Lipaglyn (saroglitazar) / Zydus Lifesci - LARVOL DELTA

PPARs in Diabetic Retinopathy: Pathophysiological Insights and Emerging Pharmacological Strategies. (PubMed, Can J Diabetes) - "PPARα agonists such as fenofibrate and pemafibrate exert antioxidant, anti-inflammatory, and vasoprotective effects, while PPARγ agonists (e.g., pioglitazone) improve insulin sensitivity and attenuate oxidative damage, albeit with safety concerns such as fluid retention. Dual PPARα/γ agonists, including saroglitazar, provide synergistic benefits by reducing leukostasis, neovascularization, and inflammatory signaling, whereas PPARβ/δ is gaining attention for its role in retinal energy metabolism...Targeting both PPAR and non-PPAR pathways may enable preventive and multimodal management of DR. Future efforts should prioritize early-stage interventions, combination strategies, and innovative ocular drug delivery systems to overcome current therapeutic limitations and shift from reactive to preventive care."

Journal • Review • Diabetes • Diabetic Retinopathy • Dyslipidemia • Inflammation • Metabolic Disorders • Preventive care • Retinal Disorders • AKR1B1 • PPARA

A Comparative Evaluation of the Effects of Saroglitazar and Pioglitazone on Hepatic and Metabolic Parameters in Type 2 Diabetes Mellitus With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD). (PubMed, Cureus) - "Both treatments were well tolerated, with no major adverse events reported. Conclusions Saroglitazar demonstrated superior benefits over pioglitazone in improving hepatic steatosis and fibrosis, glycemic control, and BMI in patients with T2DM and MASLD, while maintaining a favorable safety profile."

Journal • Diabetes • Fibrosis • Hepatology • Immunology • Metabolic Disorders • Metabolic Dysfunction-Associated Steatotic Liver Disease • Type 2 Diabetes Mellitus • PPARA

Effect of Saroglitazar on Glycemic Status: A Meta-analysis. (PubMed, Cureus) - "Our meta-analysis has found that saroglitazar causes a significant reduction in the HbA1c, FBS, and PPBS levels in patients treated for diabetic dyslipidemia."

Journal • Retrospective data • Review • Diabetes • Dyslipidemia • Metabolic Disorders • Type 2 Diabetes Mellitus

Role of Saroglitazar in Improving Transient Elastography Parameters in Significant and Advanced Metabolic Dysfunction-Associated Steatohepatitis. (PubMed, Cureus) - "Saroglitazar 4 mg daily was associated with significant improvements in liver stiffness, steatosis, transaminases, and lipid parameters over 52 weeks. These findings support its hepatometabolic potential across both early and advanced MASLD/MASH stages in real-world practice."

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

Targeting TXNIP With Saroglitazar Mitigates Acute Hepatic Injury in Rats Challenged With Thioacetamide: A Multistep Computational and Experimental Approach. (PubMed, Arch Pharm (Weinheim)) - "In conclusion, SAR demonstrates potential as a preventive treatment for inflammatory liver disorders. To render these preclinical findings into efficient techniques for enhancing hepatic function, more research is required, particularly in the context of diabetes."

IO biomarker • Journal • Preclinical • Diabetes • Dyslipidemia • Hepatology • Inflammation • Liver Failure • Metabolic Disorders • BCL2 • CASP3 • IL18 • IL1B • NLRP3 • TXNIP

Effectiveness of Saroglitazar in MASLD Patients: A Prospective, Real-World Assessment of Liver and Metabolic Health. (PubMed, Endocrinol Diabetes Metab) - "Despite a slight increase in BMI, Saroglitazar significantly improved transient elastography parameters and hepatic parameters in MASLD patients, suggesting that this drug alone effectively manages MASLD-related metabolic and hepatic dysfunctions."

Journal • Real-world evidence • Cardiovascular • Dyslipidemia • Fibrosis • Hepatology • Immunology • Liver Cirrhosis • Liver Failure • Metabolic Disorders • Metabolic Dysfunction-Associated Steatotic Liver Disease • PPARA

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