Triglide (fenofibrate) / Vectura, Shionogi - LARVOL DELTA

Fenofibrate in Patients With Cervical Intraepithelial Neoplasia and Invasive Cervical Carcinoma (clinicaltrials.gov) - P1 | N=24 | Recruiting | Sponsor: Lindsay Ferguson, MD | Not yet recruiting ➔ Recruiting

Enrollment open • Cervical Cancer • Gynecology • Oncology • Solid Tumor • TP53

Fenofibrate in Patients with Cervical Intraepithelial Neoplasia and Invasive Cervical Carcinoma (clinicaltrials.gov) - P1 | N=24 | Not yet recruiting | Sponsor: Lindsay Ferguson, MD | Trial completion date: May 2025 ➔ Nov 2026 | Initiation date: Aug 2024 ➔ Nov 2024 | Trial primary completion date: Jan 2025 ➔ Jun 2026

Trial completion date • Trial initiation date • Trial primary completion date • Cervical Cancer • Gynecology • Oncology • Solid Tumor • TP53

Fenofibrate in Patients With Cervical Intraepithelial Neoplasia and Invasive Cervical Carcinoma (clinicaltrials.gov) - P1 | N=24 | Not yet recruiting | Sponsor: Lindsay Ferguson, MD | Initiation date: Feb 2024 ➔ Aug 2024

Trial initiation date • Cervical Cancer • Gynecology • Oncology • Solid Tumor • TP53

Fenofibrate in Patients With Cervical Intraepithelial Neoplasia and Invasive Cervical Carcinoma (clinicaltrials.gov) - P1 | N=24 | Not yet recruiting | Sponsor: Lindsay Ferguson, MD

New P1 trial • Cervical Cancer • Gynecology • Oncology • Solid Tumor • TP53

A METRONOMIC ANTIANGIOGENIC COMBINATION THERAPY MAY PROLONG SURVIVAL FOR PATIENTS WITH RECURRENT MEDULLOBLASTOMA AND ATYPICAL TERATOID RHABDOID TUMOR (SNO 2018) - P2; "Treatment consisted of an antiangiogenic multidrug-regime including IV bevacizumab, oral thalidomide, celecoxib, fenofibrate, and etoposide alternating with cyclophosphamide, and augmented with intraventricular therapy (etoposide and aqueous or liposomal cytarabine). As of 05/2018, 10/20 patients with medulloblastoma are alive, eight in CR, six off therapy for 96, 79, 77, 34, 12, and 4 months. 5-year-OS is 54.5 ± 11.2% and 5-year-EFS is 25.0 ± 9.7%. One patient died of an accident in CR 23 months after initiation of antiangiogenic therapy."

Clinical • Combination therapy • Neuroendocrine Tumor • Oncology • Solid Tumor

[VIRTUAL] The safety and pharmacokinetics of fenofibrate in patients with advanced fibrosis including those with non-alcoholic steatohepatitis (NASH) (EASL-ILC-I 2020) - P2 | "FENO has shown promise for mitigating hypertriglyceridemia observed in NASH patients treated with the acetyl-CoA carboxylase (ACC) inhibitor firsocostat (FIR). In patients with mild HI or NASH with advanced fibrosis, FENO was well tolerated and the PK of fenofibric acid was unaltered. These data suggest that FENO may be a safe option for the management of hypertriglyceridemia in patients with advanced fibrosis and represent a meaningful contribution to our understanding of the PK of FENO in a previously unevaluated population."

Clinical • PK/PD data • Dyslipidemia • Fibrosis • Hepatology • Hypertriglyceridemia • Immunology • Non-alcoholic Fatty Liver Disease • Non-alcoholic Steatohepatitis

Comparison table: Some lipid-lowering drugs. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal

[VIRTUAL] PRURITUS IN PRIMARY BILIARY CHOLANGITIS IS UNDER-TREATED IN CLINICAL PRACTICE: RESULTS FROM TARGET-PBC (AASLD 2020) - "Patients with CS itch were more likely to be taking multiple treatments for PBC than those with mild itch or no itch (32% vs 22% vs 22%) and to be taking fenofibrate (16% vs 1% vs 5%)... Pruritus is under-treated in this real world PBC population and many patients with CS itch never receive treatment. TARGET-PBC is sponsored by TARGET PharmaSolutions; GSK provided funding for this analysis (213259)."

Clinical • Dermatology • Fatigue • Fibrosis • Hepatology • Immunology • Primary Biliary Cholangitis • Pruritus

Practical guidance for combination lipid-modifying therapy in high- and very-high-risk patients: A statement from a European Atherosclerosis Society Task Force. (PubMed, Atherosclerosis) - "This guidance aims to improve real-world use of guideline-recommended combination lipid modifying treatment."

