bezafibrate / Generic mfg. - LARVOL DELTA

Comparative Efficacy and Safety of IBAT Inhibitors, Bezafibrate, Rifampin, and Naltrexone for Cholestatic Pruritus in Primary Biliary Cholangitis: A Systematic Review and Network Meta-Analysis (ACG 2026) - "Our network meta-analysis included 14 randomized controlled trials comprising 1,142 patients with primary biliary cholangitisâassociated cholestatic pruritus. The cohort was predominantly female (94.2%), with a mean age of 52.8 years and severe baseline pruritus (mean WI-NRS 7.2±1.1). Treatment allocation included Linerixibat (n=238), Maralixibat (n=96), Odevixibat (n=82), Bezafibrate (n=184), Rifampin (n=112), Naltrexone (n=98), and placebo (n=332)."

Retrospective data • Review • Dermatology • Hepatology • Immunology • Primary Biliary Cholangitis • Pruritus

Repositioning Bezafibrate in the Second-Line Treatment of Primary Biliary Cholangitis: A Systematic Review and Meta-Analysis of Biochemical Response, Lipid Effects, and Clinical Outcomes (ACG 2026) - "Introduction: Up to 40% of patients with primary biliary cholangitis (PBC) respond inadequately to ursodeoxycholic acid (UDCA) and require second-line therapy. PubMed, EMBASE, and the Cochrane Central Register were searched from inception through December 2025 for studies of bezafibrate in adults with UDCA-refractory PBC. Outcomes were stratified a priori by comparator: bezafibrate+UDCA versus inactive control and versus obeticholic acid (OCA). ALP normalization proportions were pooled using a random-effects model (REML; logit transformation)."

Clinical data • Retrospective data • Review • Hepatology • Immunology • Primary Biliary Cholangitis

Efficacy, symptoms, and safety of second-line PBC therapies: a network meta-analysis. (PubMed, Front Pharmacol) - "The therapeutic landscape for primary biliary cholangitis (PBC) with an inadequate response to ursodeoxycholic acid (UDCA) is rapidly evolving...We included randomized controlled trials (RCTs) with durations of 12-52 weeks evaluating PPAR agonists (bezafibrate, seladelpar, elafibranor, saroglitazar), farnesoid X receptor (FXR) agonists (obeticholic acid [OCA]), and IBAT inhibitors (linerixibat) against placebo/UDCA...While bezafibrate offers unparalleled potency for POISE criteria, seladelpar 10 mg provides the most advantageous clinical balance, achieving deep biochemical remission (ALP normalization) alongside profound pruritus relief and a favorable safety profile. https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=261351, identifier 420261351426."

Journal • Retrospective data • Review • Dermatology • Hepatology • Immunology • Primary Biliary Cholangitis • Pruritus

Austrian Society of Gastroenterology and Hepatology (ÖGGH) consensus on primary biliary cholangitis. (PubMed, Wien Klin Wochenschr) - "Approximately 60-70% of patients achieve clinical and biochemical remission with first-line treatment, i.e., ursodeoxycholic acid (UDCA). For patients who do not sufficiently respond to UDCA, the newly approved peroxisome proliferator-activated receptor (PPAR) agonists elafibranor and seladelpar, as well as bezafibrate (off-label use), should be used as a combination treatment with UDCA. In patients with decompensated cirrhosis, liver transplantation has been associated with good long-term outcomes, albeit disease recurrence occurs in up to 50% by 15 years."

Journal • Autoimmune Hepatitis • Fibrosis • Hepatology • Immunology • Inflammation • Liver Cirrhosis • Primary Biliary Cholangitis • Transplantation

Bezafibrate and Cholic Acid-Mediated Lipid Reduction Improves the Cryotolerance of Vitrified In Vivo-Derived Porcine Embryos. (PubMed, Animals (Basel)) - "Bezafibrate combined with cholic acid reduced embryonic lipid contents and improved cryotolerance, providing a practical strategy for porcine embryo cryopreservation."

Journal • Preclinical

Generation of a glycogen storage disease mouse model with fatty liver and its treatment by PPAR-α agonist bezafibrate. (PubMed, Front Pharmacol) - "Finally, bezafibrate, a proliferator-activated receptor α (PPAR-α) agonist, enhanced autophagic activity and attenuated inflammatory responses, fat deposition, and glycogen storage in G6PC KO mice. This study successfully generated a fatty liver model using G6PC KO adult mice and demonstrated that pharmacological activation of PPAR-α may have therapeutic potential in adult G6PC KO mice."

