Lipaglyn (saroglitazar) / Zydus Lifesci - LARVOL DELTA

Advancing care in primary biliary cholangitis: emerging insights and novel therapies. (PubMed, Expert Opin Pharmacother) - "Ursodeoxycholic acid (UDCA) has been the mainstay of therapy for over 40 years...Notably, seladelpar and elafibranor, two selective agonists of peroxisome proliferator-activated receptors, achieved high rates of biochemical response and good tolerability, leading to their recent approval for second-line treatment of PBC...- Personalized treatment approaches for PBC are both feasible and essential to improve biochemical response, extend transplant-free survival and alleviate symptom burden. Well-tolerated novel therapies are poised to reshape the treatment landscape in the near future."

Journal • Review • Cholestasis • Dermatology • Fatigue • Fibrosis • Hepatology • Immunology • Primary Biliary Cholangitis • Pruritus • Transplantation

Peroxisome Proliferator-Activated Receptor (PPAR) Agonists for Patients With Primary Biliary Cholangitis With Inadequate Response to Ursodeoxycholic Acid (UDCA): A Systematic Review and Meta-Analysis of Randomized Controlled Trials. (PubMed, JGH Open) - "However, further studies with larger sample sizes, longer follow-up durations, and a focus on patient-centered outcomes are necessary. Additionally, exploring combination therapies and mechanistic insights will help us fully realize the therapeutic potential of PPAR agonists in PBC."

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

Emerging role of peroxisome proliferator-activated receptor agonists in the treatment of cholestatic liver disease. (PubMed, Curr Opin Gastroenterol) - "This review highlights the evolving role of PPAR agonists as second-line agents for PBC and investigational treatments for PSC."

Journal • Review • Cholestasis • Dermatology • Hepatology • Immunology • Primary Biliary Cholangitis • Pruritus

EPICS-III: Saroglitazar Magnesium for Treatment of Primary Biliary Cholangitis (clinicaltrials.gov) - P2/3 | N=196 | Completed | Sponsor: Zydus Therapeutics Inc. | Active, not recruiting ➔ Completed

Trial completion • Hepatology • Immunology • Primary Biliary Cholangitis

Efficacy and Safety of Novel Oral Anti-Cholestatic Agents for Primary Biliary Cholangitis: Meta-Analyses and Systematic Review. (PubMed, Pharmaceuticals (Basel)) - "While ursodeoxycholic acid (UDCA) is the first-line therapy, approximately 40% of patients have incomplete responses, necessitating alternative treatments...Novel agents included seladelpar, fenofibrate, saroglitazar, bezafibrate, elafibranor, and budesonide...However, study heterogeneity and limited long-term data restrict direct comparisons. Larger standardized trials with extended follow-up are needed to confirm long-term efficacy and safety."

Journal • Review • Cholestasis • Dermatology • Hepatology • Immunology • Primary Biliary Cholangitis • Pruritus

LEADS - a comprehensive human liver-on-a-chip for non-alcoholic steatohepatitis (NASH) drug testing. (PubMed, Lab Chip) - "Notably, treatment with saroglitazar, pioglitazone, cenicriviroc (CVC), obeticholic acid (OCA) and resmetirom produced responses similar to those observed in clinical trials. Taken together, our LEADS model is the first model developed using patient-derived hepatic stem cells which recapitulated all key features used for comprehensive drug testing, with results matching to clinical responses."

Journal • Fibrosis • Hepatocellular Cancer • Hepatology • Immunology • Liver Failure • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis • Oncology • Solid Tumor

PPAR-mediated reduction of lipid accumulation in hepatocytes involves the autophagy-lysosome-mitochondrion axis. (PubMed, Ann Med) - "HepG2 cells were treated with oleate/palmitate (O/P) to induce lipid accumulation and exposed to the PPARα agonist fenofibric acid, the γ agonist pioglitazone, the δ agonist seladelpar, or the dual α/γ agonist saroglitazar. All PPAR agonists were able to promote the clearance of lipids in cells loaded with long-chain fatty acids. The key role of acid hydrolysis to generate fatty acids, which can be then catabolized in the mitochondria, and the ability of the PPAR system to sustain each phase of this clearing process were elucidated."

Journal • PPARA • TFEB

COMPARING THE SAFTEY AND EFFICACY OF SECOND LINE THERAPIES FOR PBC WITH OBETHICOLIC ACID: A NETWORK META-ANALYSIS (DDW 2025) - "Introduction: Ursodeoxycholic acid (UDCA), the gold standard therapy for Primary Biliary Cholangitis (PBC) slows disease progression by improving biochemical markers of liver function, particularly alkaline phosphatase (ALP) levels...The second-line therapy, obeticholic acid (OCA), provides an alternative but is associated with significant adverse effects, including pruritus, a debilitating symptom of PBC...Comparison was done between different doses of OCA (5 mg, 10 mg, 50 mg), Elafibranor (80 mg), Seladelpar (10 mg) and Saroglitazar (2 mg and 4 mg) against placebo... Elafibranor demonstrates superior outcomes in achieving biochemical response and improvement in pruritus symptoms when compared to OCA. Additionally, OCA worsened pruritus in PBC patients. Our findings highlight the need for additional randomized controlled trials (RCTs) investigating Elafibranor as effective second line therapy and a potential first line monotherapy for PBC."