Clinical • Journal • Atherosclerosis • Cardiovascular • Diabetes • Dyslipidemia • Familial Hypercholesterolemia • Metabolic Disorders • Type 2 Diabetes Mellitus

Optimization of Nanostructured Lipid Carriers of Fenofibrate Using a Box-Behnken Design for Oral Bioavailability Enhancement. (PubMed, Curr Drug Deliv) - "A Box-Behnken design was successfully applied to optimize FNB-NLC formulation for the enhancement of the dissolution and bioavailability of FNB, a poorly water-soluble drug."

Journal

The use of polymer blends to improve stability and performance of electrospun solid dispersions: the role of miscibility and phase separation. (PubMed, Int J Pharm) - "This study investigated the use of polymer blends to modify PVP-based ES formulations of a model poorly soluble drug, fenofibrate (FF), to improve its physical stability without compromising dissolution enhancement. The data revealed the importance of miscibility and phase separation in understanding the physical stability of the ES fibre mats. The findings provide insight into the design of formulations that can provide dissolution enhancement balanced with improved storage stability."

Journal

Visualizing the Journey of Fenofibrate through the Rat Gastrointestinal Tract by Matrix-Assisted Laser Desorption/Ionization-Mass Spectrometry Imaging. (PubMed, Mol Pharm) - "Fenofibrate was detected by MALDI-MSI throughout the GIT, which also revealed that fenofibrate was hydrolyzed to the active drug fenofibric acid already in the stomach. Furthermore, the presence of lyso-phosphatidylcholine (lyso-PC) and taurocholate was confirmed in the lumen of the small intestine. MALDI-MSI was shown to be a useful qualitative tool for localizing parent prodrugs and active drugs, with a possibility for gaining insight into not only the location for activation but also the role of endogenous molecules in the process."

Journal • Preclinical • Gastrointestinal Disorder

Safety and Efficacy of Fenofibrate as a Treatment for Huntington's Disease (clinicaltrials.gov) - P2a; N=20; Active, not recruiting; Sponsor: University of California, Irvine; Trial completion date: Dec 2019 ➔ Aug 2021; Trial primary completion date: Dec 2019 ➔ Aug 2021

Clinical • Trial completion date • Trial primary completion date • Genetic Disorders • Huntington's Disease • Movement Disorders

Identification of Plitidepsin as Potent Inhibitor of SARS-CoV-2-Induced Cytopathic Effect After a Drug Repurposing Screen. (PubMed, Front Pharmacol) - "These included plitidepsin, novel cathepsin inhibitors, nelfinavir mesylate hydrate, interferon 2-alpha, interferon-gamma, fenofibrate, camostat along the well-known remdesivir and chloroquine derivatives. Antivirals prioritized herein identify novel compounds and their mode of action, while independently replicating the activity of a reduced proportion of drugs which are mostly approved for clinical use. Combinations of these drugs should be tested in animal models to inform the design of fast track clinical trials."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • IFNG

Goodbye fouling: a unique coaxial lamination mixer (CLM) enabled by two-photon polymerization for the stable production of monodisperse drug carrier nanoparticles. (PubMed, Lab Chip) - "Stable castor oil nanoemulsions loaded with the poorly soluble drugs fenofibrate or cannabidiol were prepared. In conclusion, the unique 3D design of the CLM enables prolonged, stable and scalable production of small as well as very narrowly distributed, in most cases even monodisperse drug-loaded lipid nanoparticles."

Journal

Association Analysis of Hyperlipidemia with the 28-Day All-Cause Mortality of COVID-19 in Hospitalized Patients. (PubMed, Chin Med Sci J) - "Patients who were aged < 18 or ≥ 85 years old, in pregnancy, with acute lethal organ injury (e.g., acute myocardial infarction, severe acute pancreatitis, acute stroke), hypothyroidism, malignant diseases, severe malnutrition, and those with normal lipid profile under lipid-lowering medicines (e.g., statin, niacin, fenofibrate, gemfibrozil, and ezetimibe) were excluded. Similar results were also obtained in subgroup analyses of abnormal lipid parameters. Therefore, hyperlipidemia might be not a major causative factor for poor outcome of COVID-19, which provides guidance for the intervention of inpatients during the epidemic of COVID-19."

Clinical • Journal • Cardiovascular • Diabetes • Dyslipidemia • Endocrine Disorders • Infectious Disease • Metabolic Disorders • Myocardial Infarction • Novel Coronavirus Disease • Pancreatitis • Type 2 Diabetes Mellitus

Microparticle formulations alter the toxicity of fenofibrate to the zebrafish Danio rerio embryo. (PubMed, Aquat Toxicol) - "This could explain the higher ecotoxicity. The toxic effects on the zebrafish embryo thus suggested that the formulation as well as the solvent increased the bioavailability of fenofibrate."

