Lipaglyn (saroglitazar) / Zydus Lifesci - LARVOL DELTA

Effectiveness and safety of saroglitazar in managing dyslipidaemia and liver enzymes in patients with type 2 diabetes, MASLD, and Stage 3 chronic kidney disease: A 12-month observational study. (PubMed, Diabetes Obes Metab) - No abstract available

Journal • Observational data • Chronic Kidney Disease • Diabetes • Dyslipidemia • Hepatology • Metabolic Disorders • Metabolic Dysfunction-Associated Steatotic Liver Disease • Nephrology • Renal Disease • Type 2 Diabetes Mellitus

Effect of Addition of Saroglitazar to Lifestyle Modifications in Patients with Nonalcoholic Fatty Liver Disease: A Prospective Observational Study. (PubMed, Ann Afr Med) - "The addition of Saroglitazar to lifestyle modifications showed a beneficial effect in improving NAFLD-related parameters over 12 weeks compared to lifestyle modifications alone."

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

Saroglitazar at the Crossroads of Metabolic and Neurodegenerative Disease: A Critical Review of the Hepato-Neuro Axis and Translational Horizons. (PubMed, Neurochem Res) - "While preclinical evidence is promising, robust human studies are essential to validate SGZ's potential in mitigating NAFLD-associated cognitive impairment. This article aims to advance a novel conceptual synthesis and call for integrative strategies targeting the hepato-neuro axis."

Journal • Review • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Dyslipidemia • Hepatology • Inflammation • Metabolic Disorders • Metabolic Dysfunction-Associated Steatotic Liver Disease • Vascular Neurology

Use of Oral Semaglutide in the Management of MASLD in Failures of Standard Therapy (ACG 2025) - "Oral semaglutide was given along with standard treatment of lifestyle modification, saroglitazar/pioglitazone, lipid-lowering drugs (statins-wherever lipid parameters were elevated) and medications for other comorbidities as indicated and patients were followed up for 8 months After 8 months, mean weight loss was 13.14% and BMI reduction was 3.9 kg/m² (both p=0.01). After 8 months, mean weight loss was 13.14% and BMI reduction was 3.9 kg/m² (both p=0.01). Body fat mass significantly declined (31.8 kg to 24.3 kg; p< 0.01), while skeletal muscle mass remained stable. AST levels fell from 60.9 to 26.3 U/L (p< 0.01) and ALT from 67.9 to 30.3 U/L (p=0.001)."

Diabetes • Dyslipidemia • Fibrosis • Hepatocellular Cancer • Hepatology • Hypertriglyceridemia • Immunology • Liver Cirrhosis • Metabolic Disorders • Metabolic Dysfunction-Associated Steatotic Liver Disease • Obesity • Solid Tumor • Type 2 Diabetes Mellitus

SARO.20.002: Saroglitazar Magnesium for the Treatment of Nonalcoholic Steatohepatitis With Fibrosis (clinicaltrials.gov) - P2 | N=189 | Completed | Sponsor: Zydus Therapeutics Inc. | Active, not recruiting ➔ Completed

Trial completion • Fibrosis • Hepatology • Immunology • Metabolic Dysfunction-Associated Steatohepatitis

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

Enrollment open • Trial completion date • Trial primary completion date • Cholestasis • Fibrosis • Hepatology • Immunology

Impact of Saroglitazar on Liver Stiffness Measurements in Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) With Compensated Cirrhosis: A Single-Arm Study. (PubMed, Cureus) - "Using pragmatic thresholds, changes in liver stiffness over 24 weeks did not differ significantly. Larger prospective studies with longer follow-up are warranted."

Journal • Dermatology • Diabetes • Fibrosis • Hepatology • Immunology • Metabolic Disorders • Metabolic Dysfunction-Associated Steatotic Liver Disease • Obesity • Pruritus

EPICS-V: Long-Term Study to Evaluate the Safety and Efficacy in Participants With Primary Biliary Cholangitis of Saroglitazar Magnesium-V on Clinical Outcomes (clinicaltrials.gov) - P3 | N=386 | Not yet recruiting | Sponsor: Zydus Therapeutics Inc.

