bezafibrate / Generic mfg. - LARVOL DELTA

Long-term real-world outcomes of obeticholic acid treatment for primary biliary cholangitis: insights from a pharmacy-led single-centre study (EASL 2025) - "Background and Aims: First line therapy for the management of Primary Biliary Cholangitis (PBC) is with ursodeoxycholic acid (UDCA). The results confirm the effectiveness and safety of OCA, with the response rate mirroring that which was reported in the POISE trial. Access to second-line treatment with OCA is widely available across our region, aided by our pharmacy-led regional MDM and virtual clinic that allow patients to remain with their local clinicians, ensuring continuity of care. Overall, virtual monitoring of response after starting OCA can be challenging as this is dependent on referring clinicians sending timely follow-up data."

Clinical • Real-world • Real-world evidence • Dermatology • Fibrosis • Hepatology • Immunology • Liver Failure • Primary Biliary Cholangitis • Pruritus

Mitochondrial dynamics and auto(mito)phagy are altered in experimental models of primary biliary cholangitis, contributing to disease pathogenesis (EASL 2025) - "In line, the exposure of cholangiocytes to auto(mito)phagy inhibitors (3-MA and bafilomycin) induced cell death, particularly in miR-506 cells, while the activation of autophagy with Dactolisib (BEZ235) significantly reduced the toxic bile acid-induced apoptosis. Importantly, the treatment of H69 miR-506 cholangiocytes with the anti-cholestatic drugs ursodeoxycholic acid (UDCA), bezafibrate (BZF) or obeticholic acid (OCA), improved mitochondrial functionality and energy metabolism, reducing PDC-E2 overexpression... Our data suggest that PBC cholangiocytes are characterized by disturbances in mitochondrial integrity and auto(mito)phagy, leading to the accumulation of dysfunctional mitochondria and aberrant presentation of mitochondrial antigens. Of note, different anti-cholestatic drugs modulate these mitochondrial disturbances, providing insights into their mechanism of therapeutic action. Besides, targeting mitochondrial dynamics and mitophagy presents a promising novel..."

Cholestasis • Hepatology • Immunology • Inflammation • Metabolic Disorders • Primary Biliary Cholangitis • MIR506

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

Is the POISE really valid as a surrogate endpoint for patients with PBC treated with UDCA and PPAR agonist? – a retrospective validation study from the real-world data in Japan (EASL 2025) - "Background and Aims: In clinical trials evaluating PPAR agonists for primary biliary cholangitis (PBC) with an incomplete response to ursodeoxycholic acid (UDCA), the POISE criteria are commonly used as the primary endpoint...This study aimed to retrospectively evaluate whether the POISE criteria are predictive of long-term outcomes in patients treated with UDCA and bezafibrate (BZF) based on the real-world data from a nationwide survey of PBC in Japan... These findings demonstrate that achieving the POISE criteria is significantly associated with improved long-term prognosis in patients receiving UDCA and BZF, strongly supporting the use of the POISE in clinical trials evaluating UDCA and PPAR agonist combination therapy."

Real-world • Real-world evidence • Retrospective data • Autoimmune Hepatitis • CNS Disorders • Fibrosis • Gastroenterology • Gastrointestinal Disorder • Hepatic Encephalopathy • Hepatitis B • Hepatitis C • Hepatocellular Cancer • Hepatology • Infectious Disease • Oncology • Primary Biliary Cholangitis • Solid Tumor

Pruritus is not a clinical feature of early-onset primary sclerosing cholangitis during late teenage years (EASL 2025) - "Ursodeoxycholic acid (UDCA) was used in 71 (66.4%). Current pruritus was noted in 19 (17.8%) of the cohort: 2 (1.9%) were on rifampicin for pruritus, 1 (0.9%) was on a clinical trial for pruritus, no patients were on bezafibrate... In our cohort of patients with early-onset PSC, pruritus was not a significant symptom in patients in their late teenage years, but was more common during early adulthood. Pruritus was associated with biochemical markers of biliary damage, suggesting it develops in more advanced stages of cholangiopathy. Further work is required to fully characterize this subgroup of patients, and to discover therapeutic options to ideally prevent progressive cholangiopathy."

