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Compound · clinical trials

Saroglitazar Magnesium

Source: ClinicalTrials.gov, U.S. National Library of Medicine — the 5 trials in our USA register that name Saroglitazar Magnesium as an intervention. Synced 24 Sep 2026
5Trials tracked
4Recruiting now
1Lead sponsor
1Country register
Maintained by Sreepriya Prasannan
MSc Digital Transformation of Life Sciences (Innopharma Education / Griffith College); MSc & BSc Botany HSE Spark Ignite 2026 โ€” Top 14 finalist
Compiled from ClinicalTrials.gov registry records ยท Last verified ยท Editorial standards

Saroglitazar Magnesium is named as a drug or biological intervention in 5 clinical trials in our USA trial register, 4 of which are recruiting. The lead sponsor is Zydus Therapeutics Inc.. Registered phases: Phase 3 and Phase 1. Conditions studied include Primary Biliary Cholangitis; Cholestatic Liver Disease; Hepatic Impairment.

01

Clinical trials of Saroglitazar Magnesium

5 trials
NCT IDStudyPhaseStatusLead sponsorRegister
NCT07216235 Long-Term Study to Evaluate the Safety and Efficacy in Participants With Primary Biliary Cholangitis of Saroglitazar Magnesium-V on Clinical Outcomes (ClinicalTrials.gov ↗)
Primary Biliary Cholangitis
Phase 3 Recruiting Zydus Therapeutics Inc. USA
NCT07424677 Study of Saroglitazar Magnesium for PBC Patients With Incomplete Response or Intolerant to UDCA Therapy (ClinicalTrials.gov ↗)
Primary Biliary Cholangitis
Phase 3 Recruiting Zydus Therapeutics Inc. USA
NCT05045482 Hepatic Impairment With Cirrhosis Due to Cholestatic Liver Disease (ClinicalTrials.gov ↗)
Hepatic Impairment, Cirrhosis, Cholestatic Liver Disease
Phase 1 Recruiting Zydus Therapeutics Inc. USA
NCT06825559 Evaluate PK & Safety of Saroglitazar in Subjects With Moderate Hepatic Impairment Due to Cholestatic Liver Disease (ClinicalTrials.gov ↗)
Cholestatic Liver Disease
Phase 1 Recruiting Zydus Therapeutics Inc. USA
NCT06427395 Open-Label Extension Study of Saroglitazar Magnesium in Participants With Primary Biliary Cholangitis (ClinicalTrials.gov ↗)
Primary Biliary Cholangitis
Phase 3 Active, closed Zydus Therapeutics Inc. USA

Registers list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.

02

Conditions studied

4 conditions
Condition (as registered)Trials
Primary Biliary Cholangitis3
Cholestatic Liver Disease2
Hepatic Impairment1
Cirrhosis1
03

Sponsors

lead sponsor per trial
Lead sponsorTrials
Zydus Therapeutics Inc.5
04

Trials by country register

RegisterSaroglitazar Magnesium trials
Clinical trials in USA5

A trial with sites in more than one country appears in each of those registers.

How this page is built

Everything on this page is copied from public ClinicalTrials.gov registry records โ€” it is not written from memory, and nothing here describes how Saroglitazar Magnesium works or whether it is effective. Each trial links to its own record so you can check it yourself.

This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Saroglitazar Magnesium (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 24 Sep 2026.

Please verify before you rely on this. This page is general information for life-science and pharmaceutical professionals. It is not medical advice, and it has not been reviewed by a clinician โ€” our editorial team holds life-science qualifications, not clinical ones. It is not exhaustive and may not reflect the most recent label change. Always check the official prescribing information (US Prescribing Information or EU SmPC) and speak to your doctor or pharmacist before acting on anything here. Drugs in the same class are not automatically interchangeable, and approvals, brand names and indications differ between the US, the EU/Ireland (EMA/HPRA) and other regions. Spotted an error? Tell us โ€” we correct promptly and log it.