Lipaglyn (saroglitazar) / Zydus Lifesci - LARVOL DELTA

Saroglitazar Ameliorates Pulmonary Fibrosis Progression in Mice by Suppressing NF-κB Activation and Attenuating Macrophage M1 Polarization. (PubMed, Medicina (Kaunas)) - "Current therapies (pirfenidone, nintedanib) exhibit modest efficacy and significant side effects, underscoring the need for novel strategies targeting early pathogenic drivers...Materials and Using a bleomycin (BLM)-induced murine pulmonary fibrosis model, we administered SGZ therapeutically... SGZ attenuates pulmonary fibrosis by suppressing macrophage-driven inflammation via NF-κB/NLRP3 inhibition and disrupting the macrophage-fibroblast crosstalk. These findings nominate SGZ as a promising candidate for preclinical optimization and future clinical evaluation in IPF."

Journal • Preclinical • Dyslipidemia • Fibrosis • Idiopathic Pulmonary Fibrosis • Immunology • Inflammation • Interstitial Lung Disease • Metabolic Disorders • Pneumonia • Pulmonary Disease • Respiratory Diseases • CD86 • IL1B • IL6 • NLRP3 • PPARA • TNFA

Saroglitazar Improves Hepatic Steatosis And Liver Enzymes In Women With PCOS And MASLD: Results Of Evidences VII Randomized Control Study (ENDO 2025) - P2 | "In patients with PCOS and MASLD, saroglitazar 4mg/day significantly improved hepatic steatosis, liver enzymes, and dyslipidemia."

Clinical • Late-breaking abstract • Dyslipidemia • Hepatology • Metabolic Disorders • Metabolic Dysfunction-Associated Steatotic Liver Disease • Polycystic Ovary Syndrome

Efficacy and safety of peroxisome proliferator-activated receptor agonists in primary biliary cholangitis: a systematic review and meta-analysis (BSG 2025) - "Ursodeoxycholic acid (UDCA) is the standard treatment, but up to 40% of patients are non-responders...This study evaluates the efficacy and safety of PPAR agonists for PBC management.Methods A systematic review and meta-analysis were performed, including eight randomized controlled trials (RCTs) evaluating selective PPAR agonists (fenofibrate, seladelpar) and multi-subtype PPAR agonists (bezafibrate, saroglitazar, elafibranor)...However, their effect on ALT, AST, and pruritus remains limited. Further studies with larger sample sizes and longer durations are required to fully explore the therapeutic potential of PPAR agonists in managing PBC."

Retrospective data • Review • Cholestasis • Dermatology • Fibrosis • Hepatology • Immunology • Inflammation • Liver Cirrhosis • Liver Failure • Primary Biliary Cholangitis • Pruritus

Saroglitazar Versus Simvastatin for Metabolic and Alcohol-Associated Liver Disease (MetALD). (PubMed, Cureus) - "Saroglitazar is more effective than simvastatin in reducing CAP, LSM, and HbA1c over six months. Further prospective, well-controlled randomized studies are warranted to validate these findings."

Journal • Dyslipidemia • Hepatology • Metabolic Disorders

Neuroprotective Potential of Saroglitazar Against Cerebral Ischemia/Reperfusion Injury in Sprague-Dawley Rats: Targeting HMGB-1/NF-κB Pathway. (PubMed, Assay Drug Dev Technol) - "It improved antioxidant levels and inhibited proinflammatory cytokines by suppressing the HMGB-1/NF-κB signaling pathway. These findings underscore the potential of saroglitazar in mitigating cerebral I/R injury."

Journal • Preclinical • Cardiovascular • CNS Disorders • Oncology • Reperfusion Injury • CAT • HMGB1 • IL6 • PPARA • TNFA

Evaluate PK & Safety of Saroglitazar in Subjects With Moderate Hepatic Impairment Due to Cholestatic Liver Disease (clinicaltrials.gov) - P1 | N=6 | Not yet recruiting | Sponsor: Zydus Therapeutics Inc. | Initiation date: May 2025 ➔ Aug 2025

Trial initiation date • Cholestasis • Fibrosis • Hepatology • Immunology

Repurposing Saroglitazar for neurodegenerative disorders: insight into molecular signalling pathways and neuroprotective modulations. (PubMed, Inflammopharmacology) - "The review explores the mechanistic interplay among these pathways and emphasizes the potential of Saroglitazar as a neuroprotective agent, highlighting the need for further studies to validate its clinical efficacy and disease-modifying capabilities in NDDs. All supporting data were obtained from peer-reviewed literature accessed via PubMed, Web of Science, and Scopus."

Journal • Review • Alzheimer's Disease • CNS Disorders • Diabetes • Epilepsy • Inflammation • Metabolic Disorders • Movement Disorders • Parkinson's Disease • Type 2 Diabetes Mellitus • Vascular Neurology • HMGB1 • TRPA1

Effect of saroglitazar on glycaemic parameters: A systematic review and meta-analysis of randomized controlled trials. (PubMed, Diabetes Obes Metab) - "Our results revealed that saroglitazar therapy improves glycaemic parameters through the reduction of fasting glucose, postprandial glucose and HbA1c."

Journal • Retrospective data • Review • Diabetes • Dyslipidemia • Hepatology • Metabolic Disorders • Metabolic Dysfunction-Associated Steatotic Liver Disease • Type 2 Diabetes Mellitus

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