Clinical • Dermatology • Hepatology • Immunology • Pruritus

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

Impact of non-classical phenotypes of primary biliary cholangitis on treatment response and long-term prognosis. Results from the ColHai registry (EASL 2025) - " This multicenter retrospective study included 505 PBC patients who received second-line treatment (2LT) with bezafibrate and/or obeticholic acid... Non-classical PBC phenotypes have worse long-term prognosis and lower response to treatment. In patients with PBC and elevated transaminase levels (G2), AST and platelet counts are the main factors associated with prognosis. Further studies are needed to determine the impact of AST normalization on the prognosis of these patients."

Cholestasis • Dermatology • Hepatology • Immunology • Inflammation • Primary Biliary Cholangitis • Pruritus

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

Evaluation of the response criteria following second-line treatment with bezafibrate in patients with primary biliary cholangitis (EASL 2025) - "Background and Aims: Multiple criteria exist to assess the response to ursodeoxycholic acid in primary biliary cholangitis (PBC); however, their efficacy in evaluating the response to second-line (2L) therapy remains undetermined... Most patients were female (89%), with a median age of 56 years (IQR: 49-64), 45 (11%) had cirrhosis (LC) and in 15.5% obeticholic acid was added as a third line... The Paris II has high sensitivity, so patients who respond rarely experience events. In non-responders according to Paris II, those with a Globe-score ≤0.35 have an excellent EFS; therefore, it may not be necessary to add a third-line treatment. Poise criteria had low accuracy to evaluate response after BZF."

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

Engineered Genetic Circuits Activated by Bezafibrate Improve ESC-Based TAA Cancer Vaccine Efficacy and PD-L1 Nanobody Therapy. (PubMed, Adv Sci (Weinh)) - "ESC-based and intratumoral delivery of the synthetic gene circuits and cargo genes, particularly PD-L1 nb, significantly inhibit tumor growth. PD-L1 nb effectively blocks PD-L1 expression both in vitro and in vivo, as confirmed by using a mutant PD-L1 nb sequence."

IO biomarker • Journal • Embryonal Tumor • Oncology • CD8 • PPARG

Fixed-dose combination of obeticholic acid and bezafibrate vs bezafibrate monotherapy in patients with primary biliary cholangitis: 12-week results from 2 phase 2 trials with real-world outcomes from the GLOBAL PBC study group (EASL 2025) - No abstract available

Clinical • Monotherapy • P2 data • Real-world • Real-world evidence • Hepatology • Immunology • Primary Biliary Cholangitis

Decline of Persistent Jaundice in a Patient With Autoimmune Hepatitis and Vanishing Bile Duct Syndrome Treated With Elobixibat for Constipation. (PubMed, Cureus) - "Standard treatment, including methylprednisolone pulse therapy, prednisolone, azathioprine, bezafibrate, and ursodeoxycholic acid, failed to resolve jaundice. The observed efficacy of elobixibat suggests that it may be a valuable adjunctive therapy for severe cholestasis. Further research is warranted to clarify its therapeutic potential and underlying mechanisms in similar cases."

Journal • Autoimmune Hepatitis • Cholestasis • Constipation • Gastroenterology • Gastrointestinal Disorder • Hepatology • Immunology • Inflammation • Primary Biliary Cholangitis

EFFECTS OF PEMAFIBRATE VERSUS BEZAFIBRATE ON LIVER AND VASCULAR ENDOTHELIAL FUNCTION IN PATIENTS WITH CORONARY ARTERY DISEASE AND METABOLIC DYSFUNCTION-ASSOCIATED STEATOTIC LIVER DISEASE - Akihiro Nakamura (ACC 2025) - "Compared to bezafibrate, pemafibrate is more effective in reducing ALT and γGT levels while having similar beneficial effects on insulin resistance and endothelial function in CAD patients with MASLD."

