Saroglitazar

Generic Name: Saroglitazar

Drug Type: Small Molecule

Chemical Formula: C_₂₅H_₂₉NO_₄S

CAS Number: 495399-09-2

Unique Ingredient Identifier: E0YMX3S4JD

Background: Saroglitazar has been investigated for the treatment of Fatty Liver.

Clinical Trials

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

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: Saroglitazar magnesium

First Posted Date: 2019-10-02

Last Posted Date: 2019-11-13

Lead Sponsor: Zydus Therapeutics Inc.

Target Recruit Count: 8

Registration Number: NCT04112446

Locations: 🇺🇸
Covance Clinical Research Unit Inc., Madison, Wisconsin, United States

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

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: Saroglitazar magnesium 4mg
Drug: Moxifloxacin 400mg
Drug: Saroglitazar magnesium 20 mg
Drug: Placebos

First Posted Date: 2019-08-06

Last Posted Date: 2020-04-21

Lead Sponsor: Zydus Therapeutics Inc.

Target Recruit Count: 52

Registration Number: NCT04045769

Locations: 🇮🇳
Cliantha Research Limited, Ahmedabad, Gujarat, India

Saroglitazar Magnesium in the Treatment of Non-Alcoholic Steatohepatitis

Phase 2

Completed

Conditions: Non Alcoholic Steatohepatitis

Interventions: Drug: Saroglitazar Magnesium 4mg
Drug: Placebos
Drug: Saroglitazar Magnesium 2mg

First Posted Date: 2019-03-05

Last Posted Date: 2024-10-11

Lead Sponsor: Zydus Therapeutics Inc.

Target Recruit Count: 16

Registration Number: NCT03863574

Locations: 🇺🇸
Texas Liver Institute, San Antonio, Texas, United States
🇺🇸
Southern Therapy and Advanced Research (STAR) LLC, Jackson, Mississippi, United States
🇺🇸
Gastro One, Germantown, Tennessee, United States

and more 3 locations

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

Phase 2

Completed

Conditions: Liver Transplant; Complications
NAFLD

Interventions: Drug: Saroglitazar

First Posted Date: 2018-08-21

Last Posted Date: 2024-10-24

Lead Sponsor: Zydus Therapeutics Inc.

Target Recruit Count: 20

Registration Number: NCT03639623

Locations: 🇺🇸
Virginia Commonwealth University, Richmond, Virginia, United States

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

Phase 2

Terminated

Conditions: Non-alcoholic Fatty Liver Disease in Women With PCOS

Interventions: Drug: Placebo
Drug: Saroglitazar Magnesium 4 mg Tablet

First Posted Date: 2018-08-06

Last Posted Date: 2025-05-13

Lead Sponsor: Zydus Therapeutics Inc.

Target Recruit Count: 90

Registration Number: NCT03617263

Locations: 🇺🇸
Zydus US002, San Francisco, California, United States
🇺🇸
Zydus US008, Aurora, Colorado, United States
🇺🇸
Zydus US005, Chandler, Arizona, United States

and more 16 locations

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

Phase 2

Completed

Conditions: Primary Biliary Cirrhosis

Interventions: Drug: Saroglitazar magnesium 2 mg
Drug: Saroglitazar magnesium 4 mg
Drug: Placebo Oral Tablet

First Posted Date: 2017-04-13

Last Posted Date: 2024-01-05

Lead Sponsor: Zydus Therapeutics Inc.

Target Recruit Count: 37

Registration Number: NCT03112681

Locations: 🇺🇸
California Liver Research Institute, Pasadena, California, United States
🇺🇸
Carolinas Healthcare System, Charlotte, North Carolina, United States
🇺🇸
Schiff Center for Liver Diseases/University of Miami, Miami, Florida, United States

and more 6 locations

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

Phase 2

Suspended

Conditions: Dyslipidemias

Interventions: Drug: Placebo
Drug: Saroglitazar Magnesium 1 mg
Drug: Saroglitazar Magnesium 2 mg
Drug: Saroglitazar Magnesium 4 mg

First Posted Date: 2017-03-31

Last Posted Date: 2023-02-08

Lead Sponsor: Zydus Therapeutics Inc.

Target Recruit Count: 124

Registration Number: NCT03097107

Locations: 🇺🇸
Herman Clinical Research, LLC, Suwanee, Georgia, United States
🇺🇸
Drug Studies America, Marietta, Georgia, United States
🇺🇸
River Birch Research Alliance LLC, Blue Ridge, Georgia, United States

and more 29 locations

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

Phase 2

Completed

Conditions: Nonalcoholic Steatohepatitis
Non-Alcoholic Fatty Liver Disease

Interventions: Drug: Saroglitazar magnesium 1 mg
Drug: Saroglitazar magnesium 2 mg
Drug: Saroglitazar magnesium 4 mg
Drug: Placebos

First Posted Date: 2017-02-23

Last Posted Date: 2024-10-24

Lead Sponsor: Zydus Therapeutics Inc.

Target Recruit Count: 106

Registration Number: NCT03061721

Locations: 🇺🇸
Precision Research, San Diego, California, United States
🇺🇸
Cedars-Sinai Medical Center, Los Angeles, California, United States
🇺🇸
Catalina Research Institute, Montclair, California, United States

and more 14 locations

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

Phase 3

Conditions: Fatty Liver

Interventions: Drug: Pioglitazone
Drug: Saroglitazar

First Posted Date: 2014-10-15

Last Posted Date: 2014-10-16

Lead Sponsor: Command Hospital, India

Target Recruit Count: 100

Registration Number: NCT02265276

Locations: 🇮🇳
Command Hospital, Panchkula, Haryana, India

Drug Development Updates

Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.

Home Terms & Conditions Privacy Policy