreatitis.
  • ||||||||||  Triglide (fenofibrate) / Vectura, Shionogi
    [VIRTUAL] Challenges in Managing Metabolic Complications in a Patient With Familial Partial Lipodystrophy Type 3 (On-Demand) -  Feb 2, 2021 - Abstract #ENDO2021ENDO_1016;    
    She also was found to have Polycystic Ovarian Syndrome (PCOS) based on menstrual irregularities, hirsutism and ultrasound showing multiple ovarian cysts, and was treated with spironolactone...Often these are not sufficient in addressing the complexity of metabolic derangements in these patients who have an increased risk of cardiovascular events at a young age. Further research about agents targeting this gene in particular would be beneficial.
  • ||||||||||  Triglide (fenofibrate) / Vectura, Shionogi
    [VIRTUAL] Metabolic Improvements After Gastric Sleeve Surgery in a Patient With Familial Partial Lipodystrophy (On-Demand) -  Feb 2, 2021 - Abstract #ENDO2021ENDO_619;    
    Despite aggressive therapy with dietary changes, fenofibrate, statin, omega-3, and niacin, he had multiple episodes of pancreatitis with TG levels >5000 mg/dl on many occasions...He has not required plasmapheresis for over a year so far and his TG levels are consistently <500 mg/dl while only on rosuvastatin 40 mg, with the most recent TG level of 182 mg/dl...For oral presentations, the abstracts are embargoed until the session begins. The Endocrine Society reserves the right to lift the embargo on specific abstracts that are selected for promotion prior to or during ENDO 2021.