Clinical Trials

Numerous clinical trials spanning Phase 1 through Phase 4 evaluate saroglitazar for hepatic and metabolic conditions, including nonalcoholic fatty liver disease, nonalcoholic steatohepatitis, primary biliary cholangitis, type 2 diabetes, dyslipidemias, hepatic impairment, and post-liver transplant complications. Sponsored predominantly by Zydus entities alongside institutional investigators such as the Asian Institute of Gastroenterology, these studies encompass early-phase pharmacokinetic and late-phase efficacy protocols with recruitment statuses ranging from completed and recruiting to active and terminated.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07216235 RECRUITING
Primary Biliary Cholangitis
Zydus Therapeutics Inc.
 2026-03-24 PHASE3
NCT07424677 NOT_YET_RECRUITING
Primary Biliary Cholangitis
Zydus Therapeutics Inc.
 2026-06 PHASE3
NCT06427395 ACTIVE_NOT_RECRUITING
Primary Biliary Cholangitis
Zydus Therapeutics Inc.
 2024-07-16 PHASE3
NCT06825559 RECRUITING
Cholestatic Liver Disease
Zydus Therapeutics Inc.
 2025-08-05 PHASE1
NCT05045482 RECRUITING
Hepatic Impairment; Cirrhosis; Cholestatic Liver Disease
Zydus Therapeutics Inc.
 2021-10-21 PHASE1
NCT05011305 COMPLETED
Nonalcoholic Steatohepatitis; Fibrosis
Zydus Therapeutics Inc.
 2021-08-18 PHASE2
NCT05133336 COMPLETED
Primary Biliary Cholangitis
Zydus Therapeutics Inc.
 2022-04-01 PHASE2; PHASE3
NCT05872269 UNKNOWN
NAFLD; Obesity; Type 2 Diabetes; Dyslipidemias; Metabolic Syndrome
Zydus Lifesciences Limited
 2023-07-20 PHASE4
NCT03617263 TERMINATED
Non-alcoholic Fatty Liver Disease in Women With PCOS
Zydus Therapeutics Inc.
 2019-02-12 PHASE2
NCT04446507 COMPLETED
Renal Impairment
Zydus Therapeutics Inc.
 2020-07-27 PHASE1
NCT03097107 SUSPENDED
Dyslipidemias
Zydus Therapeutics Inc.
 2017-04-06 PHASE2
NCT05211284 TERMINATED
Nonalcoholic Fatty Liver Disease
Zydus Therapeutics Inc.
 2022-12-08 PHASE2
NCT05211284 Recruiting
Nonalcoholic Steatohepatitis
Zydus Therapeutics Inc.
 2022-09-26 Phase 2
NCT04469920 COMPLETED
Hepatic Impairment
Zydus Therapeutics Inc.
 2020-07-16 PHASE1
NCT03639623 COMPLETED
Liver Transplant; Complications; NAFLD
Zydus Therapeutics Inc.
 2019-02-25 PHASE2
NCT04193982 UNKNOWN
NAFLD
Asian Institute of Gastroenterology, India
 2021-01-31 PHASE3
NCT03112681 COMPLETED
Primary Biliary Cirrhosis
Zydus Therapeutics Inc.
 2017-08-18 PHASE2
NCT03863574 COMPLETED
Non Alcoholic Steatohepatitis
Zydus Therapeutics Inc.
 2019-06-12 PHASE2
NCT04045769 COMPLETED
Healthy
Zydus Therapeutics Inc.
 2019-08-19 PHASE1
NCT04112446 COMPLETED
Healthy
Zydus Therapeutics Inc.
 2019-09-20 PHASE1
NCT04112446 Completed
Healthy
Zydus Therapeutics Inc.
 2019-09-20 Phase 1
NCT03061721 COMPLETED
Non-Alcoholic Fatty Liver Disease; Nonalcoholic Steatohepatitis
Zydus Therapeutics Inc.
 2017-04-06 PHASE2
NCT02265276 UNKNOWN
Fatty Liver
Command Hospital, India
 2014-10 PHASE3

(data from https://clinicaltrials.gov, updated on 2026-08-04)

Check the Saroglitazar product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Saroglitazar acts as a dual peroxisome proliferator-activated receptor alpha/gamma (PPARα/γ) agonist, exhibiting predominant activity against hPPARα (EC50 = 0.65 pM) and moderate activity against hPPARγ (EC50 = 3 nM) to upregulate genes involved in fatty acid oxidation and lipid metabolism while modulating insulin sensitivity. This target engagement reduces intracellular hepatic lipid accumulation and improves metabolic parameters, providing therapeutic benefit in metabolic and liver disorders such as nonalcoholic fatty liver disease, nonalcoholic steatohepatitis, and primary biliary cholangitis.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.