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

Saroglitazar Magnesium 4 mg in the Treatment of NAFLD in Women With PCOS (EVIDENCES VII) (clinicaltrials.gov) - P2 | N=60 | Terminated | Sponsor: Zydus Therapeutics Inc. | Completed ➔ Terminated; Sponsor Decision

Trial termination • Hepatology • Metabolic Dysfunction-Associated Steatotic Liver Disease • Polycystic Ovary Syndrome

The PPAR agonists Saroglitazar and Rosiglitazone provide hepatoprotection after APAP-induced liver injury in E2f1-/- mice (EASL 2025) - No abstract available

Preclinical • Hepatology • Liver Failure • E2F1

A single centre, comparative study of Saroglitazar combined with vitamin E versus Saroglitazar alone in managing steatotic liver disease and/or metabolic dysfunction among liver transplant recipients (EASL 2025) - "Saroglitazar, when used independently of Vitamin E, has shown effectiveness in mitigating metabolic risk factors associated with steatotic liver disease in liver transplant recipients. Further studies including MR-PDFF are needed to assess reduction in hepatic fat content with Saroglitazar."

Clinical • Diabetes • Dyslipidemia • Hepatology • Liver Failure • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis • Metabolic Dysfunction-Associated Steatotic Liver Disease • Transplantation

The PPAR agonists Saroglitazar and Rosiglitazone provide hepatoprotection after APAP-induced liver injury in E2f1-/- mice (EASL 2025) - "E2F1 deficiency increases hepatic vulnerability by impairing activation of the PPAR- CREB axis, dysregulation of lipid metabolism and increased oxidative stress. However, activation of this axis by PPAR agonists before and even after APAP-induced hepatotoxicity confers protection that may be valuable as a potential treatment in the future."

Preclinical • Hepatology • Liver Failure • Metabolic Disorders • E2F1 • E2F2 • PPARA

Overcoming barriers to unlock the therapeutic potential of saroglitazar for the management of metabolic dysfunction-associated steatotic liver disease. (PubMed, Clin Nutr) - "However, its clinical adoption and widespread utilization are hindered by several challenges, ranging from limited clinical data to regulatory and awareness barriers. This article explores the obstacles to saroglitazar acceptance, evaluates its therapeutic potential, and discusses strategies to integrate it into mainstream MASLD management."

Journal • Hepatology • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis • Metabolic Dysfunction-Associated Steatotic Liver Disease

Saroglitazar vs. vitamin E in metabolic-dysfunction associated fatty liver disease related compensated chronic liver disease- a cohort study (EASL 2025) - "Saroglitazar is comparable to vitamin E in improving metabolic and clinical outcomes, as well as non-invasive surrogates of liver fibrosis and portal hypertension in patients with MAFLD-related cirrhosis. Patients with hypothyroidism, lower ALT, higher BMI, and higher fasting blood sugar are at a higher risk of disease progression and require targeted pharmacotherapy."

Cardiovascular • Endocrine Disorders • Fibrosis • Hepatology • Immunology • Liver Cirrhosis • Metabolic Disorders • Metabolic Dysfunction-Associated Steatotic Liver Disease • Portal Hypertension • PNPLA3

Extended Evaluation of Saroglitazar in Metabolic Dysfunction-Associated Steatotic Liver Disease: Efficacy and Safety Insights (APASL 2025) - "These findings highlight the potential of Saroglitazar as a key long-term therapy for managing MASLD/MASH. Saroglitazar's demonstrated effectiveness in improving liver health markers supports the need for further investigation to enhance treatment outcomes. Table and Figure:Figure 1.Table 1.: Change in parameters after 52 weeks therapy"

Clinical • Fibrosis • Hepatology • Immunology • Inflammation • Liver Cirrhosis • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis • Metabolic Dysfunction-Associated Steatotic Liver Disease

Efficacy of Saroglitazar in treatment of Metabolic associated fatty liver disease (MAFLD (APASL 2025) - "In patients with MAFLD, a 12 weeks therapy with saroglitazar can improve transaminases and CAP values irrespective of weight reduction. But weight reduction along with saroglitazar are needed to improve LSM value"

Clinical • Fibrosis • Hepatology • Immunology • Metabolic Dysfunction-Associated Steatotic Liver Disease

Real-World Assessment of Saroglitazar for improving FAST Score and Fibroscan Parameters (LSM and CAP) in Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD): An Open-Label, Prospective Study (APASL 2025) - "Saroglitazar shows significant benefits in managing MASLD in the Indian population over 24 weeks, improving liver biomarkers, metabolic parameters, and imaging outcomes, and reducing MASLD severity as indicated by a lower FAST score. Further studies with a larger sample size and extended duration are recommended to validate and strengthen these findings, providing a more comprehensive understanding of Saroglitazar's long-term efficacy and safety in MASLD management. Table and Figure:Figure 1.Fig 1: Changes in Liver Stiffness Measurement Figure 2.Fig 2: Changes in Steatosis"

