Drugs / Saroglitazar
Saroglitazar
also known as
Saroglitazar Magnesium
Small molecule targets PPARA, PPARG via activation
Trials 20 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 16 trials | ||||||
| Phase 1 | NCT06825559 | Aug → Dec 2025 overdue | cholestasis | Zydus Therapeutics Inc. | Recruiting | No outcome recorded |
| Phase 1 | NCT05045482 | Oct 2021 → Mar 2026 overdue | cholestasis, cirrhosis of liver | Zydus Therapeutics Inc. | Recruiting | No outcome recorded |
| Phase 1 | NCT04446507 | Jul 2020 → May 2024 | impaired renal function disease | Zydus Therapeutics Inc. | Completed | No outcome recorded |
| Phase 1 | NCT04469920 | Jul 2020 → Mar 2022 | — | Zydus Therapeutics Inc. | Completed | No outcome recorded |
| Phase 1 | NCT04112446 | Sep → Oct 2019 | — | Zydus Therapeutics Inc. | Completed | No outcome recorded |
| Phase 1 | NCT04045769 | Aug → Nov 2019 | — | Zydus Therapeutics Inc. | Completed | No outcome recorded |
| Phase 28 trials | ||||||
| Phase 2 | NCT05211284 | Dec 2022 → Oct 2023 | NAFLD1 | Zydus Therapeutics Inc. | Terminated | No outcome recorded |
| Phase 2 | NCT05011305 | Aug 2021 → Sep 2025 | metabolic dysfunction-associated steatohepatitis | Zydus Therapeutics Inc. | Completed | No outcome recorded |
| Phase 2 | NCT03863574 | Jun 2019 → Mar 2020 | metabolic dysfunction-associated steatohepatitis | Zydus Therapeutics Inc. | Completed | No outcome recorded |
| Phase 2 | NCT03639623 | Feb 2019 → Dec 2021 | NAFLD1 | Zydus Therapeutics Inc. | Completed | No outcome recorded |
| Phase 2 | NCT03617263 | Feb 2019 → Oct 2024 | NAFLD1 | Zydus Therapeutics Inc. | Terminated | No outcome recorded |
| Phase 2 | NCT03112681 | Aug 2017 → Aug 2020 | primary biliary cholangitis | Zydus Therapeutics Inc. | Completed | No outcome recorded |
| Phase 2 | NCT03097107 | Apr 2017 → Dec 2023 | hyperlipidemia | Zydus Therapeutics Inc. | Suspended | No outcome recorded |
| Phase 2 | NCT03061721 | Apr 2017 → Aug 2019 | NAFLD1, metabolic dysfunction-associated steatohepatitis | Zydus Therapeutics Inc. | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT05133336 | Apr 2022 → Apr 2025 | primary biliary cholangitis | Zydus Therapeutics Inc. | Completed | No outcome recorded |
| Phase 34 trials | ||||||
| Phase 3 | NCT07424677 | Jun 2026 → Jul 2028 expected | primary biliary cholangitis | Zydus Therapeutics Inc. | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT07216235 | Feb 2026 → Nov 2032 expected | primary biliary cholangitis | Zydus Therapeutics Inc. | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT06427395 | Jul 2024 → Apr 2027 expected | primary biliary cholangitis | Zydus Therapeutics Inc. | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04193982 | Jan → Sep 2021 | NAFLD1 | Asian Institute of Gastroenterology, India | Unknown | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT05872269 | Jul 2023 → Jan 2025 | hyperlipidemia, metabolic dysfunction-associated steatotic liver disease, metabolic syndrome X, obesity disorder +1 | Zydus Lifesciences Limited | Unknown | No outcome recorded |
Also used as a comparator or background therapy in 1 trial
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 3 | NCT02265276 Comparator | Oct 2014 → Sep 2015 | fatty liver disease | Command Hospital, India | Unknown | No outcome recorded |
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 23 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Saroglitazar | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05872269 ↗ |
| Known as | Saroglitazar Magnesium | “Saroglitazar magnesium 1 mg once daily, orally each morning before breakfast” NCT07424677 ↗4“Saroglitazar magnesium 1 mg once daily, orally each morning before breakfast” NCT07216235 ↗ |
| Action | Activate | “Saroglitazar, a dual peroxisome proliferator activated receptor-α/γ agonist” PMID 33811367 ↗ Jul 20212“Peroxisome proliferator-activated receptor alpha agonist” CHEMBL4297530 ↗ “Peroxisome proliferator-activated receptor gamma agonist” CHEMBL4297530 ↗ |
| Modality | Small molecule | — CHEMBL4297530 ↗ |
| Route | Oral | “Tab Saroglitazar 4 mg oral daily for 24 weeks” NCT02265276 ↗ |
| Target | PPARA | “Peroxisome proliferator-activated receptor alpha agonist” CHEMBL4297530 ↗ |
| Target | PPARG | “Peroxisome proliferator-activated receptor gamma agonist” CHEMBL4297530 ↗ |