Journal • Preclinical • Inflammation • Metabolic Disorders

Clinical and Nutritional Management of Gallbladder Mucocele in Dogs: A Four-Case Series. (PubMed, Animals (Basel)) - "The pharmacological protocol included ursodeoxycholic acid, silymarin, S-adenosyl-L-methionine, bezafibrate, and omega-3 fatty acids, with doses adjusted according to body weight. Clinical and ultrasonographic outcomes varied among cases, with partial or complete resolution observed over different follow-up periods. These findings suggest that clinical management combined with individualized nutritional protocols may be a potential approach for asymptomatic dogs with gallbladder mucocele, particularly when surgery is not feasible, and could inform future investigations."

Journal • Dyslipidemia • Endocrine Disorders • Genetic Disorders • Hepatology • Obesity

Iodothyronine deiodinases: biological roles and clinical implications. (PubMed, Endocr J) - "Additionally, resistance to thyroid hormone β can be associated with bezafibrate-induced consumptive hypothyroidism through increased hepatic D3 expression. This review summarizes current knowledge on the biological properties and clinical implications of DIOs and highlights their significant role in the regulation of thyroid hormone action."

Journal • Endocrine Disorders • Nephrology • Renal Disease • Targeted Protein Degradation

Primary Biliary Cholangitis. (PubMed, Clin Liver Dis) - "Ursodeoxycholic acid (UDCA) remains first-line, with on treatment biochemical response predicting long-term prognosis...Long-term care includes surveillance for treatment response, development of fibrosis, portal hypertension, bone disease, and hepatocellular carcinoma. Liver transplantation (LT) remains definitive for end-stage or refractory disease, with post-LT UDCA recommended to reduce its recurrence."

Journal • Review • Cardiovascular • Cholestasis • Dermatology • Fatigue • Fibrosis • Hepatocellular Cancer • Hepatology • Hypertension • Immunology • Oncology • Portal Hypertension • Primary Biliary Cholangitis • Pruritus • Solid Tumor • Transplantation

Early real-world experiences of elafibranor in primary biliary cholangitis (PBC) (BSG 2026) - "Methods The effectiveness, safety and tolerability of Ela was evaluated in patients (pts) initiating therapy in combination with ursodeoxycholic acid (UDCA), obeticholic acid (OCA), and amongst those switching from bezafibrate (BZF). 24 pts who switched from BZF reported pruritus at baseline, and 12 reported improvement on Ela. Conclusions Treatment with Ela in real-world PBC settings is associated with early biochemical and symptomatic improvement, including in pts previously treated with BZF, and in combination with OCA."

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

From papules to plasma: Eruptive xanthomas revealing hypertriglyceridemia and diabetes in a teenager (BAD 2026) - "He received urgent treatment for hypertriglyceridemia and diabetes (metformin, degludec insulin, bezafibrate and semaglutide injection). This case highlights the importance of recognizing eruptive xanthomas as a cutaneous marker of severe metabolic disease. Early dermatological diagnosis enabled timely intervention, which is important to prevent serious complications such as acute pancreatitis."

Diabetes • Dyslipidemia • Hypertriglyceridemia • Metabolic Disorders • Pancreatitis • Severe Hypertriglyceridemia • Type 1 Diabetes Mellitus • Type 2 Diabetes Mellitus • CD1a • CD68

Autoimmune Hepatitis Induced by Immune Checkpoint Inhibitors in Adults: A Systematic Review. (PubMed, Diagnostics (Basel)) - "Mycophenolate mofetil was the main second-line agent for steroid-refractory disease, with response reported in 9/10 treated patients. Other therapies, including tacrolimus, azathioprine, ursodeoxycholic acid, bezafibrate, tocilizumab, basiliximab, infliximab, budesonide, and double plasma molecular adsorption system with or without plasma exchange, were described only in small numbers or isolated cases...However, the strength of evidence is limited by uncontrolled designs, variable terminology, inconsistent diagnostic work-up, and non-standardised outcome definitions. Future studies should separate classical AIH from AIH-like immune-mediated hepatitis, use uniform criteria for severity and response, and report treatment denominators clearly, especially for rechallenge and steroid-refractory disease."

Checkpoint inhibition • Journal • Review • Autoimmune Hepatitis • Hepatology • Immunology • Inflammation • Liver Failure • Oncology

Bezafibrate-associated rhabdomyolysis in a patient with diabetic kidney disease: A case report and successful transition to tafolecimab. (PubMed, Medicine (Baltimore)) - "Bezafibrate may result in severe rhabdomyolysis in diabetic CKD, particularly when combined with nifedipine (a CYP3A4 inhibitor) and reduced renal clearance. Tafolecimab's nonrenal metabolism and low myotoxicity make it a safe and efficient substitute."

