fenofibrate / Generic mfg. - LARVOL DELTA

Combination obeticholic acid (OCA) and fibrate therapy is associated with greater probability of biochemical response than switching from OCA to a fibrate in primary biliary cholangitis (EASL 2025) - "Background and Aims: Approximately 40% of patients (pts) with primary biliary cholangitis (PBC) are non-responders to ursodeoxycholic acid (UDCA) and candidates for second-line therapy (SLT). Until recently, the latter consisted of licensed treatment with obeticholic acid (OCA), or off-licensed bezafibrate/fenofibrate (fibrates)... Biochemical response rates under OCA+fibrate treatment are greater than stopping/switching from OCA to fibrates as part of a SLT regimen. Our data support the need for ongoing studies of combination SLT, alongside treatment paradigms associated with greater probability of biochemical response in PBC."

Fibrosis • Hepatocellular Cancer • Hepatology • Immunology • Oncology • Primary Biliary Cholangitis • Solid Tumor

The omega-3 fatty acids, eicosapentaenoic acid and docosahexaenoic acid, improve the response to fibrates in human liver cell models (EASL 2025) - "Currently, ursodeoxycholic acid (UDCA) and obeticholic acid (OCA) are two of the few drugs approved for the treatment of PBC, while no drugs are available for PSC...Fibrates, such as fenofibrate and bezafibrate, are currently tested in off- labeled trials... The addition of EPA/DHA to fibrates seems to be a promising way to reduce hepatic BA concentration. Further analysis is, however, required to validate this hypothesis."

Hepatology • Immunology • CYP27A1

Fibrates in primary sclerosing cholangitis: a multicenter retrospective observational study (EASL 2025) - "Seventy-two PSC patients were included: 40 (55.6%) received bezafibrate, 32 (44.4%) fenofibrate; 70 (97.3%) were already on ursodeoxycholic acid therapy. In PSC patients, fibrates demonstrated significant ALP reduction, with 30.0% of patients achieving normalization in 6 months with no difference between fenofibrates and bezafibrate. LSM remained stable at 12 months. Safety was acceptable, with discontinuation driven mainly by inefficacy and in the first 6 months of treatment."

Observational data • Retrospective data • Autoimmune Hepatitis • Cholestasis • Dermatology • Hepatology • Immunology • Inflammation • Pruritus

Electrokinetic Chromatography-based Micro Methods for Separation and Physiochemical Characterization of Very Hydrophobic Pharmaceuticals. (PubMed, J Sep Sci) - "This study established an efficient separation of the highly hydrophobic analytes fenofibrate, orlistat, lumefantrine and a micelle marker using microemulsion electrokinetic capillary chromatography. 12) could be clearly distinguished. Due to observed variabilities in retention time when changing the capillaries, it is advisable to calibrate with a standard mixture before each measurement series."

Journal

Pharmacologic Approaches to Preventing Primary Sclerosing Cholangitis Recurrence After Liver Transplantation (clinicaltrials.gov) - P2 | N=80 | Recruiting | Sponsor: Mayo Clinic | Not yet recruiting ➔ Recruiting

Enrollment open • Hepatology • Transplantation

Triiodothyronine ameliorates S-ketamine-induced hypomyelination via the PPARα pathway in neonatal rat. (PubMed, Exp Neurol) - "The pharmacological activator of PPARα, fenofibrate, rescued the motor coordination deficits and the inhibition of OPC maturation induced by S-ketamine. In conclusion, our study demonstrates that S-ketamine anesthesia induces the decline of thyroid hormone and hypomyelination in neonatal rats. Administration of T3 ameliorates S-ketamine-induced hypomyelination through the PPARα signaling pathway."