New P3 trial • Hepatology • Immunology • Primary Biliary Cholangitis

COMPARATIVE EFFECTIVENESS OF PEROXISOME PROLIFERATOR-ACTIVATED RECEPTOR AGONISTS AS SECOND-LINE THERAPIES FOR PRIMARY BILIARY CHOLANGITIS: A SYSTEMATIC REVIEW AND NETWORK META-ANALYSIS (AASLD 2025) - "For patients with inadequate response or intolerance to ursodeoxycholic acid (UDCA), peroxisome proliferator-activated receptor (PPAR) agonists have emerged as promising second-line therapies...A sensitivity analysis for the primary outcome including obeticholic acid (OCA) was also performed. Eight RCTs comprising 727 participants and four PPAR agonists (bezafibrate, seladelpar, elafibranor and saroglitazar) were included... Add-on PPAR agonists are effective second-line therapies in PBC, bridging an important treatment gap. Treatment ranking variability may reflect heterogeneity in patient populations and drug mechanisms. In the absence of head-to-head trials, NMA provides valuable comparative insights; however, long-term safety data and patient-centered outcomes remain priorities for future studies."

HEOR • Retrospective data • Review • Cholestasis • Fibrosis • Hepatology • Immunology • Liver Cirrhosis • Liver Failure • Primary Biliary Cholangitis

META-ANALYSIS OF THE EFFICACY AND SAFETY OF NOVEL ORAL ANTI-CHOLESTATIC AGENTS FOR PRIMARY BILIARY CHOLANGITIS (UEGW 2025) - "While ursodeoxycholic acid (UDCA) is the first-line therapy, about 40% of patients have incomplete responses, necessitating alternative treatments...Investigated therapies included seladelpar, fenofibrate, saroglitazar, bezafibrate, elafibranor, and budesonide... Novel oral anti-cholestatic agents show promise in managing PBC patients with suboptimal UDCA responses, demonstrating significant improvements in biochemical markers and some symptomatic relief. However, study heterogeneity, small sample sizes, and limited follow-up durations restrict direct comparisons and generalizability. Further research is needed to confirm long-term efficacy and safety."

Retrospective data • Cholestasis • Dermatology • Fatigue • Hepatology • Immunology • Primary Biliary Cholangitis • Pruritus

SAROGLITAZAR TREATMENT REDUCED SEVERITY OF MASLD PHENOTYPES BY LIPIDOMIC-BASED TEST OWLIVER IN SUBJECTS WITH MASLD IN A 16-WEEK PHASE 2 TRIAL (AASLD 2025) - P2 | "Most patients treated with Saroglitazar 4 mg regressed to less severe MASLD phenotypes after 16-weeks treatment. Evaluation of the effects of Saroglitazar on MASLD/MASH using OWLiver test provides further evidence supporting the beneficial effects of the intervention, especially the 4mg dose."

Clinical • P2 data • Cardiovascular • Dyslipidemia • Fibrosis • Immunology • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis • Metabolic Dysfunction-Associated Steatotic Liver Disease

EFFICACY OF SAROGLITAZAR IN REAL WORLD PATIENTS WITH METABOLIC DYSFUNCTION ASSOCIATED STEATOTIC LIVER DISEASE WITH COMPENSATED ADVANCED CHRONIC LIVER DISEASE (AASLD 2025) - "Saroglitazar is effective in improving biochemical parameters of metabolic syndrome and LSM value in patients with cACLD. Patients with cACLD tolerate saroglitazar well without progression to decompensation."

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

IMMUNOMODULATION OF CYTO/CHEMOKINES AND T CELL ACTIVATION BY PPAR AGONISTS IN PBC: A COMPARATIVE ANALYSIS (AASLD 2025) - " Primary human hepatocytes isolated from residual surgical specimens were plated then treated with GCDCA (100 uM) ± individual fibrates/PPAR agonists: bezafibrate, fenofibrate, seladelpar, elafibranor, or saroglitazar for 24 hrs. Our findings reveal heterogeneity among PPAR agonists' ability to modulate bile acid-induced cyto/chemokine secretion by hepatocytes, and to reduce peripheral T cell activation. Among the PPAR agonists tested, seladelpar was the most effective in vitro, while fenofibrate reduced reactivity of T cells from PBC patients ex vivo. Further studies comparing immunomodulatory properties of PPAR agonists in PBC patients receiving treatment are warranted."

Immunomodulating • Immunology • Primary Biliary Cholangitis • CCL2 • CCL20 • CD4 • CD69 • CXCL8 • IL17A

SAROGLITAZAR IMPROVES HEPATIC STEATOSIS IN WOMEN WITH PCOS AND MASLD: RESULTS: OF EVIDENCES VII RANDOMIZED CONTROL STUDY (AASLD 2025) - P2 | "In patients with PCOS and MASLD, saroglitazar 4mg/day significantly improved hepatic steatosis and dyslipidemia."

