Lipaglyn (saroglitazar) / Zydus Lifesciences - LARVOL DELTA

Rewiring the psoriasis-metabolism axis: therapeutic potential of saroglitazar beyond PPAR modulation. (PubMed, Inflammopharmacology) - "To our knowledge, this is the first comprehensive synthesis to unravel SGZ's mechanistic intersections across metabolic and inflammatory axes and map its clinical relevance to psoriasis. By bridging the dermatological landscape with metabolic comorbidity management and lifestyle interventions, SGZ-proposed mechanisms in the skin, however, have not yet been thoroughly investigated with direct preclinical and clinical evidence in psoriasis and are still hypothesis-generating."

Journal • Review • Cardiovascular • Dermatology • Diabetes • Dyslipidemia • Hepatology • Hypertension • Immunology • Inflammation • Metabolic Disorders • Metabolic Dysfunction-Associated Steatotic Liver Disease • Psoriasis • Type 2 Diabetes Mellitus • STAT3

Efficacy of Dapagliflozin vs. Saroglitazar on Hepatic Steatosis and Fibrosis in Patients of Type 2 Diabetes Mellitus and Metabolic-Associated Steatotic Liver Disease (MASLD). (PubMed, Indian J Endocrinol Metab) - "Minimal but statistically significant intergroup differences were noted only for BMI (P = 0.033) and LDL cholesterol (P = 0.020) in the Dapagliflozin cohort and alanine transaminase levels (P = 0.037) in the Saroglitazar cohort. Both Dapagliflozin and Saroglitazar are potent therapeutic options in patients with type 2 diabetes mellitus who also have MASLD."

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

Greater Treatment Response to Saroglitazar in US Versus Non-US Patients With Primary Biliary Cholangitis: A Geographic Subgroup Analysis of the Phase 3 EPICS-III Trial (Late-Breaking Abstract) (ACG 2026) - "Abstract text will be released on Sunday, October 11, 2026, at 12:00 pm CT (1:00 pm ET) when the ACG 2026 embargo lifts."

Clinical • Late-breaking abstract • P3 data • Hepatology • Immunology • Primary Biliary Cholangitis

Efficacy, symptoms, and safety of second-line PBC therapies: a network meta-analysis. (PubMed, Front Pharmacol) - "The therapeutic landscape for primary biliary cholangitis (PBC) with an inadequate response to ursodeoxycholic acid (UDCA) is rapidly evolving...We included randomized controlled trials (RCTs) with durations of 12-52 weeks evaluating PPAR agonists (bezafibrate, seladelpar, elafibranor, saroglitazar), farnesoid X receptor (FXR) agonists (obeticholic acid [OCA]), and IBAT inhibitors (linerixibat) against placebo/UDCA...While bezafibrate offers unparalleled potency for POISE criteria, seladelpar 10 mg provides the most advantageous clinical balance, achieving deep biochemical remission (ALP normalization) alongside profound pruritus relief and a favorable safety profile. https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=261351, identifier 420261351426."

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

A flow cytometry-based assay system for the in vitro screening of anti-steatotic compounds. (PubMed, In Vitro Model) - "The assay was validated using known anti-steatotic drugs, where Saroglitazar, Pioglitazone, Empagliflozin, and Atorvastatin significantly reduced lipid accumulation in HepG2 cells. The present flow cytometry assay is a human cell-based and animal-free system that offers a sensitive, accurate, and high-throughput platform for evaluating anti-steatotic compounds, with clear advantages over conventional methods for early-stage drug discovery. The online version contains supplementary material available at https://doi.org/10.1007/s44164-026-00110-4."

Journal • Preclinical • Hepatology • Metabolic Dysfunction-Associated Steatotic Liver Disease

Cardiometabolic Response to Saroglitazar in a Young Indian Man With Obesity, Prediabetes, Insulin Resistance, and High-Normal Albuminuria: A Case Report. (PubMed, Cureus) - "The overall direction of these changes suggests potential beneficial effects of early pharmacological intervention across metabolic, hepatic, and renal parameters. However, adequately powered controlled trials are needed before such early intervention strategies can be recommended for routine clinical use."

Journal • Genetic Disorders • Metabolic Disorders • Obesity • Renal Disease

Saroglitazar improves post-liver transplant metabolic associated steatotic liver disease- A randomized controlled trial- interim analysis (TTS 2026) - "Saroglitazar demonstrates a significant improvement in liver fat and lipid profile in post–liver transplant MASLD, with an excellent safety profile. This interim results suggest that saroglitazar may be an effective therapeutic option for managing post-transplant MASLD."