Journal • Cardiovascular • Chronic Kidney Disease • Diabetes • Diabetic Nephropathy • Dyslipidemia • Fatigue • Hypertension • Metabolic Disorders • Musculoskeletal Pain • Nephrology • Pain • Renal Disease

Misclassification of UDCA treatment response in patients with primary biliary cholangitis (PBC) in the real-world setting. (PubMed, Ann Hepatol) - "Clinical judgement and Paris II classification differ in 20% of patients. Higher baseline ALP levels and kinetics may lead to misclassification. This may result in withholding of second line treatments in these patients."

Journal • Real-world evidence • Hepatology • Immunology • Primary Biliary Cholangitis

Discovery of novel chalcone-benzenesulfonamide conjugates as PPARγ agonists: Design, synthesis, and biological evaluation. (PubMed, Eur J Med Chem) - "Selected compounds 7g, 7l, and 7o were further examined to determine their PPARα/δ agonistic activities compared to fenofibrate, and bezafibrate, respectively. In vivo studies revealed that compound 7o at a dose 72 mg/kg possessed antidiabetic activity better than that of pioglitazone. Furthermore, molecular docking studies and molecular dynamic simulations were carried out for the newly synthesized compounds to study their predicted binding modes and energies in the PPARγ/α binding sites."

Journal • PPARA

New and emerging treatments for PBC-related pruritus. (PubMed, Drugs Context) - "Traditional management relies on a stepwise approach, with bile acid sequestrants as first-line therapy and rifampin, naltrexone, or sertraline for refractory cases, but these agents often provide incomplete relief and are limited by tolerability and drug-drug interaction concerns. Advances in understanding the mechanisms of cholestatic itch have expanded treatment options to include peroxisome proliferator-activated receptor (PPAR) agonists, such as seladelpar, elafibranor and bezafibrate that uniquely offer both antipruritic effects and improvement in biochemical markers of disease activity...By addressing both the biological and experiential dimensions of pruritus, this comprehensive framework enables clinicians to improve symptom control and enhance overall quality of life for patients living with PBC. Emerging therapies and a mechanism-informed treatment approach offer promise for more effective, individualized care in this challenging clinical context."

Journal • Review • CNS Disorders • Dermatology • Fatigue • Hepatology • Immunology • Mood Disorders • Primary Biliary Cholangitis • Pruritus • Psychiatry • Sleep Disorder

Second-line treatment with novel PPAR agonists in patients with primary biliary cholangitis: real-world experience from a european tertiary care center (EASL 2026) - "Background and aims: A relevant proportion of patients with primary biliary cholangitis (PBC) require second-line therapy due to insufficient response or intolerance to ursodeoxycholic acid (UDCA). After withdrawal of conditional approval for obeticholic acid (OCA) in the EU, alternative treatment strategies became necessary...Among 27 patients previously treated with OCA, 17 (63%), including four on triple therapy (UDCA+OCA+bezafibrate), were switched to PPAR agonists (ELA n=13, SELA n=4), while one-third initiated second-line therapy de novo... In this real-world cohort, elafibranor and seladelpar were associated with rapid biochemical improvement and good tolerability. Transition from OCA to PPAR agonists was feasible, including in patients with advanced liver disease, supporting their role as effective second-line options in PBC."

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

Management of patients with primary biliary cholangitis in the post-obeticholic era: real-world effectiveness data on elafibranor and seladelpar from the ColHai registry (EASL 2026) - "Background and aims: Obeticholic acid (OCA) withdrawal and approval of new drugs have represented a major shift in the management of patients with PBC... Patients were mostly female (91%) with a median age of 60 years (51.4-67.9), median ALP 1.5 x ULN (1.1- 2.1), GGT 1.9 x ULN (0.9-5), AST 1.03 x ULN (0.8-1.4), ALT 0.8 x ULN (0.5-1.3), and bilirubin of 0.6xULN (0.4- 0.9), 20% had cirrhosis, 20% were on ursodeoxycholic acid (UDCA) monotherapy, 39% on OCA+UDCA, 13% on bezafibrate (BZF)+UDCA, 26% on OCA+UDCA+BZF, and 2% were UDCA intolerant... In this first real-world experience from the ColHai registry, ELA and SEL demonstrated clinically relevant reductions in ALP and early biochemical response in patients with PBC, even in those previously exposed to second-line therapies."

Clinical • Real-world • Real-world effectiveness • Real-world evidence • Fibrosis • Hepatology • Immunology • Primary Biliary Cholangitis • Pruritus

From Correlation to Causality: Identifying Potential Environmental Drivers of Pathogenic Antibiotic-Resistant Bacteria in River Water Using Causal Machine Learning. (PubMed, Environ Pollut) - "Both Spearman correlation and explainable machine learning identified numerous potentially important factors, notably non-antibiotic pharmaceuticals such as carbamazepine and bezafibrate...Under predefined assumptions, this approach estimated potential causal effects for dissolved oxygen, the nitrate-to-ammonium ratio, specific antibiotics (roxithromycin, azithromycin), and non-antibiotic compounds (acenaphthene, 2-chloroanthracene)...Functional profiles suggested potential stress-adaptation mechanisms related to signal transduction and metabolic regulation pathways. By shifting from associative prediction to causal inference, this causal machine learning-guided framework provides a robust analytical basis for identifying environmental drivers and informing targeted management of PARB risks in aquatic ecosystems."

