Lipaglyn

(Saroglitazar)

Phase 3Small molecule

Saroglitazar is used to treat diabetic patients with high triglycerides and cholesterol levels, helping to reduce fat in the blood and improve metabolic health in people with type 2 diabetes.[1] Lipaglyn is currently being investigated across 4 indications[3], with its most advanced program in Phase 3.[1]

Lipaglyn is one of 41 small molecule programs targeting Cholestatic liver disease. It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

Pipeline

Status by Indication[3][1]

Indication

Cholestatic Liver DiseaseRecruiting

Primary Biliary CholangitisRecruiting

Inherited Lipid Metabolism DisorderUnknown

Hepatic ImpairmentRecruiting

Cholestatic Liver DiseasePhase 1

Recruiting

Primary Biliary CholangitisPhase 3

Recruiting

Inherited Lipid Metabolism DisorderPreclinical

Unknown

Hepatic ImpairmentPhase 1

Recruiting

Competition

Competitive Landscape

20 competitors in Hepatic Impairment

#DrugCompanyPhaseTrials

Lipaglyn

ZZydus Therapeutics Inc.

Phase 3

1 2

Vanflyta

Daiichi Sankyo

Phase 1

1 3

Fotivda

Roche

Phase 1

1 4

Luye

Ascentage Pharma Group Inc.

Phase 1

1 5

AZD6234

AstraZeneca

Phase 1

1 6

DWP16001

Daewoong Pharmaceutical Co. LTD.

Phase 1

1 7

Atirmociclib

Pfizer

Phase 1

1 8

AZD9550

AstraZeneca

Phase 1

1 9

Casdatifan

Arcus Biosciences

Phase 1

1 10

ASTX727

Taiho Oncology, Inc.

Phase 1

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 1Recruiting

Cholestatic Liver Disease

NCT06825559

Phase 1Recruiting

Hepatic Impairment

NCT05045482

Q3 2027

Phase 3Recruiting

Primary Biliary Cholangitis

NCT06427395

Q4 2028

Phase 3Recruiting

Primary Biliary Cholangitis

NCT07424677

Q4 2032

Phase 3Recruiting

Primary Biliary Cholangitis

NCT07216235

Clinical

Trials by Indication[1]

Alcoholic Fatty Liver Disease6 trials

A Prospective, Randomized Trial to Compare saroGLitazar With pioglitAZone in Nonalcoholic Fatty livEr Disease

Unknown status·—·Phase 3·NCT02265276·100 enrolled

Safety, Tolerability, and Efficacy of Saroglitazar Mg 4 mg in Liver Transplant Recipients With Nonalcoholic Fatty Liver Disease (NAFLD)

Completed·ZZydus Therapeutics Inc.·Phase 2·NCT03639623·20 enrolled

An Investigator Initiated Prospective, Four Arms Randomized Comparative Study of Efficacy and Safety of Saroglitazar, Vitamin E and Life Style Modification in Patients With Nonalcoholic Fatty Liver Disease (NAFLD)/ Non-alcoholic Steatohepatitis (NASH)

Unknown status·—·Phase 3·NCT04193982·250 enrolled

Show 3 more trials

Saroglitazar Magnesium in Patients With Nonalcoholic Fatty Liver Disease and/or Nonalcoholic Steatohepatitis

Completed·ZZydus Therapeutics Inc.·Phase 2·NCT03061721·106 enrolled

Saroglitazar Magnesium 4 mg for Nonalcoholic Fatty Liver Disease (NAFLD) in People Living With HIV in the US

Terminated·ZZydus Therapeutics Inc.·Phase 2·NCT05211284·4 enrolled

Saroglitazar Magnesium 4 mg in the Treatment of Nonalcoholic Fatty Liver Disease (NAFLD) in Women With PCOS (EVIDENCES VII)

Terminated·ZZydus Therapeutics Inc.·Phase 2·NCT03617263·60 enrolled

Primary Biliary Cholangitis5 trials

Study to Evaluate Safety, Tolerability and Efficacy of Saroglitazar Mg in Patients With Primary Biliary Cholangitis

Completed·ZZydus Therapeutics Inc.·Phase 2·NCT03112681·37 enrolled

Open-Label Extension Study of Saroglitazar Magnesium in Participants With Primary Biliary Cholangitis

Recruiting·ZZydus Therapeutics Inc.·Phase 3·NCT06427395·150 enrolled

A Multicenter, Randomized, Double-blind, Placebo Controlled, Phase 2b/3 Study to Evaluate the Efficacy and Safety of Saroglitazar Magnesium in Subjects With Primary Biliary Cholangitis