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

Evaluation of Effectiveness and Tolerability of Saroglitazar in Metabolic Disease Patients of India: A Retrospective, Observational, Electronic Medical Record-Based Real-World Evidence Study. (PubMed, Cureus) - "No significant adverse events and renal impairment were observed. Conclusion Saroglitazar demonstrated significant improvements in glycemic control, lipid profile, and liver enzymes with a favorable safety profile in Indian patients with metabolic diseases."

HEOR • Journal • Real-world evidence • Retrospective data • Cardiovascular • Diabetes • Dyslipidemia • Hepatology • Hypertension • Metabolic Disorders • Metabolic Dysfunction-Associated Steatotic Liver Disease • Renal Disease • Type 2 Diabetes Mellitus

Cardioprotective Effects of SAR Through Attenuating Cardiac-Specific Markers, Inflammatory Markers, Oxidative Stress, and Anxiety in Rats Challenged with 5-Fluorouracil. (PubMed, J Xenobiot) - "This study aimed to evaluate the cardioprotective effects of two different doses of saroglitazar (SAR) in an animal model of cardiotoxicity induced by 5-fluorouracil (5-FU). Thirty-five rats were randomly allocated into five groups: the negative control, which received distilled water; the 5-FU (150 mg/kg as I.P.) group; the N-acetylcysteine (100 mg/kg) group; and the SAR (0.5 and 5 mg/kg) groups...These findings render SAR a promising candidate to be tested in clinical trials. Further studies are warranted with other cardiotoxicants to confirm these findings."

Journal • Preclinical • Cardiovascular • Inflammation • Psychiatry • IL1B • TNFA

MASLD Pharmacotherapy: Current Standards, Emerging Treatments, and Practical Guidance for Indian Physicians. (PubMed, J Assoc Physicians India) - "Metabolic dysfunction-associated steatotic liver disease (MASLD), formerly known as nonalcoholic fatty liver disease (NAFLD), has become a significant public health issue worldwide, with a pronounced impact in India due to the escalating rates of obesity and type 2 diabetes mellitus (T2DM) driving its prevalence...Several pharmacological agents have shown encouraging results in clinical trials, including thyroid hormone receptor-β agonist resmetirom, glucagon-like peptide-1 receptor agonists (GLP-1RAs) like semaglutide, peroxisome proliferator-activated receptor (PPAR) agonists such as pioglitazone and saroglitazar, sodium-glucose cotransporter-2 inhibitors (SGLT2i), and vitamin E. Furthermore, emerging therapies, including the dual incretin agonist tirzepatide and fibroblast growth factor (FGF) analogs, hold the potential to transform future treatment strategies...Given India's vast and diverse patient population, ensuring access to cost-effective therapies remains..."

Journal • Review • Cardiovascular • Diabetes • Fibrosis • Genetic Disorders • Hepatology • Immunology • Liver Cancer • Liver Cirrhosis • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis • Metabolic Dysfunction-Associated Steatotic Liver Disease • Obesity • Oncology • Solid Tumor • Type 2 Diabetes Mellitus

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 pro-inflammatory 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

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

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

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

Prospects of Late-Stage Development Agents in the Treatment of Metabolic Dysfunction-Associated Steatohepatitis (MASH). (PubMed, Clin Mol Hepatol) - "Recently, the U.S. Food and Drug Administration approved resmetirom, a selective thyroid hormone receptor-beta agonist, as the first treatment for patients with MASH. In India, the Drug Controller General of India approved saroglitazar, a dual peroxisome proliferator-activated receptor (PPAR) α/γ agonist, for the treatment of MASLD. Currently, we have various drug classes, including liver-specific therapies, in Phase 3 development with even more agents earlier in the pipeline. This review will discuss prospective therapies in later stages of development such as thyroid hormone receptor-beta agonists, PPAR agonists, glucagon-like peptide-1 receptor agonists, fibroblast growth factor 21 agonists, and fatty acid synthase inhibitors."

Journal • Review • Diabetes • Fibrosis • Genetic Disorders • Hepatocellular Cancer • Hepatology • Immunology • Liver Failure • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis • Metabolic Dysfunction-Associated Steatotic Liver Disease • Obesity • Oncology • Solid Tumor • Type 2 Diabetes Mellitus • FASN • FGF21

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

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