Lipaglyn (saroglitazar) / Zydus Lifesciences - LARVOL DELTA

Comparative Efficacy of Pioglitazone, Saroglitazar, and Silymarin on Biochemical and Histopathological Hepatic Outcomes in a Wistar Rat Model of Non-alcoholic Fatty Liver Disease and Their Correlation With Insulin Sensitivity. (PubMed, Cureus) - " Saroglitazar demonstrated the most comprehensive protective effects against NAFLD progression, surpassing pioglitazone and silymarin in biochemical, histological, and insulin resistance parameters. Its dual PPAR‑α/γ activity may offer a more effective therapeutic approach, supporting further translational evaluation in NAFLD management."

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

"Saroglitazar in MASLD: Translating Clinical Trials into Practice Through Liver Metrics (APASL 2026) - No abstract available

Clinical • Metabolic Dysfunction-Associated Steatotic Liver Disease

"Evaluating the Early Biochemical Impact of Saroglitazar on Liver Function Tests in MASLD Patients (APASL 2026) - No abstract available

Clinical • Metabolic Dysfunction-Associated Steatotic Liver Disease

Therapy in diabetic dyslipidemia. (PubMed, Indian J Pharmacol) - "Hence, the combination of saroglitazar and gemfibrozil has shown a good safety profile and may represent a novel therapeutic agent that will fulfill the unmet needs in T2DM and diabetic dyslipidemia."

Journal • Cardiovascular • Dyslipidemia • Metabolic Disorders • Type 2 Diabetes Mellitus

Perspectives of Indian Gastroenterologists and Hepatologists on Nonalcoholic Fatty Liver Disease Diagnosis and Management: Insights From the Nationwide Web-Based Cross-Sectional DRIVE Survey. (PubMed, Interact J Med Res) - "This large, nationwide survey highlights that NAFLD and NASH constitute a major part of gastroenterology and hepatology practice in India. Although transient elastography and pharmacological agents such as saroglitazar and vitamin E are widely used, considerable heterogeneity exists in diagnostic and management approaches. The lack of patient awareness and effective treatment options remain the major hurdles in managing NAFLD and NASH. These findings underscore the need for the wider implementation of existing India-specific consensus recommendations, continued physician education, and future research focusing on tailored interventions in the management of NAFLD and NASH for the Indian population."

Journal • Diabetes • Fibrosis • Genetic Disorders • Hepatology • Immunology • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis • Metabolic Dysfunction-Associated Steatotic Liver Disease • Obesity

Saroglitazar Mitigated Cyclophosphamide-Induced Testicular Injury: Crosstalk Between Oxidative Stress, Inflammation and Apoptosis. (PubMed, Pharmaceuticals (Basel)) - "SAR also significantly decreased testicular expression of caspase-3 and Bax and increased Bcl2 expression, indicating its anti-apoptotic effect. SAR at doses (2 and 4 mg/kg) could ameliorate CYC-induced testicular injury in rats, possibly through antioxidant, anti-inflammatory and anti-apoptotic effect."

IO biomarker • Journal • Dyslipidemia • Inflammation • Metabolic Disorders • BAX • BCL2 • CASP3 • IL6 • NFKB1 • PPARA • PPARG • TNFA

Saroglitazar 4 Mg in Metabolic Dysfunction-Associated Steatotic Liver Disease: 24-Week Results From Phase 4 Study. (PubMed, Liver Int) - "In this interim real-world analysis, saroglitazar 4 mg was associated with improvements in liver stiffness, hepatic steatosis, metabolic parameters and non-invasive fibrosis markers in patients with MASLD. The treatment was generally well tolerated. These findings warrant further confirmation upon completion of the 52-week analysis."

Journal • P4 data • Fibrosis • Genetic Disorders • Hepatology • Immunology • Liver Failure • Metabolic Disorders • Metabolic Dysfunction-Associated Steatotic Liver Disease • Obesity

EPICS-IV: Study of Saroglitazar Magnesium for PBC Patients With Incomplete Response or Intolerant to UDCA Therapy (clinicaltrials.gov) - P3 | N=89 | Not yet recruiting | Sponsor: Zydus Therapeutics Inc.

New P3 trial • Hepatology • Immunology • Primary Biliary Cholangitis

Hepatic Impairment With Cirrhosis Due to Cholestatic Liver Disease (clinicaltrials.gov) - P1 | N=30 | Recruiting | Sponsor: Zydus Therapeutics Inc. | Trial completion date: Dec 2025 ➔ Mar 2026 | Trial primary completion date: Dec 2025 ➔ Mar 2026

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

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