Clinical • Cardiovascular • Coronary Artery Disease • Dyslipidemia • Hepatology • Hypertriglyceridemia • Metabolic Disorders • Metabolic Dysfunction-Associated Steatotic Liver Disease

Alterations in PD-L1 succinylation shape anti-tumor immune responses in melanoma. (PubMed, Nat Genet) - "Preclinically, bezafibrate, a hyperlipidemia drug, upregulated CPT1A and synergized with CTLA-4 monoclonal antibody to inhibit tumor growth. Clinically, higher PD-L1 and lower CPT1A levels in tumors correlated with better anti-PD-1 therapy responses, suggesting potential biomarkers for prediction of treatment efficacy."

IO biomarker • Journal • Dyslipidemia • Melanoma • Oncology • Solid Tumor • CPT1A • CTLA4 • PD-L1

STaRT: Lipoprotein(a) Levels in Patients With Atherosclerotic Cardiovascular Diseases in Russia (clinicaltrials.gov) - P=N/A | N=2382 | Not yet recruiting | Sponsor: Novartis Pharmaceuticals

New trial • Atherosclerosis • Cardiovascular

Unveiling transformation processes of cardiovascular pharmaceuticals in wastewater based on nontarget screening. (PubMed, Water Res) - "To fill this knowledge gap, nontarget screening combined with batch experiments were employed to reveal the transformation of five cardiovascular pharmaceuticals (atenolol, metoprolol, propranolol, bezafibrate and candesartan) in aerobic activated sludge. Furthermore, the predicted results suggested that about 30 % TPs have higher persistence and bioaccumulation than parent compounds while about 40 % TPs harbored higher toxicity than parent compounds of cardiovascular pharmaceuticals. Collectively, this study unveiled the fate and transformation pathways of five cardiovascular pharmaceuticals and summarized the specific transformation patterns for them in aerobic activated sludge, which is theoretically useful to effectively remove pharmaceuticals from wastewater."

Journal • Cardiovascular

PHARMACOKINETIC AND PHARMACODYNAMIC INTERACTION OF OBETICHOLIC ACID AND BEZAFIBRATE IN HEALTHY VOLUNTEERS (DDW 2025) - No abstract available

Clinical • PK/PD data • Hepatology • Immunology

COMBINED EFFECT OF OBETICHOLIC ACID AND BEZAFIBRATE IN PATIENTS WITH PRIMARY BILIARY CHOLANGITIS AND INADEQUATE RESPONSE OR INTOLERANCE TO URSODEOXYCHOLIC ACID: 6-MONTH RESULTS FROM A PHASE 2 TRIAL (DDW 2025) - No abstract available

Clinical • P2 data • Hepatology • Immunology • Primary Biliary Cholangitis

Hepatic antifibrotic effects of Bezafibrate in vitro and in vivo models of liver fibrosis. (PubMed, Food Chem Toxicol) - "In addition, BZF promoted a protective effect on tetrachloride-induced liver fibrosis in mice, through antifibrotic actions. These findings suggest that BZF may have a potential antifibrotic effect, which could emerge as a possible new therapy for the treatment of liver fibrosis."

Journal • Preclinical • Fibrosis • Hepatology • Immunology • Inflammation • Liver Cirrhosis

Therapeutic Approach to Epilepsy in Patients with Mitochondrial Diseases. (PubMed, Yonsei Med J) - "Emerging treatments include gene therapy, mitochondrial transplantation, and antioxidants such as EPI-743, which protect mitochondrial integrity and improve neurological function. Additionally, therapies that promote mitochondrial biogenesis, such as bezafibrate and epicatechin, are being explored for their potential to enhance mitochondrial proliferation and energy production...Patient-derived induced pluripotent stem cells can model specific mitochondrial dysfunctions in vitro, allowing for the testing of various treatments tailored to individual genetic and biochemical profiles. The future of mitochondrial medicine is promising, with the development of more targeted and personalized therapeutic strategies offering hope for improved management and prognosis of mitochondrial epilepsy."

