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 12 indications[3], with its most advanced program in Phase 3.[1]

Lipaglyn is one of 300 small molecule programs targeting Cirrhosis of Liver. It is currently in Phase 3.

Indications

Total Trials

Active Trials

299

Competitors

Pipeline

Status by Indication[3][1]

Indication

Cirrhosis of LiverActive, not recruiting

Disorder of Lipid MetabolismActive, not recruiting

Cholestatic Liver DiseaseActive, not recruiting

HepatitisActive, not recruiting

Non-Alcoholic Fatty Liver DiseaseActive, not recruiting

Alcoholic Fatty Liver DiseaseActive, not recruiting

Kidney DiseaseActive, not recruiting

Inherited Lipid Metabolism DisorderUnknown

Non-Alcoholic SteatohepatitisActive, not recruiting

Primary Biliary CirrhosisActive, not recruiting

Cirrhosis of LiverPhase 1

Active, not recruiting

Disorder of Lipid MetabolismPhase 2

Active, not recruiting

Cholestatic Liver DiseasePhase 1

Active, not recruiting

HepatitisPhase 2

Active, not recruiting

Non-Alcoholic Fatty Liver DiseasePhase 3

Active, not recruiting

Alcoholic Fatty Liver DiseasePhase 2

Active, not recruiting

Kidney DiseasePhase 1

Active, not recruiting

Inherited Lipid Metabolism DisorderPreclinical

Unknown

Non-Alcoholic SteatohepatitisPhase 2

Active, not recruiting

Primary Biliary CirrhosisPhase 3

Active, not recruiting

Showing 10 of 12 indications

Competition

Competitive Landscape

245 competitors in Kidney Disease

#DrugCompanyPhaseTrials

Lipaglyn

ZZydus Therapeutics Inc.

Phase 3

21 2

Invirase

Roche

Phase 3

1 3

Reata

Biogen

Phase 3

1 4

Edarbi

Takeda

Phase 3

1 5

Victoza

Novo Nordisk

Phase 3

1 6

Evrenzo

Astellas

Phase 3

1 7

Zemplar

AbbVie

Phase 3

1 8

Rituxan

Myfortic

Gazyva

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

Timeline

Expected Milestones

Q3 2027

Phase 3Recruiting

Primary Biliary Cholangitis

NCT06427395

Q4 2028

Phase 3Not yet recruiting

Complete Response

NCT07424677

Q4 2032

Phase 3Not yet recruiting

Primary Biliary Cholangitis

NCT07216235

Clinical

Trials by Indication[1]

Alcoholic Fatty Liver Disease6 trials

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

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

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

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

Primary Biliary Cholangitis4 trials

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

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

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

Saroglitazar Magnesium for Treatment of Primary Biliary Cholangitis

Completed·ZZydus Therapeutics Inc.·Phase 2/3·NCT05133336·196 enrolled

Show 1 more trial

Long-Term Study to Evaluate the Safety and Efficacy in Participants With Primary Biliary Cholangitis of Saroglitazar Magnesium-V on Clinical Outcomes

Not yet recruiting·ZZydus Therapeutics Inc.·Phase 3·NCT07216235·386 enrolled

Cholestatic liver disease3 trials

Evaluate PK & Safety of Saroglitazar in Subjects With Moderate Hepatic Impairment Due to Cholestatic Liver Disease

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

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

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

Hepatic Impairment With Cirrhosis Due to Cholestatic Liver Disease

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

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

6 more indications

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

Complete Response1 trial

Study of Saroglitazar Magnesium for PBC Patients With Incomplete Response or Intolerant to UDCA Therapy

Not yet recruiting·ZZydus Therapeutics Inc.·Phase 3·NCT07424677·89 enrolled

Non-Alcoholic Steatohepatitis1 trial

Saroglitazar Magnesium in the Treatment of Non-Alcoholic Steatohepatitis

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

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

Q3 2027

Q4 2028

Q4 2032

Trials by Indication[1]

Alcoholic Fatty Liver Disease6 trials

Primary Biliary Cholangitis4 trials

Cholestatic liver disease3 trials

Effectiveness1 trial

Absorption1 trial

Renal Impairment1 trial

Complete Response1 trial

Non-Alcoholic Steatohepatitis1 trial

Hepatitis1 trial

Safety and Efficacy1 trial

Unspecified1 trial

References

Drug Info

Quick Facts

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