fenofibrate nanoparticle formulation / Generic mfg. - LARVOL DELTA

PPARα activation attenuates neobavaisoflavone-induced hepatotoxicity by modulating metabolic disorder and oxidative stress. (PubMed, Phytomedicine) - "Collectively, these findings uncover a novel mechanism whereby Neo disrupts lipid homeostasis and induces oxidative stress via PPARα inhibition, and highlight PPARα activation as a potential strategy to mitigate Neo-associated hepatotoxicity, offering valuable insights for its safer therapeutic application."

Journal • Metabolic Disorders • Oncology • PPARA

Fenofibrate in Patients With Cervical Intraepithelial Neoplasia and Invasive Cervical Carcinoma (clinicaltrials.gov) - P1 | N=24 | Recruiting | Sponsor: Lindsay Ferguson, MD | Suspended ➔ Recruiting

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

The effect of fenofibrate on progression of diabetic retinopathy according to background statin use and retinopathy grading (EASD 2025) - P4 | "We randomised participants to receive 145-mg nanoparticle fenofibrate tablets or placebo. Fenofibrate provides consistent benefit to patients with non-referable diabetic retinopathy regardless of background statin use or retinopathy grading."

Diabetes • Metabolic Disorders

Beyond lipids: fenofibrate in diabetic retinopathy and nephropathy. (PubMed, Trends Pharmacol Sci) - "In this review, we integrate mechanistic insights with clinical outcomes, critically evaluate landmark trials, and explore emerging molecular targets of fenofibrate. We highlight the multifunctional actions of fenofibrate and propose strategies to advance its clinical utility in diabetic microvascular complications."

Journal • Review • Diabetes • Diabetic Nephropathy • Diabetic Retinopathy • Dyslipidemia • Metabolic Disorders • Nephrology • Renal Disease • Retinal Disorders

Fenofibrate in Patients With Cervical Intraepithelial Neoplasia and Invasive Cervical Carcinoma (clinicaltrials.gov) - P1 | N=24 | Suspended | Sponsor: Lindsay Ferguson, MD | Recruiting ➔ Suspended

Trial suspension • Cervical Cancer • Gynecology • Oncology • Solid Tumor

Treatment algorithm for acute pancreatitis caused by hypertriglyceridemia and lipid apheresis (Euroanaesthesia 2025) - "Patient's medical history, revealed that he used matofin, lustral, beneday and lipanthyl. In his family there was a history of coronary artery disease related death (father) and hypertriglyceridemia/hypercholesterolemia."

Cardiovascular • Coronary Artery Disease • Diabetes • Dyslipidemia • Hypertension • Hypertriglyceridemia • Infectious Disease • Metabolic Disorders • Pancreatitis • Septic Shock • Type 2 Diabetes Mellitus

Effect of Fenofibrate on Markers of Gut Barrier Function in Dogs With Naturally Occurring Diabetes Mellitus. (PubMed, J Vet Intern Med) - "Fenofibrate treatment was not associated with a decrease in markers of systemic or pancreatic inflammation. In diabetic dogs, short-term fenofibrate treatment appears to be safe, and the improvement in gut barrier function and lipid profiles might lead to long-term benefits, such as reduction in pancreatitis risk and frequency of signs of gastrointestinal disease."

Biomarker • Journal • Diabetes • Gastroenterology • Gastrointestinal Disorder • Inflammation • Metabolic Disorders • Pancreatitis

Comparative pharmacokinetics and bioequivalence of 145-mg fenofibrate formulations in healthy Korean participants. (PubMed, Naunyn Schmiedebergs Arch Pharmacol) - "This study aimed to compare the pharmacokinetics (PKs) and establish bioequivalence of two 145-mg fenofibrate formulations, AD-104 (test) and TRICOR® (reference). Clinical Research Information Service No. is as follows: KCT0009332 (April 12, 2024)."