Journal • Review • CNS Disorders • Epilepsy • Gene Therapies • Genetic Disorders • Metabolic Disorders • Transplantation

TRIM21 Promotes Tumor Growth and Gemcitabine Resistance in Pancreatic Cancer by Inhibiting EPHX1-Mediated Arachidonic Acid Metabolism. (PubMed, Adv Sci (Weinh)) - "Given the targeting potential, this work screens Bezafibrate to block the interaction between TRIM21 and EPHX1 and validates its sensitizing effect. In summary, TRIM21 promotes tumour growth and gemcitabine resistance in PC by inhibiting EPHX1-mediated arachidonic acid metabolism. This provides a novel and promising target for clinical treatment of PC."

Journal • Hepatology • Oncology • Pancreatic Cancer • Solid Tumor • Targeted Protein Degradation • EPHX1 • TRIM21

Wastewater surveillance for chronic disease drugs in wastewater treatment plants: Mass load, removal, and sewage epidemiology. (PubMed, J Hazard Mater) - "Based on the WBE method, the prevalence of diabetes, hypertension, and dyslipidemia estimated by gliclazide, glipizide, valsartan, and bezafibrate in this study was consistent with those obtained via cross-sectional survey. The results formulated the contamination characteristics of chronic disease drugs in China and assessed the accuracy of chronic disease drugs used for disease prevalence estimation."

Journal • Cardiovascular • Diabetes • Dyslipidemia • Hypertension • Metabolic Disorders

Bezafibrate Treatment Alters Cerebral Energy Metabolism in Female Rats Undergoing Nicotine and Oral Contraceptive Withdrawal (ISC 2025) - "Bezafibrate could potentially mitigate effects of N+OC on the brain and rescue cerebral energy metabolism. Future studies are needed to evaluate it's impact on stroke outcomes."

Preclinical • Cardiovascular • CNS Disorders • Vascular Neurology

Microbial metabolic enzymes, pathways and microbial hosts for co-metabolic degradation of organic micropollutants in wastewater. (PubMed, Water Res) - "Our findings reveal that oxidoreductases, particularly cytochrome P450s and peroxidases, are crucial for recalcitrant OMPs containing halogen groups (-Cl, -F) like fluoxetine and diuron. Hydrolases, including amidases, are instrumental in targeting amide-containing (-CONH₂) OMPs such as bezafibrate and carbamazepine. Regarding microbial metabolism involved in OMP co-metabolic degradation, we found that amino acid metabolism is crucial for degrading amine-containing (-NH₂) OMPs like metoprolol and citalopram. Lipid metabolism, particularly for fatty acids, contributes to the degradation of carboxylic acid (-COOH) containing OMPs such as bezafibrate and naproxen. Finally, with Actinobacteria, Bacteroidetes, and Proteobacteria emerging as primary contributors to these functionalities, we established connections between OMP functional groups, degradation enzymes, metabolic pathways, and microbial phyla. Our findings provide generalized insights into structure-function..."

Journal • Metabolic Disorders

Long-Term Stabilized and Highly Soluble Bezafibrate-Gliclazide Co-Amorphous Binary System. (PubMed, AAPS PharmSciTech) - "The structural stability of the samples was verified by XRD and DSC, showing long-term stability retention of the amorphous state for more than eight years. The enhanced solubility and stability of the co-amorphous systems make them potential formulations for regulating lipids and lowering glycemia."

Journal • Cardiovascular • Diabetes • Dyslipidemia • Hypertension • Metabolic Disorders