Journal • Preclinical • Anesthesia • Endocrine Disorders • Metabolic Disorders • Pediatrics • Solid Tumor • PPARA

Asprosin-FABP5 Interaction Modulates Mitochondrial Fatty Acid Oxidation through PPARα Contributing to MASLD Development. (PubMed, Adv Sci (Weinh)) - "Hepatocyte-specific overexpression of asprosin impairs mitochondrial fatty acid β-oxidation (FAO), whereas its knockdown not only enhances FAO in mice but also compensates for fenofibrate's limitations in MASLD treatment...These findings reveal that the secretory adipose factor asprosin is expected to act as a biological marker for early clinical diagnosis and prognostic evaluation of MASLD. Moreover, targeting hepatic asprosin gene inhibition and GalNAc-siRNAs to inhibit hepatic FABP5 both offer potential therapeutic benefits in the treatment of MASLD."

Journal • Hepatology • Metabolic Disorders • Metabolic Dysfunction-Associated Steatotic Liver Disease • FABP5 • PPARA

Proliferator-Activated Receptor Alpha Inhibits Abnormal Extracellular Matrix Accumulation and Maintains Energy Metabolism in Late-Onset Fuchs Endothelial Corneal Dystrophy. (PubMed, Invest Ophthalmol Vis Sci) - "In vitro experiments revealed that fenofibrate could reverse fibrosis and damage of cell-to-cell connections induced by TGF-β...Overall, we suggested that the overexpression or activation of PPARα can inhibit FAO energy dysfunction of corneal endothelium and the abnormal extracellular matrix formation in Descemet's membrane, which is the primary pathology of FECD. Thus, PPARα may be a potential target for attenuating the progression of FECD."

Journal • Fibrosis • Immunology • Ophthalmology • Transplantation • PPARA • TGFB1

FICsDCD: A Study to Assess the Role of Fenofibrate in Preventing Ischemic Cholangiopathy After Liver Transplantation (clinicaltrials.gov) - P2 | N=5 | Completed | Sponsor: Mayo Clinic | Recruiting ➔ Completed | N=148 ➔ 5

Enrollment change • Trial completion • Hepatology • Transplantation

Levocabastine ameliorates cyclophosphamide-induced nephrotoxicity in Swiss albino mice via NF-κB/cleaved caspase-3/TGF-β signaling pathways. (PubMed, Drug Res (Stuttg)) - "LEV (0.05 and 0.1 mg/kg, i.p.) and fenofibrate (FF) (80 mg/kg, p.o.) were given daily for 14 days. LEV 0.1 and FF 80 significantly reversed these changes toward normal and showed nephroprotective potential. Thus, seeing the protective effect of LEV on CP-intoxicated mice, we conclude that LEV may be used as an adjuvant with CP in cancer, however, it needs more studies with the direct cancer model to confirm the claim."

Journal • Preclinical • Fibrosis • Immunology • Oncology • CASP3 • CAT • IL1B • IL6 • TGFB1 • TNFA

Fenofibrate in Ulcerative Colitis (clinicaltrials.gov) - P2/3 | N=60 | Recruiting | Sponsor: Tanta University | Trial completion date: Jun 2025 ➔ Jun 2026 | Trial primary completion date: Feb 2025 ➔ Feb 2026

Trial completion date • Trial primary completion date • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis

Racing to Normal: A Case Report of Rapid and Notable Cholesterol Reduction With Statin and Ezetimibe Combined Therapy. (PubMed, Cureus) - "Initial therapy included rosuvastatin 20 mg, ezetimibe 10 mg, and fenofibrate 145 mg, combined with smoking cessation, alcohol restriction, and dietary changes. The substantial lipid reduction achieved reinforces current recommendations for early and aggressive treatment in high-risk patients. Continuous monitoring and individualized therapy adjustments remain essential for long-term cardiovascular risk reduction."

