Drugs / Saroglitazar
Saroglitazar
also known as
Saroglitazar Magnesium
Small molecule targets PPARA, PPARG via activation
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed metabolic dysfunction-associated steatohepatitis 1 milestone | |||||
| Filed | Other | — | metabolic dysfunction-associated steatohepatitis | 2019-12-05 | “announced that it has filed the NDA of Saroglitazar Mg in Non-alcoholic Steatohepatitis (NASH) with the Drug Controller General of India (DCGI).” zyduslife.com ↗ |
| Filed primary biliary cholangitis 3 1 milestone | |||||
| Filed | US (FDA) | — | primary biliary cholangitis 3 | 2026-05-28 | “Zydus Therapeutics’ New Drug Application (NDA) for Saroglitazar to treat Primary Biliary Cholangitis (PBC) granted Priority Review by the US FDA” zyduslife.com ↗ |
Trials 20
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 16 trials | ||||||
| Phase 1 | NCT06825559 | Aug 2025 → Dec 2026 expected | cholestasis | Zydus Therapeutics Inc. | Recruiting | No outcome recorded |
| Phase 1 | NCT05045482 | Oct 2021 → Dec 2026 expected | 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 · 2 met primary · 1 missed | ||||||
| Phase 2 | NCT05211284 | Dec 2022 → Oct 2023 | NAFLD1 | Zydus Therapeutics Inc. | Terminated | No outcome recorded Stop: Business |
| 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 | Missed primary Stop: Business |
| Phase 2 | NCT03112681 | Aug 2017 → Aug 2020 | primary biliary cholangitis | Zydus Therapeutics Inc. | Completed | Met primary |
| Phase 2 | NCT03061721 | Apr 2017 → Aug 2019 | NAFLD1, metabolic dysfunction-associated steatohepatitis | Zydus Therapeutics Inc. | Completed | Met primary |
| Phase 2 | NCT03097107 | Apr 2017 → Dec 2023 | hyperlipidemia | Zydus Therapeutics Inc. | Suspended | No outcome recorded Stop: Enrollment |
| Phase 2/31 trial · 1 met primary | ||||||
| Phase 2/3 | NCT05133336 | Apr 2022 → Apr 2025 | primary biliary cholangitis | Zydus Therapeutics Inc. | Completed | Met primary |
| Phase 34 trials | ||||||
| Phase 3 | NCT07424677 | Aug 2026 → Jul 2028 expected | primary biliary cholangitis | Zydus Therapeutics Inc. | 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 |
| Comparator or background therapy1 trial | ||||||
| Phase 3 | NCT02265276 Comparator | Oct 2014 → Sep 2015 | fatty liver disease | Command Hospital, India | Unknown | No outcome recorded |
News releases announcing trial results or a regulatory action · 21
| Date | Issuer | Release |
|---|---|---|
| 2026-08-31 | Zydus Lifesciences Limited | Results Zydus Announces Positive Topline Results from Completed EVIDENCES-X Phase II(b) Clinical Trial of Saroglitazar Mg in MASH zyduslife.com ↗
The study successfully met its primary endpoint of resolution of steatohepatitis with no worsening of fibrosis at week 52 with the treatment difference of 26.5%. |
| 2026-05-28 | Zydus Lifesciences Limited | Regulatory Zydus Therapeutics New Drug Application (NDA) for Saroglitazar to treat Primary Biliary Cholangitis (PBC) granted Priority Review by the US FDA zyduslife.com ↗
US FDA granted Priority Review and assigned PDUFA target action date of November 27, 2026. |
| 2025-08-29 | Zydus Lifesciences Limited | Results Zydus Therapeutics Reports Positive Topline Results from EPICS-III Phase 2(b)/3 Trial of Saroglitazar Magnesium in Patients with Primary Biliary Cholangitis zyduslife.com ↗
Zydus Therapeutics, a wholly owned subsidiary of Zydus Lifesciences Ltd., a global innovation led healthcare company, today announced positive topline results from the pivotal EPICS-III Phase 2(b)/3 clinical trial. |
| 2021-12-10 | Zydus Lifesciences Limited | Regulatory Zydus announces EPICS-IIITM Phase 2(b)/3 adaptive pivotal clinical trial of Saroglitazar Mg in PBC zyduslife.com ↗
Zydus has initiated a global pivotal Phase 2(b)/3 clinical trial in patients with Primary Biliary Cholangitis (PBC) - EPICS-IIITM |
| 2021-07-21 | Zydus Lifesciences Limited | Regulatory European Medicines Agency grants Orphan Drug Designation to Saroglitazar Mg for the treatment of patients with Primary Biliary Cholangitis (PBC) zyduslife.com ↗
Zydus, a leading discovery -based, global pharmaceutical company, today announced that European Medicines Agency (EMA) has granted ‘Orphan Drug Designation’ (ODD) to Saroglitazar Mg for the treatment of patients with Primary Biliary Cholangitis (PBC). |
| 2021-01-28 | Zydus Lifesciences Limited | Regulatory Zydus granted Orphan Drug Designation by the USFDA for Saroglitazar in the treatment of patients with Primary Biliary Cholangitis (PBC) zyduslife.com ↗
Zydus, a leading discovery based, global pharmaceutical company today announced that United States Food and Drug Admi nistration (USFDA) has granted ‘Orphan Drug Designation’ (ODD) to Saroglitazar Mg for the treatment of patients with Primary Biliary Cholangitis (PBC). |