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

EPICS-IV: Study of Saroglitazar Magnesium for PBC Patients With Incomplete Response or Intolerant to UDCA Therapy (clinicaltrials.gov) - P3 | N=90 | Recruiting | Sponsor: Zydus Therapeutics Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Hepatology • Immunology • Primary Biliary Cholangitis

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: Jul 2026 ➔ Dec 2026 | Trial primary completion date: Jul 2026 ➔ Dec 2026

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

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

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

EVALUATING THE REAL-WORLD IMPACT OF SAROGLITAZAR ON HEPATIC STEATOSIS AND FIBROSIS IN PATIENTS WITH MASLD, WITH AND WITHOUT DIABETES: A PROSPECTIVE INDIAN COHORT (UEGW 2026) - No abstract available

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

The new era of MASH pharmacotherapy: a comprehensive review of FDA-approved and emerging agents. (PubMed, Front Gastroenterol (Lausanne)) - "This comprehensive narrative review synthesizes the evidence for newly approved and emerging pharmacotherapies for MASH, addressing the mechanisms of action, pivotal clinical trial data, efficacy, safety profiles, and place in therapy for resmetirom and semaglutide. It also discusses key agents including pioglitazone, saroglitazar, and vitamin E, and evaluates the non-invasive testing (NIT) toolkit-including FIB-4, VCTE, shear wave elastography, MRE, and ELF-in the context of a structured, risk-stratified clinical algorithm...A risk-stratified algorithmic approach using NITs guides patient selection, with liver biopsy reserved for specific clinical scenarios. The therapeutic landscape is rapidly evolving, with saroglitazar and combination approaches representing key frontiers."

FDA event • Journal • Review • Diabetes • Fibrosis • Genetic Disorders • Hepatology • Immunology • Liver Cirrhosis • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis • Obesity • Type 2 Diabetes Mellitus

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 | Recruiting | Sponsor: Zydus Therapeutics Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Hepatology • Immunology • Primary Biliary Cholangitis

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: Dec 2025 ➔ Jul 2026 | Trial primary completion date: Dec 2025 ➔ Jul 2026

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

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

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

Metabolic Benefits of Saroglitazar 4 mg in Type 2 Diabetes Mellitus With Dyslipidemia: A Retrospective Real-World Observational Cohort Study From India. (PubMed, Cureus) - "Alanine aminotransferase (ALT), aspartate aminotransferase (AST), controlled attenuation parameter (CAP) score, liver stiffness measurement (LSM), serum creatinine, estimated glomerular filtration rate (eGFR), and body weight also improved. Conclusion Saroglitazar 4 mg significantly improved glycemic, lipid, hepatic, renal, and weight-related outcomes over six months in patients with T2DM and dyslipidemia."

Journal • Observational data • Real-world evidence • Retrospective data • Diabetes • Dyslipidemia • Hepatology • Hypertriglyceridemia • Metabolic Disorders • Metabolic Dysfunction-Associated Steatotic Liver Disease • Type 2 Diabetes Mellitus

A Lean Metabolic Catastrophe - A Case Report on Congenital Generalized Lipodystrophy Presenting as Severe Insulin Resistance and Hypertriglyceridemia. (PubMed, Ann Afr Med) - "Congenital lipodystrophy is characterized by ectopic fat accumulation in the liver, muscles, and pancreas, with resultant severe insulin resistance and metabolic complications. Management with dual PPAR agonist therapy (saroglitazar), omega-3 fatty acids (icosapent ethyl), thiazolidinediones (pioglitazone-metformin combination), and basal insulin resulted in significant improvement in lipid and glycemic parameters on subsequent follow-ups."

Journal • Diabetes • Dyslipidemia • Hypertriglyceridemia • Lipodystrophy • Metabolic Disorders • Pain • Pancreatitis • Severe Hypertriglyceridemia

Effects of PPARα, PPARγ, and dual PPARα/γ agonists on liver tissue and biochemical markers in NAFLD-induced Wistar rats. (PubMed, Res Pharm Sci) - "Fenofibrate, pioglitazone, and saroglitazar exert beneficial effects on NAFLD progression through partially distinct mechanisms. Dual PPARα/γ activation appears to preferentially enhance hepatic histological outcomes, supporting the therapeutic relevance of saroglitazar in NAFLD."

Journal • Preclinical • Fibrosis • Hepatology • Immunology • Inflammation • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis • Metabolic Dysfunction-Associated Steatotic Liver Disease • FGF21 • PPARA • PPARG • SREBF1

Dual Genetic Drivers of Severe Hypertriglyceridemia and Recurrent Pancreatitis: A Case Highlighting APOA5 and PRSS1 Variants (ENDO 2026) - "Despite adherence to insulin therapy, metformin, high-intensity statin therapy, saroglitazar, and dietary fat restriction, triglyceride levels remained markedly elevated with poor therapeutic response...Management and Outcome Management was intensified with strict dietary fat restriction, optimized insulin therapy, planned initiation of icosapent ethyl, and genetic counselling...Conclusion This case illustrates a dual-hit model in which genetically mediated hypertriglyceridemia (APOA5) coexists with inherited pancreatic susceptibility (PRSS1), resulting in severe, recurrent pancreatitis. Early genomic evaluation should be considered in patients with refractory hypertriglyceridemia and pancreatitis to enable precision management and risk stratification."