Journal

Bezafibrate for Primary Biliary Cholangitis: a Number Needed to Treat Analysis. (PubMed, JHEP Rep) - "The overall projected efficacy of continued BZF in terms of the NNT to prevent solid clinical endpoints was strong, also in case people had a relatively favourable ALP level (1.0-1.5xULN) after one year of UDCA. These findings highlight the potential clinical benefit of off-label BZF in UDCA-treated people without ALP normalisation."

Journal • Fibrosis • Hepatology • Immunology • Primary Biliary Cholangitis • Transplantation

Real-world efficacy and safety of fibrates in patients with primary biliary cholangitis (EASL 2026) - "Background and aims: Fibric acid derivatives are used off-label as second-line therapy in patients with primary biliary cholangitis (PBC) with an inadequate response to ursodeoxycholic acid (UDCA) and are recommended by EASL for the treatment of cholestatic pruritus...Due to lack of efficacy or tolerability, fenofibrate treatment was switched to bezafibrate in 10 patients, with recurrent intolerance observed in half of them...Owing to insufficient response, elafibranor was initiated recently in two patients, while linerixibat was introduced in two patients with refractory pruritus... In real-world clinical practice, more than one-third of patients with PBC require second-line therapy. Fibrates provide significant biochemical improvement in vast majority of these patients; however, adverse events occur in a substantial proportion, leading to the discontinuation of therapy. This finding highlights the need for novel therapeutic alternatives with better tolerability,..."

Clinical • Real-world • Real-world effectiveness • Real-world evidence • Dyslipidemia • Fibrosis • Hepatology • Immunology • Liver Cirrhosis • Myositis • Primary Biliary Cholangitis • Pruritus

Early UK experience with elafibranor in primary biliary cholangitis: a multicentre pharmacist-led review (EASL 2026) - "It was introduced recently as a second line option for patients with an inadequate response, or intolerance to, ursodeoxycholic acid (UDCA)...34 (75.6%) patients had trialled obeticholic acid and/or bezafibrate before starting elafibranor... Patients on elafibranor demonstrated a positive initial biochemical response to therapy. Adverse effects led to discontinuation in a number of patients. Additional real-world data is needed to better understand treatment response."

Clinical • Review • Fibrosis • Hepatology • Immunology • Liver Cirrhosis • Primary Biliary Cholangitis • Pruritus

Early real-world experiences of Elafibranor in primary biliary cholangitis (PBC) (EASL 2026) - " The effectiveness, safety and tolerability of Ela was evaluated in patients (pts) initiating therapy in combination with ursodeoxycholic acid (UDCA), obeticholic acid (OCA), and amongst those switching from bezafibrate (BZF). Treatment with Ela in real-world PBC settings is associated with early biochemical and symptomatic improvement, including in pts previously treated with BZF, and in combination with OCA."

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

Elafibranor tolerability and response in patients with primary biliary cholangitis previously treated with bezafibrate: a real-world single-centre experience (EASL 2026) - "Background and aims: Patients with primary biliary cholangitis (PBC) with inadequate biochemical response or intolerance to ursodeoxycholic acid (UDCA) may require second-line therapy, including bezafibrate (BZF), used off- licence in PBC. In this cohort, AEs with ELA were common regardless of prior BZF exposure but often did not lead to treatment discontinuation. While prior BZF intolerance accounted for half of ELA discontinuations, BZF intolerance did not uniformly preclude treatment with ELA. However, biochemical response to ELA appeared lower in patients previously non-responsive to BZF compared with BZF-naïve patients."

Clinical • Real-world • Real-world evidence • Hepatology • Immunology • Primary Biliary Cholangitis • Pruritus

Biochemical response to Elafibranor in primary biliary cholangitis (PBC): impact of prior second-line therapy exposure (EASL 2026) - "Ursodeoxycholic acid plus elafibranor combination therapy represents the most effective and consistent treatment option, showing highest mean ALP reduction and response rate without paradoxical worsening. Switching from bezafibrate to elafibranor may benefit selected patients with relatively higher baseline ALP, but requires careful monitoring. Transitions from obeticholic acid warrants caution given paradoxical responses in some patients."

Clinical • Hepatology • Immunology • Primary Biliary Cholangitis