Journal • PK/PD data • Dyslipidemia • Metabolic Disorders

Variable pore size of mesoporous silica in improving physical stability and oral bioavailability of insoluble drugs. (PubMed, Int J Pharm) - "Fenofibrate (Fen) was loaded into MSNs, commercial mesoporous silica excipients, and a traditional solid dispersion excipient (PVP K-30) using the solvent evaporation method. Pharmacokinetic studies in rats showed that the bioavailability of self-made Fen capsules was 1.31 times higher than that of commercial capsules (Lipanthyl®). In summary, these results highlighted the potential of MSNs to improve the stability and oral absorption of poorly soluble drugs."

Journal

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 Role in Breast Cancer Patients (clinicaltrials.gov) - P=N/A | N=50 | Completed | Sponsor: Damanhour University | Recruiting ➔ Completed | Trial completion date: Feb 2024 ➔ Aug 2024 | Trial primary completion date: Jan 2024 ➔ Aug 2024

Trial completion • Trial completion date • Trial primary completion date • Breast Cancer • Oncology • Solid Tumor • NEFL

Tailored Sugar-Mediated Porous Particle Structures for Improved Dispersion of Drug Nanoparticles in Spray-Freeze-Drying. (PubMed, Langmuir) - "We fabricated porous particles incorporating sugars (mannitol, sucrose, or dextran) and fenofibrate nanoparticles (FNPs) by using spray-freeze-drying (SFD)...Dextran formed a highly porous network irrespective of the presence of FNPs, whereas mannitol tended to alter the particle attributes upon FNP inclusion. In conclusion, SFD particles derived from dextran and mannitol might help to increase FNP dispersibility by increasing the formation of porous architectures."

Journal

Cardiovascular, Pulmonary, and Integrative Functional Phenotypes in COVID-19 Survivors - Effect of Fenofibrate (clinicaltrials.gov) - P=N/A | N=12 | Completed | Sponsor: University of Pennsylvania | Recruiting ➔ Completed | N=40 ➔ 12

Enrollment change • Trial completion • Cardiovascular • Infectious Disease • Novel Coronavirus Disease

Designing starch-based fenofibrate formulations using the melting method. (PubMed, Int J Biol Macromol) - "However, FNF is a poorly water-soluble drug, and the dosage of commercial products is relatively high at 160 mg in a Lipidil® tablet. In particular, it was challenging to secure stability when starch#1500 was excluded from the SD2 formulation. In conclusion, the dissolution percentage of FNF in the SD2 formulation was improved owing to the weak binding force between FNF and the excipients, stability was secured, and favorable results are expected in future animal experiments."

Journal • Dyslipidemia

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

CARE OF PATIENTS WITH VITAMIN D DEFICIENCY AND MYASTHENIA GRAVIS (ICE-EDEC 2024) - "The Endocrine nurse plays a crucial role in the multidisciplinary team, and should have good understanding the complexity of this neuromuscular disorder and bone health so as to provide best care for the patient to improve patient's quality of life."

Clinical • CNS Disorders • Diabetes • Immunology • Inflammation • Metabolic Disorders • Myasthenia Gravis • Novel Coronavirus Disease • Orthopedics • Pneumonia

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

Role of PPAR-allopregnanolone signaling in behavioral and inflammatory gut-brain axis communications. (PubMed, Biol Psychiatry) - "Both PPAR-α and allopregnanolone are abundantly expressed in the colon and they exert potent anti-inflammatory actions by blocking toll-like receptor-4-NFkB pathway in peripheral immune cells, neurons, and glia. The perspective that PPAR-α regulation in the colon by gut microbiota or metabolites influences central allopregnanolone content after trafficking to the brain -thereby serving as a mediator of gut-brain axis communications- is examined."

