Saroglitazar Magnesium clinical trials
Saroglitazar Magnesium is named as an intervention in 5 current clinical trials in our USA and Turkey registers. 4 are recruiting patients now. The most common phase is Phase 3. The lead sponsor is Zydus Therapeutics Inc. The most-studied condition is Primary Biliary Cholangitis. The EU clinical trials register (CTIS) separately lists 2 authorised or ongoing trials, 1 with a site in Ireland.
Where Saroglitazar Magnesium is approved
All regulators →- 1 EU orphan designation, most recently for treatment of primary biliary cholangitis (19 Jul 2021, positive)
From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.
How Saroglitazar Magnesium works
All drug targets →- Peroxisome proliferator-activated receptor alpha agonist AgonistTarget: PPARA peroxisome proliferator activated receptor alpha✓ In ChEMBL and the Guide to Pharmacology
- Peroxisome proliferator-activated receptor gamma agonist AgonistTarget: PPARG peroxisome proliferator activated receptor gamma✓ In ChEMBL and the Guide to Pharmacology
- Metabolic dysfunction-associated steatohepatitisPhase 3
- Non-alcoholic fatty liverPhase 3
- Primary biliary cholangitisPhase 3
- FibrosisPhase 2
- HypertriglyceridemiaPhase 2
- Cholestatic liver diseasePhase 1
- Cirrhosis of liverPhase 1
- Liver disorderPhase 1
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL4297530, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 14341, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.
Patient leaflets for Saroglitazar Magnesium
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- UKUnited Kingdom: Search MHRA ProductsPatient information leaflets and SmPCs for UK-licensed products.
- USUnited States: Search DailyMedFDA-approved labels, including patient and medication guides.
Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.
Trials by status
Trials by phase
Clinical trials of Saroglitazar Magnesium
5 trialsRegisters 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.
Saroglitazar Magnesium in the EU trials register (CTIS)
2 trials · 1 in IrelandAuthorised or ongoing trials in the EU Clinical Trials Information System that list a product containing Saroglitazar Magnesium. Many trials are registered in both CTIS and ClinicalTrials.gov, so these are shown separately rather than added to the count above. Trials with a site in Ireland are listed first.
| Study | Phase | Status | Sponsor | Countries |
|---|---|---|---|---|
|
A Phase 3b/4, Multicenter, Parallel-Group, Double-Blind, Placebo-Controlled, Two-Arm, Long-Term Study to Evaluate the Safety and Efficacy of Saroglitazar Magnesium on Clinical Outcomes in Participants with Primary Biliary Cholangitis (PBC)
2025-524067-20-00 · Digestive System Diseases
|
Phase 3 | Authorised | Zydus Therapeutics Inc | Ireland + 11 more |
|
A Double-blind, Placebo-controlled, Randomized, Phase 3 Study to Evaluate the Efficacy and Safety of Saroglitazar Magnesium on Normalization of Alkaline Phosphatase Levels in Patients with Primary Biliary Cholangitis (PBC) and an Incomplete Response or Intolerance to Ursodeoxycholic Acid (UDCA)
2026-526680-38-00 · CTIS ↗ · Digestive System Diseases
|
Phase 3 | Authorised | Zydus Therapeutics Inc | Greece, Italy, Czechia |
Conditions studied with Saroglitazar Magnesium
4 conditionsSponsors
lead sponsor per trial| Lead sponsor | Trials |
|---|---|
| Zydus Therapeutics Inc | 5 |
By country register
| Register | Trials | Recruiting |
|---|---|---|
| Clinical trials in USA | 5 | 4 |
| Clinical trials in Turkey | 1 | 0 |
| EU register (CTIS) | 2 | — |
A trial with sites in more than one country appears in each of those registers. CTIS does not publish a recruiting flag; its trials may also appear in the registers above.
Related compounds
Questions about Saroglitazar Magnesium trials
How many clinical trials are testing Saroglitazar Magnesium?
5 current trials in our USA and Turkey registers name Saroglitazar Magnesium as a drug or biological intervention, as of the registry sync on 10 November 2026. Completed and withdrawn studies are not counted.
Are Saroglitazar Magnesium trials recruiting patients?
Yes. 4 of the 5 trials are recruiting: 4 with sites in USA. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Who sponsors Saroglitazar Magnesium clinical trials?
The lead sponsor is Zydus Therapeutics Inc. The number in brackets is how many trials each organisation leads.
Are there Saroglitazar Magnesium clinical trials in Ireland?
Yes. 1 trial in the EU register (CTIS) list a site in Ireland. Some may be the same study registered in both. See the Irish clinical trials register for sites and contacts.
Where does this information come from?
Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Saroglitazar Magnesium works or whether it is effective, and it is not medical advice.
How this page is built
Everything on this page is copied from public ClinicalTrials.gov registry records — 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.
- ClinicalTrials.gov (U.S. National Library of Medicine) ↗ Trial IDs, titles, intervention names and synonyms, phase, overall status, lead sponsor and conditions for every trial on this page
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 10 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.