Clinical • Real-world • Real-world evidence • Fibrosis • Hepatology • Immunology • Metabolic Disorders • Metabolic Dysfunction-Associated Steatotic Liver Disease

Real-World Evaluation of Therapy with Saroglitazar in MASLD-Associated Compensated Advanced Chronic Liver Disease (cACLD) : An Open-Label, Single-Center Study (APASL 2025) - "This study demonstrates that Saroglitazar (Bilypsa®) significantly improves liver stiffness and reduces steatosis in MASLD-associated cACLD, diagnosed via Agile 4 Score and FibroScan imaging. Over 144 weeks, consistent improvements suggest that Saroglitazar may halt or reverse disease progression. The treatment was well-tolerated, with no unexpected adverse events."

Clinical • HEOR • Metastases • Real-world • Real-world evidence • CNS Disorders • Dermatology • Fibrosis • Hepatology • Immunology • Liver Failure • Metabolic Dysfunction-Associated Steatotic Liver Disease • PPARA

In Silico Analysis of Saroglitazar and Ferulic Acid Binding to Human Ketohexokinase: Implications for Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD). (PubMed, Cureus) - "The study shows that saroglitazar and ferulic acid are potent KHK inhibitors for metabolic diseases, including MASLD, suggesting multi-target treatments."

Journal • Fibrosis • Hepatitis C • Hepatocellular Cancer • Hepatology • Immunology • Liver Cirrhosis • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis • Metabolic Dysfunction-Associated Steatotic Liver Disease • Oncology • Solid Tumor

Hepatic Impairment with Cirrhosis Due to Cholestatic Liver Disease (clinicaltrials.gov) - P1 | N=30 | Recruiting | Sponsor: Zydus Therapeutics Inc. | Trial completion date: Nov 2024 ➔ Jun 2025 | Trial primary completion date: Nov 2024 ➔ Jun 2025

Trial completion date • Trial primary completion date • Cholestasis • Fibrosis • Hepatology • Immunology • AFP

Saroglitazar Magnesium 4 Mg in the Treatment of NAFLD in Women with PCOS (EVIDENCES VII) (clinicaltrials.gov) - P2 | N=60 | Completed | Sponsor: Zydus Therapeutics Inc. | Active, not recruiting ➔ Completed

Trial completion • Hepatology • Metabolic Dysfunction-Associated Steatotic Liver Disease • Polycystic Ovary Syndrome

Evaluating Pharmacokinetic and Safety of Saroglitazar Magnesium 1 Mg When Dosed on Alternate Days in Subjects Having Moderate Hepatic Impairment with Cirrhosis Due to Cholestatic Liver Disease (clinicaltrials.gov) - P1 | N=6 | Not yet recruiting | Sponsor: Zydus Therapeutics Inc.

New P1 trial • Cholestasis • Fibrosis • Hepatology • Immunology

Metabolic Flexibility Predicts Response to Saroglitazar in Liver Transplant Recipients With Metabolic Dysfunction-Associated Steatotic Liver Disease. (PubMed, Transplantation) - No abstract available

Journal • Hepatology • Metabolic Disorders • Metabolic Dysfunction-Associated Steatotic Liver Disease • Transplantation

Liver Organoids From Hepatocytes of Healthy Humans and Non-alcoholic Fatty Liver Disease (NAFLD) Patients Display Multilineage Architecture and can be Used to Develop an In Vitro Model of Steatohepatitis. (PubMed, J Clin Exp Hepatol) - "Metformin and saroglitazar were used to validate the liver organoid model of steatohepatitis. The in vitro models developed in our lab employing HLOs and HLONAFLD display all three key hallmarks of NAFLD: steatosis, inflammation, and fibrosis without the necessity for coculture with other nonparenchymal cells. The implementation of the HLONAFLD-based model is also expected to provide a more realistic assessment of test substances to develop therapeutics for NAFLD."

Journal • Preclinical • Fibrosis • Hepatology • Immunology • Inflammation • Metabolic Dysfunction-Associated Steatotic Liver Disease • CD68

PPAR agonists for the treatment of cholestatic liver diseases: Over a decade of clinical progress. (PubMed, Hepatol Commun) - "First-line therapy for PBC is ursodeoxycholic acid, although up to 40% of treated individuals are incomplete responders, and there is no effective therapy for PSC, highlighting the need for better therapeutic options in these diseases. Several PPAR agonists have been investigated as second-line therapy for people living with PBC, including the recent accelerated United States Food and Drug Administration approval of elafibranor and seladelpar. This review evaluates available data on the efficacy and safety of the five PPAR agonists investigated for the treatment of cholestasis and associated pruritus in PBC and PSC, namely fenofibrate, bezafibrate, saroglitazar, elafibranor, and seladelpar."

Journal • Review • Cholestasis • Dermatology • Fibrosis • Hepatology • Immunology • Liver Cirrhosis • Liver Failure • Primary Biliary Cholangitis • Pruritus • PPARA