Clinical • Diabetes • Dyslipidemia • Genetic Disorders • Hypertriglyceridemia • Inflammation • Metabolic Disorders • Mixed Hyperlipidemia • Obesity • Pancreatitis • Severe Hypertriglyceridemia • Type 2 Diabetes Mellitus • APOA5 • PRSS1

Efficacy and safety of SarogLItazar as an add-on medication to Metformin and lifestyle intervention in women with PolyCystic Ovary Syndrome (SLIM-PCOS trial): study protocol for a randomized, open-label, parallel group clinical trial. (PubMed, Trials) - "SLIM-PCOS trial will provide evidence on the potential therapeutic application of saroglitazar in PCOS. Based on the study outcomes and the drug's mechanism of action, future studies may be planned to investigate into the role of this novel glitazar in PCOS patients having diabetes, dyslipidemia, non-alcoholic fatty liver disease and other associated co-morbidities."

Journal • Diabetes • Dyslipidemia • Hematological Disorders • Hepatology • Metabolic Disorders • Metabolic Dysfunction-Associated Steatotic Liver Disease • Polyendocrine Metabolic Ovarian Syndrome

Effectiveness and Safety of Saroglitazar on Hypertriglyceridemia and Glycemic Parameters in Type 2 Diabetes with Comorbidities: Six-Month Study in India (LEAD INDIA-V) (ADA 2026) - "Saroglitazar demonstrated significant effectiveness in improving metabolic parameters with statistically significant declines in HbA1c and triglycerides. Stable renal function parameters indicate treatment was renal-safe. Low adverse drug reaction incidence suggests good tolerability."

Clinical • Diabetes • Hypertriglyceridemia • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

Comparable Hepatic Benefits with Differential Effects on Triglycerides and Glycemic Control: A 24-Week Prospective Study (ADA 2026) - "Comparative data between saroglitazar (SARO) and dapagliflozin (DAPA) in MASLD are limited. A 24-week, prospective, multicenter, open-label, active-controlled study (CTRI/2024/08/071848) enrolled adults aged 18-70 years with FibroScan®-confirmed MASLD (controlled attenuation parameter [CAP] ≥300 dB/m and liver stiffness measurement [LSM] ≥8 kPa). In adults with MASLD, SARO and DAPA produced comparable short-term improvements in hepatic steatosis but had no significant effects on fibrosis over 24 weeks. SARO was associated with greater improvements in glycemic control and triglyceride levels, highlighting potential differences by metabolic phenotype, supporting individualized treatment selection in MASLD, which warrants longer-term outcome studies."

Clinical • Diabetes • Metabolic Disorders • Metabolic Dysfunction-Associated Steatotic Liver Disease • Obesity • Type 2 Diabetes Mellitus

Saroglitazar and vitamin E vs. lifestyle interventions in metabolic dysfunction associated steatotic liver disease: A 3-arm randomised study. (PubMed, Indian J Med Res) - "A considerable proportion of patients had at least '2 Kpa reduction' in liver stiffness measurement in arm A (39%) compared to C (19%). Interpretation and conclusions Saroglitazar or vitamin E are similar to lifestyle interventions in improving different non-invasive parameters in MASLD at 24 weeks of intervention."

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

A phase 2b/3 trial of saroglitazar in primary biliary cholangitis (EPICS III) (EASL 2026) - "We conducted a phase2b/3 study of saroglitazar in patients with PBC who had an inadequate response to or intolerance to ursodeoxycholic acid (UDCA). In this Phase2b/3 EPICS III program, saroglitazar significantly improved biochemical response and ALP normalization in individuals with PBC who had an inadequate response to or intolerance to UDCA. Saroglitazar is an effective second line therapy for PBC."

Late-breaking abstract • P2/3 data • P2b data • Hepatology • Immunology • Musculoskeletal Diseases • Nephrology • Orthopedics • Primary Biliary Cholangitis • Pruritus • Renal Disease • PPARA

Saroglitazar for non-obese metabolic-dysfunction associated steatotic liver disease (MASLD): An open-label randomised controlled trial. (PubMed, Indian J Med Res) - "No serious adverse events were observed. Interpretation and conclusions In non-obese NAFLD/MASLD patients, the combination of saroglitazar with lifestyle changes over a period of six months improved insulin resistance, triglycerides, and ALT but did not confer additional benefit over lifestyle intervention alone for non-invasive hepatic steatosis or liver fibrosis markers."

Clinical • Journal • Fibrosis • Hepatology • Immunology • Liver Cirrhosis • Metabolic Disorders • Metabolic Dysfunction-Associated Steatotic Liver Disease • Obesity