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

Evaluating Pharmacokinetic and Safety of Saroglitazar Magnesium 1 Mg When Dosed on Alternate Days in Subjects Having Moderate Hepatic Impairment with Cirrhosis Due to Cholestatic Liver Disease

Phase 1

Not yet recruiting

Conditions: Cholestatic Liver Disease

Interventions: Drug: Saroglitazar Magnesium 1 mg

First Posted Date: 2025-02-13

Last Posted Date: 2025-02-13

Lead Sponsor: Zydus Therapeutics Inc.

Target Recruit Count: 6

Registration Number: NCT06825559

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

Phase 3

Recruiting

Conditions: Primary Biliary Cholangitis

Interventions: Drug: Saroglitazar Magnesium 1 mg

First Posted Date: 2024-05-23

Last Posted Date: 2025-03-04

Lead Sponsor: Zydus Therapeutics Inc.

Target Recruit Count: 150

Registration Number: NCT06427395

Locations: 🇺🇸
Zydus US007, Birmingham, Alabama, United States
🇺🇸
Zydus US013, Los Angeles, California, United States
🇺🇸
Zydus US011, Pasadena, California, United States

and more 38 locations

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

Phase 4

Recruiting

Conditions: NAFLD
Type 2 Diabetes
Obesity
Dyslipidemias
Metabolic Syndrome

Interventions: Drug: Saroglitazar

First Posted Date: 2023-05-24

Last Posted Date: 2024-02-07

Lead Sponsor: Zydus Lifesciences Limited

Target Recruit Count: 1500

Registration Number: NCT05872269

Locations: 🇮🇳
Gastroplus Digestive Disease Centre, Ahmedabad, India
🇮🇳
Medanta- TheMedicity, Gurgaon, India
🇮🇳
Mission GastroHospital, Ahmedabad, India

and more 16 locations

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

Phase 2

Terminated

Conditions: Nonalcoholic Fatty Liver Disease

Interventions: Drug: Saroglitazar Magnesium 4 mg
Drug: Placebo

First Posted Date: 2022-01-27

Last Posted Date: 2024-12-02

Lead Sponsor: Zydus Therapeutics Inc.

Target Recruit Count: 160

Registration Number: NCT05211284

Locations: 🇺🇸
Zydus US002, Indianapolis, Indiana, United States
🇺🇸
Zydus US004, Birmingham, Alabama, United States
🇺🇸
Zydus US005, La Jolla, California, United States

and more 5 locations

Saroglitazar Magnesium for Treatment of Primary Biliary Cholangitis

Phase 2

Active, not recruiting

Conditions: Primary Biliary Cholangitis

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

First Posted Date: 2021-11-24

Last Posted Date: 2025-03-04

Lead Sponsor: Zydus Therapeutics Inc.

Target Recruit Count: 186

Registration Number: NCT05133336

Locations: 🇹🇷
Zydus TR010, Istanbul, Turkey
🇹🇷
Zydus TR003, Istanbul, Turkey
🇹🇷
Zydus TR001, Istanbul, Turkey

and more 54 locations

Hepatic Impairment With Cirrhosis Due to Cholestatic Liver Disease

Phase 1

Recruiting

Conditions: Cholestatic Liver Disease
Hepatic Impairment
Cirrhosis

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

First Posted Date: 2021-09-16

Last Posted Date: 2025-03-04

Lead Sponsor: Zydus Therapeutics Inc.

Target Recruit Count: 30

Registration Number: NCT05045482

Locations: 🇺🇸
Zydus US002, Indianapolis, Indiana, United States

Saroglitazar Magnesium for the Treatment of Nonalcoholic Steatohepatitis With Fibrosis

Phase 2

Active, not recruiting

Conditions: Nonalcoholic Steatohepatitis
Fibrosis

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

First Posted Date: 2021-08-18

Last Posted Date: 2025-03-04

Lead Sponsor: Zydus Therapeutics Inc.

Target Recruit Count: 240

Registration Number: NCT05011305

Locations: 🇺🇸
Zydus US090, Long Beach, California, United States
🇺🇸
Zydus US040, Los Angeles, California, United States
🇺🇸
Zydus US059, Rancho Cucamonga, California, United States

and more 149 locations

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

Phase 1

Recruiting

Conditions: Hepatic Impairment

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

First Posted Date: 2020-07-14

Last Posted Date: 2023-10-10

Lead Sponsor: Zydus Therapeutics Inc.

Target Recruit Count: 100

Registration Number: NCT04469920

Locations: 🇺🇸
Indiana University School of Medicine, Indianapolis, Indiana, United States
🇺🇸
American Research Corporation at Texas Liver Institute, San Antonio, Texas, United States

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

Phase 1

Recruiting

Conditions: Renal Impairment

Interventions: Drug: Saroglitazar magnesium

First Posted Date: 2020-06-25

Last Posted Date: 2024-05-13

Lead Sponsor: Zydus Therapeutics Inc.

Target Recruit Count: 32

Registration Number: NCT04446507

Locations: 🇺🇸
Zydus US003, DeLand, Florida, United States
🇺🇸
Zydus US001, San Antonio, Texas, United States

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)

Phase 3

Conditions: NAFLD

Interventions: Behavioral: Lifestyle Changes
Drug: Combination drug
Drug: Vitamin E
Drug: Saroglitazar

First Posted Date: 2019-12-11

Last Posted Date: 2021-01-26

Lead Sponsor: Asian Institute of Gastroenterology, India

Target Recruit Count: 250

Registration Number: NCT04193982

Locations: 🇮🇳
Asian Institute of Gastroenterology Hospitals, Hyderabad, Telangana, India

Drug Development Updates

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