Journal • Atherosclerosis • Cardiovascular • Dyslipidemia • Familial Hypercholesterolemia • Genetic Disorders • Metabolic Disorders • Mixed Hyperlipidemia • Tobacco Cessation

FAME 1 EYE: The Fenofibrate And Microvascular Events in Type 1 Diabetes Eye. (clinicaltrials.gov) - P3 | N=450 | Recruiting | Sponsor: University of Sydney | Trial primary completion date: Dec 2024 ➔ Dec 2025

Trial primary completion date • Diabetes • Diabetic Nephropathy • Diabetic Retinopathy • Metabolic Disorders • Nephrology • Renal Disease • Retinal Disorders • Type 1 Diabetes Mellitus

DOUBLE TROUBLE: ACUTE MANAGEMENT CONSIDERATIONS OF SEVERE GESTATIONAL HYPERTRIGLYCERIDEMIA - Kevin Driscoll (ACC 2025) - "Cardiology, Endocrinology, and Nutrition teams were consulted.Decision-making: Her treatment plan included an NPO diet, intravenous fluids, fenofibrate, and omega 3 fatty acids...Pravastatin was added during follow-up and weekly monitoring occurred until she underwent delivery 47 days after presentation... This case of severe hypertriglyceridemia in the third trimester illustrates need for investigation of acute treatment options to prevent life-threatening maternal and fetal outcomes. Peers have described treatments involving statins, heparin, insulin, and plasmapheresis, but limited data exists. Timing of diagnosis makes this encounter unique as treatment options become limited due to concern for teratogenicity."

Diabetes • Dyslipidemia • Endocrine Disorders • Gestational Diabetes • Gynecology • Heart Failure • Hematological Disorders • Hypertriglyceridemia • Pain • Pancreatitis • Severe Hypertriglyceridemia

NAVIGATING FAMILIAL HYPERCHOLESTEROLEMIA IN PREGNANCY - Cassandra Garraud (ACC 2025) - "Her LDL-C has been effectively managed with high intensity statin and ezetimibe which were discontinued during a prior pregnancy due to teratogenicity concerns...Recent cohort studies have not shown anomalies in those treated with hydrophilic statins and possible benefit in preeclampsia prevention, prompting the FDA to remove contraindication for use in selected patients in 2021.1 Other options for therapy during pregnancy include lifestyle, bile acid sequestrants, fenofibrates, omega-3 fatty acids, and mipomersen... Women of childbearing age with FH benefit from multidisciplinary care and individualized preconception counseling. Further studies with large clinical trials are needed to provide definitive safety data on statins."

Dyslipidemia • Familial Hypercholesterolemia • Genetic Disorders • Gynecology • Metabolic Disorders

CASE REPORT: XANTHOMA RESOLUTION WITH PCSK9 INHIBITION IN FAMILIAL HYPERCHOLESTEROLEMIA - IMPLICATIONS FOR PREVENTION - Liam Flanagan (ACC 2025) - "He endorsed severe and disfiguring xanthomatosis since childhood, first misdiagnosed as verrucae before being unsuccessfully treated with niacin, fenofibrates, and several plastic surgeries...Laboratory evaluation revealed total cholesterol of 455 mg/dL and triglycerides of 553 mg/dL.After being noted to meet Simon Broome, Dutch Lipid Network, and MED-PED criteria for diagnosis of FH, he was started on alirocumab... Presence of xanthoma should raise suspicion for FH and carries important implications for prevention of ASCVD."

Case report • Clinical • Atherosclerosis • Cardiomyopathy • Dyslipidemia • Familial Hypercholesterolemia • Genetic Disorders • Metabolic Disorders • Myocardial Infarction

Pharmacologic Approaches to Preventing Primary Sclerosing Cholangitis Recurrence After Liver Transplantation (clinicaltrials.gov) - P2 | N=80 | Not yet recruiting | Sponsor: Mayo Clinic

New P2 trial • Hepatology • Transplantation

Co-Milling of GFA Class III Drugs: Comparing the impact of Low and High Glass Transition Temperatures. (PubMed, Eur J Pharm Sci) - "Therefore, this work aims to present insights of co-milling fenofibrate and apremilast, two good glass formers with low and high glass transition temperatures (Tgs) respectively. This study demonstrated that co-milling with croscarmellose sodium is ideally suited to good glass formers with a high Tg. The melting point depression is thereby proposed as an easily accessible critical quality attribute to estimate likely dissolution performance of drugs in dry co-milled formulations."