IO biomarker • Journal • Review • CNS Disorders • Depression • Dyslipidemia • Genetic Disorders • Immune Modulation • Inflammation • Metabolic Disorders • Mood Disorders • Obesity • Post-traumatic Stress Disorder • Psychiatry • PPARA • TLR4

Regulating T-cell metabolic reprogramming and blocking PD-1 co-promote personalized postoperative autologous nanovaccines. (PubMed, Biomaterials) - "In particular, combination therapy with nanovaccines, fenofibrate, and PD-1 antibody effectively inhibited the progression of recurrent melanoma and prolonged the survival time. Our work highlights the critical role of the T-cell metabolic reprogramming and PD-1 blocking in autologous nanovaccines, offering a novel strategy for strengthening the function of CTLs."

Journal • Melanoma • Oncology • Solid Tumor

Fenofibrate Role in Breast Cancer Patients (clinicaltrials.gov) - P=N/A | N=50 | Recruiting | Sponsor: Damanhour University

New trial • Breast Cancer • Oncology • Solid Tumor • NEFL

Insight into the mechanism behind oral bioavailability-enhancement by nanosuspensions through combined dissolution/permeation studies. (PubMed, Eur J Pharm Sci) - "Permeation rates were found significantly increased for both nanosuspensions when compared to the raw APIs, indicating a direct implication that formulation strategies are needed, be it stabilization of supersaturation by precipitation inhibition and/or dissolution rate enhancement. This study indicates that in vitro dissolution/permeation studies can be employed to better understand the oral absorption enhancement of nanocrystal formulations."

Journal

Usefulness of the BioGIT system in screening for differences in early exposure in the fasted state on an a priori basis. (PubMed, Int J Pharm) - "BioGIT experiments were performed with four APIs: Compound Α (tablet, three dose levels), Compound E (capsule PiC1, capsule PiC2 and tablet), fenofibrate (Lipidil® capsule and Lipidil 145 ONE® tablet) and Compound F (HP-β-CD aqueous solution and tablet)...The log-transformed ratios of mean BioGIT AUC values for two doses and/or two formulations estimated in this study and in a recent study for two diclofenac potassium products (Cataflam® tablet and Voltfast® sachet, same dose) vs. the corresponding log-transformed ratios of mean plasma AUC values (n=7 pairs of ratios), were included in a previously established correlation between log-transformed ratios of mean BioGIT AUC values and log-transformed ratios of plasma AUC values (n=9 pairs of ratios).The correlation between log-transformed plasma AUC ratios vs. log-transformed BioGIT AUC ratios was confirmed (n=16 pairs of ratios, R=0.90). Compared with the previously established correlation the..."

Journal

A Randomized Trial of Lipid Metabolism Modulation With Fenofibrate for Acute Coronavirus Disease 2019 (AHA 2022) - P2 | "These agents have been shown to inhibit SARS-CoV-2 replication in cell culture systems in vitro. We randomly assigned 701 participants with COVID-19 within 14 days of symptom onset to 145 mg of fenofibrate (nanocrystal formulation with dose adjustment for renal function or dose-equivalent preparations of micronized fenofibrate or fenofibric acid) vs. placebo for 10 days, in a double-blinded fashion. Among patients with COVID-19, fenofibrate has no significant effect on various clinically relevant outcomes."

Clinical • Diabetes • Genetic Disorders • Infectious Disease • Metabolic Disorders • Novel Coronavirus Disease • Obesity • Respiratory Diseases • PPARA

A randomized clinical trial of lipid metabolism modulation with fenofibrate for acute coronavirus disease 2019. (PubMed, Nat Metab) - P2 | "Here, we randomly assigned inpatients and outpatients with COVID-19 within 14 d of symptom onset to 145 mg of oral fenofibrate nanocrystal formulation versus placebo for 10 d, in a double-blinded fashion. There were 61 (17%) adverse events in the placebo arm compared with 46 (13%) in the fenofibrate arm, with slightly higher incidence of gastrointestinal side effects in the fenofibrate group. Overall, among patients with COVID-19, fenofibrate has no significant effect on various clinically relevant outcomes ( NCT04517396 )."

Clinical • Journal • Diabetes • Gastrointestinal Disorder • Infectious Disease • Metabolic Disorders • Novel Coronavirus Disease • Respiratory Diseases • PPARA