Completed·ZZydus Therapeutics Inc.·Preclinical·NCT05133336·196 enrolled

Show 2 more trials

A Double-blind, Placebo-controlled, Randomized, Phase 3 Study to Evaluate the Efficacy and Safety of Saroglitazar Magnesium on Normalization of Alkaline Phosphatase Levels in Patients With Primary Biliary Cholangitis and an Incomplete Response or Intolerance to Ursodeoxycholic Acid

Recruiting·ZZydus Therapeutics Inc.·Phase 3·NCT07424677·90 enrolled

A Phase 3b/4, Multicenter, Parallel-Group, Double-Blind, Placebo Controlled, Two-Arm, Long-Term Study to Evaluate the Safety and Efficacy of Saroglitazar Magnesium on Clinical Outcomes in Participants With Primary Biliary Cholangitis (PBC)

Recruiting·ZZydus Therapeutics Inc.·Phase 3·NCT07216235·386 enrolled

Cholestatic liver disease2 trials

Hepatic Impairment, Cholestatic Liver Disease, & NASH with Advanced Fibrosis & Normal Hepatic Function

Completed·ZZydus Therapeutics Inc.·Phase 1·NCT04469920·98 enrolled

A Phase 1, Open-label, Single Arm Study to Evaluate Pharmacokinetics, Safety, and Tolerability of Saroglitazar Magnesium Dosed on Alternate Days in Subjects Having Moderate Hepatic Impairment With Cirrhosis Due to Cholestatic Liver Disease

Recruiting·ZZydus Therapeutics Inc.·Phase 1·NCT06825559·6 enrolled

Hepatitis1 trial

Saroglitazar Magnesium for the Treatment of Nonalcoholic Steatohepatitis With Fibrosis

Completed·ZZydus Therapeutics Inc.·Phase 2·NCT05011305·189 enrolled

Safety and Efficacy1 trial

Evaluate the Safety and Efficacy of Saroglitazar Mg in Patients With Fasting Triglyceride ≥500 mg/dL and ≤1500 mg/dL

Suspended·ZZydus Therapeutics Inc.·Phase 2·NCT03097107·124 enrolled

6 more indications

Non-Alcoholic Steatohepatitis1 trial

Saroglitazar Magnesium in the Treatment of Non-Alcoholic Steatohepatitis

Completed·ZZydus Therapeutics Inc.·Phase 2·NCT03863574·16 enrolled

Absorption1 trial

Study to Evaluate Absorption, Metabolism and Excretion of Single-dose [14C]-Saroglitazar in Healthy Male Subjects

Completed·ZZydus Therapeutics Inc.·Phase 1·NCT04112446·8 enrolled

Renal Impairment1 trial

A Pharmacokinetic Study of Saroglitazar Magnesium in Subjects with Severe Renal Impairment and Normal Renal Function

Completed·ZZydus Therapeutics Inc.·Phase 1·NCT04446507·32 enrolled

Effectiveness1 trial

A Study to Evaluate the Safety and Effectiveness of Saroglitazar 4 mg in Patients With NAFLD With Comorbidities

Unknown status·ZZydus Lifesciences Limited·Phase 4·NCT05872269·1,500 enrolled

Hepatic Impairment1 trial

A Phase 1, Open-Label Extension Groups Study in Subjects Having Hepatic Impairment With Cirrhosis Due to Cholestatic Liver Disease

Recruiting·ZZydus Therapeutics Inc.·Phase 1·NCT05045482·30 enrolled

Unspecified1 trial

A Study to Evaluate the Effect of Saroglitazar Magnesium on the QTc Interval in Healthy Volunteers

Completed·ZZydus Therapeutics Inc.·Phase 1·NCT04045769·52 enrolled

Sources

References

[1]
ClinicalTrials.gov — 21 trial records for Saroglitazar. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Saroglitazar compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Saroglitazar. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Zydus Therapeutics Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Peroxisome Proliferator-Activated Receptor Alpha Agonist; Peroxisome Proliferator-Activated Receptor Gamma Agonist[2]
Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: ZZydus Therapeutics Inc.

Lipaglyn

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q3 2027

Q4 2028

Q4 2032

Trials by Indication[1]

Alcoholic Fatty Liver Disease6 trials

Primary Biliary Cholangitis5 trials

Cholestatic liver disease2 trials

Hepatitis1 trial

Safety and Efficacy1 trial

Non-Alcoholic Steatohepatitis1 trial

Absorption1 trial

Renal Impairment1 trial

Effectiveness1 trial

Hepatic Impairment1 trial

Unspecified1 trial

References

Drug Info

Quick Facts

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