Journal • CNS Disorders • Depression • Psychiatry

Severe HDL Cholesterol Reduction with Bempedoic Acid and Fenofibrate. (PubMed, N Engl J Med) - No abstract available

Journal

A rare clinical case of drug induced cholestasis due to Tribulus Terrestris supplementation (APASL 2025) - "At that time, ursodeoxycholic acid (UDCA) and Sertraline were prescribed, but no relief of symptoms was observed and he has discontinued the prescribed treatment...The use of the supplement was discontinued, and UDCA and Fenofibrate were prescribed. Two months later, there was complete normalisation of liver biochemical markers and itch resolution. It was advised to avoid supplements containing Tribulus Terrestris."

Clinical • Cholestasis • Cytomegalovirus Infection • Dermatology • Epstein-Barr Virus Infections • Fibrosis • Hepatology • Herpes Simplex • Immunology • Infectious Disease • Inflammation • Liver Failure • Pruritus

A Rare Case of Primary Biliary Cholangitis with Multiple Myeloma (APASL 2025) - "The above complaints started 2 years ago, last 9 months he used Ursodeoxycholic acid (UDCA) 1500mg/day, without any improvement...After confirming the diagnosis, treatment with Cholestyramine (16g/day) was initiated, which resulted in a reduction of pruritus, and Fenofibrate was added to UDCA therapy...Given that ALP is also present in bones, it was difficult to access objectively. Whether there is a causal relationship of PBC and multiple myeloma is unknown, because the insidious onset and chronic nature of these diseases make it impossible to evaluate the temporal relationship between the two conditions."

Clinical • Amyloidosis • Cholestasis • Dermatology • Fatigue • Fibrosis • Hematological Disorders • Hematological Malignancies • Hepatitis B • Hepatology • Immunology • Infectious Disease • Monoclonal Gammopathy • Multiple Myeloma • Oncology • Primary Biliary Cholangitis • Pruritus

Effectiveness and Safety of Fenofibrate in Treatment-Naive Patients With Primary Biliary Cholangitis (APASL 2025) - "Ursodeoxycholic acid (UDCA) is the only approved first-line treatment for PBC, but there are still 30%-40% of patients with poor response to UDCA and poor long-term prognosis. The initial combination of fenofibrate can effectively improve the biochemical response rate and has good long-term safety. Glycerophospholipid metabolic pathway might be the key in the add-on effects of fenofibrate."

Clinical • Cholestasis • Hepatology • Immunology • Metabolic Disorders • Primary Biliary Cholangitis

Self-dispersible eutectic mixtures with fenofibrate and ibuprofen: Processability and API particle size. (PubMed, Eur J Pharm Biopharm) - "The eutectics with the self-dispersing excipients disintegrated faster than more conventional eutectics containing polyethylene glycols that were prepared for comparison. The drug particle sizes were smaller for mixtures with higher recrystallization tendency and with drug concentrations close to the eutectic concentration."

Journal

High-efficiency antioxidant ROS-responsive thermosensitive hydrogel se-PEG-PPG encapsulated Fenofibrate for the treatment of corneal neovascularization. (PubMed, J Control Release) - "Finally, the combined anti-oxidation, anti-inflammation, and anti-angiogenesis therapeutic effect of Feno@Se-PEG-PPG (SePEP-Feno) eye drops were demonstrated in a corneal neovascularization animal model. In conclusion, the multifunctional delivery system provided a promising method for the treatment of CNV and various ROS-related ocular diseases."

Journal • Inflammation • Ophthalmology

Late-Stage Photoredox-Catalyzed Aryl C-H Bond Diazomethylation with Atomic Carbon Reagents. (PubMed, J Am Chem Soc) - "Subsequent construction of chiral centers with readily available starting materials proceeded using a broad range of well-known diazo and redox-active ester functionalizations. Moreover, the applicability of our novel atomic carbon reagent was tested in the automated parallel synthesis of a library of Fenofibrate derivatives."

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