Journal • PCR

Fenofibrate Protects against Retinal Dysfunction in a Murine Model of Common Carotid Artery Occlusion-Induced Ocular Ischemia. (PubMed, Pharmaceuticals (Basel)) - "We found that fenofibrate boosted liver function, increased serum levels of fibroblast growth factor 21 (FGF21), one of the neuroprotective molecules in the central nervous system, and protected against UCCAO-induced retinal dysfunction. Our current data suggest a promising fenofibrate therapy in ischemic retinopathies."

Journal • Preclinical • Diabetic Retinopathy • Ophthalmology • Retinal Disorders • FGF21

[VIRTUAL] Statin Intolerance: Prevalence and Management in a Specialized Lipid Clinic (ENDO 2021) - "Statins caused more adverse effects than other drugs, with atorvastatin (63%) and simvastatin (64%) achieving the lowest rates, pravastatin (87%) and fluvastatin (100%) the highest. 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."

Cardiovascular • Gastrointestinal Disorder • Musculoskeletal Diseases

PPARα agonist fenofibrate relieves acquired resistance to gefitinib in non-small cell lung cancer by promoting apoptosis via PPARα/AMPK/AKT/FoxO1 pathway. (PubMed, Acta Pharmacol Sin) - "All the results suggest that fenofibrate relieves acquired resistance to gefitinib in NSCLC by promoting apoptosis via regulating PPARα/AMPK/AKT/FoxO1 pathway. We propose that combination of gefitinib and fenofibrate is a potential strategy for overcoming the gefitinib resistance in NSCLC."

Journal • Preclinical • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • AKT1 • FOXO1

Covalent organic nanospheres modified magnetic nanoparticles for extraction of blood lipid regulators in water samples. (PubMed, J Sep Sci) - "In this work, magnetic nanoparticles were attached to the surface of covalent organic nanospheres and the obtained composites were used for the extraction of blood lipid regulators such as clofibrate and fenofibrate. This method exhibited outstanding analytical performance with wide linear range and excellent reproducibility and had low limits of detection in the range of 0.02-0.03 ng/mL. This method was also applied to the detection of clofibrate and fenofibrate in lake water samples and good recoveries in the range of 92.6%-112.6% was obtained."

Journal

Protocol AF: Fenofibrate for Prevention of DR Worsening (clinicaltrials.gov) - P3; N=910; Recruiting; Sponsor: Jaeb Center for Health Research; Not yet recruiting ➔ Recruiting

Enrollment open • Diabetic Retinopathy • Retinal Disorders

[VIRTUAL] Hypertriglyceridemia-Induced Pancreatitis (ENDO 2021) - "She was kept nil by mouth and commenced on insulin infusion, fenofibrate and a low-fat diet. 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."

Acute Respiratory Distress Syndrome • Diabetes • Dyslipidemia • Endocrine Disorders • Gastroenterology • Hepatology • Hypertriglyceridemia • Immunology • Inflammation • Metabolic Disorders • Pain • Pancreatitis • Respiratory Diseases

[VIRTUAL] Targeted Therapeutic Approach in Patients With Familial Partial Lipodystrophy Type 3 (ENDO 2021) - "The patient was treated with an insulin drip with decline in triglyceride levels (450 mg/dL) and discharged on atorvastatin, fenofibrate, metformin, and pioglitazone. Our patient was treated with pioglitazone with excellent response to therapy in three months. TZDs may offer a targeted approach to treat FPLD3 based on PPARγ ligand-dependent responsiveness."

Clinical • Cardiovascular • Diabetes • Dyslipidemia • Fibrosis • Genetic Disorders • Hepatology • Hypertension • Hypertriglyceridemia • Immunology • Lipodystrophy • Metabolic Disorders • Obesity • Pain • Pancreatitis • Rare Diseases • Type 2 Diabetes Mellitus • LEP

[VIRTUAL] Bone Breaking Triglycerides (ENDO 2021) - "Patient was fasted for 24 hours and then started on intensive insulin regimen as well as fenofibrate for hypertriglyceridemia. 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."

Cardiovascular • Diabetes • Dyslipidemia • Hematological Malignancies • Hypertriglyceridemia • Metabolic Disorders • Monoclonal Gammopathy • Multiple Myeloma • Musculoskeletal Diseases • Oncology • Orthopedics • Pain • Pancreatitis • Type 2 Diabetes Mellitus