| 2020-12-30 | Zydus Lifesciences Limited | Regulatory Zydus announces the approval of Saroglitazar Mg for the treatment of Non-Alcoholic Fatty Liver Disease in India zyduslife.com ↗ |
| 2020-12-09 | Zydus Lifesciences Limited | Regulatory Zydus granted Fast Track Designation by the USFDA for Saroglitazar in the treatment of patients with Primary Biliary Cholangitis (PBC) zyduslife.com ↗
Zydus, a leading discovery based, global pharmaceutical company today announced that United States Food and Drug Administration (USFDA) has granted “Fast Track Designation” to Saroglitazar Mg for the treatment of patients with Primary Biliary Cholangitis (PBC). |
| 2020-03-05 | Zydus Lifesciences Limited | Regulatory Zydus announces worlds first drug for the treatment of Non-Cirrhotic NASH zyduslife.com ↗ |
| 2020-03-05 | Zydus Lifesciences Limited | Regulatory DCGI Approval zyduslife.com ↗
We hereby inform that the Company has received the approval from the Drug Controller General of India (DCGI) for its New Drug Application (NDA) for Saroglitazar for the treatment of Non-Cirrhotic Non-Alcoholic SteatoHepatitis (NASH) in India. |
| 2020-02-03 | Zydus Lifesciences Limited | Regulatory Zydus receives approval from DCGI for Saroglitazar Magnesium for treatment of Type II Diabetes zyduslife.com ↗
Zydus Cadila, an innovation-driven, global pharmaceutical company, announced that it has received the approval from the Drug Controller General of India for use of Saroglitazar Mg in the treatment of Type II Diabetes Mellitus as an add on therapy with Metformin. |
| 2019-12-05 | Zydus Lifesciences Limited | Regulatory Zydus announces NDA filing of Saroglitazar Magnesium with DCGI for treatment of NASH zyduslife.com ↗
Zydus Cadila, an innovation- driven, global pharmaceutical company, announced that it has filed the NDA of Saroglitazar Mg in Non-alcoholic Steatohepatitis (NASH) with the Drug Controller General of India (DCGI). |
| 2019-10-23 | Zydus Lifesciences Limited | Results EVIDENCES IV presentation at AASLD zyduslife.com ↗
Statistically significant 44.39 % reduction in ALT observed with Saroglitazar Magnesium treated patients |
| 2019-10-02 | Zydus Lifesciences Limited | Results EVIDENCES IV Saroglitazar NAFLD and NASH zyduslife.com ↗
Zydus Cadila, an innovation- driven, global pharmaceutical company, announced that Saroglitazar Magnesium has achieved the primary end -points in the EVIDENCES IV trial in patients with NAFLD and NASH. |
| 2019-08-02 | Zydus Lifesciences Limited | Results Zydus Announces Completion of Phase III trials of Saroglitazar Magnesium in Type 2 Diabetes Mellitus zyduslife.com ↗
The Phase 3 trial has demonstrated efficacy and achieved statistical significance for its primary endpoint which was the change in mean HbA1c as compared to the baseline. |
| 2018-02-08 | Zydus Lifesciences Limited | Regulatory Zydus Cadilas EBIDTA up by 108% in Q3 zyduslife.com ↗ |
| 2017-10-28 | Zydus Lifesciences Limited | Regulatory Zydus announces regulatory approval of Lipaglyn (Saroglitazar Magnesium) in Mexico zyduslife.com ↗ |
| 2017-02-23 | Zydus Lifesciences Limited | Regulatory Zydus receives approval from USFDA to initiate Phase II clinical studies of Saroglitazar Magnesium in patients with Primary Biliary Cholangitis (PBC) zyduslife.com ↗
Zydus Cadila , a research -driven, global healthcare provider, today announced that the USFDA has approved the group’s plans to initiate a Phase 2 clinical trial of Saroglitazar Magnesium (Mg) in patients with Primary Biliary Cholangitis (PBC) of the liver. |
| 2016-10-31 | Zydus Lifesciences Limited | Results Zydus To Present New Scientific Data Of Investigational Saroglitazar zyduslife.com ↗ |
| 2016-06-04 | Zydus Lifesciences Limited | Regulatory Zydus receives approval from the USFDA to initiate Phase 2 clinical trials of Saroglitazar in patients with Non-Alcoholic Steatohepatitis (NASH) of the liver in USA. zyduslife.com ↗
Zydus receives approval from USFDA to initiate Phase 2 clinical trials of Saroglitazar in patients with Non-Alcoholic Steatohepatitis (NASH) of the liver in USA. |
| 2015-02-06 | Zydus Lifesciences Limited | Results Zydus announces data presentations on Saroglitazar for treating NASH, a liver disease, at the 2015 Keystone Symposia Conference on Liver Metabolism and Nonalcoholic Fatty Liver Disease (NAFLD) in British Columbia, Canada zyduslife.com ↗
Further, the recently completed phase 2 studies of Saroglitazar in patients with biopsy proven nonalcoholic fatty liver disease, have shown improvement in both liver enzymes along with favorable effects on lipid and glycemic indices. |
All press releases naming this drug 31 releases
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 NCT07216235 ↗ |
| 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 ↗ |